chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Stress fracture, Tumour excision
Clinical narrative: Developed severe upper respiratory systems, nodules on the skin, had a tumor removed, bone fractures, gall bladder removal, chest pains, swollen liver, swollen spleen, chronic pancreatitis.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Swelling
Clinical narrative: Swelling/bruising.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram, Echocardiogram, Hemiparesis, Hypertension, Ischaemic stroke
Clinical narrative: Approximately 2 hours post vaccine, patient had high blood pressure, right sided weakness, and blurry vision; patient was treated for an ischemic stroke.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging, Ultrasound Doppler, Vision blurred
Clinical narrative: Approximately 2 hours post vaccine, patient had high blood pressure, right sided weakness, and blurry vision; patient was treated for an ischemic stroke.
Age: 49.0
Sex: F
Vaccine: HEP, MEN, TYP, YF
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Headache, diarrhea fatigue, nausea, muscle and joint aches and pains. Continues to get worse, On May 5, 2017 in addition to other symptoms started with SOB, weakness, increase muscle ache.
Age: 49.0
Sex: F
Vaccine: HEP, MEN, TYP, YF
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache, diarrhea fatigue, nausea, muscle and joint aches and pains. Continues to get worse, On May 5, 2017 in addition to other symptoms started with SOB, weakness, increase muscle ache.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site urticaria, Pyrexia, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Patient started having high fevers 1 day after vaccination. Patient also had a large welt on injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Right Thigh: Swelling 31cm in diameter -marked area. 28cm diameter of left thigh and palpation of the thigh revealed tenderness. Left Thigh: Left thigh was normal, no swelling, and the thigh was not tender on palpation.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat, pain, at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin lesion, Skin warm
Clinical narrative: This spontaneous report has been received from a Physician assistant, concerning to 65 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown by reporter. On 07-APR- 2017 (reported as a week ago), the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, frequency, lot # and expiration date were not provided) for prevention of shingles. Approximately in April 2017,  the patient developed a 9 inch circle on the back of her arm that was red, warm and swollen. The patient was treated with an unspecified antihistamine and ice. The outcome of skin lesion, erythema, warm and swollen was unknown. The causal relationship between the therapy with ZOSTAVAX and the events of  skin lesion, erythema, warm and swollen was unknown. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Nurse via a Company Representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition an concomitant medications were not provided. On 20-APR-2017, an unspecified health care provider was administering a dose of properly stored vaccine of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis; and while drawing up the vaccine from the vial into a syringe, lost some of the vaccine liquid which spilled onto the surface of the patient's arm. The remainder of the incomplete dose was "wasted" and the patient was administered a new fresh dose of GARDASIL 9 with no problems. No adverse effects reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient ranging from 25 to 84 years old of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unspecified date between 19-APR-2017 and 01-MAY-2017, the patient received an intramuscular dose of PNEUMOVAX 23 (lot: N003997; expiration date: 20-OCT-2018) to prevent pneumococcal infection (dose was not provided). On an unspecified date in 2017, within 24 hours of receiving the dose of PNEUMOVAX 23, the patient developed a red, swollen, warm, sore area at the site of injection. Additionally the patient experienced cellulitis which was treated with BACTRIM DS and prednisone (manufacturer unknown). The patient called the nurse for medical attention. There were no laboratories performed. On an unspecified date in 2017, the patient recovered from the events. The relatedness of the events with PNEUMOVAX 23 was not reported. This is one of several reports from same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005377: US-009507513-1705USA005378.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Activated partial thromboplastin time shortened, Blood fibrinogen decreased, Death, Endotracheal intubation, Intensive care
Clinical narrative: This literature marketed report was received from the authors in a published literature abstract title concerning to 50 year old male with a history of Chronic obstructive pulmonary disease (COPD) and prior splenectomy following traumatic splenic rupture who presented with fever, altered mental status, and sonmolence. He was subsequently intubated and transferred to the Intensive care Unit (ICU), at which time his wife was able to report that since splenectomy he had experienced two episodes of pneumococcal meningitis in the past few years. Following the second bout of meningitis he had undergone proper vaccination with both PREVNAR 13 and vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, lot# and the expiration date were not reported) one year prior to his presentation. On an unknown date, on exam, he was noted to had a temperature of 103.7, heart rate of 126, and Blood Pressure (BP) of 109/63. He was initially noted to had retiform purpura diffusely spread over his body with a dark, dusky appearance of the nose, ears, eyelids, bilateral hands and feet, and tip of the penis. These areas eventually became pulseless and developed necrosis. His labs were remarkable for a White Blood Cells (WBC) of 47,000, platelets of 34,000, Prothrombin time (PT) of 16.1, International normalised ratio (INR) of 1.5, Partial thromboplastin time (PTT) of 58.7,and fibrinogen of 185. Schistocytes were noted on peripheral blood smear. Two sets of blood cultures were positive for pneumococcus. The diagnosis of purpura fulminans from Pneumococcus was made. Despite being on appropriate antibiotics and maximal supportive care, the patient developed multisystem organ dysfunction and was eventually transitioned to a comfort care approach and passed away shortly after. This case was interesting in the fact that this patient developed invasive pneumococcal disease despite being properly vaccinated with pneumococcal vaccine, polyvalent  (23-valent)(manufacturer unknown) and PREVNAR 13 and having no other immunodeficiencies. At the time of reporting, the  outcome of vaccination failure was not provided. The reporter considered vaccination failure to be related to PNEUMOVAX23 and PREVNAR 13.  Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: International normalised ratio increased, Mental status changes, Multiple organ dysfunction syndrome, Necrosis, Palliative care
Clinical narrative: This literature marketed report was received from the authors in a published literature abstract title concerning to 50 year old male with a history of Chronic obstructive pulmonary disease (COPD) and prior splenectomy following traumatic splenic rupture who presented with fever, altered mental status, and sonmolence. He was subsequently intubated and transferred to the Intensive care Unit (ICU), at which time his wife was able to report that since splenectomy he had experienced two episodes of pneumococcal meningitis in the past few years. Following the second bout of meningitis he had undergone proper vaccination with both PREVNAR 13 and vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, lot# and the expiration date were not reported) one year prior to his presentation. On an unknown date, on exam, he was noted to had a temperature of 103.7, heart rate of 126, and Blood Pressure (BP) of 109/63. He was initially noted to had retiform purpura diffusely spread over his body with a dark, dusky appearance of the nose, ears, eyelids, bilateral hands and feet, and tip of the penis. These areas eventually became pulseless and developed necrosis. His labs were remarkable for a White Blood Cells (WBC) of 47,000, platelets of 34,000, Prothrombin time (PT) of 16.1, International normalised ratio (INR) of 1.5, Partial thromboplastin time (PTT) of 58.7,and fibrinogen of 185. Schistocytes were noted on peripheral blood smear. Two sets of blood cultures were positive for pneumococcus. The diagnosis of purpura fulminans from Pneumococcus was made. Despite being on appropriate antibiotics and maximal supportive care, the patient developed multisystem organ dysfunction and was eventually transitioned to a comfort care approach and passed away shortly after. This case was interesting in the fact that this patient developed invasive pneumococcal disease despite being properly vaccinated with pneumococcal vaccine, polyvalent  (23-valent)(manufacturer unknown) and PREVNAR 13 and having no other immunodeficiencies. At the time of reporting, the  outcome of vaccination failure was not provided. The reporter considered vaccination failure to be related to PNEUMOVAX23 and PREVNAR 13.  Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Platelet count decreased, Pneumococcal infection, Prothrombin time prolonged, Pulse absent, Purpura
Clinical narrative: This literature marketed report was received from the authors in a published literature abstract title concerning to 50 year old male with a history of Chronic obstructive pulmonary disease (COPD) and prior splenectomy following traumatic splenic rupture who presented with fever, altered mental status, and sonmolence. He was subsequently intubated and transferred to the Intensive care Unit (ICU), at which time his wife was able to report that since splenectomy he had experienced two episodes of pneumococcal meningitis in the past few years. Following the second bout of meningitis he had undergone proper vaccination with both PREVNAR 13 and vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, lot# and the expiration date were not reported) one year prior to his presentation. On an unknown date, on exam, he was noted to had a temperature of 103.7, heart rate of 126, and Blood Pressure (BP) of 109/63. He was initially noted to had retiform purpura diffusely spread over his body with a dark, dusky appearance of the nose, ears, eyelids, bilateral hands and feet, and tip of the penis. These areas eventually became pulseless and developed necrosis. His labs were remarkable for a White Blood Cells (WBC) of 47,000, platelets of 34,000, Prothrombin time (PT) of 16.1, International normalised ratio (INR) of 1.5, Partial thromboplastin time (PTT) of 58.7,and fibrinogen of 185. Schistocytes were noted on peripheral blood smear. Two sets of blood cultures were positive for pneumococcus. The diagnosis of purpura fulminans from Pneumococcus was made. Despite being on appropriate antibiotics and maximal supportive care, the patient developed multisystem organ dysfunction and was eventually transitioned to a comfort care approach and passed away shortly after. This case was interesting in the fact that this patient developed invasive pneumococcal disease despite being properly vaccinated with pneumococcal vaccine, polyvalent  (23-valent)(manufacturer unknown) and PREVNAR 13 and having no other immunodeficiencies. At the time of reporting, the  outcome of vaccination failure was not provided. The reporter considered vaccination failure to be related to PNEUMOVAX23 and PREVNAR 13.  Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Purpura fulminans, Pyrexia, Red blood cell schistocytes present, Skin discolouration, Somnolence
Clinical narrative: This literature marketed report was received from the authors in a published literature abstract title concerning to 50 year old male with a history of Chronic obstructive pulmonary disease (COPD) and prior splenectomy following traumatic splenic rupture who presented with fever, altered mental status, and sonmolence. He was subsequently intubated and transferred to the Intensive care Unit (ICU), at which time his wife was able to report that since splenectomy he had experienced two episodes of pneumococcal meningitis in the past few years. Following the second bout of meningitis he had undergone proper vaccination with both PREVNAR 13 and vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, lot# and the expiration date were not reported) one year prior to his presentation. On an unknown date, on exam, he was noted to had a temperature of 103.7, heart rate of 126, and Blood Pressure (BP) of 109/63. He was initially noted to had retiform purpura diffusely spread over his body with a dark, dusky appearance of the nose, ears, eyelids, bilateral hands and feet, and tip of the penis. These areas eventually became pulseless and developed necrosis. His labs were remarkable for a White Blood Cells (WBC) of 47,000, platelets of 34,000, Prothrombin time (PT) of 16.1, International normalised ratio (INR) of 1.5, Partial thromboplastin time (PTT) of 58.7,and fibrinogen of 185. Schistocytes were noted on peripheral blood smear. Two sets of blood cultures were positive for pneumococcus. The diagnosis of purpura fulminans from Pneumococcus was made. Despite being on appropriate antibiotics and maximal supportive care, the patient developed multisystem organ dysfunction and was eventually transitioned to a comfort care approach and passed away shortly after. This case was interesting in the fact that this patient developed invasive pneumococcal disease despite being properly vaccinated with pneumococcal vaccine, polyvalent  (23-valent)(manufacturer unknown) and PREVNAR 13 and having no other immunodeficiencies. At the time of reporting, the  outcome of vaccination failure was not provided. The reporter considered vaccination failure to be related to PNEUMOVAX23 and PREVNAR 13.  Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Streptococcus test positive, Vaccination failure, White blood cell count increased
Clinical narrative: This literature marketed report was received from the authors in a published literature abstract title concerning to 50 year old male with a history of Chronic obstructive pulmonary disease (COPD) and prior splenectomy following traumatic splenic rupture who presented with fever, altered mental status, and sonmolence. He was subsequently intubated and transferred to the Intensive care Unit (ICU), at which time his wife was able to report that since splenectomy he had experienced two episodes of pneumococcal meningitis in the past few years. Following the second bout of meningitis he had undergone proper vaccination with both PREVNAR 13 and vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, lot# and the expiration date were not reported) one year prior to his presentation. On an unknown date, on exam, he was noted to had a temperature of 103.7, heart rate of 126, and Blood Pressure (BP) of 109/63. He was initially noted to had retiform purpura diffusely spread over his body with a dark, dusky appearance of the nose, ears, eyelids, bilateral hands and feet, and tip of the penis. These areas eventually became pulseless and developed necrosis. His labs were remarkable for a White Blood Cells (WBC) of 47,000, platelets of 34,000, Prothrombin time (PT) of 16.1, International normalised ratio (INR) of 1.5, Partial thromboplastin time (PTT) of 58.7,and fibrinogen of 185. Schistocytes were noted on peripheral blood smear. Two sets of blood cultures were positive for pneumococcus. The diagnosis of purpura fulminans from Pneumococcus was made. Despite being on appropriate antibiotics and maximal supportive care, the patient developed multisystem organ dysfunction and was eventually transitioned to a comfort care approach and passed away shortly after. This case was interesting in the fact that this patient developed invasive pneumococcal disease despite being properly vaccinated with pneumococcal vaccine, polyvalent  (23-valent)(manufacturer unknown) and PREVNAR 13 and having no other immunodeficiencies. At the time of reporting, the  outcome of vaccination failure was not provided. The reporter considered vaccination failure to be related to PNEUMOVAX23 and PREVNAR 13.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 17 year old female patient. The patient had none pertinent medical history nor drug reactions/allergies. Concomitant therapies included MENVEO (also reported as "Concomitant Medication: no"). On 06-APR-2017. the patient was vaccinated with the first dose of GARDASIL 9 (lot # M041212, expiration date 21-JUN-2019) in the left arm, for prophylaxis (dose and route of administration were not reported). On 06-APR-2017 as well, the patient's left entire arm became swollen, red, itchy and painful. It was reported that the patient's mother took her to an urgent care facility on 07-APR-2017 and she started treatment with prednisone (manufacturer unknown) 20 mg for 10 days. Her left arm was better after treatment and the adverse effects resolved on an unspecified date in 2017. No laboratory diagnostics studies were performed. The medical assistant also reported that the patient had also been administered MENVEO to the right arm and no adverse effects occurred to that arm. Causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 4 patients ranging in age from 25 to 84 years old of unknown gender. The patiens' concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates between 19-APR-2017 and 01-MAY-2017, the patients received an intramuscular dose of PNEUMOVAX23 (lot: N003997; expiration date: 20-OCT-2018) to prevent pneumococcal infection (dose was not provided). On an unspecified date in 2017, within 24 hours of receiving the dose of PNEUMOVAX23, each patient developed a red, swollen, warm, sore area at the site of injection. The patients called the nurse for medical attention. No laboratories were performed.  On unknown dates, the patients recovered from the events. The relatedness of the events with PNEUMOVAX23 was not reported. This is one of several reports from same source. Additional information has been requested; Sender's Comments:  US-009507513-1705USA005378: US-009507513-1705USA001719:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Emotional distress, Fatigue, Herpes zoster, Injury
Clinical narrative: Information was received on 09-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. On 21-MAR-2015, the patient received a dose of ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. Shortly thereafter, the patient noticed a rash on her right buttock and right labia and experienced mild pain and burning, aches, fever and fatigue. On or about 28-MAR-2015, the patient presented to her physician for these complaints and was diagnosed with herpes zoster.  The patient's physician diagnosed her complaints as being related to receiving the ZOSTAVAX vaccine. The patient subsequently suffered from recurring itchy, burning bumps on her legs and ankles, sporadic nerve pain in the area where she had the rash. The patient was eventually diagnosed with postherpetic neuralgia. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent injuries. Further as a 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, physical impairment and injury. She has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Herpes zoster and post herpetic neuralgia were considered disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Physical disability, Post herpetic neuralgia, Pyrexia
Clinical narrative: Information was received on 09-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. On 21-MAR-2015, the patient received a dose of ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. Shortly thereafter, the patient noticed a rash on her right buttock and right labia and experienced mild pain and burning, aches, fever and fatigue. On or about 28-MAR-2015, the patient presented to her physician for these complaints and was diagnosed with herpes zoster.  The patient's physician diagnosed her complaints as being related to receiving the ZOSTAVAX vaccine. The patient subsequently suffered from recurring itchy, burning bumps on her legs and ankles, sporadic nerve pain in the area where she had the rash. The patient was eventually diagnosed with postherpetic neuralgia. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent injuries. Further as a 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, physical impairment and injury. She has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Herpes zoster and post herpetic neuralgia were considered disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Quality of life decreased, Rash, Rash pruritic
Clinical narrative: Information was received on 09-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. On 21-MAR-2015, the patient received a dose of ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. Shortly thereafter, the patient noticed a rash on her right buttock and right labia and experienced mild pain and burning, aches, fever and fatigue. On or about 28-MAR-2015, the patient presented to her physician for these complaints and was diagnosed with herpes zoster.  The patient's physician diagnosed her complaints as being related to receiving the ZOSTAVAX vaccine. The patient subsequently suffered from recurring itchy, burning bumps on her legs and ankles, sporadic nerve pain in the area where she had the rash. The patient was eventually diagnosed with postherpetic neuralgia. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent injuries. Further as a 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, physical impairment and injury. She has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Herpes zoster and post herpetic neuralgia were considered disabling. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 10-MAY-2017, the patient was inadvertently vaccinated with a dose of GARDASIL after its labeled expiration date (which had the lot # K010215, expiration date 05-MAY-2017) (dosage information, route and anatomical site of vaccination were not informed) for prophylaxis . Information regarding concomitant medication was not provided. No adverse effects were reported in the patient. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, XELSOURCE received from a contactable consumer. A 70-year-old female patient of an unspecified race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient could not lift her arm without help on an unspecified date with outcome of not recovered.  Pfizer is Marketing Authorization Holder Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has been submitted the same report to the regulatory authorities.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) on 05-MAY-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer unknown, dose, batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed Bell's palsy. Patient's lab data and corrective treatment were not reported. The event outcome was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event [Bell's palsy]. List of documents held by sender: none.; Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not conformed. Time to onset is unknown. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies, name of vaccine administered, time to onset and patient's history of reaction after previous vaccinations are needed to further assess this case. Based on information role of vaccine cannot be assessed.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Cold sweat, Fatigue, Influenza like illness, Injected limb mobility decreased
Clinical narrative: 05/05/17 @ 1:10 PM- 10 minutes after the vaccination my heart hurt. I experienced pain with each heartbeat for 10 minutes or so. 05/05/17 - 05/07/17- Extreme fatigue, I slept most of the weekend and had flu like exhaustion. 05/06/17 @ midnight- Cold sweats and chills including shivering and shaking. Increased pain in the injection site making it impossible to sleep. Redness, swelling and warmth in the injection site. Reduced mobility in the injection (right) arm. Unable to lift injection arm and had to hold arm like a sling to reduce pain enough to walk around the house. 05/07/17 @ 1200- Pain lessened and mobility returned.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: 05/05/17 @ 1:10 PM- 10 minutes after the vaccination my heart hurt. I experienced pain with each heartbeat for 10 minutes or so. 05/05/17 - 05/07/17- Extreme fatigue, I slept most of the weekend and had flu like exhaustion. 05/06/17 @ midnight- Cold sweats and chills including shivering and shaking. Increased pain in the injection site making it impossible to sleep. Redness, swelling and warmth in the injection site. Reduced mobility in the injection (right) arm. Unable to lift injection arm and had to hold arm like a sling to reduce pain enough to walk around the house. 05/07/17 @ 1200- Pain lessened and mobility returned.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Tremor
Clinical narrative: 05/05/17 @ 1:10 PM- 10 minutes after the vaccination my heart hurt. I experienced pain with each heartbeat for 10 minutes or so. 05/05/17 - 05/07/17- Extreme fatigue, I slept most of the weekend and had flu like exhaustion. 05/06/17 @ midnight- Cold sweats and chills including shivering and shaking. Increased pain in the injection site making it impossible to sleep. Redness, swelling and warmth in the injection site. Reduced mobility in the injection (right) arm. Unable to lift injection arm and had to hold arm like a sling to reduce pain enough to walk around the house. 05/07/17 @ 1200- Pain lessened and mobility returned.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Tremor
Clinical narrative: Body shaking, crying "all night".
Age: 7.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Contusion, Erythema, Insomnia, Mobility decreased, Pain
Clinical narrative: Circular rash, redness, swelling, hives itchiness, bruising, pain, difficulty with moving limbs, difficulty sleeping.
Age: 7.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Circular rash, redness, swelling, hives itchiness, bruising, pain, difficulty with moving limbs, difficulty sleeping.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, and warmth at the injection site. Lasted for 4 days.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Allergic reaction to vaccine including 103.2 fever and was given Tylenol & ibuprofen.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling at area of injection (left arm subcu.) Then developed "shingles" on the right back of shoulder on 5/10/17 and was seen in the clinic on 5/11/17 and diagnosed with shingles.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history or concomitant medications. On an unknown date, unknown patients were vaccinated with improperly stored GARDASIL 9 lot # M037770, expiration date of 01-JUN-2019, for prophylaxis (dose and route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32.1 degrees Fahrenheit for 12 hours. There were no previous excursions or data logger involved. No further information provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001636:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. n an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 1 DS Vial 00006411902, lot # M036059 with expiration date of 03-JUN-2019, for prophylaxis (dose and route of administration were not reported). The vaccines were exposed to a temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. The error was not noticed with a data logger. There were not previous excursions. No adverse symptoms were reported. No other information was provided.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA002242: US-009507513-1705USA002243: US-009507513-1705USA002244:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient ranging in age from 25 to 84 years old of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates between 19-APR-2017 and 01-MAY-2017, the patients received an intramuscular dose of PNEUMOVAX23 (lot: N003997; expiration date: 20-OCT-2018) to prevent pneumococcal infection (dose was not provided). On an unspecified date in 2017, within 24 hours of receiving the dose of PNEUMOVAX23, the patient developed a red, swollen, warm, sore area at the site of injection. The patient called the nurse for medical attention. No laboratories were performed. At the time of the reporting the patient was not recovered from the events. The relatedness of the events with PNEUMOVAX23 was not reported. This is one of several reports from same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001719: US-009507513-1705USA005377:
Sex: U
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age reported as: ("Age appropriate") and gender. The patient's concurrent conditions included diabetes mellitus and allergy to penicillin. On 09-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 subcutaneously, lot # M033086, expiration date on 05-MAY-2018 (strength, dose number and anatomical location were not provided) for prophylaxis. Concomitant therapies included metformin and JANUVIA. On an unknown date, the patient experienced swelling, induration, redness in large part of deltoid. Physician stated that the patient had not received treatment for reaction. The case did not involve cancer or overdose. At the time of the report, the outcome of induration, peripheral swelling and erythema was reported as not recovered. The reporter did not assess the relatedness between induration, peripheral swelling and erythema and PNEUMOVAX 23. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 19-year-old male patient of an unspecified race/ethnicity received the first dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed pain at the injection site and the area was red and warm for 3 to 5 days. Final outcome was unknown.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Chills, Decreased appetite, Feeling of body temperature change, Influenza
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 28Mar2017, at single dose, for immunisation. Medical history included blood cholesterol increased. Concomitant medication included NEXIUM, from an unspecified date and ongoing, for acid reflux. The patient previously took Aspirin and experienced drug intolerance. The patient experienced pain in arm like if had just gotten the injection/ woke up with the arm pain on 29Mar2017 with outcome of unknown, flu symptoms on 30Mar2017 with outcome of not recovered, nausea on 30Mar2017 with outcome of not recovered, lost 10 lb on an unspecified date with outcome of not recovered, muscles hurt on 30Mar2017 with outcome of not recovered, no appetite on 30Mar2017 with outcome of not recovered, joint pain on 30Mar2017 with outcome of not recovered, lethargic on 30Mar2017 with outcome of not recovered, arm still aching on 30Mar2017 with outcome of not recovered, hot and cold chills on 30Mar2017 with outcome of not recovered. On an unspecified date the patient underwent lab tests and procedures which included blood test: it came wonderful.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Myalgia, Nausea, Pain in extremity, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 28Mar2017, at single dose, for immunisation. Medical history included blood cholesterol increased. Concomitant medication included NEXIUM, from an unspecified date and ongoing, for acid reflux. The patient previously took Aspirin and experienced drug intolerance. The patient experienced pain in arm like if had just gotten the injection/ woke up with the arm pain on 29Mar2017 with outcome of unknown, flu symptoms on 30Mar2017 with outcome of not recovered, nausea on 30Mar2017 with outcome of not recovered, lost 10 lb on an unspecified date with outcome of not recovered, muscles hurt on 30Mar2017 with outcome of not recovered, no appetite on 30Mar2017 with outcome of not recovered, joint pain on 30Mar2017 with outcome of not recovered, lethargic on 30Mar2017 with outcome of not recovered, arm still aching on 30Mar2017 with outcome of not recovered, hot and cold chills on 30Mar2017 with outcome of not recovered. On an unspecified date the patient underwent lab tests and procedures which included blood test: it came wonderful.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Initial unsolicited report received from a consumer on 02-MAY-2017. This case involves a 78 years old female patient who was vaccinated with a dose of ADACEL (batch number, expiry date, route of administration was dose was not reported) in arm on 21-APR-2017. Patient's medical history was not reported and Illness at time of vaccination was reported as none. Concomitant medications was not provided. On 21-APR-2017, few hours (reported as that night) following the vaccination the patient experienced upper arm soreness in arm she had received vaccination, slight swelling of site, headache, chills, and nausea. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment was not provided. On 22-APR-2017(reported as next day), patient recovered from the chills, nausea and headache. On unspecified date patient recovered from swelling. It was reported that upper arm soreness lasted about 3 to 4 more days and then decreased to soreness at only the injection site. It was also reported that patient continued to experience soreness at the injection site. List of documents held by sender: none.
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a pharmacist on 02-MAY-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TYPHOID VACCINE (batch number, expiry date, dose was not reported) orally on an unspecified date. Patient's medical history and concomitant medications was not provided. On unspecified date, following the vaccination the patient experienced hives. Lab data and corrective treatment was not provided. The outcome of the events was not reported. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, itching, hot to touch around injection site area- md diagnosis: localized cellulitis.
Age: 39.0
Sex: M
Vaccine: DTAP
Symptoms: Back pain, Influenza, Musculoskeletal stiffness
Clinical narrative: Patient is pharmacy employee and he called in with complaint of "flu with back pain and stiffness.  This is the worst my back has ever been."
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Patient reported to me on 11 May 17 that in November 2016, after he received his seasonal influenza vaccine, he sustained a 'red rash all over my body" for approx. 3 days which dissipated without complications. He did not seek medical attention at the time. He had no previous history of similar reaction to that or any other vaccine to his knowledge.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling in left arm.  Reaction was just above the elbow line, below the deltoid muscle.  Reported to pharmacy on 5/11/17.  I identified that it was below where the injection site would have been.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Mother called and reports it to use on hives and itching from head to toe, as of yesterday hives was better and almost gone today.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Diffuse body rash which appears classic for measles.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Oedema, Pyrexia, Rash
Clinical narrative: Severe edema, rash, severe muscle pain and stiffness, fever.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Brief self-resolved seizure.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, PNC13, RVX
Symptoms: Body temperature increased, Erythema, Skin test positive, Urticaria
Clinical narrative: Hives over entire body <20 hours after vaccination. Mom is unsure when she put her to bed night before if she had hives. She did have red cheeks and temperature of ~101 on the night of vaccination. She was given Hib, Dtap, PREVNAR and rotavirus.
Age: 74.0
Sex: F
Vaccine: PNC
Symptoms: Chills, Dizziness, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Chills, fever shortness of breath, nausea, dizziness, sleepiness.
Age: 74.0
Sex: F
Vaccine: PNC
Symptoms: Somnolence
Clinical narrative: Chills, fever shortness of breath, nausea, dizziness, sleepiness.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Swelling of extremity with intermittent discoloration at immunization site.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Burning sensation, Induration, Limb mass, Paraesthesia
Clinical narrative: Within a few minutes of giving the vaccine, patient reported a burning and tingling sensation down her arm and towards her fingers. She also reported a "lump" in her forearm.  There was a firm feeling area in her forearm.  There was no visible swelling or discoloration. An ice pack was applied. Symptoms gradually resolved over the rest of her office visit, approximately 20-30 minutes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient reported that she had left shoulder pain and rash about 3 weeks ago. She took some over the counter Aleve and felt better and the rash has got better since then.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Blood test, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection started swelling a lot and was red and hot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: SWELLING AND REDNESS FROM SHOULDER TO ELBOW AROUND VACCINATION AREA.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Autoimmune disorder, Gastrointestinal disorder, Irritable bowel syndrome
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Abdominal X-ray, Abdominal discomfort, Abdominal pain, Adenovirus test, Alanine aminotransferase normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Amylase normal, Arthralgia, Aspartate aminotransferase normal, Bacterial test negative, Bacterial vulvovaginitis
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Basophil count normal, Basophil percentage, Biopsy colon abnormal, Biopsy small intestine normal, Blood albumin normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone, Blood urea normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: C-reactive protein normal, Carbon dioxide normal, Central pain syndrome, Chronic gastritis, Clostridium test negative
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Colonoscopy normal, Crohn's disease, Diarrhoea, Endoscopy gastrointestinal normal, Eosinophil count normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Eosinophil percentage, Escherichia test negative, Fibromyalgia, Gallbladder polyp, Gastritis
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Gastrointestinal motility disorder, Gastrooesophageal reflux disease, Giardia test negative, Glomerular filtration rate normal, Granulocyte count
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Hiatus hernia
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Human chorionic gonadotropin negative, Hypoaesthesia, Imaging procedure, Inflammatory bowel disease, Irritable bowel syndrome
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.