chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Malaise
Clinical narrative: Mother came in to have PPD read. While at clinic, she mentions a reaction to injection site. Child has felt malaise for since injection day. Denies fever. Reaction occurred next day. Reddened welted area approx. 6cm in diameter to R deltoid (Kinrix injection site). Ice pack is applied after inspection.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Convulsion, Pyrexia
Clinical narrative: She began to run a fever, the fever was very high she had a seizure due to the fever, had to be taken to the ER.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. The medical assistant reported that, on an unkonwn date of 2014, unknown number of patients were vaccinated with a dose of PROQUAD (Merck) (lot#, dose/frequency and route not reported) which had been improperly stored in March 2014. No adverse effects reported. This is one of two reports (MARRS# 1404USA005034 and 1404USA006997) from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site reaction, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Erythema, flu-like symptoms, injection site reaction, swollen lymph nodes, muscular pain in neck and shoulders.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain
Clinical narrative: Erythema, flu-like symptoms, injection site reaction, swollen lymph nodes, muscular pain in neck and shoulders.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Eyelid irritation, Eyelids pruritus, Pruritus, Skin burning sensation
Clinical narrative: This spontaneous report was received from a 63 year old female patient with ragweeds allergy, mold allergy, CLINORIL allergy and dry eyes. On 27-MAR-2014 the patient was vaccinated with zoster vaccine live (manufacturer unknown), route not provided. Other suspect therapy included REFRESH OPTIVE and REFRESH OPTIVE ADVANCED. No concomitant medications were reported. Consumer reported that she had started REFRESH OPTIVE was started over 20 years ago (unspecified date). Dose regimen was one to two drops to eyes, used morning and evening. REFRESH OPTIVE ADVANCED was started on 17-MAR-2014. Dose regimen was one to two drops to eyes, used morning and evening. On 18-MAR-2014, patient reported eyelids started to itch, which patient attributes to allergies. Non-medical treatment was reported as cold washcloths on eyelids for itching. Patient's eyelid skin became red and raw, which patient attributed to wiping eyelids with wet washcloths. Patient also noted using new hair product which she thought might have caused the reaction. Patient washed her hair twice to remove product. On 17-MAR-2014, patient started REFRESH OPTIVE ADVANCED and reaction worsened. On 18-MAR-2014, patient discontinued FRESH OPTIVE. Patient reported having itching around the nose, neck and ears, but no rash, red ears, and a burning sensation to skin and around eyes. On 20-MAR-2014 and 21-MAR-2014, these events "got really bad", and patient called pharmacist and the manufacturer of the zoster vaccine live (manufacturer unknown) vaccine and was told the reaction was not due to the vaccine. No treatment was required for reported events, and patient wanted it noted that she did not think events were related to use of eye drops and plans to see a dermatologist. It was unknown if FRESH OPTIVE ADVANCED was continued. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain rt. upper arm to elbow x 2 days.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Feeling abnormal, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient is a 53 year old male who presents for an injection reaction. Wednesday had the pneumonia shot (indication: Smoker). Then after that in the middle of the night he felt the site to be hot and hurting. The following day, around the Band Aid there was redness about 6 cm. This has increased since and pain has been more apparent as well. He has felt "under the weather." He has had joint achiness in general but no joints that are red or swollen. The patient denies fever, chills, sweats or rash. The achiness may have started last weekend with a cold, nasal congestion. No facial or sinus pain, just congestion. Using MUCINEX, daily; ALKA SELTZER. No breathing issues. He has had neck pains but this is usual for him, preceded the PNEUMOVAX. He has not had vaccine reactions in the past. WORK: does physical work and a lot of lifting.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Nasal congestion, Nasopharyngitis, Neck pain
Clinical narrative: Patient is a 53 year old male who presents for an injection reaction. Wednesday had the pneumonia shot (indication: Smoker). Then after that in the middle of the night he felt the site to be hot and hurting. The following day, around the Band Aid there was redness about 6 cm. This has increased since and pain has been more apparent as well. He has felt "under the weather." He has had joint achiness in general but no joints that are red or swollen. The patient denies fever, chills, sweats or rash. The achiness may have started last weekend with a cold, nasal congestion. No facial or sinus pain, just congestion. Using MUCINEX, daily; ALKA SELTZER. No breathing issues. He has had neck pains but this is usual for him, preceded the PNEUMOVAX. He has not had vaccine reactions in the past. WORK: does physical work and a lot of lifting.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Insomnia, Pain
Clinical narrative: Patient is a 33 year old female who presents for vaccine site pain and swelling. Thursday 4/3/2014: No problems right after the shot was given. Friday 4/4/2014: she felt that she was under stress at work then and felt "just sore" on the left deltoid injection area, maybe a little warmth. That night though, she had difficulty sleeping due to the soreness on the left deltoid injection area; she was unable to lay on it, movements of the left arm would cause soreness. Saturday, woke up with tiredness and increased pain, warmth and tenderness on the left deltoid injection area. About 2/5 pain. The pain worsened later in the day with increased redness and swelling. She felt feverish but did not take temp. She iced the area. Sunday: she had persistent pain and soreness, redness and felt swollen in the left deltoid injection area. She took her temp: highest about 101F, less by the evening. She took Ibuprofen: 400 mg 4x a day since Saturday (after the 101F). Since then, continuing on the Ibuprofen, she had been feeling a little better, no fevers today (last ibuprofen was at 8 am); the redness and soreness have been less. No facial swelling, lip or tongue swelling; no swallowing or breathing problems. Patient denies cough, dyspnea, wheezing. No history of skin reactions to vaccinations. No respiratory allergies or asthma. No frequent skin rashes or dermatitis; no other new medications, foods, drinks, cosmetics, detergents, soaps.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient is a 33 year old female who presents for vaccine site pain and swelling. Thursday 4/3/2014: No problems right after the shot was given. Friday 4/4/2014: she felt that she was under stress at work then and felt "just sore" on the left deltoid injection area, maybe a little warmth. That night though, she had difficulty sleeping due to the soreness on the left deltoid injection area; she was unable to lay on it, movements of the left arm would cause soreness. Saturday, woke up with tiredness and increased pain, warmth and tenderness on the left deltoid injection area. About 2/5 pain. The pain worsened later in the day with increased redness and swelling. She felt feverish but did not take temp. She iced the area. Sunday: she had persistent pain and soreness, redness and felt swollen in the left deltoid injection area. She took her temp: highest about 101F, less by the evening. She took Ibuprofen: 400 mg 4x a day since Saturday (after the 101F). Since then, continuing on the Ibuprofen, she had been feeling a little better, no fevers today (last ibuprofen was at 8 am); the redness and soreness have been less. No facial swelling, lip or tongue swelling; no swallowing or breathing problems. Patient denies cough, dyspnea, wheezing. No history of skin reactions to vaccinations. No respiratory allergies or asthma. No frequent skin rashes or dermatitis; no other new medications, foods, drinks, cosmetics, detergents, soaps.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Pt stayed at office for 30 min after receiving injection. Pt's mom states, 30 min after injections patient, felt nauseous/swelling at injection site, burning and itching, mom stated she did not call office wanted to wait til patient felt better - Pt's mom was given info regarding reactions verbally with VIS info hardcopy. Pt is scheduled for 2nd HPV on 4/14/14 which prompted mom to call.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Mom brought child for PPD reading and mentioned redness in right deltoid, no swelling, not warm. No symptoms. Child had received MMRV on right arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Burning sensation, Dry eye, Eye pruritus, Pruritus
Clinical narrative: This spontaneous report was received from the patient's husband refers to her wife an approximately 72 year old female patient. Patient with high blood pressure, depression and sleep at night. Patient with no drug reactions or allergies. On an unknown date in June 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included lisinopril (manufacturer unknown), sertraline hydrochloride and AMBIEN. Patient's husband reported that two weeks (in approximately June 2013) after his wife received ZOSTAVAX, she began to experience a burning, itchy sensation, much like a sunburn underneath her breast, scalp, neck, ears and back. Patient's husband reported that his wife when to two dermatologists, one of whom recommended she a rheumatologist. Patient's husband reported that his wife saw a rheumatologist in 09-JAN-2014 who conducted a batter of blood tests. Two weeks later 23-JAN-2014, the rheumatologist diagnosed the patient with Sjogren's Syndrome. Patient was being treated with SALAGEN. Patient's husband also reported that his wife began to experience dry and itchy eyes as a result of the Sjogren's Syndrome. The wife saw an eye doctor who treated this by plugging the patient's tear ducts. The dry eye became worse, and the plugs were removed on 01-APR-2014. Patient's eyes have been better since the removal, but not fully resolved. Patient's husband reported that his wife's issues with her skin, was not resolved. Patient's present status was reported as not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Sjogren's syndrome
Clinical narrative: This spontaneous report was received from the patient's husband refers to her wife an approximately 72 year old female patient. Patient with high blood pressure, depression and sleep at night. Patient with no drug reactions or allergies. On an unknown date in June 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included lisinopril (manufacturer unknown), sertraline hydrochloride and AMBIEN. Patient's husband reported that two weeks (in approximately June 2013) after his wife received ZOSTAVAX, she began to experience a burning, itchy sensation, much like a sunburn underneath her breast, scalp, neck, ears and back. Patient's husband reported that his wife when to two dermatologists, one of whom recommended she a rheumatologist. Patient's husband reported that his wife saw a rheumatologist in 09-JAN-2014 who conducted a batter of blood tests. Two weeks later 23-JAN-2014, the rheumatologist diagnosed the patient with Sjogren's Syndrome. Patient was being treated with SALAGEN. Patient's husband also reported that his wife began to experience dry and itchy eyes as a result of the Sjogren's Syndrome. The wife saw an eye doctor who treated this by plugging the patient's tear ducts. The dry eye became worse, and the plugs were removed on 01-APR-2014. Patient's eyes have been better since the removal, but not fully resolved. Patient's husband reported that his wife's issues with her skin, was not resolved. Patient's present status was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Influenza
Clinical narrative: This spontaneous report as received from a consumer refers to his brother of unknown age. Medical history and concurrent conditions were not reported. On 22-MAR-2014 (reported as about 10 days ago), the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, lot number and expiration date was not reported). Secondary and concomitant therapies were not reported. Reporter stated that "my brother went to ER because he had trouble breathing and had the flu after he received PNEUMOVAX 23 vaccine). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Needle issue
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant refers to a female patient of unknown age. On 17-DEC-2013 the patient was vaccinated with first dose of GARDASIL intramuscularly. On an unknown date, the patient declined to receive a second dose of GARDASIL. No adverse events were reported. No further AE information was reported. Follow up information has been received on 01-APR-2014 from the physician concerning the 18 year old female patient with emotional immaturity, depression and long history of emotional problems. Physician reported that on 03-MAR-2014 at 4:45 p.m. the second dose of GARDASIL was not administered due to needle was contaminated. Physician also reported that no harm to patient only emotional upset on the same date at 4:45 p.m. It was reported that needle never touched patient. It was also reported that patient refused vaccine. No illness at time of vaccination was reported. The outcome of emotional upset was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. The medical assistant reported that, on an unknown date of 2014, unknown number of patients were vaccinated with a dose of VARIVAX (Merck) (lot#, dose/frequency and route not reported) which had been improperly stored in March 2014. No adverse effects reported. This is one of two reports (1 MARRS# 1404USA005034 and 1404USA006997) from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On approximately April 2009, "five years ago", the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) IM and on 07-APR-2014, the patient received her second 0.5 ml dose of GARDASIL (lot # not reported) IM. No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time, Arthralgia, Differential white blood cell count, Eyelid oedema, Full blood count
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Patient was afebrile and had no illnesses in past two weeks. On 28-MAR-2014 the patient was vaccinated with 3rd dose of GARDASIL (dosage information unknown). On 29-MAR-2014, patient developed fine erythematous rash on wrists, hands, ankles and feet. Physician explained that rash progressed up over shins, where it turned into a petechial rash. Patient experienced fatigue, tiredness and pain in knees, but no joint swelling. Patient was treated with BENADRYL, by patient's mother. Rash was facing off and then came back. Blood tests performed: Platelets were normal, Hemoglobin, Prothrombin Time and Activated partial thromboplastin time (APPT) were normal, white blood count was 2.8; differential showed Neutrophils -43, Monocytes - 16, Eosinophils 9. The patient had saw physician for medical attention. The outcome of the patient was unknown. The causality was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Malaise, Myalgia, Papule, Petechiae, Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Patient was afebrile and had no illnesses in past two weeks. On 28-MAR-2014 the patient was vaccinated with 3rd dose of GARDASIL (dosage information unknown). On 29-MAR-2014, patient developed fine erythematous rash on wrists, hands, ankles and feet. Physician explained that rash progressed up over shins, where it turned into a petechial rash. Patient experienced fatigue, tiredness and pain in knees, but no joint swelling. Patient was treated with BENADRYL, by patient's mother. Rash was facing off and then came back. Blood tests performed: Platelets were normal, Hemoglobin, Prothrombin Time and Activated partial thromboplastin time (APPT) were normal, white blood count was 2.8; differential showed Neutrophils -43, Monocytes - 16, Eosinophils 9. The patient had saw physician for medical attention. The outcome of the patient was unknown. The causality was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash papular, Urine analysis
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Patient was afebrile and had no illnesses in past two weeks. On 28-MAR-2014 the patient was vaccinated with 3rd dose of GARDASIL (dosage information unknown). On 29-MAR-2014, patient developed fine erythematous rash on wrists, hands, ankles and feet. Physician explained that rash progressed up over shins, where it turned into a petechial rash. Patient experienced fatigue, tiredness and pain in knees, but no joint swelling. Patient was treated with BENADRYL, by patient's mother. Rash was facing off and then came back. Blood tests performed: Platelets were normal, Hemoglobin, Prothrombin Time and Activated partial thromboplastin time (APPT) were normal, white blood count was 2.8; differential showed Neutrophils -43, Monocytes - 16, Eosinophils 9. The patient had saw physician for medical attention. The outcome of the patient was unknown. The causality was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time normal, Arthralgia, Eosinophil count, Fatigue, Haemoglobin normal
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Patient was afebrile and had no illnesses in past two weeks. On 28-MAR-2014 the patient was vaccinated with 3rd dose of GARDASIL (dosage information unknown). On 29-MAR-2014, patient developed fine erythematous rash on wrists, hands, ankles and feet. Physician explained that rash progressed up over shins, where it turned into a petechial rash. Patient experienced fatigue, tiredness and pain in knees, but no joint swelling. Patient was treated with BENADRYL, by patient's mother. Rash was facing off and then came back. Blood tests performed: Platelets were normal, Hemoglobin, Prothrombin Time and Activated partial thromboplastin time (APPT) were normal, white blood count was 2.8; differential showed Neutrophils -43, Monocytes - 16, Eosinophils 9. The patient had saw physician for medical attention. The outcome of the patient was unknown. The causality was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Monocyte count, Neutrophil count, Petechiae, Platelet count normal, Prothrombin time normal
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Patient was afebrile and had no illnesses in past two weeks. On 28-MAR-2014 the patient was vaccinated with 3rd dose of GARDASIL (dosage information unknown). On 29-MAR-2014, patient developed fine erythematous rash on wrists, hands, ankles and feet. Physician explained that rash progressed up over shins, where it turned into a petechial rash. Patient experienced fatigue, tiredness and pain in knees, but no joint swelling. Patient was treated with BENADRYL, by patient's mother. Rash was facing off and then came back. Blood tests performed: Platelets were normal, Hemoglobin, Prothrombin Time and Activated partial thromboplastin time (APPT) were normal, white blood count was 2.8; differential showed Neutrophils -43, Monocytes - 16, Eosinophils 9. The patient had saw physician for medical attention. The outcome of the patient was unknown. The causality was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous, White blood cell count decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. Patient was afebrile and had no illnesses in past two weeks. On 28-MAR-2014 the patient was vaccinated with 3rd dose of GARDASIL (dosage information unknown). On 29-MAR-2014, patient developed fine erythematous rash on wrists, hands, ankles and feet. Physician explained that rash progressed up over shins, where it turned into a petechial rash. Patient experienced fatigue, tiredness and pain in knees, but no joint swelling. Patient was treated with BENADRYL, by patient's mother. Rash was facing off and then came back. Blood tests performed: Platelets were normal, Hemoglobin, Prothrombin Time and Activated partial thromboplastin time (APPT) were normal, white blood count was 2.8; differential showed Neutrophils -43, Monocytes - 16, Eosinophils 9. The patient had saw physician for medical attention. The outcome of the patient was unknown. The causality was not provided. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old male patient without pertinent medical history, drug reactions or allergies. On 16-JAN-2014, the patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not reported). Secondary therapies were not reported. There was no concomitant medication. The physician reported that a patient experienced "pins and needles" all over his body after receiving his first dose of GARDASIL on 16-JAN-2014. The "pins and needles" began about 2 hours after he received GARDASIL and lasted for 1 day. Patient did not seek medical attention at that time but mentioned it to the physician at follow up visit on 28-MAR-2014. The outcome of "pins and needles" was reported as recovered. No treatment was given for adverse event. No lab diagnostics studies were performed. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old male patient without pertinent medical history, drug reactions or allergies. On 16-JAN-2014, the patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not reported). Secondary therapies were not reported. There was no concomitant medication. The physician reported that a patient experienced "pins and needles" all over his body after receiving his first dose of GARDASIL on 16-JAN-2014. The "pins and needles" began about 2 hours after he received GARDASIL and lasted for 1 day. Patient did not seek medical attention at that time but mentioned it to the physician at follow up visit on 28-MAR-2014. The outcome of "pins and needles" was reported as recovered. No treatment was given for adverse event. No lab diagnostics studies were performed. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: YF
Symptoms: Rash
Clinical narrative: Unexpected rash on arms and legs seen around 1 am (when I woke up in the night last night) and it is still there at 7 am but is fading.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Seizure activity, shaking arms repeatedly for approximately 1 minute 30 seconds. Second seizure next day at 4 pm. shaking head and arms for approximately 1 minute 30 seconds.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Disorientation, Hypersomnia, Listless, Pallor, Pyrexia
Clinical narrative: Normal after vaccination shot. Played basketball with friend 1hr. But then not hungry for dinner. Violent vomiting at about 6:45 pm. No fever. Fell asleep at about 8:15pm. Another round of violent vomiting at about 9pm. Slept all night after that. Pale and listless the next day. Slept a lot. Fever of 100+ starting at about 12pm. Able to eat dry cheerios but not hungry. Disoriented after afternoon nap. Gave 300 mg Motrin junior at about 5pm. Started feeling better. Slept all night. Seemed back to normal the next day (3/22), although ate cautiously for several days. Raised bumpy rash appeared on 3/23 or 3/24 (can't remember which). Round patch on front torso, upper abdomen, roughly 8 in. in diameter. Not hives, or at least not like any hives he's had before. ONLY on that one spot. Rash faded over 2-3 days. Then all back to normal.   Nobody else in the family got sick, so we don't think the vomiting was from a stomach virus.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Rash, Vomiting
Clinical narrative: Normal after vaccination shot. Played basketball with friend 1hr. But then not hungry for dinner. Violent vomiting at about 6:45 pm. No fever. Fell asleep at about 8:15pm. Another round of violent vomiting at about 9pm. Slept all night after that. Pale and listless the next day. Slept a lot. Fever of 100+ starting at about 12pm. Able to eat dry cheerios but not hungry. Disoriented after afternoon nap. Gave 300 mg Motrin junior at about 5pm. Started feeling better. Slept all night. Seemed back to normal the next day (3/22), although ate cautiously for several days. Raised bumpy rash appeared on 3/23 or 3/24 (can't remember which). Round patch on front torso, upper abdomen, roughly 8 in. in diameter. Not hives, or at least not like any hives he's had before. ONLY on that one spot. Rash faded over 2-3 days. Then all back to normal.   Nobody else in the family got sick, so we don't think the vomiting was from a stomach virus.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Autonomic nervous system imbalance, Headache, Nervous system disorder, Syncope
Clinical narrative: Joint pain, autonomic instability, neurological problems, headaches, syncope.
Age: 1.22
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Crying, Diet refusal, Dyskinesia, Gaze palsy, Pyrexia
Clinical narrative: Projectile vomiting, fever 102, eye rolling, prolonged crying, jerking movements in sleep (possibility dry heaving), refusing to eat.
Age: 1.22
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting, fever 102, eye rolling, prolonged crying, jerking movements in sleep (possibility dry heaving), refusing to eat.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with GARDASIL (dose, route, and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA005406, 1404USA007013, 1404USA007014 and 1404UAS007014 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with PNEUMOVAX 23 (dose, route, and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA005406, 1404USA007012, 1404USA007013 and 1404USA007015 via same reporter link. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Addison's disease, Antibody test positive, Blood immunoglobulin G increased, Blood immunoglobulin M decreased, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old female patient. On an unspecified day in July 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). The patient developed a vesicular "spot" on her left ear a few days after receiving ZOSTAVAX. The "spot" cleared however the patient eventually developed a diffused rash on her face in September 2013 on an unspecified day. The patient was prescribed prednisone, unspecified dose, on an unspecified date for the rash. Physician described the rash as a confluent rash that covers the patient's whole face except around her eyes. Physician stated that an IgG assay for IgG-class antibodies to varicella zoster virus was tested on an unspecified date, with positive results, another IgG test was done and the results did not differ from the first IgG test results. IgM testing was also completed with a negative result on an unspecified date. The prednisone was discontinued as the patient was starting to show signs of ADDISON's Disease on an unspecified date. The patient still had a very red rash on her entire face that was not going away. The patient sought unspecified medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old female patient. On an unspecified day in July 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). The patient developed a vesicular "spot" on her left ear a few days after receiving ZOSTAVAX. The "spot" cleared however the patient eventually developed a diffused rash on her face in September 2013 on an unspecified day. The patient was prescribed prednisone, unspecified dose, on an unspecified date for the rash. Physician described the rash as a confluent rash that covers the patient's whole face except around her eyes. Physician stated that an IgG assay for IgG-class antibodies to varicella zoster virus was tested on an unspecified date, with positive results, another IgG test was done and the results did not differ from the first IgG test results. IgM testing was also completed with a negative result on an unspecified date. The prednisone was discontinued as the patient was starting to show signs of ADDISON's Disease on an unspecified date. The patient still had a very red rash on her entire face that was not going away. The patient sought unspecified medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a 67 year old female patient reporting on herself. The patient reported that, if she takes aspirin (manufacturer unknown) for an extended amount of time, she did not feel well. No other pertinent medical history was reported. On 06-MAR-2014, the patient was vaccinated with ZOSTAVAX one shot (route, lot number and expiration date not reported) for shingles prevention. The patient stated that she received the shot at an unusual place on her arm which was behind arm and up high on the underside of the arm in front of the armpit. Concomitant therapies included SYNTHROID and omeprazole. The patient reported that the evening on the same day she received the shot she had developed an injection-site reaction which was a red spot on her arm. She also reported that the spot began as about the size of a dime and then enlarged and got redder until it was about a 4 inch oval which extended all the way down the arm and was strawberry red. At the time of the report the patient still had an injection-site spot on her arm which is about 2 inches in diameter and is still red but faded. The patient also stated that, about a week ago, in approximately 01-APR-2014, she began to experience itching and rash which has been spreading on her body and which is currently on her stomach, legs and wrist. The patient had been taking cortisone (unspecified) for her itching and rash. The patient reported that the cortisone provides only temporary relief. No lab diagnostic studies were performed. The patient sought the physician for medical attention. The outcome of the injection site reaction which was a red spot on her arm and the itching and rash which had been spreading on her body and which were currently on her stomach, legs and wrist were reported as not recovered/not resolved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: This spontaneous report as received from a 67 year old female patient reporting on herself. The patient reported that, if she takes aspirin (manufacturer unknown) for an extended amount of time, she did not feel well. No other pertinent medical history was reported. On 06-MAR-2014, the patient was vaccinated with ZOSTAVAX one shot (route, lot number and expiration date not reported) for shingles prevention. The patient stated that she received the shot at an unusual place on her arm which was behind arm and up high on the underside of the arm in front of the armpit. Concomitant therapies included SYNTHROID and omeprazole. The patient reported that the evening on the same day she received the shot she had developed an injection-site reaction which was a red spot on her arm. She also reported that the spot began as about the size of a dime and then enlarged and got redder until it was about a 4 inch oval which extended all the way down the arm and was strawberry red. At the time of the report the patient still had an injection-site spot on her arm which is about 2 inches in diameter and is still red but faded. The patient also stated that, about a week ago, in approximately 01-APR-2014, she began to experience itching and rash which has been spreading on her body and which is currently on her stomach, legs and wrist. The patient had been taking cortisone (unspecified) for her itching and rash. The patient reported that the cortisone provides only temporary relief. No lab diagnostic studies were performed. The patient sought the physician for medical attention. The outcome of the injection site reaction which was a red spot on her arm and the itching and rash which had been spreading on her body and which were currently on her stomach, legs and wrist were reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: The spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and drug reaction/allergies were not reported. On 21-MAR-2014, the patient was vaccinated with an expired dose of ROTATEQ (lot # H012981, expiration date 28-FEB-2014) (dose and route were not reported). Co-suspect therapy was not reported. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from a consumer refers to may of her daughter's friends ages and gender not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL (route and lot # not reported). The consumer reported that on an unknown date, the patients experienced injection site pain that went away in a few days and with each dose the pain was greater than the last. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Neck pain, Pain in extremity, Paraesthesia, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a consumer refers to her 22 year old daughter with no pertinent medical history and no drug reactions or allergies. In approximately April 2014, "Monday or Tuesday", the patient was vaccinated with a dose of GARDASIL route and lot # not reported). Concomitant therapies included hormonal contraceptives (unspecified). The consumer reported that after receiving GARDASIL in April 2014, the patient experienced sharp shooting pains in her arm and neck. Her arm felt like dead weight and was discolored and swollen. The consumer also explained that the patient called the doctor on "Friday" (date unspecified) who advised her to visit the emergency room. The patient went to the emergency room the same day and was not admitted. The following Tuesday (date unspecified) the patient called the doctor once more because the symptoms were still persisting. The doctor advised the patient to go back to the emergency room. the patient went to the emergency room where they performed an ultrasound to check for blood clots and was not admitted. Result of the ultrasounds showed there were not blood clots. At the time of the report, the patient had not recovered and was experiencing tingling and swelling in her hand. The patient did not receive treatment for the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from a consumer refers to her 22 year old daughter with no pertinent medical history and no drug reactions or allergies. In approximately April 2014, "Monday or Tuesday", the patient was vaccinated with a dose of GARDASIL route and lot # not reported). Concomitant therapies included hormonal contraceptives (unspecified). The consumer reported that after receiving GARDASIL in April 2014, the patient experienced sharp shooting pains in her arm and neck. Her arm felt like dead weight and was discolored and swollen. The consumer also explained that the patient called the doctor on "Friday" (date unspecified) who advised her to visit the emergency room. The patient went to the emergency room the same day and was not admitted. The following Tuesday (date unspecified) the patient called the doctor once more because the symptoms were still persisting. The doctor advised the patient to go back to the emergency room. the patient went to the emergency room where they performed an ultrasound to check for blood clots and was not admitted. Result of the ultrasounds showed there were not blood clots. At the time of the report, the patient had not recovered and was experiencing tingling and swelling in her hand. The patient did not receive treatment for the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pustular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient who was a retired nurse with no drug reactions/allergies. A retired physician mentioned to pharmacist that his wife (the patient) in the past had herpes simplex on the bottom of an unspecified foot that would heal up and go away then come back and this would occur several times. The wife at an unspecified time started taking lysine and the herpes simplex didn't come back until after wife received ZOSTAVAX. the patient was given ZOSTAVAX (lot# reported as J012659, exp date as 10-JAN-2015, 0.65ml, subcutaneous in the left arm) per unspecified physician's recommendation on the afternoon of 04-APR-2014 and on the night of 04-APR-2014 patient experienced on the bottom of the left foot blisters and pustules. The treatment of ACYCLOVIR started the evening of 04-APR-2014 after the events occurred. Patient sought medical attention that patient's husband called the pharmacy this morning 07-APR-2014. Patient present status was reported as "blisters are drying up". The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that the patient received a dose of expired ROTATEQ (suspension 2 ml, lot number H017671, expiration date 25-MAR-2014, 2ml, oral) on 07-APR-2014. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, via company representative, refers to a 12 month old patient of unknown gender. On 07-APR-2014 the patient was given an expired dose of MMR II (lot # 0183AE, expiration date reported as 18-JAN-2014) (dose and route were not reported). Concomitant medications were not reported. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with VAQTA (dose, route and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA005406, 1404USA007012, 1404USA007014 and 1404USA007015 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with MMR II (rHA status unspecified) (dose, route, and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA007012, 1404USA007013, 1404USA007014 and 1404USA007015 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report from pharmacist refers to a patient of unknown age and gender. Patient's medical history and drug allergic reaction were not reported. On 03-APR-2014, patient was vaccinated with PNEUMOVAX23 (strength, dose, lot number and expired date unknown). On 06-APR-2014 the patient was vaccinated with other dose of PNEUMOVAX23 (strength, dose unit, lot number and expired date unknown). No adverse symptoms reported. The outcome of the patient received PNEUMOVAX23 on 03-APR-2014 and 06-APR-2014 and no adverse symptoms was unknown. No further information provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a 60 year old male patient. Medical history and drug reactions/allergies were not reported. On an unspecified date in April 2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On 14-FEB-2014, the patient experienced itchiness, rash and pain. On 14-FEB-2014, the patient visited an unspecified physician's office. The patient was prescribed pain medication (unspecified name, dose/frequency and manufacturer), and cream (unspecified name, dose/frequency and manufacturer) for the itchiness. The outcome of itchiness, rash and pain was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction: erythema, edema, pruritus, warm to touch. Treated with diphenhydramine by mouth and hydrocortisone 1% (topically).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from nurse (Health care worker) refers to a female patient of unknown age. The patient's pertinent medical history was unspecified. In April 2013 the patient was vaccinated with ZOSTAVAX for vaccination. Concomitant medications were unspecified. On an unknown date the patient experienced diagnosed with shingles involving one leg. The patient sought medical attention by calling the office of the reporting nurse. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown demography. On 09-APR-2014 the patient was vaccinated with expired dose of VARIVAX lot # H006529 (Expiry: 09-MAR-2014), 0.5 ml, subcutaneous. No symptoms reported. No other details provided. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 76 year old male patient. On 13-MAR-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX subcutaneous. On 25-MAR-2014, the patient was diagnosed with shingles. The patient sought medical attention by office visit. The patient had been prescribed an unspecified antiviral medication. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a female patient of an unknown age. The patient's pertinent medical history was unknown. On 10-JAN-2007 the patient was vaccinated with first dose of GARDASIL (dose reported as 0.5 ml) (Route of administration: intramuscular) and approximately on 08-APR-2014 (reported as "is currently in the office") the patient was in the office of the reporting nurse to receive her second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, unspecified number of patients were vaccinated with VARIVAX (Merck) (dose, route and frequency were not reported) which was exposed to 29 F for four months (worst case). No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA007005 and 1404USA007006 (same reporter link). Additional information has been requested.