chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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, and concomitant medication. On or about 03-APR-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 30-MAR-2017, the patient was treated 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, pain and suffering, and other damages. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Diplopia, Eye pain, Ocular discomfort
Clinical narrative: Unknown exactly which Influenza vaccine was administered at the pharmacy. Patient reports that within 2-3 hours of vaccine administration that his eyes were throbbing and there was pressure around his eyes, he reports an onset of double vision that worsened upon standing and ambulating. Patient reports symptoms persisted  in the morning with double vision only, throbbing and pressure had improved, but double vision is significant.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted in lobby 1 minute or so after receiving vaccines, she responded quickly. Laid in exam room for 10 minutes. Was feeling better and left clinic with no complaints.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Urticaria
Clinical narrative: Patient received Hep A vaccine around 0900. At 1400 she was presented to me by her squad leader and I noticed several hives only affecting the arms of the PT. I instructed her to take 50mg of BENADRYL every 8 hours and to immediately report to the nearest ER if she noticed any difficulty in breathing otherwise report back to me in the morning. She reported back around 0900 with no improvement. I told her to continue BENADRYL and to report to the ER if her symptoms worsened. At approximately 1400 on 11 Feb I was informed that she was taken to the local ER as the hives were becoming increasingly painful. I called the patient at 1000 on 13 Feb and she reports that she is doing fine now and was given a steroid shot in the ER and was also told to continue BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Skin irritation
Clinical narrative: Left arm swollen, red irritated.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: I got the flu shot on Feb. 1st 2018 at a pharmacy. It hurt at first and then began to swell and get very hot and red. Quite sore for two weeks and more. I went to Dr. (size of baseball). Dear sirs, My arm still hurts and is sore red spot where needle went in. This size very itchy. I am to see my doctor again tomorrow, Tuesday, Feb. 13, 2018. It bleeds when I scratch it. It is very itchy and sore. Most swelling gone down.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: I got the flu shot on Feb. 1st 2018 at a pharmacy. It hurt at first and then began to swell and get very hot and red. Quite sore for two weeks and more. I went to Dr. (size of baseball). Dear sirs, My arm still hurts and is sore red spot where needle went in. This size very itchy. I am to see my doctor again tomorrow, Tuesday, Feb. 13, 2018. It bleeds when I scratch it. It is very itchy and sore. Most swelling gone down.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash macular, Rhinorrhoea
Clinical narrative: Red, blotchy rash everywhere, runny nose, fever.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache, Tinnitus
Clinical narrative: Reported having a headache and tinnitus the next day. The headache resolved in a day, but the tinnitus continued.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Back pain, Blood albumin decreased, Blood creatine phosphokinase decreased
Clinical narrative: **Lot number is extrapolated as it was not recorded on pt's record. Pt received vaccine on on June 13th, pt whose lot number is listed received it on June 27th. History is from patient phone call Jan 31st 2018 and hospital record. Pt recieved PREVNAR and one week later developed flu like symptoms., Treated with azithromycin and resolved. States joint pain and weakness started 2 weeks after injection, included bilat shoulders, with prominent weakness. Unable to hold a cup of coffee with one hand due to pain and weakness. Unable to elevate arms. Arthralgias hips, knees low back, described as 'excrutiating'. Required help of a neighbor for IADLS. Admitted to Medical Center on November 24th, 2017. Troponin negative, hgb 10.1, absolute neutrophils 7.5, albumin 3.3, magnesium 1/3, CK 30. CRP <0.02, sed rate 42. EKG normal. Dramatically responsive to prednisone 10mg. Continues on prednisone 20mg as of this report.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Blood magnesium normal, C-reactive protein normal, Electrocardiogram normal, Haemoglobin decreased, Influenza like illness
Clinical narrative: **Lot number is extrapolated as it was not recorded on pt's record. Pt received vaccine on on June 13th, pt whose lot number is listed received it on June 27th. History is from patient phone call Jan 31st 2018 and hospital record. Pt recieved PREVNAR and one week later developed flu like symptoms., Treated with azithromycin and resolved. States joint pain and weakness started 2 weeks after injection, included bilat shoulders, with prominent weakness. Unable to hold a cup of coffee with one hand due to pain and weakness. Unable to elevate arms. Arthralgias hips, knees low back, described as 'excrutiating'. Required help of a neighbor for IADLS. Admitted to Medical Center on November 24th, 2017. Troponin negative, hgb 10.1, absolute neutrophils 7.5, albumin 3.3, magnesium 1/3, CK 30. CRP <0.02, sed rate 42. EKG normal. Dramatically responsive to prednisone 10mg. Continues on prednisone 20mg as of this report.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Neutrophil count normal, Pain
Clinical narrative: **Lot number is extrapolated as it was not recorded on pt's record. Pt received vaccine on on June 13th, pt whose lot number is listed received it on June 27th. History is from patient phone call Jan 31st 2018 and hospital record. Pt recieved PREVNAR and one week later developed flu like symptoms., Treated with azithromycin and resolved. States joint pain and weakness started 2 weeks after injection, included bilat shoulders, with prominent weakness. Unable to hold a cup of coffee with one hand due to pain and weakness. Unable to elevate arms. Arthralgias hips, knees low back, described as 'excrutiating'. Required help of a neighbor for IADLS. Admitted to Medical Center on November 24th, 2017. Troponin negative, hgb 10.1, absolute neutrophils 7.5, albumin 3.3, magnesium 1/3, CK 30. CRP <0.02, sed rate 42. EKG normal. Dramatically responsive to prednisone 10mg. Continues on prednisone 20mg as of this report.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Red blood cell sedimentation rate increased, Troponin normal
Clinical narrative: **Lot number is extrapolated as it was not recorded on pt's record. Pt received vaccine on on June 13th, pt whose lot number is listed received it on June 27th. History is from patient phone call Jan 31st 2018 and hospital record. Pt recieved PREVNAR and one week later developed flu like symptoms., Treated with azithromycin and resolved. States joint pain and weakness started 2 weeks after injection, included bilat shoulders, with prominent weakness. Unable to hold a cup of coffee with one hand due to pain and weakness. Unable to elevate arms. Arthralgias hips, knees low back, described as 'excrutiating'. Required help of a neighbor for IADLS. Admitted to Medical Center on November 24th, 2017. Troponin negative, hgb 10.1, absolute neutrophils 7.5, albumin 3.3, magnesium 1/3, CK 30. CRP <0.02, sed rate 42. EKG normal. Dramatically responsive to prednisone 10mg. Continues on prednisone 20mg as of this report.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Eye swelling, Musculoskeletal disorder
Clinical narrative: Client states that upon waking on 2/12/2018 left eye swollen and she is unable to use left hand. Referred to PMD and will follow-up with client on 02/14/2018.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Swelling around shot site, severe pain in shoulder, trouble moving arm, muscle aches.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Paraesthesia
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a currently 66 years old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history and concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, frequency, route administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient's body felt inflamed diffuse pins and needles sensation an unspecified amount of time after receiving the vaccine. The outcome of inflammation and paraesthesia was unknown. At the time of this report, the causality between the aforementioned events and ZOSTAVAX was not reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 59 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 07-FEB-2018, the patient was vaccinated with expired dose of ZOSTAVAX, lot # N009167, expiration date: 02-FEB-2018, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Loss of consciousness, Seizure
Clinical narrative: This spontaneous report was received from an unspecified reporter, via a company representative, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient experienced headache, passed out (syncope) and had a seizure. It was unknown by the reporter whether the patient received treatment, sought medical attention or if any laboratory tests were carried out. The outcome of seizure, syncope and headache was reported as recovered,on an unknown date. The reporter did not assess the relatedness of GARDASIL with the adverse events. Upon internal review, seizure was determined to be a medically significant event.
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 received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 13-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, 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 31-MAR-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 was prescribed acyclovir for management of his persistent and 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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, and concomitant medication. On or about 10-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health department 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 18-APR-2017, the patient was treated by a physician for the onset of a 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, 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: 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 01-JAN-2008, the patient was inoculated with ZOSTAVAX at an Internal Medicine office 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. In or about February 2016, the patient was treated at the same Internal Medicine office for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. 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.
Sex: M
Vaccine: VARZOS
Symptoms: 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. On an unspecified date, the patient was inoculated with ZOSTAVAX at a clinic 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 an unspecified date, the patient was treated at the same clinic for the onset of a 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy 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 28-JAN-2016, the patient was treated by a physician for the onset of a 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. The outcomes of the events were unknown at the time of reporting.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
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 10-SEP-2011, the patient was inoculated with ZOSTAVAX at a clinic 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 31-MAR-2016, the patient was treated at the same clinic for the onset of rash which was diagnosed as herpes zoster, or shingles, and related sequelae. 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.
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist reported that a 70 year-old female patient of unspecified ethnicity received on 01Feb2018 a single dose of PREVNAR 13 (lot 574424, expiration date Dec2019, NDC number 00005197102) to prevent pneumonia and FLUAD (lot 178903, expiration date May2018, NDC # 70461000201) for immunization. Medical history and concomitant medications were not reported. In Feb2018, the patient presented some side effects or local reactions like piercing pain and swelling on the injection site. Outcome was unknown.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Soreness radiating to clavicle and down towards elbow, now cellulitis-like redness above elbow (size about 2-3 inch diameter). Patient received vaccination on Saturday evening. Patient said symptoms started next day on Sunday. Patient came in to report on Monday evening. Patient said that since the start of the symptoms, the redness has reduced and also travelled downwards towards the elbow. Patient facetimed with relative who is a medical doctor (?) and relative said that it looks like cellulitis. Upon asking patient further, patient said she is taking amoxicillin to treat it.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Limb discomfort, Mobility decreased
Clinical narrative: PATIENT REPORTED NORMAL ARM DISCOMFORT IMMEDIATELY AFTER INJECTION THEN 2 WEEKS LATER SHE SAID SHE WAS HAVING AN MRI AND WHEN ASKED TO LIFT HER ARMS ABOVER HER HEAD THAT SHE HAD A DIFFICULT TIME DOING SO AND THAT IT CAUSED SOME DISCOMFORT. SHE WANTED TO WAIT A LITTLE LONGER TO SEE IF IT WOULD RESOLVE, BUT AS OF 2/13/18 THE DISCOMFORT IS STILL NOTICABLE SOMETIMES AND SHE THOUGHT SHE BETTER LET US KNOW.
Age: 1.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Medication Error, Pt was given Kinrix out of licensed age range. No negative symptoms presented post injection.
Age: 83.0
Sex: U
Vaccine: PPV
Symptoms: Injection site infection, Pain in extremity, Peripheral swelling
Clinical narrative: Later that day on Feb 5  after injecting it just start to sore the arm and swell up. And finally, she went to the Dr's office on  Feb 7 in the morning and was prescribed Doxycycline 100 mg BID for 10 days. Per pt Dr. is prescribing her antibitiocs because it got infected on the site of injection. But, as of yesterday 2/12/2018 she was cleared of infection on the site of injection. I doubt it that it got infected because the needle were sterile and I wipe the site of injection with alcohol before injecting.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Autism spectrum disorder, Cognitive disorder, Coordination abnormal, Developmental regression, Executive dysfunction
Clinical narrative: Major developmental regressions in speech, executive functioning, coordination, sensory issues, cognition-developed autism. Also developed s/s of another illness/cold < 1 week after vaccination.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Nasopharyngitis, Sensory disturbance, Speech disorder developmental
Clinical narrative: Major developmental regressions in speech, executive functioning, coordination, sensory issues, cognition-developed autism. Also developed s/s of another illness/cold < 1 week after vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia
Clinical narrative: Lost ability to say/speak words and sounds he had previously been able to say over the course of 3 months. Began speech therapy.
Age: 1.75
Sex: M
Vaccine: FLU4
Symptoms: Developmental regression, Motor developmental delay, Speech disorder developmental
Clinical narrative: Regression in fine and gross motor skills. Further regression in speech. Regression in social skills and communication.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Anxiety, Autism spectrum disorder, Cognitive disorder, Developmental regression, Intentional self-injury
Clinical narrative: Serious developmental regression in speech, motor skills, cognitive ability, increased sensory issues, anxiety, self injury-developed autism. Also developed another cold/sickness within 7 days.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test, Malaise, Nasopharyngitis, Psychomotor skills impaired, Sensory disturbance
Clinical narrative: Serious developmental regression in speech, motor skills, cognitive ability, increased sensory issues, anxiety, self injury-developed autism. Also developed another cold/sickness within 7 days.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Sleep study, Speech disorder developmental
Clinical narrative: Serious developmental regression in speech, motor skills, cognitive ability, increased sensory issues, anxiety, self injury-developed autism. Also developed another cold/sickness within 7 days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen arm around Injection.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal distension, Abdominal pain, Angina pectoris, Asthenia, Chest pain
Clinical narrative: Severe abdominal pain, bloating, intestinal inflammation, aches, body, liver, right side, kidneys, chest/heart pain. Fever, slight nausea. Weakness, fatigue, chest pain. Headaches, continued 5 days plus (arm pain).
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Gastrointestinal inflammation, Headache, Hepatic pain, Nausea
Clinical narrative: Severe abdominal pain, bloating, intestinal inflammation, aches, body, liver, right side, kidneys, chest/heart pain. Fever, slight nausea. Weakness, fatigue, chest pain. Headaches, continued 5 days plus (arm pain).
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Pyrexia, Renal pain
Clinical narrative: Severe abdominal pain, bloating, intestinal inflammation, aches, body, liver, right side, kidneys, chest/heart pain. Fever, slight nausea. Weakness, fatigue, chest pain. Headaches, continued 5 days plus (arm pain).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Electroencephalogram, Excessive eye blinking, Eye movement disorder, Hypersomnia, Lethargy
Clinical narrative: Eye rolling, absence seizures, eye fluttering, stop in play 3.5 seconds during seizure. Seizures occurred in clusters lasting about 90 seconds each occurrence. Began 3 days post vaccination and even rash 3/18/18 stopped occurring 7 days post vaccination. No fever during this time period (not febrile seizure). Excessive sleeping and lethargy for 2 days. Was referred to neurology.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Petit mal epilepsy
Clinical narrative: Eye rolling, absence seizures, eye fluttering, stop in play 3.5 seconds during seizure. Seizures occurred in clusters lasting about 90 seconds each occurrence. Began 3 days post vaccination and even rash 3/18/18 stopped occurring 7 days post vaccination. No fever during this time period (not febrile seizure). Excessive sleeping and lethargy for 2 days. Was referred to neurology.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Patient reports the area very painful, prednisone was Rx thru community Pharmacy, Area resolved in a few days.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Vaccine given as IM in left deltoid on 2/12/18. This is the 3rd in the rabies series. Client reports redness, warmth, and hard area where vaccine was given. No fever, no nausea, no vomiting. No streaking or exudate at injection site.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient called on 2/13/2018 complaining of pain, swelling, warm to the touch, redness in right arm. She started noticing the symptoms on 2/12/2018 around 8 pm or after. Patient was advised to put a cool cloth or ice bag on arm, take ibuprofen, and monitor. Patient was told to go to urgent care or er if symptoms got worse.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Limb discomfort
Clinical narrative: PATIENT COMPLAINED OF BRUISING, DISCOMFORT IN RIGHT ARM ONLY.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unspecified date in January 2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M041085, expiration date 03-JAN-2018, 0.65 mL once (strength was not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot # M035268 expiration date 19-APR-2019. The reporter denied any adverse effect reported by the patient.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, also reported as "on unspecified same day", the patient was inadvertently vaccinated with both properly stored VARIVAX (dose, route of administration, lot# and expiration date were not reported) and PROQUAD (dose, route of administration, dose, lot# and expiration date were not reported), both reconstituted with properly stored sterile diluent (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
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 received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-NOV-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 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 01-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed lidocaine and gabapentin 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: 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 15-JUN-2016, 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-JUL-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 with complications. The patient was prescribed gabapentin and diclofenac sodium (VOLTAREN) 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, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-MAR-2013, 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 04-FEB-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed gabapentin for management of his symptoms and pain. 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, 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 27-JUN-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 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 06-MAR-2017, 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 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.
Sex: F
Vaccine: VARZOS
Symptoms: 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 27-OCT-2014, 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 13-JUL-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed 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, 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 received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-AUG-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 13-MAR-2016, the patient was treated at an urgent care center 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 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, 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 09-FEB-2018 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 11-JUL-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 15-SEP-2015, 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. The patient has been prescribed Lidocaine, Tramadol and 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
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 an unknown date, 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 28-JUN-2016, the patient was treated by a physician for the onset of a rash, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neurological symptom, Pain, Post herpetic neuralgia, 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 18-OCT-2012, the patient was vaccinated at a hospital 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 21-AUG-2017, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with nervous system complication. On or about 12-SEP-2017, the patient sought subsequent for ongoing and worsening residual symptoms of shingles, which was diagnosed as post-herpetic neuralgia nervous system involvement, a chronic condition of nerve damage, pain, and neurological symptoms secondary to herpes zoster infections. The patient has been prescribed VALTREX, hydrocodone-acetaminophen, and prednisone for management of her symptoms and pain. As a direct and proximate result of these malfunctions, she 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: PPV
Symptoms: Erythema, Hallucination, visual, Vitreous floaters
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old male patient. The patient's concurrent conditions included erythromycin allergy and possibly clindamycin allergy. The patient's concomitant medications included an unspecified blood pressure medicine and an unspecified cholesterol medicine. On 09-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N025656 with expiration date 19-APR-2019, intramuscularly, for prophylaxis (dose was not provided). It was stated that after receiving PNEUMOVAX 23, the patient noticed floater in his eye which went away later on the same date. On 11-FEB-2018, the patient experienced "red streak on arm but not where shot was". The patient recovered from the event on an unspecified date in February 2018. On an unspecified date in February 2018, the patient "was seeing water dripping from ceiling of truck which was not actually there". No treatment was given for the events. At the time of reporting, the outcome of hallucination, visual was reported as not recovered. The causality assessment between the events with PNEUMOVAX 23 was not provided.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Dizziness, Hot flush, Nausea
Clinical narrative: Nausea, vomiting, severe stomach cramps, fever, chills, hot flashes, dizziness.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, severe stomach cramps, fever, chills, hot flashes, dizziness.
Age: 70.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Axillary mass, Tenderness
Clinical narrative: A lump in the left axillary region and tender sensation along neck on the left side.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness, warmth, and tenderness at injection site (Left arm); Benadryl 25mg PO Q6 Hours x 24 hours prescribed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Asthma, Chest X-ray abnormal, Cough, Decreased appetite, Dyspnoea
Clinical narrative: Mother called physician office on Feb 9, 2018 stating she took child to ER on Feb 8, 2018 due to fever, limping, lethargy, and decreased appetite.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Gait disturbance, Influenza virus test negative, Lethargy, Mouth ulceration, Pyrexia
Clinical narrative: Mother called physician office on Feb 9, 2018 stating she took child to ER on Feb 8, 2018 due to fever, limping, lethargy, and decreased appetite.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rhinorrhoea
Clinical narrative: Mother called physician office on Feb 9, 2018 stating she took child to ER on Feb 8, 2018 due to fever, limping, lethargy, and decreased appetite.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Muscle itch with extreme. (L) arm pain.
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Hyperacusis
Clinical narrative: Developed mild sensory issues (fear of loud noises) and some mild anxiety within 10 days of vaccine. Report to doctor in April 2016. Referred to O.T.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II (Lot # reported as L41456 with an expiration date in 22-OCT-2017), for prophylaxis (strength, route, dose and frequency were not provided). Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects reported and no product quality complaint (PQC) was involved. Lot number L41456 is an invalid lot number for M-M-R II.
Sex: F
Vaccine: VARZOS
Symptoms: 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 female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 28-AUG-2012, the patient was inoculated with ZOSTAVAX by a physician 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 07-JAN-2016, the patient was treated by the same physician for the onset of a 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-JAN-2015, the patient was inoculated with ZOSTAVAX at a clinic 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 01-MAR-2016, the patient was treated by a Nurse Practitioner for the onset of a 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.