chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood glucose decreased, Blood magnesium decreased, Blood potassium decreased, Diabetic coma, Hypoglycaemia
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer and additional information received on 18-Oct-2018. This case is linked to case 2018SA290310 (same reporter). This case involves a 52 years old female patient who experienced diabetic coma, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pancreatic carcinoma and only has one-half of a pancreas. On 09-Oct-2018 at 03:10 PM, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ009AA and Exp. Date 30 Jun 2019) via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with blood sugar was 34, magnesium decreased, potassium decreased and did not feel well, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. It was reported that her usual blood sugar was 115 to 120. She thought that she received an Insulin product instead of a flu shot because her blood sugar decreased. Specifically, she had later in the evening gone to a scheduled mammogram appointment at a local hospital. While there, she noted that she did not feel well so the department asked if she wanted to reschedule the mammogram appointment. Relevant tests included blood sugar was 34. Final diagnosis was not feel well and diabetic coma. The patient received unknown treatment for the event. The outcome of the event was not reported. It was reported that her blood sugar decreased like they did because she had pancreatic cancer. List of documents held by sender: none. Sender's Comments: This case concerns a patient with pancreatic cancer who presented with diabetic coma and other symptoms of hypoglycemia after vaccination with FLUZONE. The time to onset is not known. Moreover, there is no information regarding patient's blood sugar levels at time of vaccination, condition at time of vaccination and lab tests ruling out alternate etiologies of the events. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Malaise
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer and additional information received on 18-Oct-2018. This case is linked to case 2018SA290310 (same reporter). This case involves a 52 years old female patient who experienced diabetic coma, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pancreatic carcinoma and only has one-half of a pancreas. On 09-Oct-2018 at 03:10 PM, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ009AA and Exp. Date 30 Jun 2019) via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with blood sugar was 34, magnesium decreased, potassium decreased and did not feel well, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. It was reported that her usual blood sugar was 115 to 120. She thought that she received an Insulin product instead of a flu shot because her blood sugar decreased. Specifically, she had later in the evening gone to a scheduled mammogram appointment at a local hospital. While there, she noted that she did not feel well so the department asked if she wanted to reschedule the mammogram appointment. Relevant tests included blood sugar was 34. Final diagnosis was not feel well and diabetic coma. The patient received unknown treatment for the event. The outcome of the event was not reported. It was reported that her blood sugar decreased like they did because she had pancreatic cancer. List of documents held by sender: none. Sender's Comments: This case concerns a patient with pancreatic cancer who presented with diabetic coma and other symptoms of hypoglycemia after vaccination with FLUZONE. The time to onset is not known. Moreover, there is no information regarding patient's blood sugar levels at time of vaccination, condition at time of vaccination and lab tests ruling out alternate etiologies of the events. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site pain, Injection site paraesthesia, Neuralgic amyotrophy, Paraesthesia
Clinical narrative: Employee says she has been having numbness/tingling and pain to her left arm for the past 1.5 week that she says started the same day she received the shot
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Employee says she has been having numbness/tingling and pain to her left arm for the past 1.5 week that she says started the same day she received the shot
Age: 46.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: ADACEL - Snaofi Pasteur Lot U5872AA exp 2/6/2020; Pt rec'd injection TDaP on 9/23/18 at pharmacy- No complaints/pain or abnormal symptoms post injection until 2 am she woke up with bad pain in her left arm. She did not go for any medical treatment thinking it was going to get better. She continue to have pain in her left arm from the bicep into her hands- the pain is a twisting, tight feeling in her arm and the arm feels very heavy. Appears to have affected her joint- having joint pain also. The pain is worse with movement. Left upper arm is mildly swollen and warm to touch with firmness palpated to the bicep. Good mobility to the Left shoulder and elbow, Left Radial pulse is strong, equal and bilateral. Good CMS to fingers although she states the fingers feel funny.
Age: 46.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Arthralgia, Feeling abnormal, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: ADACEL - Snaofi Pasteur Lot U5872AA exp 2/6/2020; Pt rec'd injection TDaP on 9/23/18 at pharmacy- No complaints/pain or abnormal symptoms post injection until 2 am she woke up with bad pain in her left arm. She did not go for any medical treatment thinking it was going to get better. She continue to have pain in her left arm from the bicep into her hands- the pain is a twisting, tight feeling in her arm and the arm feels very heavy. Appears to have affected her joint- having joint pain also. The pain is worse with movement. Left upper arm is mildly swollen and warm to touch with firmness palpated to the bicep. Good mobility to the Left shoulder and elbow, Left Radial pulse is strong, equal and bilateral. Good CMS to fingers although she states the fingers feel funny.
Age: 46.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: ADACEL - Snaofi Pasteur Lot U5872AA exp 2/6/2020; Pt rec'd injection TDaP on 9/23/18 at pharmacy- No complaints/pain or abnormal symptoms post injection until 2 am she woke up with bad pain in her left arm. She did not go for any medical treatment thinking it was going to get better. She continue to have pain in her left arm from the bicep into her hands- the pain is a twisting, tight feeling in her arm and the arm feels very heavy. Appears to have affected her joint- having joint pain also. The pain is worse with movement. Left upper arm is mildly swollen and warm to touch with firmness palpated to the bicep. Good mobility to the Left shoulder and elbow, Left Radial pulse is strong, equal and bilateral. Good CMS to fingers although she states the fingers feel funny.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74-year-old female patient. The patient had none pertinent medical history or drug reactions/allergies. Concomitant therapies included FLUZONE HD. On 18-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R021048 (expiration date: 14-APR-2020) intramuscularly for prophylaxis. The pharmacist reported that the patient showed and explained they on 21-OCT-2018, that on an unspecified date after receiving the vaccine, cellulitis developed in the left arm, then, the patient sought for medical attention and treatment. The pharmacist recommended to the patient to apply ice to the affected area and take an unspecified dose of paracetamol (TYLENOL) or ibuprofen. No laboratory diagnostics were performed. At the time of the report, the outcome of cellulitis was reported as not recovered. No causality assessment was provided. Upon internal review, cellulitis was considered to be medically significant.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Infection, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74-year-old female patient. The patient had none pertinent medical history or drug reactions/allergies. Concomitant therapies included FLUZONE HD. On 18-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R021048 (expiration date: 14-APR-2020) intramuscularly for prophylaxis. The pharmacist reported that the patient showed and explained they on 21-OCT-2018, that on an unspecified date after receiving the vaccine, cellulitis developed in the left arm, then, the patient sought for medical attention and treatment. The pharmacist recommended to the patient to apply ice to the affected area and take an unspecified dose of paracetamol (TYLENOL) or ibuprofen. No laboratory diagnostics were performed. At the time of the report, the outcome of cellulitis was reported as not recovered. No causality assessment was provided. Upon internal review, cellulitis was considered to be medically significant.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74-year-old female patient. The patient had none pertinent medical history or drug reactions/allergies. Concomitant therapies included FLUZONE HD. On 18-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R021048 (expiration date: 14-APR-2020) intramuscularly for prophylaxis. The pharmacist reported that the patient showed and explained they on 21-OCT-2018, that on an unspecified date after receiving the vaccine, cellulitis developed in the left arm, then, the patient sought for medical attention and treatment. The pharmacist recommended to the patient to apply ice to the affected area and take an unspecified dose of paracetamol (TYLENOL) or ibuprofen. No laboratory diagnostics were performed. At the time of the report, the outcome of cellulitis was reported as not recovered. No causality assessment was provided. Upon internal review, cellulitis was considered to be medically significant.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Hyperhidrosis, Pain in extremity, Peripheral swelling, Vertigo
Clinical narrative: Swelling of arm, area is red, sore and swollen. Approx. 10 hours later awoke soaked in sweat and with severe vertigo which lasted 15 minutes.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy muscle abnormal, C-reactive protein increased, Gait disturbance, Immune system disorder, Impaired work ability
Clinical narrative: I got the GARDASIL/HPV vaccination in 11/2014, 2/2015 and 8/2015. In summer, 2016, I began to suffer a strong pain in my left forearm, the pain last for 2-4 weeks and occurred repeatedly in both forearms. Few months later, I began to feel strongly painful in my leg muscles and had difficulty to walk. During the late 2016, I saw many doctors but no one could tell what disease I have had. The symptoms persisted and intensified during 2017, which made me hardly to walk and seriously affected my work and life. In November, I was diagnosed with an immune related disease which expressed as myofasciitis. Since November, 2017, I have been taking Glucocorticoid to restrain the pain and disease, the side effects of the drugs are also destroying my health. But unfortunately, the pain of myofasciitis always recurs and could hardly be completely cured.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Myalgia, Myofascitis, Nuclear magnetic resonance imaging abnormal, Oedema
Clinical narrative: I got the GARDASIL/HPV vaccination in 11/2014, 2/2015 and 8/2015. In summer, 2016, I began to suffer a strong pain in my left forearm, the pain last for 2-4 weeks and occurred repeatedly in both forearms. Few months later, I began to feel strongly painful in my leg muscles and had difficulty to walk. During the late 2016, I saw many doctors but no one could tell what disease I have had. The symptoms persisted and intensified during 2017, which made me hardly to walk and seriously affected my work and life. In November, I was diagnosed with an immune related disease which expressed as myofasciitis. Since November, 2017, I have been taking Glucocorticoid to restrain the pain and disease, the side effects of the drugs are also destroying my health. But unfortunately, the pain of myofasciitis always recurs and could hardly be completely cured.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: I got the GARDASIL/HPV vaccination in 11/2014, 2/2015 and 8/2015. In summer, 2016, I began to suffer a strong pain in my left forearm, the pain last for 2-4 weeks and occurred repeatedly in both forearms. Few months later, I began to feel strongly painful in my leg muscles and had difficulty to walk. During the late 2016, I saw many doctors but no one could tell what disease I have had. The symptoms persisted and intensified during 2017, which made me hardly to walk and seriously affected my work and life. In November, I was diagnosed with an immune related disease which expressed as myofasciitis. Since November, 2017, I have been taking Glucocorticoid to restrain the pain and disease, the side effects of the drugs are also destroying my health. But unfortunately, the pain of myofasciitis always recurs and could hardly be completely cured.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site nodule, Product administered at inappropriate site
Clinical narrative: Patient was given the High Dose flu shot in the arm but the injection was given too low and from what we can tell afterwards missed the Deltoid and was given more in the lower Bicep. Patient called into the Pharmacy the evening of the vaccination concerned that his injection site was black and blue and a large knot was forming. RPH urged patient (not knowing the extent of how low the injection site at the time) encourage patient to take some BENADRYL in case of allergic reaction and follow up with the Pharmacy as well as the doctor if no improvement. Patient was called on Saturday (the day following the immunization event) and indicated that the reaction had worsened a touch but that he was okay.  Patient stopped into the Pharmacy and spoke with another Pharmacist on Sunday to show us the reaction and obtain advice. Patient went to see his physician on Monday or Tuesday and the Doctor's office called to ensure the Pharmacy was aware of the reaction and is working on education moving forward. Doctor indicated that the shot was given too low and that the most likely scenario for the reaction was that the injection nicked a vein/blood vessel causing internal bleeding that was slower to stop because of the onboard aspirin. Nothing more can be done to treat the patient (perse) - just monitoring and natural healing process was recommended by the physician. Since the patient is also taking aspirin it may take longer to heal. RPH to continue follow up on 10/25 to ensure patient is improving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Sore injection site, moderate pain, started immediately, about 48 hr. From about 10 hr from injection time, for about 24 hr- extreme fatigue (stayed in bed all day, could not read), chills, muscle pain, head ache, shivering. Much improved by 48 hr from injection (but not perfect yet).  Same side effects, but not as strong, also occurred on the 1st injection in July.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Sore injection site, moderate pain, started immediately, about 48 hr. From about 10 hr from injection time, for about 24 hr- extreme fatigue (stayed in bed all day, could not read), chills, muscle pain, head ache, shivering. Much improved by 48 hr from injection (but not perfect yet).  Same side effects, but not as strong, also occurred on the 1st injection in July.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies were provided. On 26-SEP-2018, the patient was vaccinated with VAQTA lot # N017094, expiration date 31-AUG-2018, intramuscular, for prophylaxis (dose number was not provided). It was reported that VAQTA was expired at the time of administration. There was no adverse event reported. The outcome of expired product administered was not provided.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Hypersomnia, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on a request by the company from Food and Drug Administration (HA# 757821) under the Act and refers to a 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with GARDASIL 9 (lot# N025428 and expiration date 19-JUN-2020), intramuscular in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (lot# 9PD92) intramuscular in the left arm and MENVEO (M17033) intramuscular in the left arm. On 09-JUL-2018, the patient experienced dizziness, injection site swelling, injection site pruritus, hypersomnia and fatigue. The patient was treated with BENADRYL. The outcome of dizziness, injection site swelling, injection site pruritus, hypersomnia and fatigue was reported as not recovered. Causality assessment of the events were not reported.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information was received from a physician via a company representative and refers to a premature infant female patient of unknown age. Her medical history, concurrent conditions and concomitant drugs were not reported. She was possibly vaccinated with other unspecified vaccines. On an unknown date, the patient was vaccinated with ROTATEQ, oral (exact dose, lot# and expiration date were not provided) for routine vaccination for rotavirus. It was reported that the patient completed the 3-dose series, however, it was unknown at what point the adverse event occurred within the 3-dose series. On an unknown date after receiving ROTATEQ, the patient was hospitalized for unspecified number of days because she would not stop vomiting. The outcome of vomiting was reported as recovered on an unknown date. The reporter did not provide causality assessment between the event and ROTATEQ. The event was considered to be life-threatening by the reporter. She was confident that the adverse event was life-threatening since the patient was a premature infant who needed to be hospitalized due to vomiting.
Age: 10.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 10 year old female patient. The patient's concomitant medication, pertinent medical History, drug reactions/allergies and concurrent condition were not reported. In October 2017 the patient was inadvertently administered with a dose of ZOSTAVAX (lot # reported as N008827; strength, route and expiration date were not reported) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to 2 female patient at the age between 11 and 12 years old. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as several years ago), the patient were vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On unknown dates, immediately after receiving their vaccines, the patients developed syncope. The outcome of syncope was unknown. The relatedness between syncope and GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA010465.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old female patient. On 29-AUG-2018 the patient was vaccinated with GARDASIL 9 for prophylaxis. Concomitant therapies included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID). On an unknown date the patient experienced adverse reaction. The outcome of adverse reaction is unknown.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 2 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours. No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 2 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours (multiple excursions were reported). No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Menstrual disorder
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (reported as several years ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, immediately after receiving the vaccine, the patient experienced menstrual changes. The outcome of menstrual changes was unknown. The relatedness between menstrual changes and GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA008724.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Child patient (age and gender was not reported) who received a dose of vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that gave a FLUZONE HIGH DOSE to a 3rd grade. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Audiogram, Balance disorder, Blood test, Body temperature decreased
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradycardia, Cardiac pacemaker insertion, Computerised tomogram head normal, Deafness unilateral, Diplopia
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Frustration tolerance decreased, Gait disturbance, General physical health deterioration
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Hypotension, Hypothermia, Impaired driving ability
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Loss of personal independence in daily activities, Metamorphopsia, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sudden hearing loss, Tinnitus, Tremor, Vertigo
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Sudden hearing loss followed by severe vertigo and severe vomiting. General decline with A-fib alternating with extreme bradycardia, dangerously low blood pressure, 94 degree core body temperature, treatment for hypothermia, 4 day hospitalization. Pacemaker surgery shingles outbreak at same time. Patient condition one month later: All doctors consulted so far agreed that CT's/MRI's show no CVA, lesion, tumor, or other cause for sudden deafness. All suspect a virus, particularly shingles virus, caused damage since patient suffered serious outbreak in conjunction with this medical emergency, which also precipitated pacemaker surgery. I am 100% deaf in my left ear - permanently, irreversibly. It happened over 2 hours! Hearing has been replaced with constant, loud ringing and buzzing which makes hearing from other ear difficult. I have a constant headache as a result of this and of the vision distortion resulting from delayed vestibular-ocular reflex caused by this event as well. My balance is shaky; walking is affected, and I'm not allowed to drive at this point. In addition to this pain and inconvenience is the frustration of not being able to participate in favorite activities, such as reading, watching TV or movies, walking on beach, dancing, doing water aerobics despite daily vestibular rehabilitation exercises. Patient presented to the office on October 8, 2018. She reported sudden hearing loss, severe vertigo and difficulty with vision since having a recent herpes zoster vaccine. The comprehensive eye examination showed all structures of the eye to be normal and healthy. Extraocular muscles appear to track normally in all directions of gaze. The patient does have nuclear sclerotic cataracts, but this was not a reaction to the vaccine. It is my belief that the zoster vaccine could have caused patient's vestibular-ocular reflex difficulties - vertigo along with occasional double vision. Patient never showed any of these problems prior to the zoster vaccination.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: 10032018 left upper arm pain with injection of flu vaccine; 10212018 left underarm blister observed. 10222018 red blisters on back near left underarm. 10232018 physician prescribed Valacyclovir for shingles treatment. 10242018 additional blisters appear on left side back and left breast.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Injection site nodule, Nausea
Clinical narrative: After receiving the vaccine, my mom experienced multiple side effects that were explicitly described on  the website. She experienced a smal hard knot at her left arm at the injection site which started to spread down to involve her upper left arm. The area became red, warm, painful. It was also very itchy. She developed fatigue, nausea, and loss of appetite. The day after the vaccine, she had a fever and developed chills for 10 minutes. She also had diffuse body aches.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: After receiving the vaccine, my mom experienced multiple side effects that were explicitly described on  the website. She experienced a smal hard knot at her left arm at the injection site which started to spread down to involve her upper left arm. The area became red, warm, painful. It was also very itchy. She developed fatigue, nausea, and loss of appetite. The day after the vaccine, she had a fever and developed chills for 10 minutes. She also had diffuse body aches.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Left arm, shoulder and neck area is very sore, and stiffness in the neck.
Age: 1.5
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given PROQUAD and VARICELLA.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe upper arm pain to the point that I could  not lift or move my arm. Initial severity resolved after about 24 hours, but still sore with limitations 48 hours later.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: This nurse asked client if she wanted to receive influenza vaccine while laying on the cot since the client has a history of "hyporesponsive collapse" on 10/23/2015, per documentation by the RN at that time on her paper chart. Client stated she thought she would be okay sitting in the chair to receive the vaccine. This nurse administered the vaccine. This nurse asked the client if she was feeling okay. The client verified that she was. This nurse looked at computer to print the client's record, then looked back at the client to see her eyes closed and sliding sideways out of chair. This nurse was unable to catch the client and the client landed on floor. This nurse called for help and rolled client onto her back with knees bent, calling her name. The client's eyes opened. The client became more alert and responded to her name. A cot was brought into the room and the client was helped to a sitting position on it. The client stated she was alright and did not want to lay down. When asked how the client felt she stated, "frustrated." She stated she did not remember what happened and did not feel dizzy or bad before she "blacked out." The client was given juice to drink and a cool compress was placed on her neck. The client's father stated she ate lunch around noon and was surprised because, "This hasn't happened for years." This nurse continued to observed the client. The client was alert and oriented to person, place, and time. She denied any pain. After several minutes, the client stated she was "okay" and able to stand up and walk without assistance or support. This nurse told the client to sit in the waiting room for a few more minutes. The client and father stated understanding. After a few minutes, the client stated she was still feeling okay, denied pain and dizziness, and left with her father.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills
Clinical narrative: About 10 hours after receiving the vaccine I started having major chills and my temperature rose to 103.7. I had to be taken to the emergency room of my local hospital.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: She received her flu shot yesterday in her primary care office. Returned to the walk in clinic this am with reports of her left arm being painful and swollen. No redness or swelling noted to injection area. She does have pain in her left arm and swelling in her left hand. Denies having any other injury to that arm.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Muscle twitching, Myalgia, Pain in extremity
Clinical narrative: While receiving the flu shot I felt my muscle shaking. Almost immediately my muscle started to hurt. I know that this is pretty common and would go away after a few days. I am now over 3 weeks from having the shot and my arm is still so sore its painful to lift it. I am so afraid some damage was done. I don't know what to do to alleviate the pain and what to do to fix it.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dizziness, Hyperhidrosis
Clinical narrative: Sudden on set of sweating, light headedness, dizziness, back pain.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: One of our NP's gave pt a PCV 13 instead of the PNEUMOVAX. Pt had already had the PCV 13 the year before.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Atelectasis, Blood pressure abnormal, Nervousness, Photopsia, Pneumonia
Clinical narrative: Patient went to the emergency room on 10/12/18 with symptoms of visual disturbance (seeing lights), feeling shaky and nervous, and erratic blood pressure. She was diagnosed with pneumonia and a partially collapsed lung lobe. Since patient received flu shot just 48 hours prior, she was concerned her symptoms may have been caused by flu vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: FEVER TO 100.4 24 HOURS AFTER VACCINES GIVEN. C/O CONGESTION. NO SITE DISCOMFORT.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Patient reports numbness of all extremities continuing for more than 4 hours. Patient consulted with and treated by rheumatologist and neurologist.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Patient stated her arm is swollen from the injection. She was advised to take OTC Ibuprofen to help manage the discomfort and swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Fatigue, Feeling of body temperature change, Muscular weakness
Clinical narrative: Patient received vaccines on 10/16- the next morning of the 17th- pt reports feeling hot/cold with chills, muscle weakness and tired. Symptoms lasted about 24hrs and then resolved. No current medical concerns.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccine positive rechallenge
Clinical narrative: REDNESS IN CIRCULAR AREA SURROUNDING INJECTION SITE. SHE STATED THAT SHE HAD A SIMILAR REACTION THE YEAR BEFORE BUT NEVER REPORTED IT. NO TREATMENT WAS ADMINISTERED.