chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgeusia, Hypoaesthesia oral, Swollen tongue
Clinical narrative: Case number PHHY2012US111089 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 465443) on 04 Dec 2012. This case refers to 32-year-old female patient. The patient's medical history included allergies. Concomitant medications included CLARITIN. The patient was vaccinated with FLUVIRIN (batch number: 1204001) intramuscularly in left arm on 14 Sep 2012. On 14 Sep 2012, after the vaccination, the patient's tongue swelled up and started to numb. She also experienced taste of metallic in her mouth. The outcome of the events was reported as condition unchanged as of 18 Sep 2012. The causality of the events was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Rash
Clinical narrative: Case number PHHY2012US111129 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465515) web site on 04 Dec 2012. This report refers to a 35-year-old female patient. Her medical history included postpartum state on 02 Aug 2012, anxiety/depression and premenstrual tension syndrome. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 12262P) intramuscularly on to left arm on 17 Sep 2012. On the same day, she walked out to the waiting room and complained of feeling dizzy. Rash was noted on cheeks, chest and abdomen. She was taken to examination room and was laid down. Her blood pressure was 94/52 (units not reported) and pulse rate was 62 (units not reported). She was administered diphenhydramine 50 mg intramuscularly and her rash subsided. She was given per oral fluids. Later when measured, her blood pressure value was 98/57 and pulse rate was 69. She sat and fifteen minutes later blood pressure was 108/60 and pulse rate was 69. Vitals monitored prior to discharge showed blood pressure as 113/60 and pulse rate as 68. The outcome of the events was reported as complete recovery as of 17 Sep 2012.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Heart rate decreased, Hypotension, Rash
Clinical narrative: Case number PHHY2012US111129 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465515) web site on 04 Dec 2012. This report refers to a 35-year-old female patient. Her medical history included postpartum state on 02 Aug 2012, anxiety/depression and premenstrual tension syndrome. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 12262P) intramuscularly on to left arm on 17 Sep 2012. On the same day, she walked out to the waiting room and complained of feeling dizzy. Rash was noted on cheeks, chest and abdomen. She was taken to examination room and was laid down. Her blood pressure was 94/52 (units not reported) and pulse rate was 62 (units not reported). She was administered diphenhydramine 50 mg intramuscularly and her rash subsided. She was given per oral fluids. Later when measured, her blood pressure value was 98/57 and pulse rate was 69. She sat and fifteen minutes later blood pressure was 108/60 and pulse rate was 69. Vitals monitored prior to discharge showed blood pressure as 113/60 and pulse rate as 68. The outcome of the events was reported as complete recovery as of 17 Sep 2012.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site vesicles
Clinical narrative: Patient received vaccine on 10-8-12 and noticed a small blister on arm on morning of 10-20-12 that was where she received injection. No signs of infection and no other symptoms.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Asthenia, Body temperature decreased, Dizziness, Full blood count, Lethargy
Clinical narrative: Initial case was received from a healthcare provider on 28 November 2012. A six-month-old female patient received dose two of PENTACEL, sanofi pasteur Ltd., lot number C4371AA, (route and site not reported) on the morning of 28 November 2012. On the same day, 28 November 2012, the patient napped in the afternoon, and woke up vomiting, dizzy and weak. The patient had no respiratory distress, but was cool to touch; and wanted to sleep more, but vomited several more times. The patient became hypotonic, pale, very sleepy and unresponsive to touch. The patient was taken to the emergency room (ER) and admitted to the hospital for observation by the reporting physician. While in the ER, the patient's heart rate was 170. The patient was diagnosed with severe dehydration. The reporting physician also reported that the family and patient had stomach virus two weeks prior to adverse event and the patient had also been seen then. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Metabolic function test, Pallor, Peripheral coldness, Somnolence, Vomiting
Clinical narrative: Initial case was received from a healthcare provider on 28 November 2012. A six-month-old female patient received dose two of PENTACEL, sanofi pasteur Ltd., lot number C4371AA, (route and site not reported) on the morning of 28 November 2012. On the same day, 28 November 2012, the patient napped in the afternoon, and woke up vomiting, dizzy and weak. The patient had no respiratory distress, but was cool to touch; and wanted to sleep more, but vomited several more times. The patient became hypotonic, pale, very sleepy and unresponsive to touch. The patient was taken to the emergency room (ER) and admitted to the hospital for observation by the reporting physician. While in the ER, the patient's heart rate was 170. The patient was diagnosed with severe dehydration. The reporting physician also reported that the family and patient had stomach virus two weeks prior to adverse event and the patient had also been seen then. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Asthenia, Dehydration, Dizziness, Hypotonia, Pallor
Clinical narrative: Initial case was received from a healthcare provider on 28 November 2012. A six-month-old female patient received dose two of PENTACEL, sanofi pasteur Ltd., lot number C4371AA, (route and site not reported) on the morning of 28 November 2012. On the same day, 28 November 2012, the patient napped in the afternoon, and woke up vomiting, dizzy and weak. The patient had no respiratory distress, but was cool to touch; and wanted to sleep more, but vomited several more times. The patient became hypotonic, pale, very sleepy and unresponsive to touch. The patient was taken to the emergency room (ER) and admitted to the hospital for observation by the reporting physician. While in the ER, the patient's heart rate was 170. The patient was diagnosed with severe dehydration. The reporting physician also reported that the family and patient had stomach virus two weeks prior to adverse event and the patient had also been seen then. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Peripheral coldness, Somnolence, Unresponsive to stimuli, Vomiting
Clinical narrative: Initial case was received from a healthcare provider on 28 November 2012. A six-month-old female patient received dose two of PENTACEL, sanofi pasteur Ltd., lot number C4371AA, (route and site not reported) on the morning of 28 November 2012. On the same day, 28 November 2012, the patient napped in the afternoon, and woke up vomiting, dizzy and weak. The patient had no respiratory distress, but was cool to touch; and wanted to sleep more, but vomited several more times. The patient became hypotonic, pale, very sleepy and unresponsive to touch. The patient was taken to the emergency room (ER) and admitted to the hospital for observation by the reporting physician. While in the ER, the patient's heart rate was 170. The patient was diagnosed with severe dehydration. The reporting physician also reported that the family and patient had stomach virus two weeks prior to adverse event and the patient had also been seen then. The patient's outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Back pain, Chills
Clinical narrative: This spontaneous report was received from a 30 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 30-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient reported that she was strongly encouraged to get the vaccine. She also mentioned that she received the vaccine at her school health center. The consumer reported that on 01-DEC-2012 after receiving GARDASIL she felt very weak and fatigued. She explained that she slept between 14 and 16 hours and developed very severe headaches, lower back pain, tingling and shooting pain on sides of her legs. The patient explained that at the time of the report on 06-DEC-2012 she developed abdominal pain and her headaches continued. This was her first dose of GARDASIL and she was treated with naproxen on 05-NOV-2012 for the pain. After beginning naproxen she developed severe bloating and stomach pain which prompted her to discontinue the naproxen and have the bloating cease. The patient had also taken over the counter pain relievers to combat her overall symptoms unsuccessfully. The patient sought unspecified medical attention. There were no lab diagnostic test performed. The outcome of felt very weak and fatigued, slept between 14 and 16 hours, lower back pain, tingling and shooting pain on sides of her legs, abdominal pain and stomach pain was unknown. The relatedness for the reported events was not provided for GARDASIL. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Eye pain, Fatigue, Headache, Hypersomnia
Clinical narrative: This spontaneous report was received from a 30 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 30-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient reported that she was strongly encouraged to get the vaccine. She also mentioned that she received the vaccine at her school health center. The consumer reported that on 01-DEC-2012 after receiving GARDASIL she felt very weak and fatigued. She explained that she slept between 14 and 16 hours and developed very severe headaches, lower back pain, tingling and shooting pain on sides of her legs. The patient explained that at the time of the report on 06-DEC-2012 she developed abdominal pain and her headaches continued. This was her first dose of GARDASIL and she was treated with naproxen on 05-NOV-2012 for the pain. After beginning naproxen she developed severe bloating and stomach pain which prompted her to discontinue the naproxen and have the bloating cease. The patient had also taken over the counter pain relievers to combat her overall symptoms unsuccessfully. The patient sought unspecified medical attention. There were no lab diagnostic test performed. The outcome of felt very weak and fatigued, slept between 14 and 16 hours, lower back pain, tingling and shooting pain on sides of her legs, abdominal pain and stomach pain was unknown. The relatedness for the reported events was not provided for GARDASIL. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Night sweats, Pain, Pain in extremity, Painful respiration, Photophobia
Clinical narrative: This spontaneous report was received from a 30 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 30-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient reported that she was strongly encouraged to get the vaccine. She also mentioned that she received the vaccine at her school health center. The consumer reported that on 01-DEC-2012 after receiving GARDASIL she felt very weak and fatigued. She explained that she slept between 14 and 16 hours and developed very severe headaches, lower back pain, tingling and shooting pain on sides of her legs. The patient explained that at the time of the report on 06-DEC-2012 she developed abdominal pain and her headaches continued. This was her first dose of GARDASIL and she was treated with naproxen on 05-NOV-2012 for the pain. After beginning naproxen she developed severe bloating and stomach pain which prompted her to discontinue the naproxen and have the bloating cease. The patient had also taken over the counter pain relievers to combat her overall symptoms unsuccessfully. The patient sought unspecified medical attention. There were no lab diagnostic test performed. The outcome of felt very weak and fatigued, slept between 14 and 16 hours, lower back pain, tingling and shooting pain on sides of her legs, abdominal pain and stomach pain was unknown. The relatedness for the reported events was not provided for GARDASIL. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a 30 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 30-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient reported that she was strongly encouraged to get the vaccine. She also mentioned that she received the vaccine at her school health center. The consumer reported that on 01-DEC-2012 after receiving GARDASIL she felt very weak and fatigued. She explained that she slept between 14 and 16 hours and developed very severe headaches, lower back pain, tingling and shooting pain on sides of her legs. The patient explained that at the time of the report on 06-DEC-2012 she developed abdominal pain and her headaches continued. This was her first dose of GARDASIL and she was treated with naproxen on 05-NOV-2012 for the pain. After beginning naproxen she developed severe bloating and stomach pain which prompted her to discontinue the naproxen and have the bloating cease. The patient had also taken over the counter pain relievers to combat her overall symptoms unsuccessfully. The patient sought unspecified medical attention. There were no lab diagnostic test performed. The outcome of felt very weak and fatigued, slept between 14 and 16 hours, lower back pain, tingling and shooting pain on sides of her legs, abdominal pain and stomach pain was unknown. The relatedness for the reported events was not provided for GARDASIL. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Abdominal pain, Asthenia, Back pain, Fatigue
Clinical narrative: This spontaneous report was received from a 30 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 30-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient reported that she was strongly encouraged to get the vaccine. She also mentioned that she received the vaccine at her school health center. The consumer reported that on 01-DEC-2012 after receiving GARDASIL she felt very weak and fatigued. She explained that she slept between 14 and 16 hours and developed very severe headaches, lower back pain, tingling and shooting pain on sides of her legs. The patient explained that at the time of the report on 06-DEC-2012 she developed abdominal pain and her headaches continued. This was her first dose of GARDASIL and she was treated with naproxen on 05-NOV-2012 for the pain. After beginning naproxen she developed severe bloating and stomach pain which prompted her to discontinue the naproxen and have the bloating cease. The patient had also taken over the counter pain relievers to combat her overall symptoms unsuccessfully. The patient sought unspecified medical attention. There were no lab diagnostic test performed. The outcome of felt very weak and fatigued, slept between 14 and 16 hours, lower back pain, tingling and shooting pain on sides of her legs, abdominal pain and stomach pain was unknown. The relatedness for the reported events was not provided for GARDASIL. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pain, Paraesthesia, Somnolence
Clinical narrative: This spontaneous report was received from a 30 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 30-NOV-2012. No other co-suspects were reported. There were no concomitant medications. The patient reported that she was strongly encouraged to get the vaccine. She also mentioned that she received the vaccine at her school health center. The consumer reported that on 01-DEC-2012 after receiving GARDASIL she felt very weak and fatigued. She explained that she slept between 14 and 16 hours and developed very severe headaches, lower back pain, tingling and shooting pain on sides of her legs. The patient explained that at the time of the report on 06-DEC-2012 she developed abdominal pain and her headaches continued. This was her first dose of GARDASIL and she was treated with naproxen on 05-NOV-2012 for the pain. After beginning naproxen she developed severe bloating and stomach pain which prompted her to discontinue the naproxen and have the bloating cease. The patient had also taken over the counter pain relievers to combat her overall symptoms unsuccessfully. The patient sought unspecified medical attention. There were no lab diagnostic test performed. The outcome of felt very weak and fatigued, slept between 14 and 16 hours, lower back pain, tingling and shooting pain on sides of her legs, abdominal pain and stomach pain was unknown. The relatedness for the reported events was not provided for GARDASIL. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Hypoaesthesia, Ocular hyperaemia
Clinical narrative: Next day right eye blood shot red for 5-7 days, follow by right hand and forearm numbness, with right side hemiparesis upper and lower extremities.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Corneal reflex decreased, Throat irritation, Tic
Clinical narrative: Pt received FLUMIST and per mom ("a couple hours after he developed a tic in which he blinks his eyes more or less constantly and makes a throat clearing noise").
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site mass
Clinical narrative: This medically confirmed report concerns an 80-year-old female patient, who had a medical history of diabetes, unspecified heart condition and an allergy to penicillin and codeine. Concomitant medication included unspecified cardiac medication and unspecified medication for diabetes. On 09-Nov-2012, the patient received AFLURIA (batch no: P50408) 0.5ml. After receiving AFLURIA the patient developed a lump on her right arm at the injection site that was the size of a peach. The patient was also having a lot of difficulty lifting her right arm. She had an appointment to see her physician. The outcome was reported as not recovered. Reporter's comment: The reporter considered the event as serious due to significant disability and incapacity.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Biopsy skin abnormal, Impaired healing, Injection site haemorrhage, Injection site scab, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30-Nov-2012) concerns a 43 year old female patient with an allergy to erythromycin and pork. The patient had no concomitant medications or pertinent medical history. On 25-Nov-2011, the patient received AFLURIA (batch: AFLU636BA (not a valid CSL batch)) via intramuscular route at a dose of 0.5 ml in the left deltoid of her arm for 'mandate requiring health care providers to receive flu vaccination'. On the same day, the patient developed pain for a couple of weeks and is still experiencing continuous bleeding at the injection site area which is slightly raised and develops into a scab every morning which will not heal. She noted a biopsy was done in this affected area on an unspecified date by an unspecified pathologist and she was told that the affected area may have developed into a cancerous lesion. The event outcome was not recovered. Refer to linked patient case with Influenza vaccine, Case number 2012034161 (Non serious).
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Precancerous skin lesion
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30-Nov-2012) concerns a 43 year old female patient with an allergy to erythromycin and pork. The patient had no concomitant medications or pertinent medical history. On 25-Nov-2011, the patient received AFLURIA (batch: AFLU636BA (not a valid CSL batch)) via intramuscular route at a dose of 0.5 ml in the left deltoid of her arm for 'mandate requiring health care providers to receive flu vaccination'. On the same day, the patient developed pain for a couple of weeks and is still experiencing continuous bleeding at the injection site area which is slightly raised and develops into a scab every morning which will not heal. She noted a biopsy was done in this affected area on an unspecified date by an unspecified pathologist and she was told that the affected area may have developed into a cancerous lesion. The event outcome was not recovered. Refer to linked patient case with Influenza vaccine, Case number 2012034161 (Non serious).
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Biopsy, Injection site discharge, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30-Nov-2012) concerns a 43 year old female patient with an allergy to erythromycin and pork. The patient had no concomitant medications or pertinent medical history. On 25-Nov-2011, the patient received AFLURIA (batch: AFLU636BA (not a valid CSL batch)) via intramuscular route at a dose of 0.5 ml in the left deltoid of her arm for 'mandate requiring health care providers to receive flu vaccination'. On the same day, the patient developed pain for a couple of weeks and is still experiencing continuous bleeding at the injection site area which is slightly raised and develops into a scab every morning which will not heal. She noted a biopsy was done in this affected area on an unspecified date by an unspecified pathologist and she was told that the affected area may have developed into a cancerous lesion. The event outcome was not recovered. Refer to linked patient case with Influenza vaccine, Case number 2012034161 (Non serious).
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site scab, Skin lesion
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30-Nov-2012) concerns a 43 year old female patient with an allergy to erythromycin and pork. The patient had no concomitant medications or pertinent medical history. On 25-Nov-2011, the patient received AFLURIA (batch: AFLU636BA (not a valid CSL batch)) via intramuscular route at a dose of 0.5 ml in the left deltoid of her arm for 'mandate requiring health care providers to receive flu vaccination'. On the same day, the patient developed pain for a couple of weeks and is still experiencing continuous bleeding at the injection site area which is slightly raised and develops into a scab every morning which will not heal. She noted a biopsy was done in this affected area on an unspecified date by an unspecified pathologist and she was told that the affected area may have developed into a cancerous lesion. The event outcome was not recovered. Refer to linked patient case with Influenza vaccine, Case number 2012034161 (Non serious).
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Initial report was received on 30 November 2012 from an unverified source via a company website from a consumer. A 20-year-old female patient received dose one of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, manufacturer unknown, lot number, route, site and side not reported on an unreported date, 13 months prior to developing whooping cough. The patient stated she just received dose two of the TDAP vaccine on an unreported date. No further information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Allergy to chemicals, Allergy to metals, Clostridium test negative, Drug hypersensitivity, Injection site erosion
Clinical narrative: Initial case was retrieved from the scientific literature on 28 November 2012. This case is linked to 2012-11464 and 2012-11465. An 18-month-old child received injection of DTAP and PREVNAR (lot numbers, routes, sites, and date of vaccination not reported) and developed nodules at the injection site 1-2 days following administration, which persisted for six years. The intensely pruritic nodules led to bleeding from excoriated lesions. Nodules were increasingly pruritic, erythematous, sore and larger at times of illness. Patient was found to have hypersensitivity to aluminum, neomycin, and formaldehyde by patch testing which were present in these vaccines. Antibody titers showed that patient was not adequately protected to tetanus vaccines without aluminum, neomycin, or formaldehyde. Patient received his initial infant vaccines of DTAP, Hib, and PREVNAR without incident. The patient's outcome was not reported. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Initial case was retrieved from the scientific literature on 28 November 2012. This case is linked to 2012-11464 and 2012-11465. An 18-month-old child received injection of DTAP and PREVNAR (lot numbers, routes, sites, and date of vaccination not reported) and developed nodules at the injection site 1-2 days following administration, which persisted for six years. The intensely pruritic nodules led to bleeding from excoriated lesions. Nodules were increasingly pruritic, erythematous, sore and larger at times of illness. Patient was found to have hypersensitivity to aluminum, neomycin, and formaldehyde by patch testing which were present in these vaccines. Antibody titers showed that patient was not adequately protected to tetanus vaccines without aluminum, neomycin, or formaldehyde. Patient received his initial infant vaccines of DTAP, Hib, and PREVNAR without incident. The patient's outcome was not reported. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Skin test positive
Clinical narrative: Initial case was retrieved from the scientific literature on 28 November 2012. This case is linked to 2012-11464 and 2012-11465. An 18-month-old child received injection of DTAP and PREVNAR (lot numbers, routes, sites, and date of vaccination not reported) and developed nodules at the injection site 1-2 days following administration, which persisted for six years. The intensely pruritic nodules led to bleeding from excoriated lesions. Nodules were increasingly pruritic, erythematous, sore and larger at times of illness. Patient was found to have hypersensitivity to aluminum, neomycin, and formaldehyde by patch testing which were present in these vaccines. Antibody titers showed that patient was not adequately protected to tetanus vaccines without aluminum, neomycin, or formaldehyde. Patient received his initial infant vaccines of DTAP, Hib, and PREVNAR without incident. The patient's outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: IPV
Symptoms: Immediate post-injection reaction, Lethargy, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Initial case was retrieved from the scientific literature on 28 November 2012. This case was linked to 2012-11464 and 2012-11468. A male patient (age unknown) received an injection of IPV (lot number, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced lethargy, a full body macular papular rash and fever immediately after administration. Patient had not been vaccinated since these episodes. Skin testing with the vaccine and physician supervised challenges were offered. The patient's outcome was not reported. Documents held by sender: none.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Laboratory test normal, Musculoskeletal stiffness, Pyrexia, Respiratory distress, Seizure like phenomena
Clinical narrative: Initial case was retrieved from the scientific literature on 28 November 2012. This case is linked to 2012-11465 and 2012-11468. An 11-year-old male patient received injections of DTaP, Hib, and IPV at his two month visit (lot numbers, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced respiratory distress, seizure-like stiffening, and a fever. He was hospitalized for five days with an extensive negative work up. Skin testing with the vaccine and physician supervised challenges were offered. The patient's outcome was not reported. Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Oxygen saturation decreased, Pneumonitis
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 67 years old male patient. The patient was vaccinated with a dose of ZOSTAVAX (dose, route, Lot # and expiration date not reported) on 14-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 17-NOV-2012, "with 3 days of vaccination", the patient started to develop symptoms of pneumonitis. The patient was admitted to hospital on 20-NOV-2012. He was given high doses of prednisone, about 80 mg and oxygen. His blood oxygen level was 58. The patient refused intubation and was admitted to the Palliative Care Unit. The outcome of symptoms of pneumonitis was reported as recovering/resolving. The relatedness for symptoms of pneumonitis was unknown for ZOSTAVAX. Symptoms of pneumonitis was considered medically significant by pharmacist because required intervention to prevent serious criteria. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, induration & itching about 8 inches from her elbow to her shoulder.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Severe local reaction - erythema and induration 7x5 cm.
Age: 36.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Erythema, Musculoskeletal discomfort, Oedema peripheral, Skin warm
Clinical narrative: (L) arm is red, warm & swollen. Slight discomfort in muscle. No itching no burning.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Haemoglobin normal, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased, White blood cell count normal
Clinical narrative: 12-4-12 started with petechiae that spread to trunk & extremities. No fever or other illness. Seen in office 12-6-12 dx'd with ITP S1 (platelet count of 8000) referred to hematology.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Rhinorrhoea, Sneezing
Clinical narrative: Pt. called pharmacy and reported having flu like symptoms 5 hrs after receiving flu shot. I.e., painful cough, runny nose, sneezing.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting & fever up to 101. Vomiting last less than 12 hrs fever lasted 24 hours - treated with TYLENOL. She was put on clear liquid diet for 24 hours.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Was given (2) 0.25 mL of influenza IM (R) thigh into 1 injection. No adverse reactions noted or reported. Should have only been given (1) 0.25 mL dose.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: FLUMIST on 12/6/12. Fever, cough, congestion on 12/9/12.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest X-ray, Dyspnoea, Full blood count, Metabolic function test, Pruritus generalised
Clinical narrative: Began experiencing itching all over body approx 2 hours after injection. Itching progressed and child became short of breath. Ambulance called at 800pm and child taken to medical center. Treated with Epi, steroids and BENADRYL. Released at approx 1am.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Blister, Fatigue, Feeling abnormal, Macule, Papule
Clinical narrative: Rash noted in AM with few previous night, tired not self, no other symptoms. Macules, papules, vesicular/pustular lesions lower abdomen to pelvic area, few on back > 30 lesions.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Rash, Rash pustular, Skin lesion
Clinical narrative: Rash noted in AM with few previous night, tired not self, no other symptoms. Macules, papules, vesicular/pustular lesions lower abdomen to pelvic area, few on back > 30 lesions.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Swelling & pain at injection site x 2 weeks. Tingling when moving arm.
Age: 1.31
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blister, Scab, Skin lesion
Clinical narrative: Pt received VARIVAX on 12/5/12 -> noted 1st lesion on forehead last night 15 hrs before visit -> new lesions continue to appear this morning - has > 30 lesions at visit -> vesicles on pink base, first lesion crusting.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: States that arm still aches and is painful such that she cannot sleep on that side. The pain has not changed since she got the shot. (No increase or decrease). I suggested that she see her physician.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Soreness in left arm weakness/ROM restriction.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Left arm (upper arm) swelling & redness & bluish discoloration that didn't go away for 3 weeks, now swelling & throbbing of (L) arm.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Painful shoulder/arm. Dr. on Nov. 19, 2012. Prescribed naproxen - 500 mg. twice day didn't help. Back to Dr Dec 3, 2012 prescribed prednisone. No recovery to date.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Erythema, Haemorrhage, Immediate post-injection reaction, Oedema peripheral
Clinical narrative: Pt stated her arm was black & blue immediately. She said the RPh had to replace her bandage because she bled so much. 6 days later it was still black & blue the size of a baseball. Her arm was also swollen & red down to 3 inches above her elbow. Finally subsided 12/7/12.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Pt stated her arm was black & blue immediately. She said the RPh had to replace her bandage because she bled so much. 6 days later it was still black & blue the size of a baseball. Her arm was also swollen & red down to 3 inches above her elbow. Finally subsided 12/7/12.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: Right arm has spasms and pins and needles going up and down my right arm - very disturbing across my back, also.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUN3, HEPA, MMRV
Symptoms: Erythema, Feeling hot, Injection site pain
Clinical narrative: 7 cm x 11 cm area of erythema & warmth with mild TTP on (L) shoulder / upper arm.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: Dizziness, got up in middle of night dizzy, less dizzy by 8 am but worn off since then. Feels a bit tired now but not dizzy. A bit of soreness in arm.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Throat irritation
Clinical narrative: Pt. given GARDASIL vaccine at 1:30 pm. 2:05p/ Pt. states face is swelling & throat itches. 2:07p. Epinephrine 0.3 ml IM. 2:10p. BENADRYL 50 mg IM. 2:19p. Pt. transported by ambulance to Emergency Room.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Swelling in the left axilla and erythema.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Awoke with hives and itching 14 hours after taking third dose oral live virus typhoid. Treated self with oral Benadryl did not seek any other care.
Age: 56.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Blepharospasm, Blood glucose decreased, Headache, Neck pain, Rash
Clinical narrative: C/o neck pain, with headache, has twitching in right eye.  Lower blood sugar than usual.  Has rash on chest.
Age: 0.54
Sex: M
Vaccine: 6VAX-F
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Difficulty breathing - wheezing.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Musculoskeletal stiffness, Oedema peripheral, Paraesthesia
Clinical narrative: Raised red erythema approximately 4 inches long, surrounded by slighter pink erythema from shoulder to elbow. Symptoms include: headache, stiff neck, low grade fever, temperature differential between hands (left hand warmer than the right), and slight tingling in hands.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Temperature difference of extremities
Clinical narrative: Raised red erythema approximately 4 inches long, surrounded by slighter pink erythema from shoulder to elbow. Symptoms include: headache, stiff neck, low grade fever, temperature differential between hands (left hand warmer than the right), and slight tingling in hands.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Disturbance in attention, Psychomotor hyperactivity
Clinical narrative: Non stop going, weird verbal noise making, not focusing on events of the day, lack of self control, seems to be hyper a lot during the day, wants to change activities very frequently, won't sit for more than a few minutes to do activity books. She has not had treatment yet we are in process of getting our insurance switched over and waiting on a dr apt.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Arthralgia, Back pain, Decreased appetite, Fatigue
Clinical narrative: Headache, nausea, body aches, joint pain, lower back pain, fever, sore abdomen, diarrhea, low appetite, extreme thirst, fatigue. Still occurring as of today, three days after administration.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pain, Pyrexia, Thirst
Clinical narrative: Headache, nausea, body aches, joint pain, lower back pain, fever, sore abdomen, diarrhea, low appetite, extreme thirst, fatigue. Still occurring as of today, three days after administration.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Eye pruritus, Palpitations, Throat tightness, Wheezing
Clinical narrative: TIGHTNESS IN THROAT, WHEEZING, HEART PALPITATIONS, ITCHY EYES.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Pruritus, Rash macular
Clinical narrative: "Itching of palms and soles of feet, hives under her arms and back of legs with itching and blotchy and right eye swollen shut" per mother.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Mass, Pruritus, Skin warm
Clinical narrative: Large swollen area, hard lump, very itchy.  By 12/7/12 the spot was the size of a softball and very red, hot, and hard.  Still red, hard and itchy on 12/10/12 but spot is finally down to the size of a quarter.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Large swollen area, hard lump, very itchy.  By 12/7/12 the spot was the size of a softball and very red, hot, and hard.  Still red, hard and itchy on 12/10/12 but spot is finally down to the size of a quarter.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blister, Injection site vesicles
Clinical narrative: Mother reports that the evening that child received varicella injection that child developed a few fluid filled lesions at site of injection. The following morning the child had fluid filled lesions over her legs, back and to a lesser extent her arms. PMD called, who said that the symptoms were similar to chickenpox and said to stay home since child was not otherwise ill. Dr. advised client to not have #2 varicella. Child attends daycare and had no known exposure to anyone with chickenpox.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Heart rate increased, Hyperhidrosis
Clinical narrative: Severe chills alternating with severe sweating. Constant 102 F fever with alternating Motrin and Tylenol.  Complete loss of appetite. Extreme weakness, rapid heartbeat upon exertion.  Aches and pains general malaise. After 36 hours arm at inoculation site developed extremely painful 4" x 4" x 1/4" to 1/2" thick red inflammation.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Malaise, Pain, Pyrexia
Clinical narrative: Severe chills alternating with severe sweating. Constant 102 F fever with alternating Motrin and Tylenol.  Complete loss of appetite. Extreme weakness, rapid heartbeat upon exertion.  Aches and pains general malaise. After 36 hours arm at inoculation site developed extremely painful 4" x 4" x 1/4" to 1/2" thick red inflammation.
Age: 1.04
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Rash, Rash morbilliform, Rash vesicular
Clinical narrative: Woke with spots on face and hands, looking similar to chicken pox or measles. Rash spread to arms and legs later in the day. As of 12/10/12, AM, has not completely cleared up.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea, Posture abnormal
Clinical narrative: PATIENT WAS SITTING IN ONE OF OUR WAITING CHAIRS WHILE HIS MOTHER PAID FOR OTHER MEDICATIONS. HE THEN TOLD HIS MOTHER HE WASN'T FEELING WELL. HIS HEAD WENT BACK AND IT LOOKED LIKE HE PASSED OUT. HIS MOTHER WENT OVER AND TRIED TO WAKE HIM UP. PATIENT THEN STARTED RESPONDING TO HER. WE GAVE HIM SOME WATER AND IMMEDIATELY LOOKED AND STARTED FEELING BETTER. HE COMPLAINED OF NAUSEA, DIZZINESS, BLURRED VISION. THE MOTHER STATED HE HAD BEED SWIMMING BEFORE THE VACCINATION AND HAD NOT EATEN SINCE BREAKFAST. I CALLED HIS MOTHER ABOUT AN HOUR LATER AND SHE SAID HE WAS DOING FINE. I BELIEVE HE FAINTED IN THE CHAIR.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope, Vision blurred
Clinical narrative: PATIENT WAS SITTING IN ONE OF OUR WAITING CHAIRS WHILE HIS MOTHER PAID FOR OTHER MEDICATIONS. HE THEN TOLD HIS MOTHER HE WASN'T FEELING WELL. HIS HEAD WENT BACK AND IT LOOKED LIKE HE PASSED OUT. HIS MOTHER WENT OVER AND TRIED TO WAKE HIM UP. PATIENT THEN STARTED RESPONDING TO HER. WE GAVE HIM SOME WATER AND IMMEDIATELY LOOKED AND STARTED FEELING BETTER. HE COMPLAINED OF NAUSEA, DIZZINESS, BLURRED VISION. THE MOTHER STATED HE HAD BEED SWIMMING BEFORE THE VACCINATION AND HAD NOT EATEN SINCE BREAKFAST. I CALLED HIS MOTHER ABOUT AN HOUR LATER AND SHE SAID HE WAS DOING FINE. I BELIEVE HE FAINTED IN THE CHAIR.
Age: 30.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Electrocardiogram normal, Palpitations, Rash, Throat tightness
Clinical narrative: Patient c/o throat closing, however no SOB, or difficulty breathing noted.  O2 sat=98% RA, 100% on 2LNC.  Patient did develop a rash to her back.  Patient c/o palpitations.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Developed cough, headache, soreness/achy joints, extreme tiredness, loss of appetite, fever, chills, nasal/sinus congestion.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nasal congestion, Pyrexia, Sinus congestion
Clinical narrative: Developed cough, headache, soreness/achy joints, extreme tiredness, loss of appetite, fever, chills, nasal/sinus congestion.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, PPV, RVX
Symptoms: Cold sweat, Crying
Clinical narrative: Persistent crying for longer than 3 hours day of vaccination, cold and clammy in days following vaccinations, coupled with continued bouts of crying not typical of infant.
Age: 29.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Blood test abnormal, Chills, Decreased appetite, Feeling of body temperature change
Clinical narrative: On 11/21/2012 woke up with 101.5 temperature. I was able take Tylenol to bring it down, but the fever kept fluctuating between normal and fever. Had nausea, uncontrollable chills, was cold and hot, very sleepy, vomiting, weakness also had loss of appetite. I had had knee surgery on 11/19/2012 for knee realignment. PNEUMOVAX was given to me on 11/20/2012 in my left shoulder. Also Influenza Split injection was given in my right shoulder.  I had a rash on my left shoulder that grew from the injection site to the elbow and shoulder that was very sore, red and hot. Started as small and grew. I kept getting worse and  On 11/23/2012 woke up with 102.5 temperature and was really sick I was able to get the temperature down with Tylenol but my Dr advised me to go to the to the emergency room. The ER did test for the flu and came back negative. The Dr also checked my leg for infection and did not see any sign on the incision of infection and said looked really good.  Also did blood tests found that came back as had infection somewhere. The ER Dr said she thought I had a infection in my left arm near the injection site and put me on antibiotic. My temperature and side effects went away on 11/25/2012 but the rash remained for another week or so.
Age: 29.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Infection, Influenza virus test negative, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: On 11/21/2012 woke up with 101.5 temperature. I was able take Tylenol to bring it down, but the fever kept fluctuating between normal and fever. Had nausea, uncontrollable chills, was cold and hot, very sleepy, vomiting, weakness also had loss of appetite. I had had knee surgery on 11/19/2012 for knee realignment. PNEUMOVAX was given to me on 11/20/2012 in my left shoulder. Also Influenza Split injection was given in my right shoulder.  I had a rash on my left shoulder that grew from the injection site to the elbow and shoulder that was very sore, red and hot. Started as small and grew. I kept getting worse and  On 11/23/2012 woke up with 102.5 temperature and was really sick I was able to get the temperature down with Tylenol but my Dr advised me to go to the to the emergency room. The ER did test for the flu and came back negative. The Dr also checked my leg for infection and did not see any sign on the incision of infection and said looked really good.  Also did blood tests found that came back as had infection somewhere. The ER Dr said she thought I had a infection in my left arm near the injection site and put me on antibiotic. My temperature and side effects went away on 11/25/2012 but the rash remained for another week or so.