chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Amnesia, Blindness unilateral, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a friend (age and gender were not reported). On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date, patient lost sight in one eye for a while (recovered). Patient still had itching, and possible inflammation in the brain, with subsequent memory loss (not recovered). The relationship between ZOSTAVAX and the events was not reported. Upon internal review lost sight in one eye and inflammation in the brain, were considered to be medically significant. This case is linked to case 1308USA003078 via same reporter link. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Tenderness
Clinical narrative: Arm started to swell and become tender starting several hours after vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approx 12 hrs after rec. PNEUMOVAX in (L) arm pt noticed swelling and pain in the injection site area. It got red and felt warm. Pt states she saw improvement 9/13/13 and was 90% better on 9/14/13.
Sex: U
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy, Laboratory test abnormal, Transposition of the great vessels
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer (patient's grandmother), concerning a baby patient of unknown gender. The consumer reported that on an unknown date the patient was exposed in utero to GARDASIL (Lot #, dose and transplacental route). Concomitant therapy was not reported. It was reported that now the patient's mother had 21 weeks pregnant and the baby had developed a heart problem known as "transposition of the great arteries". The reporter also stated that the baby had a high risk of being born with Down's syndrome. The baby's outcome was not known. This case was serious since transposition of the great arteries was considered a congenital anomaly. This case is linked to MARRS 1309USA010507 (patient's mother). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Local swelling, Oedema, Pain
Clinical narrative: Left arm below inj site there is an area of swelling from middle bicep to middle of forearm. Swelling has gotten better since inj. Significant heat, redness, pain at a 9 out of 10 and 3+ pitting edema.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Eyelid oedema, Pruritus, Swollen tongue
Clinical narrative: After 1st capsule: back and face itching, eyes puffy; 2nd capsule: swollen tongue, shortness of breath.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site: swollen, red and hot along with pain/soreness. Symptom: fever, tired and severe headache.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Injection site: swollen, red and hot along with pain/soreness. Symptom: fever, tired and severe headache.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site mass, Pain
Clinical narrative: Soreness, bruising, has a bump on the site of the shot.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Severe body aches, fever up to 102 lasting four days, headache, chills/sweating, lethargy/fatigue, injection site pain for weeks.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Severe body aches, fever up to 102 lasting four days, headache, chills/sweating, lethargy/fatigue, injection site pain for weeks.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Rash pustular
Clinical narrative: Small clear fluid filled pustules, redness, raised, itchy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient began vomiting and diarrhea at 7PM on 9/21/13 and continued for several hours until 1AM on 9/22/13. Patient has recovered since.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Itchy, sore, redness, silver dollar size.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 5 days later started itching and red at injection site only. Quarter size red, itchy spot. Called MD for patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient got ZOSTAVAX vaccine on 9/15/2013. On 9/15/2013 she started develop redness, soreness and swelling at injection site (left arm). On 9/20/13 Patient reported to pharmacy.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Local swelling, Pruritus, Skin reaction
Clinical narrative: Pt got PREVNAR 13 on Monday 9/16/13. On Saturday 9/21/13 patient has swelling, red, itchy patch size of baseball and as of today Monday 9/23/13 symptoms persist.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This pt had an injection of Pneumococcal vaccine in the (L) deltoid on 9/19/2013. She reported redness and edema in the (L) deltoid area that began several hours post injection that progressed through the reporting day of 9/23/2013. She presented today for evaluation and tx. She was instructed to use ice, ibuprofen and given a script for prednisone.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: There is a big red swollen area at the injection site. Patient is taking ADVIL for pain and will see MD on Monday.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: TDap given on 9/20/13. Pt had redness and warm to touch site of inj.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site cellulitis, Nausea, Pyrexia
Clinical narrative: Developed nausea, fever, redness, warmth. Went to E.R. and said it was cellulitis at injection site.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Swelling
Clinical narrative: Patient developed bump and bruising immediately after withdrawing syringe.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Started vomiting on 09/21/13, developed a fever 09/22/13 and on 09/23/13 fever of 100.6 F and chills. 9/23/13 pt took TYLENOL in the morning and when pt was called back at 11 AM she felt better and fever had broke.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Loss of consciousness, Muscle spasms, Pain in extremity, Tremor
Clinical narrative: Pt. states she passed out when she got home after vaccine, and had shakes and muscle spasms, and very sore arm (the arm she received PNEUMOVAX in).
Age: 0.43
Sex: M
Vaccine: PNC13, RV5
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Hives on arms, neck and left shoulder, as well as his face. Hives appeared 1-2 hrs. after vaccines were administered. Hives resolved with BENADRYL 1/2 tsp q4 hrs for 24 hr time frame. Pt also had redness at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site reaction, Paraesthesia
Clinical narrative: Pt is having "pins and needles" feeling in arm around injection site that is interfering w/ ADL's.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Patient called clinic left arm swollen from shoulder to elbow. Warm to touch, nauseous, vomited up twice and having H/A. Plan seek care after work.
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local swelling pain redness at site for varicella and TDap. Right deltoid.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt experienced raised (bruised), red, hot to touch skin around injection site some but mostly a few inches below injection site that "cuffed" went all the way around arm. She states it burned and was itchy. She has found some relief with BENADRYL, Ibuprofen and cold compress. Full recovery is expected. Asked pt to keep us updated on her recovery.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Pt experienced raised (bruised), red, hot to touch skin around injection site some but mostly a few inches below injection site that "cuffed" went all the way around arm. She states it burned and was itchy. She has found some relief with BENADRYL, Ibuprofen and cold compress. Full recovery is expected. Asked pt to keep us updated on her recovery.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Itchy, rash all over body. Going off one place and another at different places.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Sep-2012. The patient experienced TESTED POSITIVE FOR FLU A which started on 17-Jan-2013. The patient recovered from the event of TESTED POSITIVE FOR FLU A on an unspecified date. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a patient, female subject, who had been receiving Nasal FLUMIST. Concomitant medications included Loratadine. FLUMIST started on 12-Jan-2013. The patient experienced tested positive for flu B. The patient recovered from the event of tested positive for flu B on an unspecified date. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a physician concerning a 16 year old, female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. Two patients received FLUMIST and the above mentioned patient tested positive for influenza B. Event occurred on 10-Jan-2013. No hospitalization. The outcome of the event of Influenza B was recovered. The report was considered to be non-serious by reporter.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza virus test positive, Rhinorrhoea
Clinical narrative: A report has been received from a Physician concerning a 10 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 01-Nov-2012. The patient experienced tested positive for influenza and had a runny nose which started on 02-Nov-2012. The outcome of the event of tested positive for influenza and had a runny nose is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Physician concerning, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that patient had been tested positive for flu. The outcome of the event of tested positive for flu is unknown. The reporter was considered to be non-serious.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 16 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 20-Oct-2012. The patient experienced positive for flu A which started on 11-Jan-2013. The patient recovered from the event of positive for flu A on an unspecified date. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced tested positive for Flu A. The outcome of the event of tested positive for Flu A is unknown. The report was considered to be non-serious.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Bacterial test negative, Band neutrophil percentage, Basophil percentage decreased, Blood culture negative
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, C-reactive protein increased, Chills, Culture urine negative, Decreased appetite
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eosinophil count normal, Eosinophil percentage, Haematocrit decreased, Haemoglobin decreased, Injection site erythema
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Leukocytosis, Lymphadenitis
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphocyte count normal, Lymphocyte morphology abnormal, Lymphocyte percentage decreased, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count normal, Monocyte percentage decreased
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Monocyte percentage increased, Nausea, Neutrophil count normal, Neutrophil percentage decreased, Neutrophil percentage increased
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Night sweats, Platelet count normal, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width normal
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count decreased, White blood cell count increased
Clinical narrative: 33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 08-AUG-2013, was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot # reported as J003225, exp: 15-MAR-2015) which was improperly stored. The nurse reported that  VARIVAX (Merck) was exposed to a temperature of 10F to 264 hours from 06-AUG-2013 to 16-AUG-2013. The nurse reported that the overall average temperature for the VARIVAX (Merck) did not remain between -58F and 5F. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 09-AUG-2013, was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot # reported as J003225, exp: 15-MAR-2015), which was improperly stored. The nurse reported that VARIVAX (Merck) was exposed to a temperature of 10F for 264 hours from 06-AUG-2013 to 16-AUG-2013. The nurse reported that the overall average temperature for the VARIVAX (Merck) did not remain between -58F and 5F. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 20-AUG-2013, was vaccinated with a dose of GARDASIL (lot # H020002, exp: 08-AUG-2015) 0.5 ml, intramuscularly, which was improperly stored. The nurse reported that GARDASIL was exposed to a temperature of 62F for 360 hours from 06-AUG-2013 to 20-AUG-2013. The nurse did not have patient or physician details available at the time of call. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 16-AUG-2013, was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot # reported as J003225, ex: 15-MAR-2015) which was improperly stored. The nurse reported that VARIVAX (Merck) was exposed to a temperature of 10F for 264 hours from 06-AUG-2013 to 16-AUG-2013. The nurse reported that the overall average temperature for the VARIVAX (Merck) did not remain between -58F and 5F. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with arthritis. On an unspecified day in February 2013, patient started ZOSTAVAX, dose 1, unknown arm (concentration and lot number were not reported). Concomitant medication was not reported. On 15-SEP-2013, the reporting pharmacist confused the patients and accidentally administered a second ZOSTAVAX subcutaneous in the left arm, (concentration not reported) lot# J004267, expiration date: 12-JUL-2014, instead of PNEUMOVAX23 injection. It was unknown if there was any laboratory data. As of 15-SEP-2013, it was unknown if the patient will have any more ZOSTAVAX injections and she was fine after getting a second ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Cough, Eye pain, Headache
Clinical narrative: When student nurse had flu shot got flu after shot and 2 more times consecutively. Told not to get shot again. This year told to get shot had flu shot on 9/17/13 1130AM 8PM had low grade fever -> 100 and generalized aching 9/18 AM hurting all over/headache/eyes/teeth hurting abd cramps nausea joints hurting nausea cough and scratchy throat.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Throat irritation, Toothache
Clinical narrative: When student nurse had flu shot got flu after shot and 2 more times consecutively. Told not to get shot again. This year told to get shot had flu shot on 9/17/13 1130AM 8PM had low grade fever -> 100 and generalized aching 9/18 AM hurting all over/headache/eyes/teeth hurting abd cramps nausea joints hurting nausea cough and scratchy throat.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Irritability, Pyrexia, Restlessness
Clinical narrative: Fever 7 days post vaccinations (9-20-13) started at 1:30 am, clingy, fussy, restless. No runny nose, nasal congestion, no cough.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swollen right deltoid above injection site, no redness, no tenderness.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-FEB-2013 the patient was vaccinated with an expired dose ZOSTAVAX 19400 PFU, lot # 672428/1599AA, expiry date 13-JAN-2013, 0.65 ml, subcutaneous. No adverse effect reported. Additional information has been requested. This report is linked by same reporter link to case # 1309USA003230, 1309USA003219, and 1309USA003211.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Foetal disorder, Maternal exposure before pregnancy, Pregnancy test, Viral skin infection
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer (patient's mother) refers to a female patient of unknown age with none pertinent medical history or drug reaction allergies. On unknown dates the patient received all three shots of the GARDASIL vaccine (Lot #, dose and route not reported). There was no concomitant therapy. On an unknown date, after receiving the shots of GARDASIL the patient developed a viral skin infection and had chest pain. The reporter stated that the patient also became pregnant on an unspecified date after receiving the GARDASIL vaccine. The patient became pregnant with Last Menstrual Period of 24-APR-2013 and Estimated Date of Delivery of 29-JAN-2014. The patient was now 21 weeks pregnant and the baby had developed a heart problem known as transposition of the great arteries. The reporter also stated that the baby  had a high risk of being born with Downs Syndrome. The pregnancy outcome was pending. The patient sought medical attention saw the doctor on unspecified date and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. The outcome of viral skin infection and chest pain was unknown. This case is related with 1309USA009423 (Baby report). Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 03-SEP-2013 the patient was vaccinated with a dose of ROTATEQ (Lot number 1808AA, Expiration date: 29-AUG-2013) (dose and route not reported) which expired on 29-AUG-2013. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to unspecified number of unknown age and gender patients. The nurse reported that improperly stored GARDASIL (lot# unspecified) (dose, route and location unspecified) might have been administered (exact dates of administration unspecified) the GARDASIL was improperly stored in June of 2013, exact date of improper storage was unspecified). No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In August 2013, the patients were vaccinated with GARDASIL (lot # H021608, Exp date 13-AUG-2015) 0.5 ml, intramuscularly. These GARDASIL was exposed to 31 F for 15 hours and was also exposed to 33 F for an unspecified amount of times on an unspecified date. The GARDASIL could not be supported by the reporter's stability data. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to a female patient (daughter) of unknown age. On an unknown date in 2006 or 2007, the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). Since an unknown date in February 2013 she had experienced amenorrhea. The nurse also noted that her daughter was at present in rehab for heroin. Treatment information was unspecified by the reporter. It was unspecified whether any laboratory diagnostic studies were performed. The outcome of amenorrhea was unknown. It was unspecified whether patient sought medical attention for the event. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unspecified number of age and gender patients. The nurse reported that improperly stored PEDVAXHIB (lot# unspecified) (dose, route and location unspecified) might have been administered (exact dates of administration unspecified, the PEDVAXHIB was improperly stored in June of 2013, exact date of improper storage was unspecified). No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: This spontaneous report as received from a consumer refers to an unspecified number of patients of unknown age and gender. ON an unknown date, the patient were vaccinated with ZOSTAVAX (dose, route and lot # not reported). Since unknown date patients dragged shingles on for years, with extreme nerve damage. The outcome of the events was not reported. The relationship between ZOSTAVAX and the events was not reported. This case is linked to cases 1309USA010583, 1308USA003078 via same reporter link. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse for GARDASIL, a Pregnancy Registry product, refers to a 14 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of GARDASIL (unspecified dose in series, Lot # H010649, exp 20-FEB-2015) on 16-JAN-2013 (dose and route unknown). The patient also received unspecified doses of TDaP and Hepatitis A vaccines (unspecified manufacturers) during the same visit on 16-JAN-2013. THe patient was then admnistered an unspecified pregnancy test on the same date, which came back positive. The patients last menstrual period was from 15-DEC-2012 to 20-12-2012. The EDD was approximately 21-SEP-2013. The patient was exposed at first trimester. The patient did not seek medical attention. No treatment was given. Additional information has been requested. This is an ameneded report. The hepatitis A vaccine was coded as a suspect product (manufacturer unknown).
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse for GARDASIL, a Pregnancy Registry product, refers to a 14 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of GARDASIL (unspecified dose in series, Lot # H010649, exp 20-FEB-2015) on 16-JAN-2013 (dose and route unknown). The patient also received unspecified doses of TDaP and Hepatitis A vaccines (unspecified manufacturers) during the same visit on 16-JAN-2013. THe patient was then admnistered an unspecified pregnancy test on the same date, which came back positive. The patients last menstrual period was from 15-DEC-2012 to 20-12-2012. The EDD was approximately 21-SEP-2013. The patient was exposed at first trimester. The patient did not seek medical attention. No treatment was given. Additional information has been requested. This is an ameneded report. The hepatitis A vaccine was coded as a suspect product (manufacturer unknown).
Age: 65.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness of 5 cm diameter on arm with central 1 cm hard, raised, lesion. Knee pain on right - cannot walk. Muscle pain R knee, calf, leg.
Age: 65.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Joint range of motion decreased, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: Redness of 5 cm diameter on arm with central 1 cm hard, raised, lesion. Knee pain on right - cannot walk. Muscle pain R knee, calf, leg.
Age: 65.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abasia, Arthralgia, Erythema, Induration, Myalgia
Clinical narrative: Redness of 5 cm diameter on arm with central 1 cm hard, raised, lesion. Knee pain on right - cannot walk. Muscle pain R knee, calf, leg.
Age: 65.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion, Swelling
Clinical narrative: Redness of 5 cm diameter on arm with central 1 cm hard, raised, lesion. Knee pain on right - cannot walk. Muscle pain R knee, calf, leg.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest X-ray, Chills, Electrocardiogram, Ocular hyperaemia
Clinical narrative: After injection patient experienced nausea, vomiting, chills and eyes red/bloodshot. EMS was called. She was found hypotensive 90/50, CXR showed LLL infiltrate.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: After injection patient experienced nausea, vomiting, chills and eyes red/bloodshot. EMS was called. She was found hypotensive 90/50, CXR showed LLL infiltrate.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray abnormal, Chills, Hypotension, Lung infiltration, Nausea
Clinical narrative: After injection patient experienced nausea, vomiting, chills and eyes red/bloodshot. EMS was called. She was found hypotensive 90/50, CXR showed LLL infiltrate.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Vomiting
Clinical narrative: After injection patient experienced nausea, vomiting, chills and eyes red/bloodshot. EMS was called. She was found hypotensive 90/50, CXR showed LLL infiltrate.