chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm over deltoid with 8cm x 7.5 cm area of erythema. Warm and tight/swollen but no lesions or blisters or pustules. No red streaks. No significant tenderness. No abx needed as of Saturday 10/20/18.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema, Blood test, Diarrhoea haemorrhagic
Clinical narrative: He developed Intussusception. One night hospital admission. Air enema to correct the intussusception.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Enema administration, Ultrasound abdomen
Clinical narrative: He developed Intussusception. One night hospital admission. Air enema to correct the intussusception.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Abdominal X-ray, Blood test, Enema administration, Intussusception, Laboratory test
Clinical narrative: He developed Intussusception. One night hospital admission. Air enema to correct the intussusception.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Ultrasound abdomen
Clinical narrative: He developed Intussusception. One night hospital admission. Air enema to correct the intussusception.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Seizure
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of grand mal seizure in a 59-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of generalised tonic-clonic seizure (Refer case US2018GSK190822). Concurrent medical conditions included multiple sclerosis and gait disturbance. Concomitant products included fish oil, fluoxetine hydrochloride (Prozac) and mirabegron (Myrbetriq). On 14th September 2018, the patient received the 2nd dose of Hz/su + AS01B. On 22nd September 2018, 8 days after receiving Hz/su + AS01B, the patient experienced grand mal seizure (serious criteria GSK medically significant and other: As per reporter), postictal state (serious criteria other: As per reporter), unresponsive to stimuli (serious criteria GSK medically significant and other: As per reporter) and incontinence. On an unknown date, the outcome of the grand mal seizure and incontinence were recovered/resolved and the outcome of the postictal state and unresponsive to stimuli were unknown. It was unknown if the reporter considered the grand mal seizure, postictal state, unresponsive to stimuli and incontinence to be related to Hz/su + AS01B. Additional details were provided as follows: The information was received from the patient's spouse (who was also a physician). The patient received a dose of SHINGRIX in the afternoon. The patient had a generalized seizure while sleeping. During the seizure, the patient was incontinent. After the seizure, the patient was unresponsive for approximately 30 minutes and then postical. The patient's spouse contacted the patient's neurologist who told them the patient could stay at home under observation. Follow up electroencephalogram (EEG) or magnetic resonance imaging (MRl) were unremarkable. The patient's spouse reported that it again took about 36 hours for the patient to return to her baseline state.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure, Incontinence, Nuclear magnetic resonance imaging normal, Postictal state
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of grand mal seizure in a 59-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of generalised tonic-clonic seizure (Refer case US2018GSK190822). Concurrent medical conditions included multiple sclerosis and gait disturbance. Concomitant products included fish oil, fluoxetine hydrochloride (Prozac) and mirabegron (Myrbetriq). On 14th September 2018, the patient received the 2nd dose of Hz/su + AS01B. On 22nd September 2018, 8 days after receiving Hz/su + AS01B, the patient experienced grand mal seizure (serious criteria GSK medically significant and other: As per reporter), postictal state (serious criteria other: As per reporter), unresponsive to stimuli (serious criteria GSK medically significant and other: As per reporter) and incontinence. On an unknown date, the outcome of the grand mal seizure and incontinence were recovered/resolved and the outcome of the postictal state and unresponsive to stimuli were unknown. It was unknown if the reporter considered the grand mal seizure, postictal state, unresponsive to stimuli and incontinence to be related to Hz/su + AS01B. Additional details were provided as follows: The information was received from the patient's spouse (who was also a physician). The patient received a dose of SHINGRIX in the afternoon. The patient had a generalized seizure while sleeping. During the seizure, the patient was incontinent. After the seizure, the patient was unresponsive for approximately 30 minutes and then postical. The patient's spouse contacted the patient's neurologist who told them the patient could stay at home under observation. Follow up electroencephalogram (EEG) or magnetic resonance imaging (MRl) were unremarkable. The patient's spouse reported that it again took about 36 hours for the patient to return to her baseline state.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of grand mal seizure in a 59-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of generalised tonic-clonic seizure (Refer case US2018GSK190822). Concurrent medical conditions included multiple sclerosis and gait disturbance. Concomitant products included fish oil, fluoxetine hydrochloride (Prozac) and mirabegron (Myrbetriq). On 14th September 2018, the patient received the 2nd dose of Hz/su + AS01B. On 22nd September 2018, 8 days after receiving Hz/su + AS01B, the patient experienced grand mal seizure (serious criteria GSK medically significant and other: As per reporter), postictal state (serious criteria other: As per reporter), unresponsive to stimuli (serious criteria GSK medically significant and other: As per reporter) and incontinence. On an unknown date, the outcome of the grand mal seizure and incontinence were recovered/resolved and the outcome of the postictal state and unresponsive to stimuli were unknown. It was unknown if the reporter considered the grand mal seizure, postictal state, unresponsive to stimuli and incontinence to be related to Hz/su + AS01B. Additional details were provided as follows: The information was received from the patient's spouse (who was also a physician). The patient received a dose of SHINGRIX in the afternoon. The patient had a generalized seizure while sleeping. During the seizure, the patient was incontinent. After the seizure, the patient was unresponsive for approximately 30 minutes and then postical. The patient's spouse contacted the patient's neurologist who told them the patient could stay at home under observation. Follow up electroencephalogram (EEG) or magnetic resonance imaging (MRl) were unremarkable. The patient's spouse reported that it again took about 36 hours for the patient to return to her baseline state.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Irritability, Wrong product administered
Clinical narrative: Information has been received from a nurse, referring to a 1 year old male infant. Information of concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On 05-OCT-2018 the patient was inadvertently administered one dose of PROQUAD rHA (recombinant Human albumin) (lot # R004442, 12-AUG-2019, strength and route were unknown) and one dose of VARIVAX (lot R009409, 29-MAR-2020, strength and route were unknown) for prophylaxis. The patient's mother also reported that she gave her son TYLENOL prophylactically but he was not experiencing any adverse effects. This is one of two linked cases received from a same reporter. Sender's Comments: US-009507513-1810USA003716.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a 1 year old male infant. Information of concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On 05-OCT-2018 the patient was inadvertently administered one dose of PROQUAD rHA (recombinant Human albumin) (lot # R004442, 12-AUG-2019, strength and route were unknown) and one dose of VARIVAX (lot R009409, 29-MAR-2020, strength and route were unknown) for prophylaxis. The patient's mother also reported that she gave her son TYLENOL prophylactically but he was not experiencing any adverse effects. This is one of two linked cases received from a same reporter. Sender's Comments: US-009507513-1810USA003716.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, Irritability, Wrong product administered
Clinical narrative: Information has been received from a nurse, referring to a 1 year old male infant. Information of concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On 05-OCT-2018 the patient was inadvertently administered one dose of PROQUAD rHA (recombinant Human albumin) (lot # R004442, 12-AUG-2019, strength and route were unknown) and one dose of VARIVAX (lot R009409, 29-MAR-2020, strength and route were unknown) for prophylaxis. The patient's mother also reported that she gave her son TYLENOL prophylactically but he was not experiencing any adverse effects. This is one of two linked cases received from a same reporter. Sender's Comments: US-009507513-1810USA006623.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a 1 year old male infant. Information of concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On 05-OCT-2018 the patient was inadvertently administered one dose of PROQUAD rHA (recombinant Human albumin) (lot # R004442, 12-AUG-2019, strength and route were unknown) and one dose of VARIVAX (lot R009409, 29-MAR-2020, strength and route were unknown) for prophylaxis. The patient's mother also reported that she gave her son TYLENOL prophylactically but he was not experiencing any adverse effects. This is one of two linked cases received from a same reporter. Sender's Comments: US-009507513-1810USA006623.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Aggression, Amnesia, Anxiety, Blood glucose decreased, Blood magnesium decreased
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Confusional state, Diabetic coma, Differential white blood cell count, Fear, Full blood count
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Hyperhidrosis, Hypoglycaemia, Impaired driving ability, Metabolic function test, Troponin I
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Urine analysis, Vision blurred
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Blood glucose decreased, Diabetic coma, Hyperhidrosis, Hypoglycaemia, Impaired driving ability
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Road traffic accident, Vision blurred
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Diabetic coma, Hyperhidrosis, Hypoglycaemia
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 71 years old female patient who experienced diabetic coma, sweating profusely, hypoglycemia and while driving things got blurry and crashing into cornfield, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 at 3:15, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiration date: 30-Jun-2019 via unknown route in the left arm. On 09-Oct-2018, the patient experienced a serious diabetic coma within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On 09-Oct-2018, the patient experienced a non-serious sweating profusely and hypoglycemia within one hour following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 09-Oct-2018, the patient developed a non-serious while driving things got blurry and crashing into cornfield (Consumer was driving at the time) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient was taken to ER. Other relevant tests included blood sugar was 30. Final diagnosis was while driving things got blurry, hypoglycemia, sweating profusely and diabetic coma. The patient received a corrective treatment with sugar water/glucose in a tube. The patient was unable to report medicine name. Consumer reported she ate and blood sugar came back up. The patient outcome is not reported. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who presented with hypoglycemia and associated symptoms (incl. diabetic coma) the same day after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. There is no mention of diabetes as ongoing condition in this patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 44.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Hyperhidrosis
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 44 years old female patient who experienced shakiness, felt super-hot and flushed and sweat being sopping, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. 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 via unknown route in unknown administration site. On an unknown date at 3:45 PM, the patient developed a non-serious shakiness, felt super-hot and flushed and sweat being sopping following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Relevant tests included Test Name: blood sugar test, Date: UNK Result: decrease. Final diagnosis was sweat being sopping, felt super-hot and flushed and shakiness. No corrective treatment was received. The patient was recovered after 1 hour from events. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Blood glucose decreased, Feeling hot, Flushing, Hyperhidrosis, Tremor
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 44 years old female patient who experienced shakiness, felt super-hot and flushed and sweat being sopping, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. 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 via unknown route in unknown administration site. On an unknown date at 3:45 PM, the patient developed a non-serious shakiness, felt super-hot and flushed and sweat being sopping following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Relevant tests included Test Name: blood sugar test, Date: UNK Result: decrease. Final diagnosis was sweat being sopping, felt super-hot and flushed and shakiness. No corrective treatment was received. The patient was recovered after 1 hour from events. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: On 10/22/18 patient was administered another dose of FLUZONE HD. The patient previously received a dose on 09/18/2018.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: On 10/22/2018 patient was administered another dose of FLUZONE HD. The patient previously received a dose on 09/18/2018.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pain, Pyrexia
Clinical narrative: Night fever about 103 degrees starting 1w hour a after shot approx. Maybe earlier in her sleep. Flushing. Resp rate 40-50 per min. Heart rate 120. Severe body aches. Fever poorly controlled by MOTRIN. Required MOTRIN and TYLENOL around the clock to keep fever down.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Erythema, Skin warm, Swelling
Clinical narrative: After 48 hrs turned red, hot, swollen, burning sensation. Over 2 inches long of redness.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Immobile
Clinical narrative: Extreme tiredness, I slept or was in bed 20 out of 24 hours. This happened 24 hours after the injection. It exacerbated my usual back pain to the extent I became functionally immobile. The only side effect of the first injection 3 months ago was a very sore arm at the injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection site soreness ..101 fever.. Body aches... weakness...Fever gone by next morning.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an administrator referring to multiple patients of unknown age and gender. The patients' concurrent condition, concomitant medication and medical history were not reported. On unknown date (s), the patients' were vaccinated with improperly stored ROTATEQ (lot # N030176, expiration date 17-JUN-2019; lot# N034400, expiration date 10-MAY-2019) for prophylaxis. The vaccine was exposed to temperature excursion of 9 Celsius degrees to 25 Celsius degrees for 44 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This case was considered to be Non-Valid case due to lack of patient's identifier.
Sex: U
Vaccine: HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with incorrectly storage GARDASIL 9 (dose, route of administration, lot # and expiration date were unspecified), M-M-R II (dose, route of administration, lot # and expiration date were unspecified) and ROTATEQ orally (dose, lot # and expiration date were unspecified) all for prophylaxis. No adverse event were reported. Digital data logger was involved.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist, referring to a 75 year old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On 21-SEP-2016, the patient was vaccinated with one dose of PNEUMOVAX 23 (0.5 ml; strength, lot # and expiration date unknown) intramuscularly for prophylaxis. On 01-OCT-2018, the patient was vaccinated with another dose of PNEUMOVAX 23 (0.5 ml, lot # R000692, expiration date: 09-SEP-2019; strength unknown) intramuscularly for prophylaxis. No adverse effect was reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 67 year old female patient with hypertension and osteoporosis. Concomitant therapies included FOSAMAX, calcium (unspecified) and lisinopril. The patient was allergic to adhesive tape. On 04-OCT-2018 the patient was administered an improperly stored dose of PNEUMOVAX 23 (lot # R009162 and expiration date 06-JAN-2020, intramuscular, strength, dose and frequency were not reported) for prophylaxis. On the same date hours after receiving the PNEUMOVAX 23, the patient experienced an unspecified injection site reaction that lasted for an unspecified amount of time. No treatment was given to the patient. No lab diagnostics/studies were performed. The patient did not seek medical attention. The patient recovered from the injection site reaction on an unknown date in October 2018. The causality was not provided. The temperature excursion was 32 Fahrenheit to 35 Fahrenheit for 10 hours. There was no previous excursion. The call was because of a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 05-OCT-2018 the patient was administered an improperly stored dose of VARIVAX (lot # N030409 and expiration date 30-OCT-2019, route, strength and frequency were not reported) with properly stored sterile diluent (MERCK) for prophylaxis. The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 days and -9 degrees Celsius to 8 degrees Celsius for 3 days. There were no previous excursions reported. The call was not because of a data logger. No adverse effect was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA006946: US-009507513-1810USA004588.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Paralysis
Clinical narrative: This spontaneous report has been received from a 60 years old female patient referring to herself. The patient's concomitant medication included unspecified flu shot. The patient had none pertinent medical history or drug reactions/allergies. On 03-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (batch/lot#, expiration date and route were unknown) for prevention of pneumonia. On the same day, the patient's arm started to hurt and it became full body pain for about 48 hours. The patient couldn't move and felt like paralyzed. No treatment was given for all the events and no lab diagnostics/studies were performed. The patient didn't sought medical attention. The outcome of all the events was reported as recovering. The causality between PNEUMOVAX 23 and all the events was unknown. Upon internal review, the event of paralyzed was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 20-JAN-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his (Conflicting information, as patient's first name is a female name) body. The patient did not have a shingles outbreak until 02-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information) condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, 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. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the shingles outbreak to be related to ZOSTAVAX. The event of Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a seven patients (unknown gender) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to over dose, inappropriate age at vaccine administration (seven patients who were under 65 years received FLUZONE HD vaccine) and Off label use (off label use of FLUZONE HD). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves five patients of an unknown demographics who were vaccinated with a dose of FLUZONE HD lot number not reported on an unknown date. The patient's past medical history, medical treatment(s), vaccination(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 medical assistant gave high dose to 5 patients under 65 years of age. It was not reported if the patient experienced any administered or not. 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. Documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old male patient who was inadvertently vaccinated with extra dose of 0.5 ml FLUZONE HIGH DOSE lot UJ036AB, exp date: 09 May 2019 via intramuscular route in the left deltoid on 15-Oct-2018. No information regarding medical history. Concomitant vaccine included PREVENAR 13 on 15-Oct-2018. It is an actual medication error due to extra dose administered. It was reported that the patient received a first dose three weeks ago and inadvertently received a second dose on 15Oct2018. It was unknown that any adverse event was occurred or not. 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 2001/83/EC 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: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 63 years old female patient for whom they have a patient under 65 yr old a FLUZONDE HD yesterday was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 16-Oct-2018, the patient received a 0.5 ml  once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI977AC via intramuscular route in the right deltoid. The patient developed a non-serious they have a patient under 65 yr old a FLUZONE HD yesterday (drug administered to patient of inappropriate age) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient had not reported any side effects. Lab data was not reported. Final diagnosis was they have a patient under 65 yr old a FLUZONE HD yesterday.  This case is actual medication error due to inappropriate age at vaccine administration. Outcome of the event was not applicable. 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. Documents held by sender: none
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years and four months old female patient and reported that 0.25 ml, in a prefilled-syringe, IM, was administered in the left arm of a patient that was 3years and 4 months old, she should have received the 0.5 ml dose, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 16-Oct-2018, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT626ma and expiry date: 30-Jun-2019) via intramuscular route in the left arm. It was a case of actual medication error due to under dose. 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 2001/83/EC 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.
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non- health care professional office staff. This case involves a 63 years old male patient and reported that employee administered FLUZONE HIGH DOSE to a 63 year old patient, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. 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 2001/83/EC 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: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chills, Cough, Decreased appetite, Dizziness
Clinical narrative: Patient states that after receiving the vaccine later that night, he started experiencing cold; shivering and went to bed early. The next morning he woke up experiencing dizziness and could not function. He was very thirsty, he drunk 10 glasses of water and felt very sick and his stomach could not digest water. He states he was experiencing intense sweats, very warm and very cold, tension in the head, feeling dizzy, coughing and loss of appetite in the past 4 - 5 days. Patient states that last night he was cold and had 2 - 3 layers of clothes and a blanket. He went to see his PCP for the severe thirst and they ran blood work. The results of this blood work are still pending as of this morning of 10/23/18 and patient stated feeling better today.