chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV4, MMR, MNQ, HPV4, MMR, MNQ
Symptoms: Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: Case number PHHY2013US127758 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498321) website on 11 Nov 2013, with a follow up received from the QA department (264315) on 15 Nov 2013, with a follow up received from the QA department on 29 Nov 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M11077) intramuscularly, GARDASIL (other manufacturer, batch number: H014645) intramuscularly and MMR II (other manufacturer, batch number: H010134) subcutaneously on 29 Jul 2013. On the same day, after vaccination, he became diaphoretic and developed dizziness and blurred vision. And his blood pressure was reported as 74/42 at 10:53 am, 84/44 at 10:58 am and 110/54 at 11:03 am. It was reported that this was atypical reaction for this patient. Outcome of the events was reported as recovered on the same day. Seriousness and causality were not reported for the events. Based on the batch review, it was stated that the concerned MENVEO batch number M11077 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the QA department on 15 Nov 2013: Updated QA reference number (264315) only. Significant follow up received from the QA department on 29 Nov 2013: Updated batch report.
Age: 35.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Chills, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2013US127698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499296) website on 11 Nov 2013 with a follow up received from the quality assurance department (QA reference number: 263328) on 02 Dec 2013. This report refers to a 35-year-old female patient. Her historical drugs included PHENERGAN and COMPAZINE. This poly medicated patient was vaccinated with MENVEO (batch number: A12011) in the right arm on 02 Aug 2013. On 04 Aug 2013, her injection site became very red and sore. On 07 Aug 2013, she went to emergency room (ER) and was treated for allergic reaction with antibiotic. On an unknown date, she was having chills and fever and so went back to ER and was diagnosed with cellulitis. She was hospitalized for 3 days and treated with antibiotics. The patient was released on oral antibiotics and was doing well. The seriousness of the events (injection site red and sore, allergic reaction) were not reported. The causality of the events was not reported. Based on the batch review report it was concluded that the concerned MENVEO batch A12011 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirement. Follow up information received from the quality assurance department on 02 Dec 2013: Update batch review report.
Age: 35.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US127698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499296) website on 11 Nov 2013 with a follow up received from the quality assurance department (QA reference number: 263328) on 02 Dec 2013. This report refers to a 35-year-old female patient. Her historical drugs included PHENERGAN and COMPAZINE. This poly medicated patient was vaccinated with MENVEO (batch number: A12011) in the right arm on 02 Aug 2013. On 04 Aug 2013, her injection site became very red and sore. On 07 Aug 2013, she went to emergency room (ER) and was treated for allergic reaction with antibiotic. On an unknown date, she was having chills and fever and so went back to ER and was diagnosed with cellulitis. She was hospitalized for 3 days and treated with antibiotics. The patient was released on oral antibiotics and was doing well. The seriousness of the events (injection site red and sore, allergic reaction) were not reported. The causality of the events was not reported. Based on the batch review report it was concluded that the concerned MENVEO batch A12011 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirement. Follow up information received from the quality assurance department on 02 Dec 2013: Update batch review report.
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dyskinesia, Fall, Syncope
Clinical narrative: This case was received on 04 December 2013 via a third party query tool search on the VAERS database, under reference number 50169. A 21 year-old male patient had received the following vaccinations on 13 August 2013: a left arm injection of ACAM2000 (lot number VV04003A), an intramuscular right arm injection of TYPHIMVI (lot number H1418) and an intramuscular right arm injection of BIOTHRAX (lot number FAV317A). Anthrax and typhoid vaccinations were administered without incident, then approximately 3-4 minutes later the smallpox vaccine was administered while the patient was seated in a chair. At the 13th scarification, the patient began to faint. An ammonia inhaler was administered. The patient did not respond. His arms and legs were jerking and the patient slumped to the floor. After approximately 30 seconds, he became more alert and was oriented to person and place. An office worker and one corpsman were present at the time of the reaction. The patient was assisted back into a chair without incident. The patient's vital signs were stable. The patient was monitored for 30 minutes then dismissed to return to his squadron. The patient's current illnesses and history were reported as none. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dyskinesia, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: This case was received on 04 December 2013 via a third party query tool search on the VAERS database, under reference number 50169. A 21 year-old male patient had received the following vaccinations on 13 August 2013: a left arm injection of ACAM2000 (lot number VV04003A), an intramuscular right arm injection of TYPHIMVI (lot number H1418) and an intramuscular right arm injection of BIOTHRAX (lot number FAV317A). Anthrax and typhoid vaccinations were administered without incident, then approximately 3-4 minutes later the smallpox vaccine was administered while the patient was seated in a chair. At the 13th scarification, the patient began to faint. An ammonia inhaler was administered. The patient did not respond. His arms and legs were jerking and the patient slumped to the floor. After approximately 30 seconds, he became more alert and was oriented to person and place. An office worker and one corpsman were present at the time of the reaction. The patient was assisted back into a chair without incident. The patient's vital signs were stable. The patient was monitored for 30 minutes then dismissed to return to his squadron. The patient's current illnesses and history were reported as none. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling of body temperature change, General physical health deterioration, Heart rate increased
Clinical narrative: Case number PHEH2013US024257 is an initial spontaneous report received from a consumer on 18 Nov 2013, with a follow up received from the pharmacist on 03 Dec 2013: This report refers to a 28-year-old female patient. Her medical history included iodine allergy. It was reported that the vaccine was tolerated in the past. She was vaccinated with FLUVIRIN (batch number: 1307601 and expiry date: 31 Mar 2014) 0.5 ml intramuscularly on 17 Sep 2013 at 11:50 am. Five minutes after vaccination, she experienced dizziness, increase in blood pressure and heart rate at 11:55 am, flushing, feeling extremely warm and significant shaking at 12:00 pm, nausea at 12:10 pm, decreased responsiveness, throat pain and tightness at 12:23 pm. She was administered EPIPEN at 12:24 pm and the paramedics arrived almost immediately. She was transferred to the emergency room where she was given further treatment. It was reported that by the time paramedics got her into the stretcher, she said her throat felt better. The event outcome was completely recovered. The seriousness was assessed as life-threatening. The causality was not reported. Follow up received from the pharmacist on 03 Dec 2013: Updated events (dizziness, increased blood pressure, increased heart rate, flushing, feeling extremely warm, shaking, nausea, decreased responsiveness, throat pain and tightness), time of vaccination, time of event onset, medical history, route of administration, dosage and patient's date of birth.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Case number PHEH2013US024257 is an initial spontaneous report received from a consumer on 18 Nov 2013, with a follow up received from the pharmacist on 03 Dec 2013: This report refers to a 28-year-old female patient. Her medical history included iodine allergy. It was reported that the vaccine was tolerated in the past. She was vaccinated with FLUVIRIN (batch number: 1307601 and expiry date: 31 Mar 2014) 0.5 ml intramuscularly on 17 Sep 2013 at 11:50 am. Five minutes after vaccination, she experienced dizziness, increase in blood pressure and heart rate at 11:55 am, flushing, feeling extremely warm and significant shaking at 12:00 pm, nausea at 12:10 pm, decreased responsiveness, throat pain and tightness at 12:23 pm. She was administered EPIPEN at 12:24 pm and the paramedics arrived almost immediately. She was transferred to the emergency room where she was given further treatment. It was reported that by the time paramedics got her into the stretcher, she said her throat felt better. The event outcome was completely recovered. The seriousness was assessed as life-threatening. The causality was not reported. Follow up received from the pharmacist on 03 Dec 2013: Updated events (dizziness, increased blood pressure, increased heart rate, flushing, feeling extremely warm, shaking, nausea, decreased responsiveness, throat pain and tightness), time of vaccination, time of event onset, medical history, route of administration, dosage and patient's date of birth.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Flushing, Heart rate increased
Clinical narrative: Case number PHEH2013US024257 is an initial spontaneous report received from a consumer on 18 Nov 2013, with a follow up received from the pharmacist on 03 Dec 2013: This report refers to a 28-year-old female patient. Her medical history included iodine allergy. It was reported that the vaccine was tolerated in the past. She was vaccinated with FLUVIRIN (batch number: 1307601 and expiry date: 31 Mar 2014) 0.5 ml intramuscularly on 17 Sep 2013 at 11:50 am. Five minutes after vaccination, she experienced dizziness, increase in blood pressure and heart rate at 11:55 am, flushing, feeling extremely warm and significant shaking at 12:00 pm, nausea at 12:10 pm, decreased responsiveness, throat pain and tightness at 12:23 pm. She was administered EPIPEN at 12:24 pm and the paramedics arrived almost immediately. She was transferred to the emergency room where she was given further treatment. It was reported that by the time paramedics got her into the stretcher, she said her throat felt better. The event outcome was completely recovered. The seriousness was assessed as life-threatening. The causality was not reported. Follow up received from the pharmacist on 03 Dec 2013: Updated events (dizziness, increased blood pressure, increased heart rate, flushing, feeling extremely warm, shaking, nausea, decreased responsiveness, throat pain and tightness), time of vaccination, time of event onset, medical history, route of administration, dosage and patient's date of birth.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyporesponsive to stimuli, Nausea, Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Case number PHEH2013US024257 is an initial spontaneous report received from a consumer on 18 Nov 2013, with a follow up received from the pharmacist on 03 Dec 2013: This report refers to a 28-year-old female patient. Her medical history included iodine allergy. It was reported that the vaccine was tolerated in the past. She was vaccinated with FLUVIRIN (batch number: 1307601 and expiry date: 31 Mar 2014) 0.5 ml intramuscularly on 17 Sep 2013 at 11:50 am. Five minutes after vaccination, she experienced dizziness, increase in blood pressure and heart rate at 11:55 am, flushing, feeling extremely warm and significant shaking at 12:00 pm, nausea at 12:10 pm, decreased responsiveness, throat pain and tightness at 12:23 pm. She was administered EPIPEN at 12:24 pm and the paramedics arrived almost immediately. She was transferred to the emergency room where she was given further treatment. It was reported that by the time paramedics got her into the stretcher, she said her throat felt better. The event outcome was completely recovered. The seriousness was assessed as life-threatening. The causality was not reported. Follow up received from the pharmacist on 03 Dec 2013: Updated events (dizziness, increased blood pressure, increased heart rate, flushing, feeling extremely warm, shaking, nausea, decreased responsiveness, throat pain and tightness), time of vaccination, time of event onset, medical history, route of administration, dosage and patient's date of birth.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: Itching on torso, arms and legs.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pruritus
Clinical narrative: Itching on torso, arms and legs.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUN4, SMALL, ANTH, FLUN4, SMALL
Symptoms: Bundle branch block left, ECG signs of ventricular hypertrophy, Electrocardiogram T wave amplitude decreased, Troponin I increased, Ventricular hypertrophy
Clinical narrative: This study case was received from the investigator in a trial on 26 November 2013 with follow-up on 02 December 2013. A 26 year-old female subject with no significant past medical history was found to have other and unspecified acute myocarditis and non-specific myocarditis 15 and 11 days respectively after the subject had received the following vaccines on 30 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and FLUMIST (lot number, route and site of administration not reported). On 11 October 2013, Troponin I result was abnormal with highest recorded value of 0.2 ng/ml with an abnormal MRI (heart). On 11 October 2013, the subject was found to have a normal ECG and echocardiogram. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUN4, SMALL, ANTH, FLUN4, SMALL
Symptoms: Cardiac imaging procedure abnormal, Echocardiogram normal, Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This study case was received from the investigator in a trial on 26 November 2013 with follow-up on 02 December 2013. A 26 year-old female subject with no significant past medical history was found to have other and unspecified acute myocarditis and non-specific myocarditis 15 and 11 days respectively after the subject had received the following vaccines on 30 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and FLUMIST (lot number, route and site of administration not reported). On 11 October 2013, Troponin I result was abnormal with highest recorded value of 0.2 ng/ml with an abnormal MRI (heart). On 11 October 2013, the subject was found to have a normal ECG and echocardiogram. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUN4, SMALL, ANTH, FLUN4, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 26 November 2013 with follow-up on 02 December 2013. A 26 year-old female subject with no significant past medical history was found to have other and unspecified acute myocarditis and non-specific myocarditis 15 and 11 days respectively after the subject had received the following vaccines on 30 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and FLUMIST (lot number, route and site of administration not reported). On 11 October 2013, Troponin I result was abnormal with highest recorded value of 0.2 ng/ml with an abnormal MRI (heart). On 11 October 2013, the subject was found to have a normal ECG and echocardiogram. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatinine increased
Clinical narrative: This spontaneous report as received from a 75 year old retired nurse reporting on herself with allergy to MACRODANTIN and possibly to narcotics, elevated blood pressure, elevated cholesterol, high creatinine level, leg cramps, osteoarthritis, might possibly had rheumatoid arthritis and urinary tract infection which began prior to ZOSTAVAX and for was prescribed BACTRIM but the consumer had not taken yet it and a history of insulin resistance, shingles and double coronary artery bypass grafting (CABG). The consumer reported that on 19-NOV-2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapies included acetaminophen, TYLENOL (8 hour extended release), aspirin, atorvastatin, hydrochlorothiazide(manufacturer unknown), lisinopril(manufacture unknown), LOVAZA, magnesium (unspecified), metoprolol, NIASPAN, nitroglycerin, omeprazole, potassium chloride and vitamin D (unspecified). The consumer reported that on 18-NOV-2013, her creatinine was 1.18 (unit not reported). On 19-NOV-2013, she received ZOSTAVAX. On 21-NOV-2013, her creatinine was 1.7 (unit not reported). The retired nurse said she normally had a high creatinine level (unspecified what her usual level was). No treatment was given for the experience. The retired nurse reported that she also experienced a quarter-sized red circle around the site of ZOSTAVAX administration in approximately November 2013 that had resolved at this point. At the time of the report, her new creatinine levels had not come back yet. The relatedness for creatinine levels increased and quarter-sized red circle around the site of administration and ZOSTAVAX was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatinine increased, Injection site erythema
Clinical narrative: This spontaneous report as received from a 75 year old retired nurse reporting on herself with allergy to MACRODANTIN and possibly to narcotics, elevated blood pressure, elevated cholesterol, high creatinine level, leg cramps, osteoarthritis, might possibly had rheumatoid arthritis and urinary tract infection which began prior to ZOSTAVAX and for was prescribed BACTRIM but the consumer had not taken yet it and a history of insulin resistance, shingles and double coronary artery bypass grafting (CABG). The consumer reported that on 19-NOV-2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapies included acetaminophen, TYLENOL (8 hour extended release), aspirin, atorvastatin, hydrochlorothiazide(manufacturer unknown), lisinopril(manufacture unknown), LOVAZA, magnesium (unspecified), metoprolol, NIASPAN, nitroglycerin, omeprazole, potassium chloride and vitamin D (unspecified). The consumer reported that on 18-NOV-2013, her creatinine was 1.18 (unit not reported). On 19-NOV-2013, she received ZOSTAVAX. On 21-NOV-2013, her creatinine was 1.7 (unit not reported). The retired nurse said she normally had a high creatinine level (unspecified what her usual level was). No treatment was given for the experience. The retired nurse reported that she also experienced a quarter-sized red circle around the site of ZOSTAVAX administration in approximately November 2013 that had resolved at this point. At the time of the report, her new creatinine levels had not come back yet. The relatedness for creatinine levels increased and quarter-sized red circle around the site of administration and ZOSTAVAX was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, UNK
Symptoms: Rash pruritic
Clinical narrative: Itching in area of shot starting 3 days after shot and continuing for 7 to 8 additional days.
Age: 66.0
Sex: M
Vaccine: VARZOS, UNK
Symptoms: Injection site pruritus
Clinical narrative: Itching in area of shot starting 3 days after shot and continuing for 7 to 8 additional days.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Headache, Rash, Rash papular
Clinical narrative: Customer received ZOSTAVAX 12-2-13, came into pharmacy 12-4-13 to report symptoms that started 12-3-13. Symptoms include rash/lump on chin, in ear, headache. Customer saw MD and was diagnosed with shingles.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Mass, Rash
Clinical narrative: Customer received ZOSTAVAX 12-2-13, came into pharmacy 12-4-13 to report symptoms that started 12-3-13. Symptoms include rash/lump on chin, in ear, headache. Customer saw MD and was diagnosed with shingles.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Cough, Fatigue, Nasopharyngitis
Clinical narrative: Terrible coughing for over one month. Some minor cold symptoms, but mostly coughing. Barking sounds (a few times in the one-month duration). Given honey and children's cough medicine. Not much relief, but symptoms ended after a little over one month. Patient's mother became ill and was much more severely affected. Mother's persistent cough lasted 3.5 months. Went to doc, chest x-ray revealed no pneumonia, though symptoms were similar. Treatment include NAC, Lobelia, and many cough formulas. Nothing helped. Finally recovered after 3.5 months of terrible coughing, some barking, and severe exhaustion.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Headache, Hypoaesthesia, Insomnia, Mobility decreased
Clinical narrative: Unusual soreness of upper arm, shoulder, neck extending to head.  Continued for 2 weeks + post vaccination. Worsening condition of arm receiving vaccine including numbness, tingling, and weakness extending to hand/fingers.  Difficulty sleeping due to pain in shoulder and neck and head.  Condition got worse as time went on (post vaccinated), not better as anticipated!  Currently following up with primary care physician.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Unusual soreness of upper arm, shoulder, neck extending to head.  Continued for 2 weeks + post vaccination. Worsening condition of arm receiving vaccine including numbness, tingling, and weakness extending to hand/fingers.  Difficulty sleeping due to pain in shoulder and neck and head.  Condition got worse as time went on (post vaccinated), not better as anticipated!  Currently following up with primary care physician.
Sex: F
Vaccine: HPV4
Symptoms: Disability, Paralysis
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. It was reported that the nurse had seen an unspecified video on "You Tube" regarding unspecified patient who had suffered paralysis after receiving unspecified doses of GARDASIL at an unspecified time and date. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, route and dosage were not reported). On an unknown date the patient experienced paralysis. The outcome of paralysis was unknown. The event 'paralysis' considered to be significant disability. Upon internal review the event 'paralysis' was considered to be medically significant. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site discomfort, Insomnia, Pain, Periarthritis
Clinical narrative: This spontaneous report as received from a 40 year old female physician (who is also the patient) refers to herself with rheumatoid arthritis and sulfa reactions/allergies. The patient was vaccinated with her first dose of PNEUMOVAX23 injection, 0.5ml, intramuscular in the left arm (lot# and expiry date not reported) in approximately December 2006 ("7 years ago"). On 04-DEC-2013 the patient was vaccinated with her second dose of PNEUMOVAX23 injection, 0.5ml, intramuscular in the left arm (lot# and expiry date not reported). Concomitant therapies included HUMIRA for rheumatoid arthritis (reported as "I have rheumatoid arthritis and on HUMIRA"), omega-3 marine triglycerides (reported as "fish oil"), vitamin D (unspecified), LEXAPRO and cephalexin. On 04-DEC-2013, 6 hours after vaccination, the patient's left shoulder was uncomfortable and frozen to the point that it could not be moved. The physician mentioned the pain was severe to the point that she could not sleep. The patient used ice pack on the area VICODIN last night (04-DEC-2013 night) to treat the adverse events. No lab diagnostics studies were performed. The patient didn't sought medical attention. At the time of reporting, the outcome of the events getting a little better. The patient considered the events were significant disability or incapacity because she couldn't move the left arm. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Blood pressure increased, Dyspnoea, Electrocardiogram abnormal, Nausea
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 70 year old male patient with no drug reactions or allergies. The patient was ex-smoker and had chronic obstructive pulmonary disease (COPD). The reporter stated that on 05-DEC-2013 (reported as yesterday) the patient was vaccinated with PNEUMOVAX23 intramuscularly in the right arm (lot # J009833 exp. Date: 25-JAN-2015, 0.5 ml). Concomitant medication included albuterol (manufacturer unknown) and influenza virus vaccine (manufacturer unknown). The reporter stated that client was also vaccinated with the influenza virus vaccine (manufacturer unknown) in the same arm, right arm, at patient's request. The patient visited the doctor office on 06-DEC-2013 (reported as today). The patient was able to walk into the office. The patient stated that he was nauseous, short of breath and his blood pressure (BP) was through the roof (unspecified what the BP reading was). On 06-DEC-2013, electrocardiogram (EKG) was performed at the doctor's office and some abnormality was found. The physician did not feel comfortable letting the patient to return home. On 06-DEC-2013, the patient was rushed from the doctor office, to the local hospital by ambulance. The reporter stated it was unknown if patient was hospitalized. The outcome of events was reported as not recovered. The relatedness between therapy with PNEUMOVAX23 and events was not reported. The reporter stated that he would not administer PNEUMOVAX23 with lot # J009833 to anyone else. This is one of two reports from the same reporter. Linked case # 1312USA003857. The events: nauseous, short of breath, blood pressure (BP) was through the roof and EKG with abnormality found were considered to medically significant by the reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown age. On an unknown date states a provider may have vaccinated clients with improperly stored RECOMBIVAX HB. No adverse effects reported at this time. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with bruises easily and none drug reactions or allergies. On 20-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX, injection (strength, douse route, lot number and expiration date not provided). Other suspected therapies included influenza virus vaccine reported as flu shot in the same arm administered on an unspecified date. In November 2013 reported as few days after receiving ZOSTAVAX, the patient experienced an injections site reaction described as: two separate sited the shape of a ring, one is larger the size of a half dollar, the other much smaller. The center of both sites are red, hard, raised and slightly warm with little hard bumps. The patient sought medical attention  visited pharmacy. No treatment was ginve for adverse event. None lab diagnostics studies were performed. The outcome of events was reported as not recovered. The relatedness between vaccinations with ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 65 year old female with hypertension, hypothyroidism and drug reactions/allergy to CIPRO, penicillin and sulfonamides. On 05-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J001005 expiry date 24-APR-2014, subcutaneously, dose unknown. On 05-AUG-2013, immediately after administration of ZOSTAVAX the patient experienced "a bump" at the injection site. No treatment was given. There were no lab tests performed. The patient sought medical attention in pharmacy. The bump has persisted since 05-AUG-2013 and has not resolved. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 year old male patient. There was no medical history and drug reactions or allergies reported. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number J005721, expiry date 29-AUG-2014) (dosing regimen and frequency unknown). Concomitant therapies included LIPITOR, ADALAT, PRADAXA, PROSCAR, SYNTHROID, amiodarone (manufacturer unknown), gabapentin (manufacturer unknown) and amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL tablets. On an unknown date in December 2013 the patient experienced increasing joint pain. The patient sought medical attention and contacted pharmacist. There was no lab diagnostics studies performed. The outcome of increasing joint pain was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness at site of injection.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Swollen tongue
Clinical narrative: Reported last year after flu vaccine - chest rash x 8 weeks. Given vaccine this year, experienced tongue swelling in 12 hrs sp vaccine tx by PCP with MEDROL dose pk. Sx resolved in 12 hrs. Overall area rash chest resolved x 24 hrs.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient c/o left arm pain with swelling and redness. Given 25mg BENADRYL by mouth.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pain in left arm with redness and swelling. Given 25mg BENADRYL by mouth.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Inflammation, Injection site erythema, Urticaria
Clinical narrative: (L) erythema to injection site instantly. 70cm x 45cm area inflamed, whelped. Area on opposite arm inflamed from tourniquet. 45 min area still inflamed. Decreasing in whelp. No SOB. Anthrax (L).
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Pain
Clinical narrative: 10/16/13 Temperature (101) per patient with c/o body aches x3 days.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (lot # not reported). The pharmacist was reporting a patient, who was administered ZOSTAVAX on an unspecified date, was diagnosed with shingles. The shingles rash affected the arm opposite to the arm that received the vaccination. The outcome of shingles was unknown. The patient sought medical attention. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Ultrasound antenatal screen abnormal
Clinical narrative: Initial pregnancy report received from a consumer who is also the patient on 02 December 2013. A 35-year-old pregnant female patient, had received a dose of FLUZONE ID in the left deltoid on 01 November 2013 (Batch number was not reported). The patient had no illness at the time of vaccination and had received has had flu shots every year, never a problem. On 29 October 2013, the patient had ultrasound which showed embryo with beating heart. On 26 November 2013, during the follow-up appointment, the fetus's heart beat were not audible and so the ultrasound was done. The ultrasound examination revealed that the fetus was not viable and the pregnancy had stopped developing on 02 November 2013. The patient had no vaccination site reactions or fever after FLUZONE ID. List of documents held by the sender is none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site cellulitis, Pruritus, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 11 September 2013. A 77-year-old female patient had received first dose of FLUZONE HIGH-DOSE (lot number U4715AA, route of administration was not reported) in left deltoid on 10 September 2013. The patient had no illness at the time of vaccination. The patient's pre-existing allergies and medical conditions include PCN, AVALOX, fluoroquinolone allergy and rash. On 11 September 2013, one day after vaccination, the patient developed palm sized red area, itchy and hot to touch without any other symptoms. Laboratory details and corrective medications were not reported. The patient outcome was not recovered. Follow up information was received from a healthcare professional on 31 October 2013. Based on the f/up information received on 31 October 2013, this case initially considered as non-serious was upgraded to serious. The patient had hypertension, COPD and sarcoidosis at the time of vaccination and was receiving SYMBICORT inhaler, PROAIR inhaler and ALTACE 10 QD as concomitant medication. On 11 September 2013, the patient was seen by physician and treated for left deltoid cellulitis. The patient was examined and given Doxycycline as corrective treatments. As of 13 September 2013, the patient was recovering from events. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood test normal, Cardiac enzymes increased, Chest discomfort, Chest pain, Dizziness
Clinical narrative: This study case was received from the investigator in a trial on 27 November 2013. A male subject (date of birth not reported) with no reported past medical history had received the following vaccines on 06 November 2013: ACAM2000 (lot number, route and site of administration not reported) and Anthrax (lot number, route, site and not reported) and Typhoid vaccine (lot number, route, site and not reported). On 09 November 2013 he experienced a one-time episode of chest pain, chest pressure, shortness of breath, dizziness and palpitations. No treatments were received. On 19 November 2013, a Troponin I level was within normal limits (<0.10) and ECG was normal. The subject did not recall activity prior to the chest pressure. The patient was seen by a physician on 19 November 2013. Smallpox injection site looked scabbed over. The medical history was reviewed and the subject reported that chest pain, chest pressure, shortness of breath, dizziness and palpitations all began while subject was running on 09 November 2013, 3 days post vaccination. The subject went to the ER upon onset of the symptoms. The ER performed an EKG and labs and referred him to the (PCM). On 12 November the subject was seen and referred to a cardiologist. On 13 November 2013, an Echo, EKG and lab tests were performed with all tests normal with the exception of one cardiac enzyme that the subject does not know. The patient was to have a cardiac stress test on 20 November and a Holter monitor. The subject stated that the Holter monitor was faulty and will be repeated at a later time. The subject stated that he was told by the cardiologist that the big symptoms were related to smallpox vaccine. Symptoms had a sudden onset and lasted about 4 hours. No medication use or other adverse events. Subject was not experiencing chest pain at the moment and marked "no hurt" on Baker Wong Scale. An EKG was performed without incident. Blood test for rapid and central lab test were negative. On 22 November 2013, central lab tests and EKG were normal. The patient will be seen by a cardiologist on 03 December 2013 as per the subject, he feels the symptoms are related to the ACAM vaccine. No further information was available at the time of the report. The subject's outcome was recovered on 09 November 2013. According to the investigator, the event of possible myopericarditis was considered another important event and probably related to vaccination. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram ambulatory, Electrocardiogram normal, Injection site scab
Clinical narrative: This study case was received from the investigator in a trial on 27 November 2013. A male subject (date of birth not reported) with no reported past medical history had received the following vaccines on 06 November 2013: ACAM2000 (lot number, route and site of administration not reported) and Anthrax (lot number, route, site and not reported) and Typhoid vaccine (lot number, route, site and not reported). On 09 November 2013 he experienced a one-time episode of chest pain, chest pressure, shortness of breath, dizziness and palpitations. No treatments were received. On 19 November 2013, a Troponin I level was within normal limits (<0.10) and ECG was normal. The subject did not recall activity prior to the chest pressure. The patient was seen by a physician on 19 November 2013. Smallpox injection site looked scabbed over. The medical history was reviewed and the subject reported that chest pain, chest pressure, shortness of breath, dizziness and palpitations all began while subject was running on 09 November 2013, 3 days post vaccination. The subject went to the ER upon onset of the symptoms. The ER performed an EKG and labs and referred him to the (PCM). On 12 November the subject was seen and referred to a cardiologist. On 13 November 2013, an Echo, EKG and lab tests were performed with all tests normal with the exception of one cardiac enzyme that the subject does not know. The patient was to have a cardiac stress test on 20 November and a Holter monitor. The subject stated that the Holter monitor was faulty and will be repeated at a later time. The subject stated that he was told by the cardiologist that the big symptoms were related to smallpox vaccine. Symptoms had a sudden onset and lasted about 4 hours. No medication use or other adverse events. Subject was not experiencing chest pain at the moment and marked "no hurt" on Baker Wong Scale. An EKG was performed without incident. Blood test for rapid and central lab test were negative. On 22 November 2013, central lab tests and EKG were normal. The patient will be seen by a cardiologist on 03 December 2013 as per the subject, he feels the symptoms are related to the ACAM vaccine. No further information was available at the time of the report. The subject's outcome was recovered on 09 November 2013. According to the investigator, the event of possible myopericarditis was considered another important event and probably related to vaccination. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Laboratory test normal, Palpitations, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 27 November 2013. A male subject (date of birth not reported) with no reported past medical history had received the following vaccines on 06 November 2013: ACAM2000 (lot number, route and site of administration not reported) and Anthrax (lot number, route, site and not reported) and Typhoid vaccine (lot number, route, site and not reported). On 09 November 2013 he experienced a one-time episode of chest pain, chest pressure, shortness of breath, dizziness and palpitations. No treatments were received. On 19 November 2013, a Troponin I level was within normal limits (<0.10) and ECG was normal. The subject did not recall activity prior to the chest pressure. The patient was seen by a physician on 19 November 2013. Smallpox injection site looked scabbed over. The medical history was reviewed and the subject reported that chest pain, chest pressure, shortness of breath, dizziness and palpitations all began while subject was running on 09 November 2013, 3 days post vaccination. The subject went to the ER upon onset of the symptoms. The ER performed an EKG and labs and referred him to the (PCM). On 12 November the subject was seen and referred to a cardiologist. On 13 November 2013, an Echo, EKG and lab tests were performed with all tests normal with the exception of one cardiac enzyme that the subject does not know. The patient was to have a cardiac stress test on 20 November and a Holter monitor. The subject stated that the Holter monitor was faulty and will be repeated at a later time. The subject stated that he was told by the cardiologist that the big symptoms were related to smallpox vaccine. Symptoms had a sudden onset and lasted about 4 hours. No medication use or other adverse events. Subject was not experiencing chest pain at the moment and marked "no hurt" on Baker Wong Scale. An EKG was performed without incident. Blood test for rapid and central lab test were negative. On 22 November 2013, central lab tests and EKG were normal. The patient will be seen by a cardiologist on 03 December 2013 as per the subject, he feels the symptoms are related to the ACAM vaccine. No further information was available at the time of the report. The subject's outcome was recovered on 09 November 2013. According to the investigator, the event of possible myopericarditis was considered another important event and probably related to vaccination. Documents held by sender: none.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: A day after vaccines were administered, pt presented with slight swelling and rash only on left leg.
Age: 29.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Atrioventricular block first degree, Cough, Dyspnoea, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 27 November 2013. A 29 year-old male subject had received on 13 November 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Typhoid (lot number, route, site and date of administration not reported) and three days later, experienced shortness of breath, dry cough and was diagnosed with possible myopericarditis. On 20 November 2013, the subject had a normal Troponin and an abnormal ECG that showed a first degree atrioventricular (AV) heart block. The subject was referred appropriately. No treatments were received. No further information was available at the time of the report. The subject's outcome was still present (not recovered). According to the investigator, the event of possible myopericarditis was considered mild, an other important event and possibly related to vaccination. Documents held by sender: none.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's wife refers to a male patient of unknown age. On an unknown date (reported as a few years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). On an unknown date (reported as soon after vaccination with ZOSTAVAX), the patient developed a mild case of the "shingles". The patient was treated with antibiotics (not specified) and fully recovered on an unknown date. The relatedness between ZOSTAVAX and shingles was not reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives - BENADRYL. Patient reported after returning home. Instructed to take BENADRYL and go to ER if anaphylactic or sxs worsen.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersensitivity, Infection, Local swelling, Skin warm
Clinical narrative: Patient came in 1 day after vaccine administered arm was red, warm, and swollen. Patient then went to ER and was given prescriptions for KEFLEX, BENADRYL, and ZANTAC. MD told her it was either an infection or allergic Rxn.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Disorientation, Dizziness, Hypoaesthesia
Clinical narrative: Patient called Pharmacy 12-5-13 in the morning to report she is still currently having a reaction that she believes is from the ZOSTAVAX Vaccination that she received 11/6/2013. She received vaccination on 11/6/2013. On 11/13/13 she went to ER because she almost blacked out. She went again to the ER on 11/19/13. She says she may have had a stroke. She is till complaining of Numbness in hands, and foot. Feeling dizzy and disoriented. She said no doctor has told her that her symptoms were a result for this vaccination.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, Borrelia test, Ear discomfort, Ear pain
Clinical narrative: C/O aching burning pain in Lt ear 2-3 days, decreased blinking of (L) eyelid, mild facial weakness in cheek and numbness of tongue. Has sched. MRI of brain. Appt with ophthalmologist.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid function disorder, Facial paresis, Full blood count, Hypoaesthesia oral, Metabolic function test
Clinical narrative: C/O aching burning pain in Lt ear 2-3 days, decreased blinking of (L) eyelid, mild facial weakness in cheek and numbness of tongue. Has sched. MRI of brain. Appt with ophthalmologist.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Serum ferritin
Clinical narrative: C/O aching burning pain in Lt ear 2-3 days, decreased blinking of (L) eyelid, mild facial weakness in cheek and numbness of tongue. Has sched. MRI of brain. Appt with ophthalmologist.