chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Respiratory depression
Clinical narrative: Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.
Age: 94.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Cough, Death, Hypertension, Hypoxia, Respiratory depression
Clinical narrative: Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Areflexia, Asthenia, Autonomic nervous system imbalance, Blood product transfusion, Body temperature decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 63 year old male with hypertension, obesity, glaucoma and gastroesophageal reflux disease on 21-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659407/0295X) IM. The patient presented to hospital on 04-JUN-2008 with 1 week history of progressive numbness and weakness. Exam was notable for significant facial weakness, dysarthria proximal > distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. The patient was thought to have Guillain Barre syndrome. Subsequently the patient was noted to have autonomic dysfunction with labile blood pressure (BP), syncope X2, pulse and profuse diaphoresis, LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes were pending, but no history of recent illness was reported. The presentation was quite consistent with a vaccine induced GBS. The patient was currently receiving intravenous immunoglobulin (IVIG), tolerating well with questionable improvement after fourth infusion. On 30-JUL-2008 records were received for date of service 04-JUN-2008 to 17-JUN-2008 with discharge diagnosis of Guillain-Barre syndrome. The patient presented with complaint of 7 day history of numbness in hands, arms, feet, legs and tongue. The day after onset of symptoms the patient felt better and played golf. The symptoms began 1 week after vaccine. Physical examination (PE) showed decreased temperature sensation cranial nerve 7 inability to close eyes, positive Romberg decreased strength in extremities, wide-based gait. No reflexes in upper or lower extremities were reported. The patient was treated with IVIG. The patient also experienced syncope. The listing indicated that one or more events required hospitalization and were considered to be life threatening. No further information is expected. The lab tests were performed as following: magnetic resonance imaging with the result of cervical MRI showed disc bulging at C6-7; blood pressure measurement with the result of SBPs ranging from 190 to 60: cerebrospinal fluid analysis with notable for absence of nucleated cells wi and spinal tap that had to be performed in reverse trendelenberg to prevent syncope. Standard lot check investigations were performed on lot # 659407/0295X. All in-process quality checks for the lot number in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and were released. This was originally reported by a consumer. The VAERS ID is 316165.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF test abnormal, Dysarthria, Eyelid function disorder, Facial paresis, Gait disturbance
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 63 year old male with hypertension, obesity, glaucoma and gastroesophageal reflux disease on 21-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659407/0295X) IM. The patient presented to hospital on 04-JUN-2008 with 1 week history of progressive numbness and weakness. Exam was notable for significant facial weakness, dysarthria proximal > distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. The patient was thought to have Guillain Barre syndrome. Subsequently the patient was noted to have autonomic dysfunction with labile blood pressure (BP), syncope X2, pulse and profuse diaphoresis, LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes were pending, but no history of recent illness was reported. The presentation was quite consistent with a vaccine induced GBS. The patient was currently receiving intravenous immunoglobulin (IVIG), tolerating well with questionable improvement after fourth infusion. On 30-JUL-2008 records were received for date of service 04-JUN-2008 to 17-JUN-2008 with discharge diagnosis of Guillain-Barre syndrome. The patient presented with complaint of 7 day history of numbness in hands, arms, feet, legs and tongue. The day after onset of symptoms the patient felt better and played golf. The symptoms began 1 week after vaccine. Physical examination (PE) showed decreased temperature sensation cranial nerve 7 inability to close eyes, positive Romberg decreased strength in extremities, wide-based gait. No reflexes in upper or lower extremities were reported. The patient was treated with IVIG. The patient also experienced syncope. The listing indicated that one or more events required hospitalization and were considered to be life threatening. No further information is expected. The lab tests were performed as following: magnetic resonance imaging with the result of cervical MRI showed disc bulging at C6-7; blood pressure measurement with the result of SBPs ranging from 190 to 60: cerebrospinal fluid analysis with notable for absence of nucleated cells wi and spinal tap that had to be performed in reverse trendelenberg to prevent syncope. Standard lot check investigations were performed on lot # 659407/0295X. All in-process quality checks for the lot number in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and were released. This was originally reported by a consumer. The VAERS ID is 316165.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Intervertebral disc protrusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 63 year old male with hypertension, obesity, glaucoma and gastroesophageal reflux disease on 21-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659407/0295X) IM. The patient presented to hospital on 04-JUN-2008 with 1 week history of progressive numbness and weakness. Exam was notable for significant facial weakness, dysarthria proximal > distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. The patient was thought to have Guillain Barre syndrome. Subsequently the patient was noted to have autonomic dysfunction with labile blood pressure (BP), syncope X2, pulse and profuse diaphoresis, LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes were pending, but no history of recent illness was reported. The presentation was quite consistent with a vaccine induced GBS. The patient was currently receiving intravenous immunoglobulin (IVIG), tolerating well with questionable improvement after fourth infusion. On 30-JUL-2008 records were received for date of service 04-JUN-2008 to 17-JUN-2008 with discharge diagnosis of Guillain-Barre syndrome. The patient presented with complaint of 7 day history of numbness in hands, arms, feet, legs and tongue. The day after onset of symptoms the patient felt better and played golf. The symptoms began 1 week after vaccine. Physical examination (PE) showed decreased temperature sensation cranial nerve 7 inability to close eyes, positive Romberg decreased strength in extremities, wide-based gait. No reflexes in upper or lower extremities were reported. The patient was treated with IVIG. The patient also experienced syncope. The listing indicated that one or more events required hospitalization and were considered to be life threatening. No further information is expected. The lab tests were performed as following: magnetic resonance imaging with the result of cervical MRI showed disc bulging at C6-7; blood pressure measurement with the result of SBPs ranging from 190 to 60: cerebrospinal fluid analysis with notable for absence of nucleated cells wi and spinal tap that had to be performed in reverse trendelenberg to prevent syncope. Standard lot check investigations were performed on lot # 659407/0295X. All in-process quality checks for the lot number in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and were released. This was originally reported by a consumer. The VAERS ID is 316165.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Positive Rombergism, Sensory loss, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 63 year old male with hypertension, obesity, glaucoma and gastroesophageal reflux disease on 21-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659407/0295X) IM. The patient presented to hospital on 04-JUN-2008 with 1 week history of progressive numbness and weakness. Exam was notable for significant facial weakness, dysarthria proximal > distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. The patient was thought to have Guillain Barre syndrome. Subsequently the patient was noted to have autonomic dysfunction with labile blood pressure (BP), syncope X2, pulse and profuse diaphoresis, LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes were pending, but no history of recent illness was reported. The presentation was quite consistent with a vaccine induced GBS. The patient was currently receiving intravenous immunoglobulin (IVIG), tolerating well with questionable improvement after fourth infusion. On 30-JUL-2008 records were received for date of service 04-JUN-2008 to 17-JUN-2008 with discharge diagnosis of Guillain-Barre syndrome. The patient presented with complaint of 7 day history of numbness in hands, arms, feet, legs and tongue. The day after onset of symptoms the patient felt better and played golf. The symptoms began 1 week after vaccine. Physical examination (PE) showed decreased temperature sensation cranial nerve 7 inability to close eyes, positive Romberg decreased strength in extremities, wide-based gait. No reflexes in upper or lower extremities were reported. The patient was treated with IVIG. The patient also experienced syncope. The listing indicated that one or more events required hospitalization and were considered to be life threatening. No further information is expected. The lab tests were performed as following: magnetic resonance imaging with the result of cervical MRI showed disc bulging at C6-7; blood pressure measurement with the result of SBPs ranging from 190 to 60: cerebrospinal fluid analysis with notable for absence of nucleated cells wi and spinal tap that had to be performed in reverse trendelenberg to prevent syncope. Standard lot check investigations were performed on lot # 659407/0295X. All in-process quality checks for the lot number in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and were released. This was originally reported by a consumer. The VAERS ID is 316165.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal X-ray, Activities of daily living impaired, Blood product transfusion, Chest X-ray, Dysphagia
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia facial, Insomnia
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Intensive care, Mechanical ventilation, Paralysis, Post-traumatic stress disorder, Respiratory failure
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tracheostomy
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Anaemia, Anxiety, Asthenia, Balance disorder
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Dysphagia, Economic problem, Emotional distress, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Pain, Palpitations, Respiratory disorder
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tremor, Vision blurred
Clinical narrative: Guillain-Barre Follow-up: Ongoing dizziness, weakness, respiratory issues. Swallowing difficulty - balance issues, anemia, numbness. Anxiety - headaches - blurred vision - tremors with physical exertion - Unable to even sing, unable to go to my grandchildren events in case some one is sick there -- Pain, palpitations. I have been without an income Full since - 12/08, partial since /09. I have had to sell my car. Unable to help my 1st daughter financially or physically get married. The emotional trauma of going from a healthy productive women to being unable to work make an income is unbelievable. It is like I am a villain and need to prove something that I deserve - like disability - shame on our government.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Gaze palsy, Malaise
Clinical narrative: Information has been received from a physician concerning a 11 year old (also reported as 15 year old) female with allergy to penicillin (PCN) and POLYTRIM eye drops and a medical history of syncope (cleared by neurologist and cardiologist) who on 14-MAY-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 660616/0570X). Concomitant therapy included MENACTRA (lot# U2875AA). The physician reported that the patient received the first dose of GARDASIL "2 months ago" (on 14-MAY-2009). The office was busy and was unable to observe the patient after vaccination (was not observed for 15 minutes post vaccination). When the patient went to the car, she had a 30-second seizure in the parking lot. No treatment was required. The patient recovered. The patient's mother sought medical attention through a telephone call. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 11 year old (also reported as 15 year old) female with allergy to penicillin (PCN) and POLYTRIM eye drops and a medical history of syncope (cleared by neurologist and cardiologist) who on 14-MAY-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 660616/0570X). Concomitant therapy included MENACTRA (lot# U2875AA). The physician reported that the patient received the first dose of GARDASIL "2 months ago" (on 14-MAY-2009). The office was busy and was unable to observe the patient after vaccination (was not observed for 15 minutes post vaccination). When the patient went to the car, she had a 30-second seizure in the parking lot. No treatment was required. The patient recovered. The patient's mother sought medical attention through a telephone call. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase normal, Muscular weakness, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician on 01-JUL-2009 concerning a male patient who on 22-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed myalgias (another symptom was mentioned on the after hours voice mail but the word was unclear to determine what the symptom was) with polymyalgia rheumatica. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the physician concerning a 76 year old male with mild hemochromatosis, no known drug allergies and no illness at the time of vaccination who on 22-DEC-2008 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck). On 23-DEC-2008 the patient experienced myalgias, muscle weakness and polymyalgia rheumatica. The value of the patient's erythrocyte sedimentation rate (ESR) was 71 on 17-MAR-2009. In July 2009, the patient recovered. Myalgias, polymyalgia rheumatica and muscle weakness were considered to be disabling by the physician. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician on 01-JUL-2009 concerning a male patient who on 22-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed myalgias (another symptom was mentioned on the after hours voice mail but the word was unclear to determine what the symptom was) with polymyalgia rheumatica. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the physician concerning a 76 year old male with mild hemochromatosis, no known drug allergies and no illness at the time of vaccination who on 22-DEC-2008 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck). On 23-DEC-2008 the patient experienced myalgias, muscle weakness and polymyalgia rheumatica. The value of the patient's erythrocyte sedimentation rate (ESR) was 71 on 17-MAR-2009. In July 2009, the patient recovered. Myalgias, polymyalgia rheumatica and muscle weakness were considered to be disabling by the physician. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old female with no medical history or concurrent condition was vaccinated orally with the third dose of ROTATEQ (lot# 660377/0274X) on 15-MAY-2009. Suspect therapy included the third dose of RECOMBIVAX HB (lot# 663281/0085Y) vaccinated intramuscularly in the left leg on 15-MAY-2009. Concomitant therapy included the third dose of PREVNAR (lot# D34438) vaccinated intramuscularly in the right leg and the third dose of QUADRACEL (lot# C3224AA) vaccinated intramuscularly in the left leg on the same date. The patient developed intussusception on 25-MAY-2009. Air contrast enema was performed, but no result was provided. The patient required an emergency room visit. A standard lot check investigation was performed. All in-process quality checks for lot number 660377/0274X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. A standard lot check investigation was performed. All in-process quality checks for lot number 663281/0085Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The listing indicated that the events required hospitalization and was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 348346. No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Biopsy bone marrow, Chemotherapy, Computerised tomogram, Deafness
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Echocardiogram, Lymphadenopathy, Nasopharyngitis, Non-Hodgkin's lymphoma, Positron emission tomogram abnormal
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Surgery
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chemotherapy, Computerised tomogram abnormal, Deafness unilateral, Diffuse large B-cell lymphoma, Haemorrhage
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lymphadenopathy, Mass, Non-Hodgkin's lymphoma, Pain
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aspiration biopsy, Aspiration bone marrow, Chemotherapy, Computerised tomogram abnormal, Deafness unilateral
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diffuse large B-cell lymphoma, Echocardiogram, Laryngoscopy, Lymphadenopathy, Lymphoma
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neoplasm, Non-Hodgkin's lymphoma, Positron emission tomogram abnormal, Surgery
Clinical narrative: On 02/02/09, patient had ZOSTAVAX vaccine injection to prevent shingles on advice of family doctor. In March, patient experienced loss of hearing in right ear and was treated by ENT specialist. On 04/13/09, patient was diagnosed with lymphoma via fine needle biopsy. Surgical biopsies on 04/29/09 confirmed diffuse large B-cell non-Hodgkins lymphoma. Neck glands were badly swollen, and a growth in nasopharynx was obstructing the ear canal, causing hearing loss.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from the husband of a 63 year old female with "heart condition" who was vaccinated with a dose of PNEUMOVAX 23 and influenza virus vaccine (unspecified). The patient was hospitalized after receiving the vaccines. The patient's husband reported his wife might be allergic to eggs and the egg component of the vaccines. The husband did not specify the manufacturers of any of the vaccines, however mentioned that she got the vaccines sometime in the 90s. At the report time the outcome was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse (R.N.), for the Pregnancy Registry for GARDASIL, concerning a 22 year old female who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL (first lot #0151X, second lot #0250X) on 28-APR-2008 and 30-JUN-2008, respectively. The patient had 3 previous pregnancies and 2 elective terminations. Subsequently, the patient discovered that she was pregnant. Her LMP was 15-JUN-2008. On 03-SEP-2008, she had ultrasound and "the results were normal and she was 12 weeks gestation at that time". On 13-OCT-2008, she had serum alpha-fetoprotein test and the result was normal. No adverse effects reported. The patient sought medical attention via office visit. Additional information was received from a physician via Initial Pregnancy Questionnaire. The physician reported the patient had 3 previous pregnancies and 2 elective terminations. The patient's LMP was 15-JUN-2008 and estimated delivery date was 02-MAR-2009. The result of patient's serum alpha-fetoprotein test was normal on 13-OCT-2008. Follow up information was received via pregnancy questionnaire indicated that the patient delivered a normal male baby on 05-MAR-2009, 38-39 weeks from the patient's LMP, weighting 9.1, length 21 inches. There was no congenital anomalies, complication, infections or illnesses during pregnancy and no complication during labor/delivery. It was also noted that the patient took VITAFOL during this pregnancy. Follow up information was received which reported the patient with G3P0 on 05-MAR-2009 underwent C-section. The baby was well health. Upon internal review, the C-section was determined to be an other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Laboratory test, Multiple sclerosis, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning his 25 year old god-daughter who, 4 or 5 months ago, in approximately February 2009, was vaccinated with her first dose of GARDASIL (route and site not reported). About a week later the patient experienced numbness on her lower body. When the patient sought medical attention, she underwent MRI and other various tests and the doctors diagnosed her with multiple sclerosis (MS). At the time of reporting the patient's multiple sclerosis persisted. Upon internal review, multiple sclerosis was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested. 10/2/09 Medical records received for Neurologist consultation for dates of service 6/30/09 and 7/15/09. DX: MS.  Presenting symptoms: initial episode of left arm and leg numbness and hives 1 day after gardasil vaccination. Later 5/09 episode numbness from navel down, abnormal sensation in both legs, bowel and bladder incontinence, later resolved. Vertigo.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Multiple sclerosis, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning one of her co workers who was vaccinated with a dose of GARDASIL (date, route and site not reported). Subsequently the patient started to experienced numbness and tingling in her right arm, hand and her feet. A few months later the patient was diagnosed with multiple sclerosis (MS). The outcome of the patient's multiple sclerosis was not reported. Upon internal review, multiple sclerosis was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Crohn's disease, Diarrhoea, Pancreatitis
Clinical narrative: Information has been received from a physician concerning his 76 year old wife with Crohn's disease and a history of pancreatitis with the use of PURINETHOL who on 07-JUL-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included prednisolone (5mg every other day). It was reported that 14 days after receiving the vaccine, on 23-JUL-2009, the patient had a flare of her Crohn's disease. She had had mild diarrhea and the physician was treating her with PEPTO BISMOL. Upon rechallenge with PURINETHOL, the patient again experienced pancreatitis. At the time of reporting, the patient had not recovered from flare of her Crohn's disease. The outcome of the pancreatitis was not reported. Upon internal review, pancreatitis was considered to be an other important medical event. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Encephalitis post immunisation
Clinical narrative: Information has been received from a physician and a nurse concerning a 61 year old male patient who on 08-JUL-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number not reported). It was reported that on approximately 14-JUL-2009 the patient developed encephalitis after the vaccination. The patient was admitted to hospital on 14-JUL-2009 for the encephalitis. At the time of the report, the patient had been home for a while and was doing better. The physician didn't known if the patient's experience had anything to do with the vaccine. Additional information has been requested.
Age: 1.8
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Condition aggravated
Clinical narrative: Febrile seizure. 8/21/09 ERrecords received for DOS 7/17/09 with dx:  Acute fever and seizures recurrent. Generalized tonic-clonic seizures following vaccinations. Pt presented several hours after receiving vax, with fever and several episodes of tonic-clonic activity.  HR 180's. RR 30's. T' 101.6'F. No further seizures with meds and reduction of fever.  8/31/09 ICD-9 Code: 780.31 Febrile seizures (simple) unspecified.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blood test, Convulsion, Electroencephalogram, Gaze palsy, Loss of consciousness
Clinical narrative: Initial report was received 27 July 2009 from another manufacturer (reference number WAES 0906USA04755), who received the report from a health care professional. The following is verbatim from the report: "Information has been received from a nurse practitioner concerning a 5 year old male patient who on 11-MAY-2009 was vaccinated with a second dose of MMRII (lot # 663519/1771X) 0.5ml, subcutaneously. Concomitant therapy also given on 11-MAY-2009, included tuberculin purified protein derivative (manufacturer unknown), DAPTACEL and IPOL. After he got the three shots and before he got MMRII "his head leaned over to the side like he had passed out". The nurse grabbed him and he started having "seizure like movements". Oxygen was administered as an intervention to prevent serious criteria. The office called 911, and he was transported to the emergency room but was not admitted. He was still having "seizure like movements" when he was taken from the office. There was no information whether or not the seizure like movements stopped and then restarted before he was taken from the office or if they lasted from when they first started until he was taken from the office. Unspecified date the patient recovered. Electroencephalography (EEG) and blood work were performed, results not reported" "Follow up information has been received via telephone call from the nurse who indicated the physician had set the patient up with a neurologist to rule out seizure disorder. The patient had no problems after receiving the first dose of MMRII." "Follow up information has received from a health care professional concerning a 5 year old male patient with no pertinent medical history and no known drug allergies, who on 11-MAY-2009 was vaccinated with the second dose of MMRII (lot # 663519/1771X) in the right deltoid, a fifth dose of DAPTACEL (lot# C3139AA) in the left deltoid and a fourth dose of POLIOVAX (Lot # B0009) in the left deltoid at 2:30 pm. On 11-MAY-2009 after given the last dose of MMRII the patient started shaking, his eyes rolled back, then he started seizuring. The patient required a visit to emergency room/doctor visit. On 11-MAY-2009, the patient recovered." "Upon internal review seizure was determined to be an other important medical event. No further information is available." Upon receipt of the above information from the other manufacturer, it was determined that (Lot # B009) (previously referred to in the above paragraph as POLIOVAX), pertained to IPOL. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Tremor
Clinical narrative: Initial report was received 27 July 2009 from another manufacturer (reference number WAES 0906USA04755), who received the report from a health care professional. The following is verbatim from the report: "Information has been received from a nurse practitioner concerning a 5 year old male patient who on 11-MAY-2009 was vaccinated with a second dose of MMRII (lot # 663519/1771X) 0.5ml, subcutaneously. Concomitant therapy also given on 11-MAY-2009, included tuberculin purified protein derivative (manufacturer unknown), DAPTACEL and IPOL. After he got the three shots and before he got MMRII "his head leaned over to the side like he had passed out". The nurse grabbed him and he started having "seizure like movements". Oxygen was administered as an intervention to prevent serious criteria. The office called 911, and he was transported to the emergency room but was not admitted. He was still having "seizure like movements" when he was taken from the office. There was no information whether or not the seizure like movements stopped and then restarted before he was taken from the office or if they lasted from when they first started until he was taken from the office. Unspecified date the patient recovered. Electroencephalography (EEG) and blood work were performed, results not reported" "Follow up information has been received via telephone call from the nurse who indicated the physician had set the patient up with a neurologist to rule out seizure disorder. The patient had no problems after receiving the first dose of MMRII." "Follow up information has received from a health care professional concerning a 5 year old male patient with no pertinent medical history and no known drug allergies, who on 11-MAY-2009 was vaccinated with the second dose of MMRII (lot # 663519/1771X) in the right deltoid, a fifth dose of DAPTACEL (lot# C3139AA) in the left deltoid and a fourth dose of POLIOVAX (Lot # B0009) in the left deltoid at 2:30 pm. On 11-MAY-2009 after given the last dose of MMRII the patient started shaking, his eyes rolled back, then he started seizuring. The patient required a visit to emergency room/doctor visit. On 11-MAY-2009, the patient recovered." "Upon internal review seizure was determined to be an other important medical event. No further information is available." Upon receipt of the above information from the other manufacturer, it was determined that (Lot # B009) (previously referred to in the above paragraph as POLIOVAX), pertained to IPOL. Documents held by sender: None.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Initial report received on 27 July 2009 from another manufacturer whose initial reporter was a consumer. A unidentified male patient received INFLUENZA VACCINE (manufacturer and lot number unknown) on an unspecified date. Post vaccination the patient developed paralysis for a few months and had "Geon Berry disease". The patient stated that he did not want to provide further information because the facility has already documented this information. Recovery status was not reported. List of Documents held by Sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Initial report was received from another manufacturer (document number 45221964) who received the report from a health care professional. A female patient (age and date of birth not reported) had received ADACEL (lot number, route, site and date of administration not reported). According to the reporter, "the patient fainted after ADACEL (Sanofi Pasteur) was given and when she had a finger stick blood test drawn the same day". No additional information was provided. Per the reporter, the medical assistant who reported the event to the other manufacturer, and the patient's physician, requested no further contact be made. Documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Asthenia, Cold sweat, Feeling hot, Haematemesis
Clinical narrative: I received an anthrax shot at 0830 on 01AUG09.  As lunch time drew near, I began getting a terrible headache.  I ate lunch and the headache persisted.  I then started to have stomach pain and broke into a cold sweat.  At 1530, I drove home and vomited violently.  I noticed blood in the vomit.  After vomiting again, my wife drove me to the hospital.  I vomited again 3 hours later.  I spent the night in the hospital on an I.V.  I was not able to attend my drill on Sunday due to doctor's orders.  I was also extremely weak from the vomiting and lack of sleep.  I was in drill status on 01AUG09 when the incident occurred.  I am still quite weak today, 04AUG09.  In addition, on 01AUG09, I had a physical fitness test immediately before receiving the anthrax shot.  I was still hot and sweating. 8/25/09-ED records received for DOS 8/1/09-DX-Headache, vomiting. C/O headache, vomiting, feeling dizzy. 9/28/09 ICD9 codes received: 784.0, 787.03, E948.8