chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Pulmonary embolism
Clinical narrative: This spontaneous report as received from a Pharmacy student refers to a male patient of unknown age with pulmonary embolism. On an unknown date when the patient was in his 60's was vaccinated with PNEUMOVAX23, (dose unknown) subcutaneous. The patient's concomitant medications were unknown. On an unknown date in 2013 (about a year ago) the patient experienced pulmonary embolism (life threatening and medically significant). The reporter when asked about the present status stated that he thought the patient was fine. The outcome of pulmonary embolism was reported as resolving (Reporter reported that I think he's fine). The reporter's causality assessment was not provided. Upon internal review the case was considered as medically significant. Additional information is not expected.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Full blood count, Ultrasound abdomen, Vomiting projectile
Clinical narrative: Projectile vomiting ROTATEQ on 03.14.14.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with GARDASIL lot # J007354, 3 doses (specific dates and times of vaccine administration was not reported). On an unknown date the patient experienced trouble breathing (Hospitalization) after receiving a dose of GARDASIL and was admitted into ER (location, duration, demographics unknown). The reporter stated that her daughter had reaction after receiving the recalled lot, lot # J007354. It was unspecified by the reporter after which dose she had the event as she had no specific information about which dose of GARDASIL was the recalled lot. The reporter was also concerned about the letter in the mail which she had received, stating about the recall from Merck. The reporter explained that she wanted Merck to contact the responsible physician in regards to the AE reported. The outcome of trouble breathing was reported as recovering/resolving. The patient had not sought medical attention. No product quality compliant was involved. The causality assessment was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Malaise, Nausea, Pyrexia
Clinical narrative: Fever (low-grade), nausea, dizziness, malaise x 24 hrs.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and tenderness 3" x 6" (R) deltoid symptoms started a few hours after vaccination. Treated with Azithromycin 200mg 1 tsp, 8ml po x 1d, 4ml x 4 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm below vaccination site red and swollen, painful. 2.7 cm more swollen than unaffected side.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient complained of pain at injection site.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus test positive
Clinical narrative: Admitted 3/18 - 3/21/14 for Rotavirus (+) gastroenteritis. Symptoms began on 3/15/14.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA, FLU3
Symptoms: Blister, Erythema, Irritability, Rash papular, Secretion discharge
Clinical narrative: Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA, FLU3
Symptoms: Cough, Dysphonia, Ear pain, Impetigo, Influenza virus test negative
Clinical narrative: Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA, FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site scab, Injection site swelling, Nasal congestion
Clinical narrative: Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA, FLU3
Symptoms: Oropharyngeal pain, Otitis media, Pharyngeal erythema, Pyrexia, Rash
Clinical narrative: Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA, FLU3
Symptoms: Rash vesicular, Rhinorrhoea, Streptococcus test positive, Tonsillar disorder, Tonsillitis streptococcal
Clinical narrative: Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA, FLU3
Symptoms: Tympanic membrane hyperaemia, Vomiting
Clinical narrative: Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient who was "in his 50's". On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified). On an unknown date the patient experienced shingles after the administration of ZOSTAVAX. The outcome of shingles was reported as recovered/resolved, recovered date unspecified. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On 24-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot number not reported). On approximately 07-NOV-2013 (reported as about 2 weeks later, at the beginning of November 2013) the patient developed shingles which presented as a traditional shingles rash including pain and itchiness. The patient was prescribed NEURONTIN cream for pain and for the most part he has recovered. Relatedness between ZOSTAVAX and shingles was not reported. Consumer also stated his cousin developed shingles inside her body (MARRS # 1403USA009551) similar to his wife after receiving ZOSTAVAX and after researching online he found that a multitude of people experienced similar things (caller did not want to provide contact information for the cousin and the information he found online). This report is linked to MAARS#1403USA008896 and MAARS#1403USA009551. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no drug reactions/allergies. On 10-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX 19400PFU (lot # J001697, expiration date 08-MAY-2014, dose not reported) subcutaneous for preventing shingles. Concomitant therapies included Lisinopril (manufacturer unknown), Latanoprost and Hydrochlorothiazide, Dyazide. On an unknown date in March 2014 the patient experienced a large, red, warm and swollen arm red area down the back of her arm where ZOSTAVAX was administered subcutaneously. No lab diagnostics studies performed. The patient sought medical attention via contacting pharmacist. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Hyperacusis, Hyperaesthesia, Lymphadenopathy, Neurological symptom, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her currently 16 year old son. The patient's historical conditions included increased blood pressure when the patient received Ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). The patient also experienced, when he was in kindergarten, an meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195).  The reporter stated that her twins boy and girl (captured in MARRS # 1403USA007226 experienced severe reactions after vaccination with booster dose of VARIVAX.  On an unknown date in 2008 the patient experienced very high fever (104 F), which persisted for 2 days and then subsided, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch. These neurologic symptoms persisted for about 6 months. The outcome of generalized lymphadenopathy was not reported. The relatedness between events and VARIVAX was not reported. The reporter stated that her children were very sensitive to vaccines and she's been closely working with allergist and immunologist to find the cause of these reactions. This is one of three same patient cases from the same source (MARRS # 1403USA003195, 1403USA007225). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007255, 1403USA007226, 1403USA007227, 1403USA007228).  Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Sensory disturbance, Stereotypy
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her currently 16 year old son. The patient's historical conditions included increased blood pressure when the patient received Ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). The patient also experienced, when he was in kindergarten, an meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195).  The reporter stated that her twins boy and girl (captured in MARRS # 1403USA007226 experienced severe reactions after vaccination with booster dose of VARIVAX.  On an unknown date in 2008 the patient experienced very high fever (104 F), which persisted for 2 days and then subsided, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch. These neurologic symptoms persisted for about 6 months. The outcome of generalized lymphadenopathy was not reported. The relatedness between events and VARIVAX was not reported. The reporter stated that her children were very sensitive to vaccines and she's been closely working with allergist and immunologist to find the cause of these reactions. This is one of three same patient cases from the same source (MARRS # 1403USA003195, 1403USA007225). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007255, 1403USA007226, 1403USA007227, 1403USA007228).  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous report prospective pregnancy report as received from a physician refers to a female patient of unknown age. On 19-MAR-2014 the patient was vaccinated with GARDASIL (lot number an expiry date was unknown) dose 1, 0.5 ml, intramuscular. On 03-MAR-2014 the patient underwent a urine pregnancy test which determined she was pregnant. The Last Menstrual Period and Estimated Date of Delivery were not known. The pregnancy outcome was unknown. It was reported that the physician was unsure whether the patient is planning to keep the unborn child or not. There was no product quality issue reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 17-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (dose, lot # and expiration date were not reported). On 17-DEC-2012, the patient received the second dose of GARDASIL (dose, lot # and expiration date were not reported). On 13-MAR-2014, was in the office 03/13/2014 to receive the 3rd dose of GARDASIL (dose, lot # and expiration date were not reported). No adverse effects reported. Additional information is not expected.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: This Spontaneous report as received from a Registered Nurse refers to a 15 month old female patient with no pertinent medical history or drug reactions/allergies. On 25-FEB-2014 the patient was vaccinated with a dose of MMR II lot J006955, expiration date 07-JUN-2015, subcutaneous. There was no concomitant medication. On 10-MAR-2014, the patient began to experience measles like rash all over the body. Patient was brought to the physician office on 11-MAR-2014 in which the physician confirmed the rash to be similar to measles. There was no treatment given for the event. No lab diagnostics studies performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Blood pressure increased, Contusion, Dyskinesia, Epistaxis, Hyperacusis
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her currently 16 years old son. The patient's historical conditions included increased blood pressure when the patient received ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). On an unknown date (reported as when he was in kindergarten), the patient experienced meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195). In 2008 the patient experienced very high fever, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007224). In 2008 the patient's sister experienced generalized lymphadenopathy, platelet level dropped, abnormal platelet function, dropped level of platelets, petechia, nose bleeds, bruising, profuse itching and very large urticaria on her thigh after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007226). The reporter stated that both her son and daughter (Described in MARRS # 1403USA007227) received a dose of GARDASIL and both experienced severe reactions. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported). Other suspect therapies included influenza virus vaccine (unspecified, manufactured by Sanofi Pasteur) (dose, strength, route and site of administration not reported) received on the same day. The reporter stated that the patient did not experienced fever but his neurologic symptoms he experienced with VARIVAX (Merck), such as sensory sensitivity and motor activity issue returned within first 12 hours of receiving GARDASIL. About a month after receiving GARDASIL, the patient experienced multi-joint swelling and found to have high (Antistreptolysin O) ASO titer for strep infection. The reporter stated that neurological symptoms for her son after receiving GARDASIL persisted for about 2 months then the patient became somewhat better after 6 months. The outcome of the events was not reported. The relatedness between events and suspect therapy was not reported. The reporter stated her children were very sensitive to vaccines and she was closely working with allergist and immunologist to find the cause for these reactions and she also mentioned that level of alum present in GARDASIL might be linked to these symptoms. This is one of three same patient cases from the same source (MARRS # 1403USA007224, 1403USA003195). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007224, 1403USA007226, 1403USA007227, 1403USA007228). Additional information is not expected.
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Hyperaesthesia, Joint swelling, Lymphadenopathy, Motor dysfunction, Neurological symptom
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her currently 16 years old son. The patient's historical conditions included increased blood pressure when the patient received ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). On an unknown date (reported as when he was in kindergarten), the patient experienced meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195). In 2008 the patient experienced very high fever, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007224). In 2008 the patient's sister experienced generalized lymphadenopathy, platelet level dropped, abnormal platelet function, dropped level of platelets, petechia, nose bleeds, bruising, profuse itching and very large urticaria on her thigh after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007226). The reporter stated that both her son and daughter (Described in MARRS # 1403USA007227) received a dose of GARDASIL and both experienced severe reactions. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported). Other suspect therapies included influenza virus vaccine (unspecified, manufactured by Sanofi Pasteur) (dose, strength, route and site of administration not reported) received on the same day. The reporter stated that the patient did not experienced fever but his neurologic symptoms he experienced with VARIVAX (Merck), such as sensory sensitivity and motor activity issue returned within first 12 hours of receiving GARDASIL. About a month after receiving GARDASIL, the patient experienced multi-joint swelling and found to have high (Antistreptolysin O) ASO titer for strep infection. The reporter stated that neurological symptoms for her son after receiving GARDASIL persisted for about 2 months then the patient became somewhat better after 6 months. The outcome of the events was not reported. The relatedness between events and suspect therapy was not reported. The reporter stated her children were very sensitive to vaccines and she was closely working with allergist and immunologist to find the cause for these reactions and she also mentioned that level of alum present in GARDASIL might be linked to these symptoms. This is one of three same patient cases from the same source (MARRS # 1403USA007224, 1403USA003195). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007224, 1403USA007226, 1403USA007227, 1403USA007228). Additional information is not expected.
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Platelet count decreased, Platelet function test abnormal, Pruritus, Pyrexia, Sensory disturbance
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her currently 16 years old son. The patient's historical conditions included increased blood pressure when the patient received ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). On an unknown date (reported as when he was in kindergarten), the patient experienced meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195). In 2008 the patient experienced very high fever, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007224). In 2008 the patient's sister experienced generalized lymphadenopathy, platelet level dropped, abnormal platelet function, dropped level of platelets, petechia, nose bleeds, bruising, profuse itching and very large urticaria on her thigh after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007226). The reporter stated that both her son and daughter (Described in MARRS # 1403USA007227) received a dose of GARDASIL and both experienced severe reactions. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported). Other suspect therapies included influenza virus vaccine (unspecified, manufactured by Sanofi Pasteur) (dose, strength, route and site of administration not reported) received on the same day. The reporter stated that the patient did not experienced fever but his neurologic symptoms he experienced with VARIVAX (Merck), such as sensory sensitivity and motor activity issue returned within first 12 hours of receiving GARDASIL. About a month after receiving GARDASIL, the patient experienced multi-joint swelling and found to have high (Antistreptolysin O) ASO titer for strep infection. The reporter stated that neurological symptoms for her son after receiving GARDASIL persisted for about 2 months then the patient became somewhat better after 6 months. The outcome of the events was not reported. The relatedness between events and suspect therapy was not reported. The reporter stated her children were very sensitive to vaccines and she was closely working with allergist and immunologist to find the cause for these reactions and she also mentioned that level of alum present in GARDASIL might be linked to these symptoms. This is one of three same patient cases from the same source (MARRS # 1403USA007224, 1403USA003195). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007224, 1403USA007226, 1403USA007227, 1403USA007228). Additional information is not expected.
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Streptococcus test positive, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her currently 16 years old son. The patient's historical conditions included increased blood pressure when the patient received ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). On an unknown date (reported as when he was in kindergarten), the patient experienced meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195). In 2008 the patient experienced very high fever, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007224). In 2008 the patient's sister experienced generalized lymphadenopathy, platelet level dropped, abnormal platelet function, dropped level of platelets, petechia, nose bleeds, bruising, profuse itching and very large urticaria on her thigh after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007226). The reporter stated that both her son and daughter (Described in MARRS # 1403USA007227) received a dose of GARDASIL and both experienced severe reactions. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported). Other suspect therapies included influenza virus vaccine (unspecified, manufactured by Sanofi Pasteur) (dose, strength, route and site of administration not reported) received on the same day. The reporter stated that the patient did not experienced fever but his neurologic symptoms he experienced with VARIVAX (Merck), such as sensory sensitivity and motor activity issue returned within first 12 hours of receiving GARDASIL. About a month after receiving GARDASIL, the patient experienced multi-joint swelling and found to have high (Antistreptolysin O) ASO titer for strep infection. The reporter stated that neurological symptoms for her son after receiving GARDASIL persisted for about 2 months then the patient became somewhat better after 6 months. The outcome of the events was not reported. The relatedness between events and suspect therapy was not reported. The reporter stated her children were very sensitive to vaccines and she was closely working with allergist and immunologist to find the cause for these reactions and she also mentioned that level of alum present in GARDASIL might be linked to these symptoms. This is one of three same patient cases from the same source (MARRS # 1403USA007224, 1403USA003195). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007224, 1403USA007226, 1403USA007227, 1403USA007228). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. The healthcare worker reported that the patient received their GARDASIL doses outside of the Prescribing Information (PI) recommended schedule. In May 2011 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. In January 2013 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular), intramuscular. In January 2014 the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mouth ulceration
Clinical narrative: Mom states patient had several ulcers in the mouth after rec. 1st and 2nd dose of the HPV vaccine.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aphthous stomatitis, Stomatitis
Clinical narrative: Mom states patient had several ulcers in the mouth after rec. 1st and 2nd dose of the HPV vaccine.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Febrile convulsion
Clinical narrative: Febrile seizure 3/20/14. MMR/VARIVAX/Hep A vaccines given 10 days prior on 3/10/14
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Diarrhoea, Immediate post-injection reaction
Clinical narrative: Mother of patient reports that patient experienced joint pain all over her body immediately following the administration of MCV 4 vaccine. Mother states that patient also reported a bowel movement od diarrhea on 3/18/14. Mother states that patient did not use anything to treat joint pain. Per mom joint pain resolved on Wednesday 3/19/2014 in the afternoon.
Age: 2.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: C-reactive protein increased, Injection site erythema, Injection site swelling, Leukocytosis, Weight bearing difficulty
Clinical narrative: After receiving pneumococcal in the left leg and meningococcal in the right leg the patient developed redness and swelling near the knee of his left leg and could not bear weight on that leg. Patient was also found to have tissue swelling and leukocytosis and increased CRP.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Full blood count normal, Laboratory test normal, Pain in extremity
Clinical narrative: Influenza, Sanofi, FLUZONE, 2013-2014, 0.5ml prefilled syringe, Lot UH888AA, in right deltoid. Tdap vaccine, GSK BOOSTRIX, 0.5ml, prefilled syringe, 0.5ml, Lot 4G995, left deltoid. Both vaccines administered near 6:30PM. Within 6 hours of the injections, leg pains and right hip pain began. Pains were in both legs, worse with sitting, laying down or standing still. Walking seemed to make the pains more tolerable. No relief of painful symptoms with cold compresses, warm compresses, warm bath with Epsom salts, massaging. Symptoms were present through 48hours when the pains began to decrease and by 96 hours were gone except pain in the right hip joint remained. Interestingly, the patient experienced the same leg pains and aggravated right hip pain 24-48hrs post-op Feb 2014.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Coma, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Lower back pain and weakness and eventual dx of Guillain Barre Syndrome. In coma like state for 2 1/2 mo, ventilator assistance for 8 mo. In ICU for 6 mo. treated with Plasmapheresis and IVIG (inpatient rehab) for 1.5 mo and continued rehab as outpatient to current.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Intensive care, Mechanical ventilation, Plasmapheresis
Clinical narrative: Lower back pain and weakness and eventual dx of Guillain Barre Syndrome. In coma like state for 2 1/2 mo, ventilator assistance for 8 mo. In ICU for 6 mo. treated with Plasmapheresis and IVIG (inpatient rehab) for 1.5 mo and continued rehab as outpatient to current.
Age: 8.0
Sex: M
Vaccine: MEA, MU, RUB
Symptoms: Asthma, Measles antibody positive, Measles post vaccine, Pruritus, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a 8 year old male patient. The patient had no pertinent medical history and no history of allergy. On an unknown date, around the age of three or four, the patient was vaccinated with ATTENUVAX (dose and frequency were not reported) one dose. Concomitant therapies included MUMPSVAX and MERUVAX II. On an unknown date, the patient experienced broke out with measles, itchiness and fever. On an unknown date, years later, the patient also experienced allergy induced asthma. The consumer stated that the allergy induced asthma would not be related to ATTENUVAX. On an unknown date, the patient underwent some blood test and result showed as would be immune to measles. The patient sought medical attention and visited the office. The patient was treated with Advil. The outcome of the events was reported as recovered. The reporter did not provide the causality between the events wand the suspect drug. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. About two years ago (approximately February 2012) the patient was vaccinated with the first two doses of GARDASIL (dosing information not provided). The reporter stated that the patient still has not yet received the 3rd shot of GARDASIL. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 17-MAR-2014 the patient was vaccinated with expired, unspecified dose of VARIVAX (lot # 0568AE, expiration date: 15-MAR-2014). No adverse events were reported. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Information regarding the patient's pertinent medical history was not provided. On 04-MAR-2014 the patient was indicated to received ZOSTAVAX, but inadvertently received VARIVAX 1350 U, 0.5 ml, subcutaneously. Lot number was unknown. No adverse effect was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. states she received shingles vaccine at pharmacy on 3/21/14. It was administered in her left bicep. Pt has approx. 3 x 3 area to left bicep with erythema, slight swelling, and warmth. Pt was treated with Acyclovir.
Age: 63.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Contusion, Erythema, Headache, Pain, Rash vesicular
Clinical narrative: Pt. states she received shingles vaccine at pharmacy on 3/21/14. It was administered in her left bicep. Pt has approx. 3 x 3 area to left bicep with erythema, slight swelling, and warmth. Pt was treated with Acyclovir.
Age: 63.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Swelling
Clinical narrative: Pt. states she received shingles vaccine at pharmacy on 3/21/14. It was administered in her left bicep. Pt has approx. 3 x 3 area to left bicep with erythema, slight swelling, and warmth. Pt was treated with Acyclovir.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and referred to a patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. On 03-SEP-2013, the patient was vaccinated with GARDASIL (lot #, expiration date, strength were not reported) injection dose 1, 0.5 ml, intramuscularly. No concomitant medications were reported. The patient received dose 2 and dose 3 of GARDASIL one week apart. Dose 2 was given on 11-MAR-2014 and dose 3 was given on 18-MAR-2014. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with second dose of GARDASIL (dose and frequency were not reported) at the age of 18. On an unknown date, the patient received the third dose of GARDASIL (dose and frequency were not reported) at the age of 19. No other additional information was available. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history was not provided. On 02-MAR-2014 the patient was vaccinated with an expired dose of MMR II (lot # 1579AA; expiration date 12-OCT-2013). Strength and dose were not reported. No adverse effects were reported. No further information was provided. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles, Throat tightness, Urticaria
Clinical narrative: Patient had large blistering rash at injection site and hives covering arms shortly after getting shot. Also throat closed. Ended up in the ER.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: Deltoid soreness, slight swelling, increase soreness w/movement.
Age: 1.25
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Body temperature increased, Convulsion, Dyskinesia, Gaze palsy
Clinical narrative: Temperature began rising with no other symptoms. Appropriate dose of Tylenol was administered at 5:00 pm. By 11 pm temperature rose to 105.9 axillary Tylenol was administered by 11:45 pm patient began to seize. Her eyes rolled back in her head and her limbs began to violently jerk it lasted for approximately one minute.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Re-occurring hives on body and face. Itchy on body.
Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Re-occurring hives on body and face. Itchy on body.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She reports redness, warmth, and upper arm "soreness" in her left arm.  She reports the injection site was "a little red" after the injection and soreness didn't begin until Wednesday evening.  She says it's slowly improving, but the symptoms are not gone yet.
Age: 0.5
Sex: M
Vaccine: 6VAX-F, RVX
Symptoms: Erythema, Generalised erythema, Pyrexia, Urticaria
Clinical narrative: SLIGHT FEVER THAT NIGHT, EARS AND BACK OF HEAD RED.  WOKE UP NEXT MORNING AND STILL HAD FEVER AND HAD RED WELPS ALL OVER BODY.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Computerised tomogram abnormal, Dyspnoea, Local swelling, Lymphadenopathy, Tracheal deviation
Clinical narrative: Patient seen at SRP on 3-19-2014 for f/u on smallpox. Normal reaction and given week 2 instructions. On 3-21-2014, patient presented to the ER for swelling in her arm and difficulty breathing. Patient transferred to hospital for observation due to CT showing minimal trachial observation. Patient was observed for 24 hours and released. The patient was seen in clinic on 3-24-2014 and doing well with no complaints.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Blood culture negative, Bruxism, CSF culture negative, Coma scale abnormal, Cyanosis
Clinical narrative: Patient was baseline but very sleepy all afternoon after vaccinations. At 7:30pm mom found patient on floor unresponsive face up, blue lips, purple face, head and hands were shaking but apparently breathing on his own. Patient taken to local hospital. Limited workup completed. No acute intracranial processes found but imaging was poor due to movement. Patient continued to be unresponsive, however did scream upon IV start. Pupils were dialated and very sluggish. Still breathing spontaneously and had one episode of emesis. Was transferred by helicopter to hospital at approximately 2340 on 3/5/14. Hospital course: On arrival GCS = 9, Assessment included encephalopathy, head twitching, teeth grinding for 5 seconds. Concern for seizures and progression of encephalopathy and presumed meningitis. Neurology recommended MRI/MRA/MRV and loaded with Keppra and an EEG. Patient received ceftriaxone and acyclovir for presumed meningitis. EEG showed severe, diffuse encephalopathy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Electroencephalogram abnormal, Encephalopathy, Head titubation, Muscle twitching, Mydriasis
Clinical narrative: Patient was baseline but very sleepy all afternoon after vaccinations. At 7:30pm mom found patient on floor unresponsive face up, blue lips, purple face, head and hands were shaking but apparently breathing on his own. Patient taken to local hospital. Limited workup completed. No acute intracranial processes found but imaging was poor due to movement. Patient continued to be unresponsive, however did scream upon IV start. Pupils were dialated and very sluggish. Still breathing spontaneously and had one episode of emesis. Was transferred by helicopter to hospital at approximately 2340 on 3/5/14. Hospital course: On arrival GCS = 9, Assessment included encephalopathy, head twitching, teeth grinding for 5 seconds. Concern for seizures and progression of encephalopathy and presumed meningitis. Neurology recommended MRI/MRA/MRV and loaded with Keppra and an EEG. Patient received ceftriaxone and acyclovir for presumed meningitis. EEG showed severe, diffuse encephalopathy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Nuclear magnetic resonance imaging brain normal, Pupillary reflex impaired, Screaming, Skin discolouration, Somnolence
Clinical narrative: Patient was baseline but very sleepy all afternoon after vaccinations. At 7:30pm mom found patient on floor unresponsive face up, blue lips, purple face, head and hands were shaking but apparently breathing on his own. Patient taken to local hospital. Limited workup completed. No acute intracranial processes found but imaging was poor due to movement. Patient continued to be unresponsive, however did scream upon IV start. Pupils were dialated and very sluggish. Still breathing spontaneously and had one episode of emesis. Was transferred by helicopter to hospital at approximately 2340 on 3/5/14. Hospital course: On arrival GCS = 9, Assessment included encephalopathy, head twitching, teeth grinding for 5 seconds. Concern for seizures and progression of encephalopathy and presumed meningitis. Neurology recommended MRI/MRA/MRV and loaded with Keppra and an EEG. Patient received ceftriaxone and acyclovir for presumed meningitis. EEG showed severe, diffuse encephalopathy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Tremor, Unresponsive to stimuli, Venogram normal, Viral test positive, Vomiting
Clinical narrative: Patient was baseline but very sleepy all afternoon after vaccinations. At 7:30pm mom found patient on floor unresponsive face up, blue lips, purple face, head and hands were shaking but apparently breathing on his own. Patient taken to local hospital. Limited workup completed. No acute intracranial processes found but imaging was poor due to movement. Patient continued to be unresponsive, however did scream upon IV start. Pupils were dialated and very sluggish. Still breathing spontaneously and had one episode of emesis. Was transferred by helicopter to hospital at approximately 2340 on 3/5/14. Hospital course: On arrival GCS = 9, Assessment included encephalopathy, head twitching, teeth grinding for 5 seconds. Concern for seizures and progression of encephalopathy and presumed meningitis. Neurology recommended MRI/MRA/MRV and loaded with Keppra and an EEG. Patient received ceftriaxone and acyclovir for presumed meningitis. EEG showed severe, diffuse encephalopathy.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Dysphagia, Dyspnoea, Local swelling, Muscle tightness
Clinical narrative: Began with very tight sensation in jaw. Swelling of tongue and neck and decreased sensation in face followed, then soreness in lower back and kidneys. Breathing and swallowing became more difficult approximately one to one and 1/2 hours post injection. Lasted two days with antihistamines.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Renal pain, Sensory disturbance, Swollen tongue
Clinical narrative: Began with very tight sensation in jaw. Swelling of tongue and neck and decreased sensation in face followed, then soreness in lower back and kidneys. Breathing and swallowing became more difficult approximately one to one and 1/2 hours post injection. Lasted two days with antihistamines.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Bump on the left thigh.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cardiac arrest, Death, Resuscitation, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient was in usual state of health.  Had bottle at about 2:30 AM and then put back to sleep in bed with father.  Another family member checked on baby few hours later and found she was unresponsive with vomit in her mouth.  Father attempted CPR; CPR en route to ED by EMS.  Asystole noted on arrival in ED.  Patient deceased.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Pt. found expired in bed with parents. Final autopsy pending.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Pt. found expired in bed with parents. Final autopsy pending.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Asphyxia, Bed sharing, Death
Clinical narrative: Pt. found expired in bed with parents. Final autopsy pending.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Erythema, Induration, Local swelling
Clinical narrative: Redness, swelling along with warmth and firmness in the left arm. Pt was having pain which on the Wong-Baker scale is a 10/10. Pt reports cough along with SOB. Treatment: cool compress, ibuprofen 800 mg, empiric Bactrim, follow up next day for re-evaluation.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin warm
Clinical narrative: Redness, swelling along with warmth and firmness in the left arm. Pt was having pain which on the Wong-Baker scale is a 10/10. Pt reports cough along with SOB. Treatment: cool compress, ibuprofen 800 mg, empiric Bactrim, follow up next day for re-evaluation.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Urticaria, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Large raised welt at vaccination site, about 3 inches by 2 inches. I have had the welt for 4 days, it is still large, red, hot to the touch and itchy.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Severe arm pain and nausea; Patient called ambulance to pick her up to take her to ER; Hospital prescribed Hydrocodone/APAP for pain and Zofran for nausea.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Activities of daily living impaired, Body temperature increased, Decreased appetite, Fatigue, Insomnia
Clinical narrative: Severe arm pain and nausea; Patient called ambulance to pick her up to take her to ER; Hospital prescribed Hydrocodone/APAP for pain and Zofran for nausea.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Weight decreased
Clinical narrative: Severe arm pain and nausea; Patient called ambulance to pick her up to take her to ER; Hospital prescribed Hydrocodone/APAP for pain and Zofran for nausea.
Age: 51.0
Sex: M
Vaccine: HEPA, MEN, PPV, TDAP, TYP, YF
Symptoms: Angina pectoris, Arthralgia, Arthritis, Asthenia, Bone pain
Clinical narrative: 101.5 temperature, strong aches in joints muscles and bones- it felt like severe arthritis, loss of strength, heart pains.
Age: 51.0
Sex: M
Vaccine: HEPA, MEN, PPV, TDAP, TYP, YF
Symptoms: Myalgia
Clinical narrative: 101.5 temperature, strong aches in joints muscles and bones- it felt like severe arthritis, loss of strength, heart pains.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at site of injections.
Age: 37.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Injection site pain, Nausea, X-ray
Clinical narrative: Severe upper arm pain of the left arm and nausea;  Patient called ambulance to pick her up to take her to ER; Hospital gave prescription for Hydrocodone/APAP and Zofran;  Hospital ordered X-Ray.
Age: 37.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Arthralgia, Chest X-ray, Pain, Pain in extremity
Clinical narrative: Severe upper arm pain of the left arm and nausea;  Patient called ambulance to pick her up to take her to ER; Hospital gave prescription for Hydrocodone/APAP and Zofran;  Hospital ordered X-Ray.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abnormal behaviour, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Her arm became very red, hot to the touch, itchy, and got some type of raised bumps. She was out of sorts and very tearful. The urgent care Dr. measured the redness on her arm at 10cmX8cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Tearfulness
Clinical narrative: Her arm became very red, hot to the touch, itchy, and got some type of raised bumps. She was out of sorts and very tearful. The urgent care Dr. measured the redness on her arm at 10cmX8cm.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Blood culture, Blood glucose normal, Convulsion, Full blood count, Influenza virus test
Clinical narrative: Seizures lasting 15 minutes, vomited while unconscious, fever 102.7 EMS transport to ED, required BVM to support breathing O2 Sat 90%.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Loss of consciousness, Pyrexia, Respiratory syncytial virus test, Vomiting
Clinical narrative: Seizures lasting 15 minutes, vomited while unconscious, fever 102.7 EMS transport to ED, required BVM to support breathing O2 Sat 90%.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Quarter sized lump to injection site with itching.  Redness 9cm by 5cm to right arm where injection given. Benadryl 50mg given and hydrocortisone 1% ointment applied to site for itching.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & Redness to right deltoid and bicep.