chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer contacting patients for re-vaccination.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Anaphylactic shock, Decreased appetite, Decreased immune responsiveness, Fatigue
Clinical narrative: Left physical and came home. Next morning, had a usual morning. Went to a doctor's appointment and started to be nauseous; started to feel better. Went to 2nd appointment and still felt bad, sat down until felt better. Drove home and called doctor so doctor called ambulance; based on the symptoms pt was going into anaphylactic shock. Taken to hospital where was admitted, and stayed there. Sent home with meds: Ondansetron, Ketorolac, Albuterol inhaler. Confirmed you had an anaphylactic reaction but they did not specify whether it was related to the vaccine. Immune system was down, so 2 days after developed a cold with chest congestion; took over the counter AIRBORNE. Last week still feeling wiped out, lethargic, appetitive still not back completely, still nursing the effects of what happened. Has a doctor appointment on 12/23 as well as lab work. Has received Flu shot with no problem for the last 10 years. Dad has allergic to eggs so has not received a Flu vaccine.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Lethargy, Nasopharyngitis, Nausea, Respiratory tract congestion
Clinical narrative: Left physical and came home. Next morning, had a usual morning. Went to a doctor's appointment and started to be nauseous; started to feel better. Went to 2nd appointment and still felt bad, sat down until felt better. Drove home and called doctor so doctor called ambulance; based on the symptoms pt was going into anaphylactic shock. Taken to hospital where was admitted, and stayed there. Sent home with meds: Ondansetron, Ketorolac, Albuterol inhaler. Confirmed you had an anaphylactic reaction but they did not specify whether it was related to the vaccine. Immune system was down, so 2 days after developed a cold with chest congestion; took over the counter AIRBORNE. Last week still feeling wiped out, lethargic, appetitive still not back completely, still nursing the effects of what happened. Has a doctor appointment on 12/23 as well as lab work. Has received Flu shot with no problem for the last 10 years. Dad has allergic to eggs so has not received a Flu vaccine.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4, MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # N003536, expiration date 02-NOV-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 19-JUL-2017 till 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 34 degrees Fahrenheit (F) to 50 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012766:
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 6-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # N000235, expiration date 26-OCT-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 21-JUN-2017 till 01-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 49 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. ; Sender's Comments:  US-009507513-1709USA012766:
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 6-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # N000235, expiration date 26-OCT-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 21-JUN-2017 till 01-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 49 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 9-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # N000235, expiration date 26-OCT-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 21-JUN-2017 till 01-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 49 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 14-SEP-2016, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) for prophylaxis (route of administration, lot number and expiration date were not reported). On 31-OCT-2017, the patient received another separate dose of ZOSTAVAX 19400 plaque-forming unit (PFU) lot # N020938 with expiration date of 31-JUL-2018, for prophylaxis (route of administration was not reported). Vaccines were reconstituted with sterile diluent (MERCK). No adverse events were reported.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 15-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N014945, expiration date 31-AUG-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Respiratory disorder
Clinical narrative: Information has been received from a pharmacy intern concerning a female patient of unknown age. The patient lived with a smoker for 30 years. The patient's medical history included reaction/allergy to soy products, feathers, latex, TYLENOL, morphine, codeine and sulfa drugs. Pharmacy intern reported that on an unspecified date, the patient received 1 dose of ZOSTAVAX (indication, strength, dose, route, injection site, lot number and expiration date, were not provided). Other suspect therapies included sterile diluent. Concomitant therapies included tramadol. On an unspecified date after receiving ZOSTAVAX, the patient received "a flu shot" (manufacturer unspecified). On an unspecified date, the patient developed "respiratory problems" and "a cough". On an unspecified date the patient then went to the doctor and was prescribed a prednisone taper as a treatment for the events. No lab diagnostic tests were performed. The outcome of cough and respiratory disorder was reported as not recovered/not resolved. The causal relationship between the events and therapy with ZOSTAVAX was not reported. Respiratory disorder and cough were considered to be potentially life threatening and potentially disabling, by the reporter.
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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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. On or about 27-APR-2015, the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir and lidocaine for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Ophthalmic herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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. On or about 03-OCT-2015 through 15-OCT-2015, the patient was admitted to the hospital for the inpatient treatment of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, zoster ocular disease, and zoster conjunctivitis (conditions of zoster infections with interference into the eyes). The patient was prescribed intravenous acyclovir and NEURONTIN for management of her painful symptoms. The patient sought subsequent treatment for neuropathic pain and is monitored by ophthalmologists for her eye disorders attributable to the vaccine. 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 was unknown. Causality assessment was related. Upon internal review, zoster ocular disease was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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. On or about 03-OCT-2015 through 15-OCT-2015, the patient was admitted to the hospital for the inpatient treatment of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, zoster ocular disease, and zoster conjunctivitis (conditions of zoster infections with interference into the eyes). The patient was prescribed intravenous acyclovir and NEURONTIN for management of her painful symptoms. The patient sought subsequent treatment for neuropathic pain and is monitored by ophthalmologists for her eye disorders attributable to the vaccine. 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 was unknown. Causality assessment was related. Upon internal review, zoster ocular disease was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-APR-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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. On or about 09-MAY-2016 the patient was treated at Internal Medicine for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir and prednisone 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-JUL-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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. On or about ,17-FEB-2015 the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 18-FEB-2015, the patient treated again at the health center for new and ongoing outbreaks of shingles infections. The patient was prescribed acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-OCT-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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. On or about 02-SEP-2014, the patient was treated by a physician's assistant for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acetaminophen with codeine for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Laboratory test, Neoplasm malignant, Pneumonia, X-ray abnormal
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration, on an unspecified date 4 years before this report, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced stage 1 cancer and pneumonia all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included x-ray: stage 1 cancer (unknown date). Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient's medical history and concomitant medications were not reported. The patient hurt for 2 days on an unspecified date. The outcome of hurt for 2 days was unknown. No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Cough, Erythema, Laboratory test normal, Oedema peripheral
Clinical narrative: Initial unsolicited case received from a consumer (patient husband) on 08 Nov 2017. This case involves 78-year-old female patient who was vaccinated with one dose of FLUZONE HD (Batch number, expiry date, dose in series and site of administration were not reported) intramuscularly on 26 Oct 2017. Patient medical history includes cough, and Non-Hodgkin's Lymphoma due to which she had finished chemo 3 weeks prior. Concomitant medications were not reported. Patient was not taking any other vaccines. On 28 Oct 2017, two days after the vaccination, patient developed edema and erythema in bilateral lower and upper extremities, patient existing cough became worse, and had generalized pain. On 04 Nov 2017, few days later patient was taken to the hospital and all diagnostic tests were negative, and she was diagnosed with mild UTI (Urinary tract infection), for which the patient was given antibiotic. Other lab tests and other corrective treatment were not reported. Outcome of all the events were reported as unknown. Upon internal review the company decided to consider the case as serious, due to important medical event: Urinary tract infection. List of documents held by sender: none.; Sender's Comments: In this case patient experienced urinary tract infection post vaccination with FLUZONE HD. Though time to onset for the event is compatible with the vaccine; further information on patient's medical history, as well as etiological infectious work-up confirming the diagnosis will be required for complete assessment. Based on the information available, the role of the vaccine cannot be assessed.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Urinary tract infection
Clinical narrative: Initial unsolicited case received from a consumer (patient husband) on 08 Nov 2017. This case involves 78-year-old female patient who was vaccinated with one dose of FLUZONE HD (Batch number, expiry date, dose in series and site of administration were not reported) intramuscularly on 26 Oct 2017. Patient medical history includes cough, and Non-Hodgkin's Lymphoma due to which she had finished chemo 3 weeks prior. Concomitant medications were not reported. Patient was not taking any other vaccines. On 28 Oct 2017, two days after the vaccination, patient developed edema and erythema in bilateral lower and upper extremities, patient existing cough became worse, and had generalized pain. On 04 Nov 2017, few days later patient was taken to the hospital and all diagnostic tests were negative, and she was diagnosed with mild UTI (Urinary tract infection), for which the patient was given antibiotic. Other lab tests and other corrective treatment were not reported. Outcome of all the events were reported as unknown. Upon internal review the company decided to consider the case as serious, due to important medical event: Urinary tract infection. List of documents held by sender: none.; Sender's Comments: In this case patient experienced urinary tract infection post vaccination with FLUZONE HD. Though time to onset for the event is compatible with the vaccine; further information on patient's medical history, as well as etiological infectious work-up confirming the diagnosis will be required for complete assessment. Based on the information available, the role of the vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Lethargy, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Fever, full body measle like rash, lethargic, cranky. Starting at day 7 and worsening on day 10. Was told to watch and make sure she doesn't have a high fever or stiffening of joints.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Rash macular
Clinical narrative: Pt had developed a blotchy, red rash, no hives, no itching. Pt did not take any medications. Rash has improved within the last 24 hours.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Called Nov. 14, 2017 complaining of continued pain in left upper arm. Did see her medical provider who suggested the injection may have been give to high on the arm.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Choking, Cough, Dysphagia, Fatigue
Clinical narrative: MAJOR ADVERSE EVENT: After 1 week, patient had trouble swallowing, choking, cough with soreness, muscle pain and fatigue. Symptoms are still ongoing. The patient went to doctor and had chest x-ray and pulmonary function tests. He was diagnosed with ILD (interstitial lung disease) with polymyositis symptoms. He is currently on prednisone for his condition and will be going to the Clinic on approximately 12/5/17.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Interstitial lung disease, Myalgia, Polymyositis, Pulmonary function test
Clinical narrative: MAJOR ADVERSE EVENT: After 1 week, patient had trouble swallowing, choking, cough with soreness, muscle pain and fatigue. Symptoms are still ongoing. The patient went to doctor and had chest x-ray and pulmonary function tests. He was diagnosed with ILD (interstitial lung disease) with polymyositis symptoms. He is currently on prednisone for his condition and will be going to the Clinic on approximately 12/5/17.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Peripheral swelling, Skin warm
Clinical narrative: Red, hot swollen on left arm but not at injection site. Also flu like symptoms.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient had pain and bruising for a couple of weeks.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 61.0
Sex: F
Vaccine: YF
Symptoms: Cognitive disorder, Headache, Hemiparesis, Laboratory test, Nausea
Clinical narrative: 10/17/2017 - Called c/o  H/A photophobia since vaccine. Fever x 1 day with bodyaches. 11/21/17 called to report she was seen by Dr. for continued issues including cognitive problems x 1 month. Weakness to right side of body (slowly improving) had N/V. 4 days after vaccine all symptoms started.
Age: 61.0
Sex: F
Vaccine: YF
Symptoms: Nuclear magnetic resonance imaging, Pain, Photophobia, Pyrexia, Vomiting
Clinical narrative: 10/17/2017 - Called c/o  H/A photophobia since vaccine. Fever x 1 day with bodyaches. 11/21/17 called to report she was seen by Dr. for continued issues including cognitive problems x 1 month. Weakness to right side of body (slowly improving) had N/V. 4 days after vaccine all symptoms started.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test negative, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Thigh and knee swelling, redness, itching.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Electrocardiogram, Human chorionic gonadotropin, Syncope, Urine analysis
Clinical narrative: Syncope.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Echocardiogram, Electroencephalogram
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Epilepsy, Epstein-Barr virus test, Fatigue, Feeling abnormal, General physical health deterioration
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Headache, Hypoaesthesia, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Malaise, Memory impairment, Migraine, Mononucleosis heterophile test
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Nuclear magnetic resonance imaging brain, Pain, Pallor, Petit mal epilepsy
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Tremor
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient began to have headaches. We did not get the 2nd and 3rd in the series due to her feeling poorly. She reported general malaise, fatigue and significant headaches. Over the course of the next year her health has continued to deteriorate. She was a previously active high school student and athlete. She was healthy without any health issues. She has developed chronic migraines, ongoing nausea, diminished appetite, intermittent shortness of breath, intermittent lymphadenopathy, pale appearance, chronic fatigue, generalized body aches, hand tremors, numbness in both hands and her left leg, memory deficits, ongoing dizziness and seizures. She had her first grand mal seizure on 7/13/17 and her second on 8/15/17. She is now diagnosed with epilepsy with no known cause. She continues to suffer from chronic fatigue and debilitating migraine headaches. She has had to stop all extracurricular activities and quit her job. She continues to have intermittent absence seizures and significant memory deficits as well.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Differential white blood cell count normal, Electrocardiogram normal, Feeling abnormal, Full blood count normal
Clinical narrative: After receiving Flu Vaccine at 8am, employee walked back to the Flu clinic at ~9:20am and stated he didn't feel right after getting the Flu shot 1.5 hours prior. Reported nausea & chills. He was transferred immediately to the ED via wheelchair. ED MD reports employee had myoclonic jerks without focality, was pale with 2+diaphoresis. By 9:29am Tx: Normal Saline IV, Diphenhydramine 50mg IV push, Lorazepam 0.5mg IV push, EpiPen Auto injector  x1. Patient stabilized and was released to home with Prednisone 50mg QD x3 days at 12:45pm.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Metabolic function test normal, Myoclonus, Nausea, Pallor
Clinical narrative: After receiving Flu Vaccine at 8am, employee walked back to the Flu clinic at ~9:20am and stated he didn't feel right after getting the Flu shot 1.5 hours prior. Reported nausea & chills. He was transferred immediately to the ED via wheelchair. ED MD reports employee had myoclonic jerks without focality, was pale with 2+diaphoresis. By 9:29am Tx: Normal Saline IV, Diphenhydramine 50mg IV push, Lorazepam 0.5mg IV push, EpiPen Auto injector  x1. Patient stabilized and was released to home with Prednisone 50mg QD x3 days at 12:45pm.
Age: 22.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Wrong immunization give to the patient.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Left ring finger and left pinky finger numb. Advised to go to ER for evaluation.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient was taken to ER on stretcher several days following vaccine administration. Patient reported feeling "in her body" (conscious) but unable to move arms or legs. Patient's PCP believes event could have been related to flu shot administration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling cold, Malaise, Pain in extremity, Rhinorrhoea
Clinical narrative: Arm was sore for a couple of days, "I just don't feel well" Chills. Difficulty getting warm. Runny nose. Pt was still not feeling well on 11/21/2017.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Encephalitis autoimmune, Seizure
Clinical narrative: On 10/27/2017, the patient developed seizures. Has no prior history of seizure disorder. She was hospitalized at Hospital. She was diagnosed with autoimmune encephalitis. She has had a prolonged hospitalization and is currently in Hospital rehabilitation program.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Breath holding, Loss of consciousness
Clinical narrative: I injected the PEDIARIX and Flu into (R) thigh the PCV 13 and ACTHIB into his left thigh and then the pt. held his breath and passed out. Less then 2 sec. later pt took a big breath.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 9-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 till 12-MAY-2017, the vaccine was exposed to various temperature excursions ranging from 47 degrees Fahrenheit (F) to 49 F for the period of up to 16 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012766:
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Herpes zoster, Injury, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-OCT-2011, the patient received ZOSTAVAX (lot number, dosage, and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 18-NOV-2015. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a further tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, a diminished quality of life, physical impairment and injury, and other losses and damages. Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Physical disability, Quality of life decreased, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-OCT-2011, the patient received ZOSTAVAX (lot number, dosage, and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 18-NOV-2015. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a further tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, a diminished quality of life, physical impairment and injury, and other losses and damages. Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-AUG-2015, 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 ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-NOV-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 valacyclovir (VALTREX) and hydrocodone bitartrate and acetaminophen (NORCO) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 07-NOV-2012, 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 20-APR-2014, the patient was treated by a family nurse practitioner at an urgent care clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and gabapentin for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.