chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (which has the lot number of L009964, expiration date 13-APR-2017) (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBICAX HB (which has the lot number of L044707, expiration date 06-OCT-2018, L0044917, expiration date 05-OCT-2018 (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to a patient (8) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On 20-JAN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (min) and 37.9 F (Max) for 24 hours. There was no previous temperatures excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine given 1 month expired.
Sex: M
Vaccine: PPV
Symptoms: Drug effect decreased
Clinical narrative: Patient took pneumonia shot and it was supposed to last for 10 yrs but only lasted for 5.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (which had the lot number of L024265, expiration date 01-JUL-2017) (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Abdominal pain upper, Abdominal tenderness, Confusional state, Dizziness, Headache
Clinical narrative: Pt states next morning 4/21/16, awoke with HA, dizzy, stomach pains. No increased T. Same PM c/o confusion. Friday 4/22/16, c/o HA, vomiting "several times". Went to ER Sat 4/23/16 AM, states tested for meningitis (neg), received IV, nausea meds. C/O continued tenderness in upper quadrant abd.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Vomiting
Clinical narrative: Pt states next morning 4/21/16, awoke with HA, dizzy, stomach pains. No increased T. Same PM c/o confusion. Friday 4/22/16, c/o HA, vomiting "several times". Went to ER Sat 4/23/16 AM, states tested for meningitis (neg), received IV, nausea meds. C/O continued tenderness in upper quadrant abd.
Age: 0.22
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 11 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 30-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram normal, Pyrexia, Seizure like phenomena
Clinical narrative: Fever of 101.2. Would go down with MOTRIN. Highest was 102. Lasting from Friday until Sunday. 8 days after shots, he started with seizure like episodes that last anywhere from 5 to 15 secs and happen multiple times a day. Could happen once a day or happen 6x a day.
Age: 0.21
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 04/19/2016.
Age: 33.0
Sex: F
Vaccine: TYP, YF
Symptoms: Rash
Clinical narrative: Asymptomatic lower extremity rash; Vaccine administered in arm.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Somnolence, Speech disorder
Clinical narrative: Child stopped interacting with the parents verbally as she had been doing. She slept more often. No fever or any other symptoms were noticed. Mother reports that after a two week period it was like a switch was turned on and the baby began to interact verbally just as she had before the immunizations. Parents did not report these concerns until today in our office 04/26/2016.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: LOCALIZED SWELLING, REDNESS, WARM TO TOUCH; APPROX 10CM IN DIAMETER.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Lymph node pain
Clinical narrative: Pain in the lymph node under the same arm.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain
Clinical narrative: Pneumococcal vaccine was given at patient's PCP office in LUE that resulted in cellulitis and pain. Cephalexin 500 mg BID x 10 days prescribed at time of visit for cellulitis. Cellulitis resolved.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 28-Sep-2015. This case involves a 61 years old female patient (age reported as 60 years) who was vaccinated with a first dose of FLUZONE ID (batch number: UT5354BA and expiry date was not provided) via intramuscular route in the left deltoid on 25-Sep-2015. There was no illness at the time of vaccination. Patient did not have any known allergies. Concomitant medications were not reported. On 26-Sep-2015, 1 day post vaccination; in the morning, the patient developed injection site "golf ball sized lump" which was red, warm to touch and there was induration at the site. The vaccine was given intramuscularly instead of intradermal route. Thus it was a wrong route of administration. Laboratory data and corrective treatment were not provided. The patient was recovering from the above mentioned events. List of documents held by sender: none. Addendum: 25 April 2016 Upon second medical examination of the case at the time of internal review the following has been change in the case; Amend the suspect product code 476 instead of 390, corresponds to the LOT number UT5354B.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Bradycardia, Dizziness, Pallor, Syncope
Clinical narrative: Within 2-3 minutes of receiving 3rd vaccine (ADACEL, MENACTRA, and HPV, pt became lightheaded and fainted for a few seconds. Slightly bradycardic for the first 1-2 min after regaining awareness, but for the next 20 minutes he continued to be pale, dizzy, lightheaded.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Crying, Diarrhoea, Faeces discoloured, Grunting
Clinical narrative: Patient had Rota vaccine on Thursday. 2 days later her stools turned a greenish color. The next day she started with green diarrhea. She has had about 1 stool per hour. She is having frequent crying spells lasting anywhere from 5-20 minutes, inconsolable during this time. Crying spells are happening about 1-2 hours. She is pulling her knees to her chest. She is making a squeak/grunting noise intermittently, does not seem to be related to stools.
Age: 1.1
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Injection site reaction, Rash generalised, Rash papular
Clinical narrative: Very dense, widespread, papular/erythematous rash in clusters on trunk and proximal extremities.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Administered #2 dose of varicella too soon for age: previous dose of varicella given 02/04/2015 so this dose should have been given 05/04/2015 per CDC recommendations. Noted this when reviewing the records with client's mother. Let her know that it was given early but that it is still considered valid.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Hypersensitivity, Lymphadenopathy
Clinical narrative: Swelling of neck glands or salivary gland - enlarged over 5 cm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgic amyotrophy
Clinical narrative: Parsonage Turner.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Headache, Nausea, Neurological examination, Syncope
Clinical narrative: Patient fainted 5-10 minutes following vaccine administration while checking out at clinic. Patient complained of visual disturbance, headache, nausea after hitting head during fainting spell. Vital signs taken following incident and brief neurological exam performed. Patient sent to Emergency Department due to headache, nausea, visual changes.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Visual impairment
Clinical narrative: Patient fainted 5-10 minutes following vaccine administration while checking out at clinic. Patient complained of visual disturbance, headache, nausea after hitting head during fainting spell. Vital signs taken following incident and brief neurological exam performed. Patient sent to Emergency Department due to headache, nausea, visual changes.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: The patient experienced pain along her left waist area. She went to her doctor and he thinks she has internal shingles.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Pt started experiencing symptoms of stroke and went to hospital. Dx was Bell's palsy. Received prescriptions for acyclovir and prednisone and was discharged same day.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Dyspnoea
Clinical narrative: COMPLAINED OF STOMACH PAIN AND HARD BREATHING.
Age: 24.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site inflammation, Injection site pain, Rotator cuff syndrome
Clinical narrative: I had a flu vaccine and the first dose of the HPV vaccine given to me in my left deltoid. The flu vaccine was administered in my mid-deltoid, and the HPV vaccine in my upper deltoid. The HPV vaccine was extremely painful. Two days after the injections I experienced extreme shoulder pain, and unable to lift my arm above head, or past 90 degrees for a week. The pain got worse at night, and I couldn't sleep on it. Massage and ice seemed to help the pain, but not eliminate it. The pain lessened with ibuprofen, but after seeing a physician and physical therapist, I was diagnosed with shoulder impingement syndrome cause by inflammation of the supraspinatus resulting from the HPV vaccination, which according to the physician was administered too high on my deltoid. I have had shoulder impingement and inflammation from the injection for 5 and a half months now, and am beginning to get relief after 5 months of physical therapy and a cortisone shot.
Age: 24.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Sleep disorder
Clinical narrative: I had a flu vaccine and the first dose of the HPV vaccine given to me in my left deltoid. The flu vaccine was administered in my mid-deltoid, and the HPV vaccine in my upper deltoid. The HPV vaccine was extremely painful. Two days after the injections I experienced extreme shoulder pain, and unable to lift my arm above head, or past 90 degrees for a week. The pain got worse at night, and I couldn't sleep on it. Massage and ice seemed to help the pain, but not eliminate it. The pain lessened with ibuprofen, but after seeing a physician and physical therapist, I was diagnosed with shoulder impingement syndrome cause by inflammation of the supraspinatus resulting from the HPV vaccination, which according to the physician was administered too high on my deltoid. I have had shoulder impingement and inflammation from the injection for 5 and a half months now, and am beginning to get relief after 5 months of physical therapy and a cortisone shot.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RVX
Symptoms: Crying
Clinical narrative: Patient cried for 5 hours straight. He was inconsolable.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Hepatic enzyme increased, Vomiting
Clinical narrative: Approximately 35 hrs after vaccine, had severe vomiting and stomach cramping - some diarrhea. After 5 hrs went to ER and received anti-nausea and cramping medicine. As well as fluids. After 4 hrs in ER, recovered rapidly.
Age: 1.31
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received the KINRIX vaccine (DTaP/IPV). This is only for the 5th dose of a vaccine series - ages 4 to 6 years of age. Patient is only 16 months.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient has pain when moves arm (R).
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: Vomiting x 3 this AM and fever (undocumented) - hot to touch.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Blood potassium decreased, Confusional state, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: On 4-23-16 at 1351 patient presented to hospital with an episode of loss of consciousness, unresponsive and confusion. Potassium level was 3.0.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Muscular weakness, Myalgia, Pain
Clinical narrative: Pt started with pain and weakness in the (L) arm the evening of 4/25/16, which progressed to significant fatigue and generalized muscle pains. Mom reports symptoms are worse today.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L048465, expiration date on 02-DEC-2016)(dose number, strength and anatomical location, were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 9F during 10 hours. Previous temperature excursion was reported as: Exposed to 45F for 24 hours. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from same source.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 3 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 25-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 3 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-APR-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L048467, expiration date on 19-APR-2016 (dose number, strength and anatomical location were not provided). Concomitant therapies were  not provided).  The vaccines were stored in a temperature of 47F during 2 hours. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a  licensed practical nurse and refers to multiple patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 F, time frame of 3.75 hours) of ROTATEQ, orally, lot # L023870 with expiration date 20-APR-2017 and lot # L035511 with expiration date 21-MAY-2017, orally(dose was not reported). No known adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified number of f patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot # L038502, expiration date on 16-AUG-2018 (dose number, strength and anatomical location were not provided). The vaccines were stored in a temperature of 52F during 30 minutes, 46.9 during 12 minutes, 46.9F during 12 minutes and 47.1F during 16 minutes (cumulative total time out of range was 70 minutes). No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of several reports  received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L020015, expiration date on 16-AUG-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 52F during 30 minutes, 46.9F during 12 minutes, 46.9F during 12 minutes and 47.1F during 16 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX23 (dose, unit and route not reported, lot # L014458 and expiration date 11-FEB-2017). The vaccines were exposed to 34F for 30 minutes, previous temperature excursion included 55F for 16 hours and 34F for 2 hours. No adverse symptoms were reported. This is one of several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose, unit and route not reported, lot # K026247 and expiration date 29-JAN-2017) (confirmed not GARDASIL). The vaccines were exposed to 34 F for 30 minutes, previous temperature excursion included 55 F for 16 hours and 34 F for 2 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 12 years old patient of unknown gender. On 25-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot number/exp date, dose were unspecified). On 10-FEB-2016, the second dose of GARDASIL 9 (lot number/exp date, dose were unspecified) was administered. On 22-APR-2016 the patient was vaccinated with the third dose of GARDASIL 9 (lot # L045711, expiration 08-MAY-2017, dose was not reported), with the third dose being administered sooner than the recommended dosing schedule (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUJN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 11 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare working referring to a 10 week old patient of unknown gender. The patient's concurrent conditions and medical histories were not provided. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 10 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2105, the patient was vaccinated with a dose of improperly stored ROTATEQ , orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 30-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.57
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 13-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender,. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of ROTATEQ orally, lot # L035511, expiration date on 21-MAY-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 52F during 30 minutes, 46.9F during 12 minutes, 46.9F during 12 minutes and 47.1F during 16 minutes (cumulative total time out of range was 70 minutes). No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of M-M-R II (lot # L015282, expiration date on 30-APR-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 52F during 30 minutes, 46.9F during 12 minutes and 47.1 F during 16 minutes (cumulative total time out of range was 70 minutes). No previous temperature excursion was reported. NO adverse events were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable consumer. A 68-year-old male patient received pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) (reported as pneumococcal vaccine; patient was unsure which pneumococcal vaccine he received) in the fall of 2004, as a single dose; manufacturer, lot number, NDC and expiration date were unspecified. The patient thinks he received the vaccine in his right upper arm at a health department. Medical history was not reported. Concomitant medication included LIPITOR at 20 mg, one by mouth daily for control of cholesterol, started in 2004 and FIORINAL WITH CODEINE, as half to 1 capsule (30 mg, as needed) by mouth, patient breaks them in half and puts them in a gel cap, for the treatment of migraines since an unspecified date. The patient experienced swelling at upper arm where injection given, pronounced redness at upper arm where injection given and heat at upper arm where injection given in 2004. The patient experienced these reactions about 30 to 60 minutes after receiving the vaccine and the symptoms lasted for approximately 1.5 days, then improved. No other medical conditions or investigations were reported. The clinical outcomes of swelling at upper arm where injection given, pronounced redness at upper arm where injection given and heat at upper arm where injection given was reported as recovering. Pfizer was Marketing Authorization Holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) has submitted the same report to the regulatory authority. Follow-up (10Apr2015:) Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Decreased appetite, Fatigue, Full blood count normal, Headache
Clinical narrative: Dizziness, fever, sweating, chills, nausea, headache. To local E.R. on 4/24/2016, received I.V. fluids and Ibuprofen 800mg, not admitted to hospital, returned to clinic on 4/26/2016 c/o persistent fever, sweats and chill, nausea, dizziness.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Influenza virus test negative, Malaise, Metabolic function test normal, Nausea, Pyrexia
Clinical narrative: Dizziness, fever, sweating, chills, nausea, headache. To local E.R. on 4/24/2016, received I.V. fluids and Ibuprofen 800mg, not admitted to hospital, returned to clinic on 4/26/2016 c/o persistent fever, sweats and chill, nausea, dizziness.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Dizziness, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Dizziness, fever, sweating, chills, nausea, headache. To local E.R. on 4/24/2016, received I.V. fluids and Ibuprofen 800mg, not admitted to hospital, returned to clinic on 4/26/2016 c/o persistent fever, sweats and chill, nausea, dizziness.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Pyrexia, Streptococcus test negative
Clinical narrative: Dizziness, fever, sweating, chills, nausea, headache. To local E.R. on 4/24/2016, received I.V. fluids and Ibuprofen 800mg, not admitted to hospital, returned to clinic on 4/26/2016 c/o persistent fever, sweats and chill, nausea, dizziness.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, fever, sweating, chills, nausea, headache. To local E.R. on 4/24/2016, received I.V. fluids and Ibuprofen 800mg, not admitted to hospital, returned to clinic on 4/26/2016 c/o persistent fever, sweats and chill, nausea, dizziness.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Pyrexia
Clinical narrative: Dizziness, fever, sweating, chills, nausea, headache. To local E.R. on 4/24/2016, received I.V. fluids and Ibuprofen 800mg, not admitted to hospital, returned to clinic on 4/26/2016 c/o persistent fever, sweats and chill, nausea, dizziness.
Age: 39.0
Sex: M
Vaccine: JEV1
Symptoms: Erythema, Flushing, Pruritus, Pruritus generalised, Skin irritation
Clinical narrative: Generalized itching and irritated sensation of skin across face, neck and shoulder. Persistent skin irritation and pruritus along head and neck, which was also associated with redness/ flushing of face and puffiness of his cheeks. Symptoms began approximately 3-4 hours after injection.
Age: 39.0
Sex: M
Vaccine: JEV1
Symptoms: Swelling face
Clinical narrative: Generalized itching and irritated sensation of skin across face, neck and shoulder. Persistent skin irritation and pruritus along head and neck, which was also associated with redness/ flushing of face and puffiness of his cheeks. Symptoms began approximately 3-4 hours after injection.
Sex: M
Vaccine: FLU3
Symptoms: Apgar score normal, Cardiac murmur, Foetal exposure during pregnancy, Pyelocaliectasis, Ultrasound kidney abnormal
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Mar-2016) concerns an infant male patient. The patient's mother had a missed abortion, G2P1, and was a smoker. The last menstrual date was 29-Dec-2014 and the expected date of delivery was 07-Oct-2015 (ultrasound confirmed dates). Ultrasound was performed during the pregnancy and the result was normal nuchal translucency. On the 11-Feb-2015 6pm, the patient receive AFLURIA (batch number 30349421A), via the mother who had it administered on her left deltoid. The mother delivered a baby boy (weight 3.85 kg) via the normal vaginal delivery at full term. The Apgar score was 9 at 5 minutes and 10 minutes. The mother had no maternal complications or problems-related to birth. On an unspecified date, the infant patient developed bilateral fetal pyelectasis (mild) on ultrasound. The patient was seen by the urology after birth and was reported normal. In Feb-2016, the patient was seen by urology and no further follow-up was needed. The 'innocent heart murmur' was to be evaluated by the paediatric-cardiology in March 2016. The outcome was unknown. Linked to case 2016060369 (mother). Case correction 18-Apr-2016: AE 1 verbatim changed from 'maternal drug exposure' to 'foetal exposure during pregnancy' and coded to PT 'foetal exposure during pregnancy'. Reporter's comments: The reporter assessed the event as non-serious and causality of 'not suspected' to the AFLURIA vaccine. Sender's Comments: Company comments: Seriousness: Non-serious. Listedness: Listed. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted. Causality: Unassessable. Overall assessment is based on maternal exposure to the vaccine. Events of pyelectasis and murmur are assessed as unrelated. Fetal pyelectasis is a relatively common finding in antenatal scans (varying from 1 to 18% prevalence) with an observed male predilection. Majority of the cases are benign, some are physiologic occurrences during development, and resolves during the third trimester. This newborn was examined to have neither pyelectasis nor hydronephrosis after birth. It is unknown at which trimester pyelectasis was detected. Given the background rate of occurrence, it is deemed unrelated to the influenza vaccine. The incidence of murmurs in children has been reported to be as high as 90%. Assessment of the patient's physician is pending at the time of reporting; however, it is unlikely that the vaccine is related to structural deformities that may have contributed to the murmur. Company evaluation and comment: No change in assessment.
Sex: U
Vaccine: DTP
Symptoms: Autism
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016219272) on 21 April 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT shot) (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced autism. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event autism. List of documents held by sender: none.; Sender's Comments: This is poorly documented case received from consumer where autism is reported after receiving DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED). Manufacturer of the vaccine not provided. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Subjective fever, myalgia, arthralgia, and chills.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Wrong injection given.
Sex: F
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Merck (manufacturer control number: 1-13570869034), for PREVNAR. A female patient of unspecified age and ethnicity received PREVNAR single dose via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced keeps getting pneumonia on an unspecified date with outcome of unknown. No additional information was reported.
Sex: U
Vaccine: PNC
Symptoms: Antibody test negative, Drug ineffective, Ear infection, Pharyngitis, Respiratory tract infection
Clinical narrative: This is a spontaneous report from a contactable nurse. A 6-year-old patient of an unspecified ethnicity and gender received the first, second, third, and fourth doses of PREVNAR; all via unspecified routes of administration on unspecified dates at single doses. Medical history included allergies, bronchitis, and being sick all the time. The patient's concomitant medications were not reported. On an unknown date, the patient experienced drug ineffective, recurrent infections that have mostly been respiratory with ear and throat infections, and the patient's pneumococcal titers were checked and they were low for several serotypes. The titer results for the pneumococcal serotypes were: type 1 = 10.1, type 3 = 5.2, type 4 = 0.2, type 8 = 0.2, type 9 = 0.7, type 12 less than 0.1, type 14 = 0.4, type 19 = 3.1, type 23 = 1.1, type 26 = 0.3, type 51 = 0.8, type 56 (18C) = 1.3, type 57 (19A) = 2.9, and type 68 (9V) = 1.2. Therapeutic measures were taken as a result of recurrent infections that have mostly been respiratory with ear and throat infections and included treatment with an urgent tonsillectomy. The clinical outcome of the events, drug ineffective, recurrent infections that have mostly been respiratory with ear and throat infections, and the patient's pneumococcal titers were checked and they were low for several serotypes, were unknown. Follow-up (07Jan2016): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Tonsillectomy
Clinical narrative: This is a spontaneous report from a contactable nurse. A 6-year-old patient of an unspecified ethnicity and gender received the first, second, third, and fourth doses of PREVNAR; all via unspecified routes of administration on unspecified dates at single doses. Medical history included allergies, bronchitis, and being sick all the time. The patient's concomitant medications were not reported. On an unknown date, the patient experienced drug ineffective, recurrent infections that have mostly been respiratory with ear and throat infections, and the patient's pneumococcal titers were checked and they were low for several serotypes. The titer results for the pneumococcal serotypes were: type 1 = 10.1, type 3 = 5.2, type 4 = 0.2, type 8 = 0.2, type 9 = 0.7, type 12 less than 0.1, type 14 = 0.4, type 19 = 3.1, type 23 = 1.1, type 26 = 0.3, type 51 = 0.8, type 56 (18C) = 1.3, type 57 (19A) = 2.9, and type 68 (9V) = 1.2. Therapeutic measures were taken as a result of recurrent infections that have mostly been respiratory with ear and throat infections and included treatment with an urgent tonsillectomy. The clinical outcome of the events, drug ineffective, recurrent infections that have mostly been respiratory with ear and throat infections, and the patient's pneumococcal titers were checked and they were low for several serotypes, were unknown. Follow-up (07Jan2016): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC
Symptoms: Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR, route of administration and date unspecified, as single dose. Medical history and concomitant medications were not reported. The patient experienced pneumococcal pneumonia on an unspecified date with outcome of unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to multiple unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date multiple unspecified patients received improperly stored (Merck) VARIVAX (lot # L005300, expiry date 17-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 9.3 degree C for a time frame of 8 hours and 2 minutes. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Blood glucose increased
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old male patient received a singe dose of PREVNAR (Lot Number: J67643; Expiration Date: Mar2016; NDC Number: 0005-1971-02), via an unspecified route of administration on 06Jul2015 at 12:00. Medical history included diabetes and grouchiness on unknown dates. Concomitant medications included atenolol, folic acid, furosemide, gabapentin, NOVOLOG, LEVEMIR, levothyroxine, omeprazole, potassium, and trazodone. On 07Jul2015, the patient experienced extremely high blood glucose level. The patient underwent lab tests and procedures and included blood glucose which showed rise in blood glucose level on 07Jul2015 and 08Jul2015 he woke up with high reading. Pharmacist stated that the event did not require any emergency or doctor visit and further added that the patient had called doctor for something and no other vaccine was given on the same day as well as four weeks prior to the adverse event. The clinical outcome for the event of extremely high blood glucose level was unknown. The Pharmacist stated that she believed that this increase in blood glucose level was because of PREVNAR. Follow-up (03SEP2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her 40's. Information regarding relevant medical history and concurrent condition were not reported. In 2006 the patient was vaccinated with a dose of GARDASIL (lot # and route not reported), when she was in her 40's (inappropriate schedule of vaccine administered). No adverse events reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of RECOMBIVAX HB lot # L038018 with expiration date 13-SEP-2017, lot # L033343 with expiration date of 13-SEP-2017 and lot # L027733 with expiration date 13-SEP-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Arm swelled to my elbow and into my chest. Very sore and hot. Took three days to ease up.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Upper respiratory tract infection, Wheezing, X-ray
Clinical narrative: Chest tightened and wheezing began.
Sex: M
Vaccine: PNC
Symptoms: Feeling abnormal, Hypoaesthesia oral, Paraesthesia oral, Restlessness
Clinical narrative: This is an spontaneous report from a contactable pharmacist from Non Clinical Study Program (IBCC (Inbound Call Center for Health Care Professionals). A male patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration from an unspecified date to an unspecified date at single for. The patient experienced tingliness of lips, numbness of lips, restless and feeling upside down on 27Apr2015 with outcome of unknown. The action taken in response to the events for PREVNAR. Follow-up (19JUN2015): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: Red raised rash and bumps at injection site; itches and feels raw. Tx with OTC hydrocortisone and Rx triamcinolone 0.5% ointments.