chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of an unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions and allergies was reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PEDVAXHIB (lot #, expiration date, dose and route of administration were not reported). The patients' concomitant medications were not reported. Administered doses of PEDVAXHIB underwent a temperature excursion at 32.8 Fahrenheit degrees for 20 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Follow up information has been received on 03-NOV-2016. All telephone attempts to obtain follow up information have been unsuccessful. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, the patients were vaccinated with improperly stored VAQTA (lot # M030598, expiration date: 13-OCT-2017; lot # M032492, expiration date: 02-MAR-2018) (dose and route not reported). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 Celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medications and medical history was not provided. On unspecified dates, multiple, unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot # M024677,expiration date 18-MAY-2018; lot # M02854, expiration date 07-JUN-2018; lot # M027347, expiration date 01-JUN-2018 and lot# M027885, expiration date 03-JUN-2018)(dose and frequency were not reported) subcutaneously. The (Oka/Merck) VARIVAX was stored at -9.7 C for 46 minutes with previous temperature excursion (Time Frame: 3 Hours and 9 Minutes at Temperature: 4.1C Time Frame: 31 Hours and 8 Minutes at Temperature: 4.6C). The temperature excursions were detected by a "data logger". No adverse effects reported. 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 medical assistant concerning, multiple, unspecified patients' of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot number: M017983, expiration date: 30-MAY-2018) (dose and route of administration were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. 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 medical assistant concerning, multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ orally (lot number: M002254, expiration date: 15-NOV-2017) (dose was not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was in the office to receive her scheduled dose (unspecified if the 2nd or the 3rd dose in the series) of GARDASIL 9 (lot # M024261, expiration date 30-JUL-2018, 0.5 ml, intramuscularly), but she "refused to receive the dose, because it would have been 3 vaccines during this visit to the office". As a result, the patient missed the dose of GARDASIL 9. No adverse effects were noted. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pollakiuria, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient. His medical history, concurrent conditions and concomitant medications were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) (reported as vaccine). On 16-NOC-2016, the patient developed fever (exact temperature was not provided), soreness at the injection site, chills and frequent urination since receiving the dose. The patient was referred to his physician for the further evaluation. At the time of this report, none lab diagnostic studies were performed and no treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Balance disorder, Diplopia, Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old male patient. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expiration date, dose and route of administration were not reported). On an unknown date, a week after receiving the first dose of GARDASIL 9, the patient came to the doctor's office experiencing lost of balance. The patient had also diplopia and symptoms consistent with Guillain-Barre Syndrome (onset dates of all events were unknown). No treatment was given, but the patient was scheduled for a spinal tap on 23-NOV-2016. There was no product quality complaint involved. At the time of the report, the patient did not recover from the events. The relationship between the events and GARDASIL 9 was not reported. Upon internal review, the event of symptoms consistent with Guillain-Barre Syndrome was considered as medically significant event. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ lot #M004542 with an expiration date 18-OCT-2017 and lot# M005732 with an expiration date 19-OCT-2017, orally (dose was not reported). Administrated doses of ROTATEQ experienced temperature excursion of 35 degrees Fahrenheit for 9 days. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Joint swelling, Pain, Urticaria
Clinical narrative: Information has been received from a physician via a company employee referring to a currently 14 years old female patient. The patient's medical history and concurrent condition were not reported. Concomitant therapies included other unspecified immunizations. On 15-JUL-2014, the patient was vaccinated with her first dose of GARDASIL 9 (lot #, expiration date and dose not reported) intramuscularly and VAQTA (lot #, expiration date and dose not reported) intramuscularly. On an unknown date (reported as "a few months later"), the patient developed joint swelling, pain and hives, which lasted for about 3-4 weeks (recovered date unknown). On 10-AUG-2016, the patient was vaccinated with her third dose of GARDASIL 9 (lot #, expiration date and dose not reported) and another dose of VAQTA (lot #, expiration date and dose not reported). On an unknown date of 2016, the patient experienced the same joint swelling, pain and hives, which lasted another 3-4 weeks (recovered date: 2016). The patient saw an unspecified specialist, who was unable to determine if the symptoms were related to the vaccines. The reporter did not provided the causality between suspect therapies and events. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 14 year old male patient. No relevant medical history or concurrent conditions were reported. On 29-OCT-2015, at the age of 13, the patient was vaccinated with his first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On 17-NOV-2016, at the age of 14, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (lot number, dose, and expiry date were not reported), orally. On an unknown date, the patient vomited an unspecified amount of vaccine after administration ROTATEQ. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 8 years old male patient. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, when the patient was 1 year old, he was vaccinated with the first dose of VARIVAX injection (dose, route of administration, lot#, expiration date were not provided). The patient received the second dose of VARIVAX injection (dose, route of administration, lot# and expiry date were not reported), on an unknown date, when he was approximately 5 years old. On an unknown date, when the patient was approximately 8 years old, he experienced a mild case of chickenpox, possibly transmitted to him by another child at school. The patient recovered from the event of chickenpox on an unspecified date. The relatedness VARIVAX and the adverse event was not reported. Additional information is not expected, as there was no consent to contact the reporting nurse.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Information has been received from a pharmacist referring to a 74 years old male patient. The patient's concurrent condition and concomitant therapy were not reported. The patient was vaccinated with PREVNAR 13 on an unspecified date in September 2015. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date not reported) intramuscularly for trying to stay up to date with immunizations. On 09-NOV-2016, the patient experienced severe pain and tenderness at the injection site. The patient said this was the worst pain he had ever had. The patient could not move his arm. The patient sought medical attention via contacting pharmacist. Unspecified treatment was given for the events. The outcome of the events was not resolved. The causality between PNEUMOVAX 23 and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M019691, expiration date 02-NOV-2017) (dose and unit were unknown) orally. The vaccine was exposed to 47F for 15 minutes, 47F for 40 minutes, 47.3F for 40 minutes, 50F for 1 hour. No previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (expiration date 20-SEP-2017) (dose, unit and route unknown). The vaccine was exposed to 47F for 15 minutes, 47F for 40 minutes, 47.3F for 40 minutes, 50F for 1 hour. No previous temperature excursion. Data logger was involved. No adverse effects reported. Lot number M00268 is an invalid lot number for hepatitis A vaccine, inactivated. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 21-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # L012042 and expiry date 18-NOV-2016, 0.5 ml, intramuscularly. No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-AUG-2013, the patient was vaccinated with the third dose of HPV vaccine (dosing details were not provided). The patient received first and second dose on 21-JAN-2013 and 12-APR-2013, respectively. Medical assistant reported that she was unable to specify if these doses were GARDASIL or GARDASIL 9 (lot/ expiry dates were unknown for first 3 doses administered). She also mentioned that on 09-NOV-2016, the patient inadvertently received a fourth dose with GARDASIL 9 (lot # M026306, expiry date: 30-APR-2018). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with GARDASIL, (lot number/expiry date and dose not reported). On an unknown date, the patients were vaccinated with unspecified doses of GARDASIL 9 injection (lot number/expiry date and dose not reported), to continue or complete a HPV vaccination series that was started with GARDASIL. No adverse effects have been reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Headache, Nausea, Urticaria
Clinical narrative: 11/23/16, pt experienced nausea, dizziness, headache, and hives. Nausea, and hives. Nausea, dizziness and headache have lessened, with hives spreading. Pt advised to take CLARITIN, monitor and to ER if worsening.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the pertinent medical history, drug allergies or reaction and concomitant therapies was reported. On 21-OCT-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L035882, expiration date 19-APR-2017 (exact dose and route of administration were not reported). The vaccine was stored 24 hours in 1 degree C. The previous temperature excursion was 24 hours at highest temperature 22 degrees C. Data logger was not involved. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: This spontaneous report concerning a female patient of unknown age was received from the patient herself. Notably, she happened to be a physician's assistant. While her concurrent conditions included spinal stenosis, and drug reactions/ allergies to penicillin and epinephrine, her medical history included a transient ischaemic attack, and a bilateral carotid endarterectomy. On 04-NOV-2016 (reported as "2 weeks ago"), the patient was vaccinated with ZOSTAVAX, done as part of a routine vaccination (the dose, dosage number, anatomical location, lot # and expiration date were unknown). Her concomitant therapies included PLAVIX, aspirin (manufacturer unknown ), TOPROL XL tablets, lisinopril (manufacturer unknown) (verbatim term was "lisinopril"), EFFEXOR XR, SYNTHROID, and LIPITOR. Subsequently, within a couple of hours of being vaccinated, on an unknown date in November 2016, the patient developed a lump along with a feeling of itchiness at the injection site. Despite receiving no treatment for the adverse events, they appeared to have resolved themselves within 2 days. Following this, on approximately 09-NOV-2016 (reportedly 5-7 days after receiving ZOSTAVAX), she developed a shooting pain which went down her left arm, all the way from her elbow to her wrist. At the time of reporting, this pain had not been resolved. Notably, no laboratory diagnostic studies were performed and now was any medical attention sought. Additionally, no product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient's concurrent conditions included allergic reactions to codeine, penicillin and "sulfa". The patient's medical history was not reported and she was not pregnant. On 09-NOV-2016, the patient was vaccinated with ZOSTAVAX (route, dose, anatomical location and lot number were not reported). Information regarding concomitant medications was not reported. On 10-NOV-2016, the patient visited the pharmacy seeking medical attention; because she developed a red rash at the injection site that was warm to touch and itchy. In addition, the patient stated that she could feel a knot at the injection site. The patient was treating the event applying cool compress to the area (also reported as "no"). However, no laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. At the reporting time, the outcome of injection site nodule, vaccination site pruritus, vaccination site warmth vaccination site rash was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to an approximately 62 year old female. The patient had no pertinent medical history or current conditions. The patient's known allergies included cephalosporin and macrolide allergy.  On 19-NOV-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. In September 2016, the patient developed a case of shingles. The pharmacist reported, she felt the shingles may had been caused by stress, as the patient's husband had recently died. The patient sought for medical attention, however it was unknown if treatment was provided for the adverse event. No  product quality issue was involved. At the time of the report, the outcome of herpes zoster was reported as recovered in 2016. Additionally, the reporter did not provide for a causality between the adverse event and vaccination with ZOSTAVAX. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M009378 with an expiration date 24-APR-2018 (dose, route of administration and anatomical location were not reported). Administered doses of GARDASIL 9 experienced temperature excursion of 35 degrees Fahrenheit for 9 days. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, warm to touch. Called PCP she had pt come in and she gave her XYZAL samples to decrease swelling.
Age: 0.17
Sex: M
Vaccine: RVX
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Haematemesis, Haematochezia
Clinical narrative: Vomiting Blood, Blood in Stool, Diarrhea. When I picked up my son from his crib in the morning, I noticed dried, bloody spit up all down the side of his onsie. The rest of the day, all of his spit up was tinged with blood. The quantity of his spit up was significantly more than usual, too. We ruled out bleeding/cracked nipples because I pumped that morning with normal, creamy white milk. I did not change my diet either - so I ruled out an allergy. When we changed his diapers, he had black, bloody blobs in his diarrhea. We called the doctor and the nurse said it is likely an adverse reaction to the Rotavirus Oral vaccine as that can cause 'minor' stomach irritation. Blood in vomit and stool doesn't seem 'minor' to me. It was horrifying. I wanted to bring him in immediately, but was advised to continue to monitor his condition. If it progressed, I was told to bring him in. The bloody vomit ceased later that afternoon, 11/19. The diarrhea has continued on and off - with and without the blood. I also notice a strong smell to it- which as a breastfed baby, I never noticed before. I plan to call the doctor this Monday to discuss.
Age: 0.17
Sex: M
Vaccine: RVX
Symptoms: Infantile spitting up
Clinical narrative: Vomiting Blood, Blood in Stool, Diarrhea. When I picked up my son from his crib in the morning, I noticed dried, bloody spit up all down the side of his onsie. The rest of the day, all of his spit up was tinged with blood. The quantity of his spit up was significantly more than usual, too. We ruled out bleeding/cracked nipples because I pumped that morning with normal, creamy white milk. I did not change my diet either - so I ruled out an allergy. When we changed his diapers, he had black, bloody blobs in his diarrhea. We called the doctor and the nurse said it is likely an adverse reaction to the Rotavirus Oral vaccine as that can cause 'minor' stomach irritation. Blood in vomit and stool doesn't seem 'minor' to me. It was horrifying. I wanted to bring him in immediately, but was advised to continue to monitor his condition. If it progressed, I was told to bring him in. The bloody vomit ceased later that afternoon, 11/19. The diarrhea has continued on and off - with and without the blood. I also notice a strong smell to it- which as a breastfed baby, I never noticed before. I plan to call the doctor this Monday to discuss.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Chills, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Fever, chills for 6 days. Severe pain at and surrounding injection site, right upper arm, loss of usage of arm, steroid injection on 11/21/2016 of no help, OTC pain meds and RX pain meds of little use, ice packs also of little use. Pain still severe after 14 days, patient needs help dressing and can barely move arm.
Age: 0.33
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Severe pain in my left shoulder. Can not sleep on left side, having difficulty lifting my arm, don't have much strength in left arm.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Chest X-ray, Pneumonia
Clinical narrative: He got pneumonia, Required cephalosporin intramuscular injection, nebulizer every 8 hours, chest x-rays.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature, Headache, Rash
Clinical narrative: Pt developed rash aroung abdominal area, and had a temperature and headache.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting pain down arm.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Adenovirus test, Anti-GAD antibody positive, Anti-VGKC antibody positive, Asthenia, Bacterial test negative
Clinical narrative: Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Bartonella test negative, Blood culture negative, CSF culture negative, CSF glucose normal, CSF protein normal
Clinical narrative: Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: CSF red blood cell count, CSF white blood cell count increased, Culture positive, Culture urine negative, Cytomegalovirus test negative
Clinical narrative: Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Ehrlichia test, Endotracheal intubation, Enterovirus test negative, Generalised tonic-clonic seizure, Gram stain
Clinical narrative: Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Gram stain negative, Herpes simplex test negative, Mycoplasma test positive, Polymerase chain reaction, Pyrexia
Clinical narrative: Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Sensation of foreign body
Clinical narrative: Redness and soreness at injection site. Patient indicates it feels as if the needle is still in the muscle.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Amenorrhoea, Axillary pain, Cyst, Hypomenorrhoea, Menstruation delayed
Clinical narrative: Very painful, tender cyst-like eruptions in right armpit. Within a day or two, same type of cysts in left armpit. Missed next two menstrual cycles; then next period was late, starting then stopping then starting again and light. Most recent period (11/16/2016) was first "normal" period since vaccine. Eruptions healed, but have had new eruptions since then, but not as many. Treated/s pain with ibuprofen and kept/keeps area clean.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tenderness
Clinical narrative: Very painful, tender cyst-like eruptions in right armpit. Within a day or two, same type of cysts in left armpit. Missed next two menstrual cycles; then next period was late, starting then stopping then starting again and light. Most recent period (11/16/2016) was first "normal" period since vaccine. Eruptions healed, but have had new eruptions since then, but not as many. Treated/s pain with ibuprofen and kept/keeps area clean.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother reports child started that evening with redness and swelling at the injection site-Mother gave BENADRYL that evening but the redness continued to grow.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Developed redness and pain at injection site with increased redness each day. Father states has been giving MOTRIN and BENADRYL but redness kept increasing.
Age: 1.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Crying, Diarrhoea, Diet refusal, Flushing, Frequent bowel movements
Clinical narrative: Diarrhea, refusing solids and only wanting to nurse, fussy, fever started around 7pm lasting until 4am. Highest temp was at 2am 102 taken by armpit. 9 bm diapers in 12hrs. Nursed almost constantly. Baby finally slept 6am to 840am. Baby warm 11/24 but much better. Instable walking and fussy. Refusing solids and nursing every 45mins for about 10mins. 5 bm diapers during the day. Refusing to nap...up 14hrs before sleeping finally and only being held. Restless all night with frequent crying and nursing. 11/25 still unstable walking, fevers gone but mild rash on trunk. Still not eating much solids. 3 bms cranky and wanting to be held a lot. 11/26. Cries while standing still. Refusing to walk or crying until picked up. Still few solids. 2 bms rash on neck, trunk and limbs. Cheeks flushed.
Age: 1.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Gait disturbance, Insomnia, Irritability, Pyrexia, Rash
Clinical narrative: Diarrhea, refusing solids and only wanting to nurse, fussy, fever started around 7pm lasting until 4am. Highest temp was at 2am 102 taken by armpit. 9 bm diapers in 12hrs. Nursed almost constantly. Baby finally slept 6am to 840am. Baby warm 11/24 but much better. Instable walking and fussy. Refusing solids and nursing every 45mins for about 10mins. 5 bm diapers during the day. Refusing to nap...up 14hrs before sleeping finally and only being held. Restless all night with frequent crying and nursing. 11/25 still unstable walking, fevers gone but mild rash on trunk. Still not eating much solids. 3 bms cranky and wanting to be held a lot. 11/26. Cries while standing still. Refusing to walk or crying until picked up. Still few solids. 2 bms rash on neck, trunk and limbs. Cheeks flushed.
Age: 1.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Restlessness, Skin warm
Clinical narrative: Diarrhea, refusing solids and only wanting to nurse, fussy, fever started around 7pm lasting until 4am. Highest temp was at 2am 102 taken by armpit. 9 bm diapers in 12hrs. Nursed almost constantly. Baby finally slept 6am to 840am. Baby warm 11/24 but much better. Instable walking and fussy. Refusing solids and nursing every 45mins for about 10mins. 5 bm diapers during the day. Refusing to nap...up 14hrs before sleeping finally and only being held. Restless all night with frequent crying and nursing. 11/25 still unstable walking, fevers gone but mild rash on trunk. Still not eating much solids. 3 bms cranky and wanting to be held a lot. 11/26. Cries while standing still. Refusing to walk or crying until picked up. Still few solids. 2 bms rash on neck, trunk and limbs. Cheeks flushed.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash in area of left arm below the immunization.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The vaccine was administered in the right deltoid muscle. Below the injection site appears to be red, swollen, and painful. The patient was instructed to take over-the-counter pain relief (acetaminophen), BENADRYL, and a cold pad against the skin. The patient refused to take any medications to help.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: LARGE LOCAL REACTION.  TOPICAL TREATMENT.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pt states that the day after he received his Fluzone HD (in right arm) and Prevnar (in left arm) vaccines his left arm was sore.  The soreness has subsided but has not completely gone away.  He can lift his arm but it is sore. He states the arm feels weak a couple of inches below the site of injection.  He has not yet had this examined by his physician.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Acupuncture, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Extreme shoulder pain tingling in fingers sharp shooting pain down arm and inability to move arm up.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Extreme shoulder pain tingling in fingers sharp shooting pain down arm and inability to move arm up.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash erythematous, Skin warm, Sleep disorder
Clinical narrative: Red rash over half of arm, hot to touch, bad pain, had to sleep on otherside. pain subsiding and redness too.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on injection site size of a coastal.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Myalgia, X-ray
Clinical narrative: EXTREME MUSCLE PAIN AND LIMITED USE, DOCTOR GAVE LIDOCAINE PATCHES, PHYSICAL THERAPY MAY BE NEEDED.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, hot, sore, itchy, painful.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Right shoulder pain after shot administer in shoulder not deltoid.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle contusion, Muscle spasms, Pain in extremity
Clinical narrative: For my pain I was put on steroids-prednisone-muscle-spasm-my doctor said I have a bruise muscle. I am also wear a elbow wrap to suppress pain. I went to DR. for pain, as to this day I have pain in my left arm.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PNEUMOVAX 23 Lot# L026033 with expiration date: 27-MAR-2017 and lot# L035882 with expiration date: 19-APR-2017 (dose and route of administration were not reported). Administered doses of PNEUMOVAX 23 underwent a temperature excursion at 9 degrees Celsius for 1 minute. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of 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 as received from a nurse (other health professional) refers to an unspecified number of patient of unknown age. Pertinent medical histories and current conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosage regimen were not reported) (lot number and expiration dates were not available) data logger was involved. Temperature and time frame was on 10-NOV-2016, 30.1F for 5.5 hours, 17-NOV-2016, 33.6F for 6 hours and 18-NOV-2016, 32.3F for 9 hours respectively. No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. Product quality complaints (PQC) were not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored GARDASIL 9 lot# L040054 with expiration date: 26-DEC-2017 and lot# M016193 with expiration date: 24-APR-2018 (dose and route of administration were not reported). Administered doses of GARDASIL 9 underwent a temperature excursion at 9 degrees Celsius for 1 minute. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant (other health professional) refers to an unknown number of patients of unknown age. Pertinent medical histories, current conditions and concomitant medications were not reported. On an unknown date, the unknown number of patients received improperly stored doses of GARDASIL 9 (dosage regimen were not reported) (lot # M013636, expiry date: 15-FEB-2018). No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. No Product quality complaints (PQC) were not involved. 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 medical assistant and refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (doses, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of GARDASIL 9 experienced temperature excursion of 35 degree Fahrenheit for 6 days, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information has been requested. This is one of several reports from the same reporter.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Drug intolerance, Malaise, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a health professional via Pfizer (manufacturer control # 2016487324) and refers to a 67-year-old female patient. Her concurrent conditions included allergy to neuromuscular blockers, steroidal, noted on 24-MAY-2012 when the patient experienced vision loss and additionally intolerance to PERCOCET, that was noted on the same date, when she also experienced headache. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiry date were not reported). Concomitant therapies were not reported. On 18-SEP-2015, the patient experienced PNEUMOVAX 23 intolerance. It was reported that she was "sicker than a dog" and suffered from nausea and vomiting. The outcome of the events was not reported. The events were considered to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a certified medical assistant refers to a patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ orally, lot# M005733 with expiration date: 01-OCT-2017. lot# M018957 with expiration date: 22-OCT-2017, lot# L046318 with expiration date: 28-SEP-2017 and lot# M004544 with expiration date: 18-OCT-2017 (dose was not reported). Administered doses of ROTATEQ underwent a temperature excursion at 9 degrees Celsius for 1 minute. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (doses, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of (Oka/Merck) VARIVAX experienced temperature excursion of 35 degree Fahrenheit for 6 days, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information has been requested. This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # L049533, expiry date 08-DEC-2017 and lot# M004663, expiry date 27-JAN-2018; dose and route of administration were not reported). The doses of the vaccine were exposed to a temperature excursion of 26 degrees Fahrenheit for a time frame of 5 hours (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient vaccinated with a dose of M-M-R II injection (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date the patient experienced unspecified reaction to the M-M-R II. The outcome of the adverse event was unknown. Additional information is not expected because the reporter did not provide contact details.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the pertinent medical history, drug allergies or reaction and concomitant therapies was reported. On 13-OCT-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB 10/1.0 mcrg/ml (lot # M017127, expiration date 15-SEP-2017) (exact dose and route of administration were not reported). The vaccine was stored 24 hours in 1 degree C. The previous temperature excursion was 24 hours at highest temperature 22 degree C. Data logger was not involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the pertinent medical history, drug allergies or reaction and concomitant therapies was reported. On 11-OCT-2016, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # L038135, expiration date 27-MAY-2016) (exact dose and route of administration were not reported). The vaccine was stored 24 hours in 1 degrees C. The previous temperature excursion was 24 hours at highest temperature 22 degrees C. Data logger was not involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-NOV-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX injection, 19400 Plaque-Forming Units (PFU) (dose was not provided; lot # M026876, expiration date: 26-JUL-2017). No adverse events was reported. Administered dose of vaccine experienced the temperature excursion of 13.64 degrees Fahrenheit for 7 hours and 30 minutes. There was no previous temperature excursions reported. Digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX with either lot M000996 and expiration date of 07-JAN-2018, lot M004663 and expiration date of 27-JAN-2018, lot M017292 with expiration date of 07-APR-2018 or lot M008173 and expiration date of 16-FEB-2018 (strength, route of administration and dose were unknown), which were stored at -14.2 Celsius degrees for 1 hour and 51 minutes. There was a previous temperature excursion for the lot number M017292 and M008173 of -12.9 Celsius degrees for 90 minutes. However, for the lot numbers M000996 and M004663 there was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. Additional information has been requested.