chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Nuclear magnetic resonance imaging, Rash
Clinical narrative: This spontaneous report as received from a wife refers to her 69 years old husband with cholesterol and allergy to penicillin who on 30-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: famciclovir, gabapentin, simvastatin (manufacturer unknown) and FLOMAX. Reporter's husband first experienced a burning sensation on his back and buttocks around 15-MAY-2012, after receiving ZOSTAVAX. The burning sensation symptoms had continued and was still present on 26-NOV-2012 (today). Reporter's husband also noticed pimple around 26-OCT-2012. Then, a full, severe rash came around 01-NOV-2012. The primary physician had treated the outbreak as a herpes virus and gave him medication to stop nerve pain (the onset day also reported as 15-NOV-2012). He had two doses of the herpes virus medication. Consumer was going to visit doctor again this week. Laboratory diagnostic studies were performed: MRI and EMG (results not provided). The patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a wife refers to her 69 years old husband with cholesterol and allergy to penicillin who on 30-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: famciclovir, gabapentin, simvastatin (manufacturer unknown) and FLOMAX. Reporter's husband first experienced a burning sensation on his back and buttocks around 15-MAY-2012, after receiving ZOSTAVAX. The burning sensation symptoms had continued and was still present on 26-NOV-2012 (today). Reporter's husband also noticed pimple around 26-OCT-2012. Then, a full, severe rash came around 01-NOV-2012. The primary physician had treated the outbreak as a herpes virus and gave him medication to stop nerve pain (the onset day also reported as 15-NOV-2012). He had two doses of the herpes virus medication. Consumer was going to visit doctor again this week. Laboratory diagnostic studies were performed: MRI and EMG (results not provided). The patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Electromyogram, Herpes virus infection, Neuralgia, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a wife refers to her 69 years old husband with cholesterol and allergy to penicillin who on 30-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: famciclovir, gabapentin, simvastatin (manufacturer unknown) and FLOMAX. Reporter's husband first experienced a burning sensation on his back and buttocks around 15-MAY-2012, after receiving ZOSTAVAX. The burning sensation symptoms had continued and was still present on 26-NOV-2012 (today). Reporter's husband also noticed pimple around 26-OCT-2012. Then, a full, severe rash came around 01-NOV-2012. The primary physician had treated the outbreak as a herpes virus and gave him medication to stop nerve pain (the onset day also reported as 15-NOV-2012). He had two doses of the herpes virus medication. Consumer was going to visit doctor again this week. Laboratory diagnostic studies were performed: MRI and EMG (results not provided). The patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a wife refers to her 69 years old husband with cholesterol and allergy to penicillin who on 30-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: famciclovir, gabapentin, simvastatin (manufacturer unknown) and FLOMAX. Reporter's husband first experienced a burning sensation on his back and buttocks around 15-MAY-2012, after receiving ZOSTAVAX. The burning sensation symptoms had continued and was still present on 26-NOV-2012 (today). Reporter's husband also noticed pimple around 26-OCT-2012. Then, a full, severe rash came around 01-NOV-2012. The primary physician had treated the outbreak as a herpes virus and gave him medication to stop nerve pain (the onset day also reported as 15-NOV-2012). He had two doses of the herpes virus medication. Consumer was going to visit doctor again this week. Laboratory diagnostic studies were performed: MRI and EMG (results not provided). The patient sought medical attention. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Herpes zoster, Injection site reaction, Myalgia
Clinical narrative: "The evening of Oct 19 I had an area of about 2" in diameter a red spot filled with pox upper back of my right shoulder above the area of the shot. The next evening I had more red spots upper chest on the right side, the spots were beginning to burn, tingle, and pox were forming in the area. Since I had shingles 4 years ago, I soon realized I had the shingles again! At that time I realized it takes a day or two to develop pox after the spots appear. Sunday morning Oct 21 I called my doctor's phone number to find who was the doctor on call, a health connection nurse called me back shortly. After giving the nurse my symptoms, he mentioned I may need to go to facility if the doctor requested. He called Dr. (doctor on call) and gave me a prescription of valacyclovir, thankfully I didn't have to go to facility. He read my medical record and noticed I had shingles 4 years ago and valacyclovir was given at that time. I called my doctor's office couple of times that week & explained my situation and wondered what else I needed to do as I was having more symptoms. My neck in front and back was stiff & achy, had right shoulder joint pain, it was going down my right arm and under my chin. I was experiencind sharp jabbing pain in the lympy node in my throat, sharp jabbing point in my jaw and my entire right side of my scalp was so tender, when I touched my hair it hurt. The doctor's called in a presciption for pain and nerve medication. I did research on the internet & found many stories of people from 2010 to Nov 2012 who got the shingles after the flu shot. I continue to have pain in the muscle where the shot was given and still some sensitivity where I had the shingles."
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Burning sensation, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: "The evening of Oct 19 I had an area of about 2" in diameter a red spot filled with pox upper back of my right shoulder above the area of the shot. The next evening I had more red spots upper chest on the right side, the spots were beginning to burn, tingle, and pox were forming in the area. Since I had shingles 4 years ago, I soon realized I had the shingles again! At that time I realized it takes a day or two to develop pox after the spots appear. Sunday morning Oct 21 I called my doctor's phone number to find who was the doctor on call, a health connection nurse called me back shortly. After giving the nurse my symptoms, he mentioned I may need to go to facility if the doctor requested. He called Dr. (doctor on call) and gave me a prescription of valacyclovir, thankfully I didn't have to go to facility. He read my medical record and noticed I had shingles 4 years ago and valacyclovir was given at that time. I called my doctor's office couple of times that week & explained my situation and wondered what else I needed to do as I was having more symptoms. My neck in front and back was stiff & achy, had right shoulder joint pain, it was going down my right arm and under my chin. I was experiencind sharp jabbing pain in the lympy node in my throat, sharp jabbing point in my jaw and my entire right side of my scalp was so tender, when I touched my hair it hurt. The doctor's called in a presciption for pain and nerve medication. I did research on the internet & found many stories of people from 2010 to Nov 2012 who got the shingles after the flu shot. I continue to have pain in the muscle where the shot was given and still some sensitivity where I had the shingles."
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pustule, Lymph node pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: "The evening of Oct 19 I had an area of about 2" in diameter a red spot filled with pox upper back of my right shoulder above the area of the shot. The next evening I had more red spots upper chest on the right side, the spots were beginning to burn, tingle, and pox were forming in the area. Since I had shingles 4 years ago, I soon realized I had the shingles again! At that time I realized it takes a day or two to develop pox after the spots appear. Sunday morning Oct 21 I called my doctor's phone number to find who was the doctor on call, a health connection nurse called me back shortly. After giving the nurse my symptoms, he mentioned I may need to go to facility if the doctor requested. He called Dr. (doctor on call) and gave me a prescription of valacyclovir, thankfully I didn't have to go to facility. He read my medical record and noticed I had shingles 4 years ago and valacyclovir was given at that time. I called my doctor's office couple of times that week & explained my situation and wondered what else I needed to do as I was having more symptoms. My neck in front and back was stiff & achy, had right shoulder joint pain, it was going down my right arm and under my chin. I was experiencind sharp jabbing pain in the lympy node in my throat, sharp jabbing point in my jaw and my entire right side of my scalp was so tender, when I touched my hair it hurt. The doctor's called in a presciption for pain and nerve medication. I did research on the internet & found many stories of people from 2010 to Nov 2012 who got the shingles after the flu shot. I continue to have pain in the muscle where the shot was given and still some sensitivity where I had the shingles."
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain of skin, Paraesthesia, Rash, Rash erythematous
Clinical narrative: "The evening of Oct 19 I had an area of about 2" in diameter a red spot filled with pox upper back of my right shoulder above the area of the shot. The next evening I had more red spots upper chest on the right side, the spots were beginning to burn, tingle, and pox were forming in the area. Since I had shingles 4 years ago, I soon realized I had the shingles again! At that time I realized it takes a day or two to develop pox after the spots appear. Sunday morning Oct 21 I called my doctor's phone number to find who was the doctor on call, a health connection nurse called me back shortly. After giving the nurse my symptoms, he mentioned I may need to go to facility if the doctor requested. He called Dr. (doctor on call) and gave me a prescription of valacyclovir, thankfully I didn't have to go to facility. He read my medical record and noticed I had shingles 4 years ago and valacyclovir was given at that time. I called my doctor's office couple of times that week & explained my situation and wondered what else I needed to do as I was having more symptoms. My neck in front and back was stiff & achy, had right shoulder joint pain, it was going down my right arm and under my chin. I was experiencind sharp jabbing pain in the lympy node in my throat, sharp jabbing point in my jaw and my entire right side of my scalp was so tender, when I touched my hair it hurt. The doctor's called in a presciption for pain and nerve medication. I did research on the internet & found many stories of people from 2010 to Nov 2012 who got the shingles after the flu shot. I continue to have pain in the muscle where the shot was given and still some sensitivity where I had the shingles."
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Malaise, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with immunization. The patient was vaccinated with ZOSTAVAX on 26-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling around injection site, 3 inches in diameter, injection site warm, aches, malaise, fatigue and redness. Treatment information with cephalosporin antibiotic (name unspecified). The outcome of swelling around injection site, 3 inches in diameter, injection site warm, aches, malaise, fatigue and redness is unknown for ZOSTAVAX. No additional information provided. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with immunization. The patient was vaccinated with ZOSTAVAX on 26-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling around injection site, 3 inches in diameter, injection site warm, aches, malaise, fatigue and redness. Treatment information with cephalosporin antibiotic (name unspecified). The outcome of swelling around injection site, 3 inches in diameter, injection site warm, aches, malaise, fatigue and redness is unknown for ZOSTAVAX. No additional information provided. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with immunization. The patient was vaccinated with ZOSTAVAX on 26-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling around injection site, 3 inches in diameter, injection site warm, aches, malaise, fatigue and redness. Treatment information with cephalosporin antibiotic (name unspecified). The outcome of swelling around injection site, 3 inches in diameter, injection site warm, aches, malaise, fatigue and redness is unknown for ZOSTAVAX. No additional information provided. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with immunisation. The patient was vaccinated with, .65 ZOSTAVAX on 30-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection site redness. No treatment information was reported. The outcome of injection site redness is not recovered. The relatedness for injection site redness is unknown for ZOSTAVAX. No other information is available at this time.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with immunisation. The patient was vaccinated with, .65 ZOSTAVAX on 30-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection site redness. No treatment information was reported. The outcome of injection site redness is not recovered. The relatedness for injection site redness is unknown for ZOSTAVAX. No other information is available at this time.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Narrative: 11/15 Nursing note states: Pt reported to nurse clinic as she developed a localized red swelling at the site of her shingles vaccine that was given on 11/13/12. Pt stated that yesterday, it was a slight bump at the site and now it has gotten much bigger. Pt has localized discomfort. Area of pink border is 3 inches x 4 inches. Red area in center is 1 inch x 2 inches. Indurated area with redness noted. No signs of cellulitis, no vesicles noted. No drainage. Educated about keeping arms elevated, ice pack and TYLENOL for pain and to reduce swelling. Patient to call us if symptoms worsen. Then 11/21 Psychiatry note states: Patient called to report that she is now out of the hospital. She was hospitalized for 4 days related to cellulitis/infection of left deltoid area post Shingles injection. She states that she was given IV antibiotics for the 4 days of hospitalization. She went to the ER on 11/16/12 and was admitted.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Metabolic function test
Clinical narrative: Narrative: 11/15 Nursing note states: Pt reported to nurse clinic as she developed a localized red swelling at the site of her shingles vaccine that was given on 11/13/12. Pt stated that yesterday, it was a slight bump at the site and now it has gotten much bigger. Pt has localized discomfort. Area of pink border is 3 inches x 4 inches. Red area in center is 1 inch x 2 inches. Indurated area with redness noted. No signs of cellulitis, no vesicles noted. No drainage. Educated about keeping arms elevated, ice pack and TYLENOL for pain and to reduce swelling. Patient to call us if symptoms worsen. Then 11/21 Psychiatry note states: Patient called to report that she is now out of the hospital. She was hospitalized for 4 days related to cellulitis/infection of left deltoid area post Shingles injection. She states that she was given IV antibiotics for the 4 days of hospitalization. She went to the ER on 11/16/12 and was admitted.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Discomfort, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site infection
Clinical narrative: Narrative: 11/15 Nursing note states: Pt reported to nurse clinic as she developed a localized red swelling at the site of her shingles vaccine that was given on 11/13/12. Pt stated that yesterday, it was a slight bump at the site and now it has gotten much bigger. Pt has localized discomfort. Area of pink border is 3 inches x 4 inches. Red area in center is 1 inch x 2 inches. Indurated area with redness noted. No signs of cellulitis, no vesicles noted. No drainage. Educated about keeping arms elevated, ice pack and TYLENOL for pain and to reduce swelling. Patient to call us if symptoms worsen. Then 11/21 Psychiatry note states: Patient called to report that she is now out of the hospital. She was hospitalized for 4 days related to cellulitis/infection of left deltoid area post Shingles injection. She states that she was given IV antibiotics for the 4 days of hospitalization. She went to the ER on 11/16/12 and was admitted.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Narrative: 11/15 Nursing note states: Pt reported to nurse clinic as she developed a localized red swelling at the site of her shingles vaccine that was given on 11/13/12. Pt stated that yesterday, it was a slight bump at the site and now it has gotten much bigger. Pt has localized discomfort. Area of pink border is 3 inches x 4 inches. Red area in center is 1 inch x 2 inches. Indurated area with redness noted. No signs of cellulitis, no vesicles noted. No drainage. Educated about keeping arms elevated, ice pack and TYLENOL for pain and to reduce swelling. Patient to call us if symptoms worsen. Then 11/21 Psychiatry note states: Patient called to report that she is now out of the hospital. She was hospitalized for 4 days related to cellulitis/infection of left deltoid area post Shingles injection. She states that she was given IV antibiotics for the 4 days of hospitalization. She went to the ER on 11/16/12 and was admitted.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Ear pain, Eye pain, Eyelid oedema
Clinical narrative: Blurry vision in right eye-several days later developed pain and sensitivity on right side of head, behind eye, drooping swollen right eyelid, pain in ear and jaw.  Eye doctor sent patient to emergency room-after blood tests, CT scan, contrast MRI, Doppler ultra sound on carotid artery, patient was diagnosed with temporal arteritis--prescribed 80 mg prednisone daily. Patient is still on reduced dose prednisone and is feeling better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid ptosis, Headache, Hyperaesthesia, Nuclear magnetic resonance imaging, Pain in jaw
Clinical narrative: Blurry vision in right eye-several days later developed pain and sensitivity on right side of head, behind eye, drooping swollen right eyelid, pain in ear and jaw.  Eye doctor sent patient to emergency room-after blood tests, CT scan, contrast MRI, Doppler ultra sound on carotid artery, patient was diagnosed with temporal arteritis--prescribed 80 mg prednisone daily. Patient is still on reduced dose prednisone and is feeling better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Scan with contrast, Temporal arteritis, Ultrasound Doppler, Ultrasound Doppler abnormal, Vision blurred
Clinical narrative: Blurry vision in right eye-several days later developed pain and sensitivity on right side of head, behind eye, drooping swollen right eyelid, pain in ear and jaw.  Eye doctor sent patient to emergency room-after blood tests, CT scan, contrast MRI, Doppler ultra sound on carotid artery, patient was diagnosed with temporal arteritis--prescribed 80 mg prednisone daily. Patient is still on reduced dose prednisone and is feeling better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen at injection site on left arm between elbow and shoulder. Length 8 inches by 4 inches, hard, hot, extremely sensitive to touch.  Appeared red. Still painful and swollen 12/06/2012.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Around 830pm rashes started on my body then to upper extremities, neck and head. Went urgent care and received a steroid shot. I was also taking Benadryl 50mg orally. Rashes lasted for 6 days.
Age: 20.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cardiac arrest, Computerised tomogram, Convulsion, Headache, Hepatic enzyme increased
Clinical narrative: This spontaneous report as received from a 20 years old female patient with anemia and asthma refers to herself. The patient was vaccinated with a dose of PNEUMOVAX23 (lot# and route unknown) and a dose of Influenza Virus Vaccine (manufacturer unknown) (lot# and route unknown) on the same day of an unknown date and had a bad allergic reaction(onset date reported as 25-OCT-2012). The concomitant medications were reported as steroids and antibiotics. The patient stated that she spent nine days at hospital. The patient stated her heart stopped, she had seizures, headaches and her liver enzymes were elevated(onset date reported as 25-OCT-2012). Lab information reported as cat scan, MRI(Magnetic Resonance Imaging), blood tests and heart sonogram. The outcome was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Nuclear magnetic resonance imaging, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a 20 years old female patient with anemia and asthma refers to herself. The patient was vaccinated with a dose of PNEUMOVAX23 (lot# and route unknown) and a dose of Influenza Virus Vaccine (manufacturer unknown) (lot# and route unknown) on the same day of an unknown date and had a bad allergic reaction(onset date reported as 25-OCT-2012). The concomitant medications were reported as steroids and antibiotics. The patient stated that she spent nine days at hospital. The patient stated her heart stopped, she had seizures, headaches and her liver enzymes were elevated(onset date reported as 25-OCT-2012). Lab information reported as cat scan, MRI(Magnetic Resonance Imaging), blood tests and heart sonogram. The outcome was reported as not recovered. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 85 years old male patient with high cholesterol, high blood pressure and glaucoma and prostate issue. The patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 (lot# reported as H013847, exp 15-MAR-2014) on 15-NOV-2012. Concomitant medications included: FLOMAX, unspecified cholesterol med and unspecified blood pressure medicine. On 16-NOV-2012 the patient experienced cellulitis in the same left arm (hospitalization and life threatening). The patient sought medical attention. The patient was admitted at least for one day in Hospital and KEFLEX was given for the treatment. The outcome of the adverse event was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Reaction to preservatives, Swelling face
Clinical narrative: Patient began to experience swelling of face, eyes & cheeks around 1:30 AM on 12/5, vaccine administered at 9:00 AM on 12/4. MD prescribed prednisone & felt allergy was to thimerosal.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: HPV vaccine on 12-4-12. On 12-5-12 evening, injection site very itchy. Used hydrocortisone cream. 12-6-12 complained of itchy, large area of redness, hard spot. Brought to MD office - left upper arm red, warm to touch, 10x16 cm area of induration. Rx for prednisone given.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site warmth
Clinical narrative: HPV vaccine on 12-4-12. On 12-5-12 evening, injection site very itchy. Used hydrocortisone cream. 12-6-12 complained of itchy, large area of redness, hard spot. Brought to MD office - left upper arm red, warm to touch, 10x16 cm area of induration. Rx for prednisone given.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Musculoskeletal chest pain, Spinal compression fracture
Clinical narrative: Shingles vaccine given 6/27/12. 6/28/12 chest wall pain - ER visit. 6/29/12 worsening radiating pain incapacitating. Admitted to hospital for dx & treatment.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus, Rash erythematous, Rash generalised, Skin exfoliation
Clinical narrative: Seven days after receiving the shingles vaccine I developed a rash from head to ankles! Despite a Prednisone Pak the rash & severe itching lasted 3 wks, I still have small red dots on my abdomen & some scaly red patches on my back, arm & thigh.
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration
Clinical narrative: Patient was administered the influenza vaccination on 11/27/12 and induration occurred at the injection site the next day.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: My insurance company encouraged me to get the PNEUMOVAX vaccine. My husband had received it earlier this year and had no adverse effect from it. However, I had swelling, tenderness and redness at the injection site. A sore muscle like feeling which starts at my axillae and extends down almost to my elbow and malaise. Today it is better. I am taking BUFFERIN for the discomfort with some degree of relief. To rate the pain, I would say a 5 on a scale of 1 to 10. This is the first time I have ever had this type of reaction to any injections. Flu shots do not bother me at all. I was told this is the only one I will have to have.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: My insurance company encouraged me to get the PNEUMOVAX vaccine. My husband had received it earlier this year and had no adverse effect from it. However, I had swelling, tenderness and redness at the injection site. A sore muscle like feeling which starts at my axillae and extends down almost to my elbow and malaise. Today it is better. I am taking BUFFERIN for the discomfort with some degree of relief. To rate the pain, I would say a 5 on a scale of 1 to 10. This is the first time I have ever had this type of reaction to any injections. Flu shots do not bother me at all. I was told this is the only one I will have to have.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 4" red band around injection site. with rash.
Age: 0.98
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 28 November 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3879AA received on 02 June 2011, lot number C3879AA received on 25 July 2011 and lot number C4001AA received on 12 March 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 23 August 2012, approximately five months after the last dose. On 23 August 2012, the subject developed a cough and paroxysmal cough on 31 August 2012 with a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 03 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: This child had received PENTACEL at 2, 4 and 12 months of age, which is not compliant with the recommended immunization schedule. It is unknown if the alternate dosing regimen resulted in a sub-optimal immune response that left the child susceptible to infection. This is one case out of a cumulative total of 175 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 28 November 2012. These 175 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.98
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 28 November 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3879AA received on 02 June 2011, lot number C3879AA received on 25 July 2011 and lot number C4001AA received on 12 March 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 23 August 2012, approximately five months after the last dose. On 23 August 2012, the subject developed a cough and paroxysmal cough on 31 August 2012 with a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 03 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: This child had received PENTACEL at 2, 4 and 12 months of age, which is not compliant with the recommended immunization schedule. It is unknown if the alternate dosing regimen resulted in a sub-optimal immune response that left the child susceptible to infection. This is one case out of a cumulative total of 175 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 28 November 2012. These 175 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.31
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 28 November 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3746AA received on 12 October 2010, lot number C3793AA received on 10 December 2010, lot number C3800AA received on 04 February 2011 and lot number C4083AA received on 01 December 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 18 May 2012, approximately five months after the last dose. On 18 May 2012, the subject developed a cough and paroxysmal cough on 19 May 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.31
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 28 November 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3746AA received on 12 October 2010, lot number C3793AA received on 10 December 2010, lot number C3800AA received on 04 February 2011 and lot number C4083AA received on 01 December 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 18 May 2012, approximately five months after the last dose. On 18 May 2012, the subject developed a cough and paroxysmal cough on 19 May 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Autopsy, Unresponsive to stimuli
Clinical narrative: ER informed me 12-1-12 that child brought to ER after being found unresponsive in parent's bed.
Age: 50.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema
Clinical narrative: Erythema to injection site the next day.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia
Clinical narrative: Patient had severe pain at site of injection that has not resolved since vaccine administration. Guest unable to sleep.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Severe chills / fever / aches / nausea. Onset 6:30/7pm. Pt. took ADVIL. Pt. much better by 12-6-12.
Age: 67.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Oedema peripheral, Pain, Tenderness
Clinical narrative: Arm is swollen. Patient reports size of 2 hard boiled eggs. Tender & painful.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Walking aid user
Clinical narrative: Given in (R) anterior thigh. Red and swollen to knee. Difficult to walk, used a crutch. 2 1/2 - 4 hrs after shot began. Still red and tender 3 days later.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm/hot to touch, itchy, started < 24 hrs after shot.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Petechiae, Vomiting
Clinical narrative: Nausea began after HPV vaccine, vomiting started at 11 PM - emesis every hour x 5 hours. Petechial rash on face and neck started 12/6/12. Low grade temp of 100. Patient returned to clinic 12/6/12, examined by Dr. and treated with ZOFRAN, 4mg. Advised to RTC if fever persisted > 3 days.
Age: 69.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Cardiac stress test, Chest pain, Injection site pain
Clinical narrative: She received JE (IXIARO) 11/26/12 (L) upper deltoid. C/O local site pain 4 days after vaccination. Developed chest pain. Went to cardiologist. No cardiac issues. 12/7/12 Still c/o (L) arm pain.
Age: 11.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Asthenia, Balance disorder, Dizziness, Dysarthria, Eye movement disorder
Clinical narrative: 2 vaccines administered. Client sat on exam table while VARIVAX given. Client laid down on (R) side while GARDASIL given. Face color pink, warm to touch. Eyes rolled back and when asked client stated he was dizzy. He remained responsive, answering questions. BP 124/85, steady pulse. When sat up was lethargic and weak, not sitting well without support. Had not eaten much. Gave apple juice. Remained weak, unsteady with VS normal. Dad helped to car 12:50 PM. Event reported to supervisor. Discussed ER, Urgent Care, call to family Dr. Mother said she would call Dr. for f/u. T.C. to Mom 2:15. Client ate lunch, feels nauseated, tired and is lying down. She called Dr. office and is waiting for return call. States client continues to be unsteady, weak. 12-6-12 T/C with Mother. R/T F/U care. Mother states con't to act "spacey and stoned", sleepy, minimal eye contact, speech slur. Mother states Dr. office has not returned call for appt. Encouraged mother to contact PMD again or take to E.R. if symptoms do not improve.
Age: 11.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Fatigue, Feeling abnormal, Lethargy, Nausea, Skin warm
Clinical narrative: 2 vaccines administered. Client sat on exam table while VARIVAX given. Client laid down on (R) side while GARDASIL given. Face color pink, warm to touch. Eyes rolled back and when asked client stated he was dizzy. He remained responsive, answering questions. BP 124/85, steady pulse. When sat up was lethargic and weak, not sitting well without support. Had not eaten much. Gave apple juice. Remained weak, unsteady with VS normal. Dad helped to car 12:50 PM. Event reported to supervisor. Discussed ER, Urgent Care, call to family Dr. Mother said she would call Dr. for f/u. T.C. to Mom 2:15. Client ate lunch, feels nauseated, tired and is lying down. She called Dr. office and is waiting for return call. States client continues to be unsteady, weak. 12-6-12 T/C with Mother. R/T F/U care. Mother states con't to act "spacey and stoned", sleepy, minimal eye contact, speech slur. Mother states Dr. office has not returned call for appt. Encouraged mother to contact PMD again or take to E.R. if symptoms do not improve.
Age: 11.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Somnolence
Clinical narrative: 2 vaccines administered. Client sat on exam table while VARIVAX given. Client laid down on (R) side while GARDASIL given. Face color pink, warm to touch. Eyes rolled back and when asked client stated he was dizzy. He remained responsive, answering questions. BP 124/85, steady pulse. When sat up was lethargic and weak, not sitting well without support. Had not eaten much. Gave apple juice. Remained weak, unsteady with VS normal. Dad helped to car 12:50 PM. Event reported to supervisor. Discussed ER, Urgent Care, call to family Dr. Mother said she would call Dr. for f/u. T.C. to Mom 2:15. Client ate lunch, feels nauseated, tired and is lying down. She called Dr. office and is waiting for return call. States client continues to be unsteady, weak. 12-6-12 T/C with Mother. R/T F/U care. Mother states con't to act "spacey and stoned", sleepy, minimal eye contact, speech slur. Mother states Dr. office has not returned call for appt. Encouraged mother to contact PMD again or take to E.R. if symptoms do not improve.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache
Clinical narrative: Headaches frontal steady radiating in band like distribution requiring rest for 48 hours, starting 12 hours after immunization. ALEVE OTC. No fever - no rash. Fully recovered.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Fainted approximately 1-2 seconds after flu shot given. Brief LOC. Hit head. Sister fainted right before patient fainted.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Rash
Clinical narrative: She was OK the first day, next day she develops rash/redness on the arm of shots and pain all over, third day she was better with some rash / redness.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Head injury, Loss of consciousness, Syncope
Clinical narrative: Hx syncope in past . Sister felt dizzy, watching brother get his flu shot. Had just received her flu shot. Fainted with 2 seconds LOC. Hit head -> ER for evaluation.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Crying, Irritability, Middle insomnia, Screaming, Sleep disorder
Clinical narrative: Child is having sleep disturbances and now wakes up crying/screaming several times a night (approx every 2-3 hours). The first few days appeared to be teething pain and she was clingy/sensative during the day. She has now been her normal self during the day for about a week but continues to wake multiple times a night. Her sleep cycle is 1-3 hours longer than normal as a result of the nighttime disturbances.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Teething
Clinical narrative: Child is having sleep disturbances and now wakes up crying/screaming several times a night (approx every 2-3 hours). The first few days appeared to be teething pain and she was clingy/sensative during the day. She has now been her normal self during the day for about a week but continues to wake multiple times a night. Her sleep cycle is 1-3 hours longer than normal as a result of the nighttime disturbances.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Asthenia, Body temperature increased, Feeling hot, Injected limb mobility decreased
Clinical narrative: Pain in injection location (left shoulder-bicep) started approx 0.5 hr after injection (6:30 pm 12/05/2012.  Woke up next morning 4:30 AM 12/06/2012 with severe pain in left bicep-could not raise left arm above shoulder.  No visible signs at site of injection.  Went to work. Approx 11 am 12/06/2012 started feeling warm and weak but pain in shoulder subsiding.  Came home and went to bed.  4 PM 12/06/2012 woke up, very hot, oral temp 104.3 F.  Blood pressure 130/71 81 bpm.  Ate small meal, drank approx 1.5 liter iced tea, took 2 x 325 mg acetominophen. Slept again. Woke up 9:15 PM 12/06/2012 oral temp 100F BP 142/78 78 bpm. Took 3 x 325 mg acetominophen. Slept again. 12:15AM 12/07/2012 woke up.  Oral temp 98.5 BP 126/78 69 bpm.  Took 3 x 325 mg acetaminophen. Slept. 7:15AM 12/07/2012 woke up; shaved/showered. 8 AM 12/07/2012 oral temp 98.6 BP 127/82 75 BPM.  Filed this report.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pain in injection location (left shoulder-bicep) started approx 0.5 hr after injection (6:30 pm 12/05/2012.  Woke up next morning 4:30 AM 12/06/2012 with severe pain in left bicep-could not raise left arm above shoulder.  No visible signs at site of injection.  Went to work. Approx 11 am 12/06/2012 started feeling warm and weak but pain in shoulder subsiding.  Came home and went to bed.  4 PM 12/06/2012 woke up, very hot, oral temp 104.3 F.  Blood pressure 130/71 81 bpm.  Ate small meal, drank approx 1.5 liter iced tea, took 2 x 325 mg acetominophen. Slept again. Woke up 9:15 PM 12/06/2012 oral temp 100F BP 142/78 78 bpm. Took 3 x 325 mg acetominophen. Slept again. 12:15AM 12/07/2012 woke up.  Oral temp 98.5 BP 126/78 69 bpm.  Took 3 x 325 mg acetaminophen. Slept. 7:15AM 12/07/2012 woke up; shaved/showered. 8 AM 12/07/2012 oral temp 98.6 BP 127/82 75 BPM.  Filed this report.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Rash, Skin irritation, Swelling
Clinical narrative: SWELLING, PAIN, REDNESS, IRRITATION, TENDERNESS TO PALPATION, RASH.  ALL SYMPTOMS BEGAN AT APPROXIMATELY 1415, PROGRESSIVELY WORSENING TO THE POINT IN WHICH THE PATIENT CAME TO THE CLINIC 0815 THE FOLLOWING MORNING.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Tenderness
Clinical narrative: SWELLING, PAIN, REDNESS, IRRITATION, TENDERNESS TO PALPATION, RASH.  ALL SYMPTOMS BEGAN AT APPROXIMATELY 1415, PROGRESSIVELY WORSENING TO THE POINT IN WHICH THE PATIENT CAME TO THE CLINIC 0815 THE FOLLOWING MORNING.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain
Clinical narrative: The shot was administered right at the top of the arm, where the shoulder joint is.  I believe it was administered into the ligament instead of the muscle as it should have been.  Since the date of the shot, I have been taking 600 mg ibuprofen, 2-3 times daily to control pain.  I am unable to lift my arm sideways without pain.  This has lasted for two months already, and the pain is not subsiding.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Musculoskeletal chest pain, Musculoskeletal pain, Rash
Clinical narrative: Pain under right shoulder going around rib. 12/05/2012 Rash appeared. Diagnosed with shingles.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Eye pruritus, Headache, Lacrimation increased
Clinical narrative: Coughing, post-nasal drip, itchy watery eyes, body aches, dizzy, headache, swollen glands (throat), sore throat.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Upper-airway cough syndrome
Clinical narrative: Coughing, post-nasal drip, itchy watery eyes, body aches, dizzy, headache, swollen glands (throat), sore throat.