chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient in her mid fifties. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-NOV-2017, the patient was vaccinated with one dose of PNEUMOVAX 23, injection, subcutaneously (frequency, lot # and expiration date were not reported) for prophylaxis. The medical assistant stated that the dose of the vaccine was administered into the fat on the back of an unspecified arm, not into the deltoid. On the same day, the patient experienced bruising on the arm at the injection site. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was reported as not recovered. The relatedness between the event and the suspected vaccine was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old female patient. On unknown date in 2016, patient received a dose of FLUZONE and an unspecified time after receiving it, the patient developed a red, hot and swollen injection site. No information regarding the patient's allergies and concomitant therapies was provided. On 02-NOV-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, site, lot # and expiration date were not reported) for prophylaxis. On 03-NOV-2017 (reported as "the next day"), the patient developed redness and swelling at the injection site the size of a soft ball, which was also hot to the touch and there was one pustule at the injection site. Patient sought medical attention via seeing an unspecified healthcare provider. Adverse events were treated with an unspecified antibiotics. The outcome of events was reported as recovered on an unspecified date in November 2017. The relatedness beetwen events and ZOSTAVAX was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N002203 and expiration date of 19-JAN-2019 for prophylaxis (dose, route of administration, lot number and expiration date were not reported), while the sterile water diluent was properly stored. The vaccine was exposed to a temperature excursion of  -9°C to 8°C (-3.27°C) with a time frame of 8 hours 10 minutes, There was a previous temperature excursion reported as -14°C to-10°C (-13.27 °C) for 1 Hour 22 Minutes. A "data logger" was involved. There was not product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
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 pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX lot # N019822, expiration date 13-JUL-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Sex: M
Vaccine: YF
Symptoms: Blister, Headache, Injection site erythema, Injection site hypersensitivity, Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280, 2017SA207282 (Same reporter). The following is the abstract from the article: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves 11 years old male patient who was vaccinated with first dose of YELLOW FEVER VACCINE (batch number: 1F21057) subcutaneously in right arm, (expiry date was not reported) on 18-Feb-1992. Patient did not have any current Illness other medication and concomitant medication included DEPAKOTE. Preexisting condition was reported seizure disorder. On 25-Feb-1992 seven days post vaccination patient had headache, arm stiff, a small single vesicle occurring at the vaccine injection site, Injection site hypersensitivity and red in a circle the size of a quarter. Laboratory investigation and corrective treatment was not reported. On an unknown date, the patient was recovered from events. List of documents held by sender: none.
Sex: M
Vaccine: YF
Symptoms: Skin hyperpigmentation, Vaccination site vesicles
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280, 2017SA207282 (Same reporter). The following is the abstract from the article: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves 11 years old male patient who was vaccinated with first dose of YELLOW FEVER VACCINE (batch number: 1F21057) subcutaneously in right arm, (expiry date was not reported) on 18-Feb-1992. Patient did not have any current Illness other medication and concomitant medication included DEPAKOTE. Preexisting condition was reported seizure disorder. On 25-Feb-1992 seven days post vaccination patient had headache, arm stiff, a small single vesicle occurring at the vaccine injection site, Injection site hypersensitivity and red in a circle the size of a quarter. Laboratory investigation and corrective treatment was not reported. On an unknown date, the patient was recovered from events. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given 3-year old Flu dose (0.5mL) instead of 6-35 month (0.25 mL) Flu dose for 2nd due Flu shot. Parent was informed immediately by phone after patient left. No adverse symptoms occurred with patient in the clinic.
Age: 73.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling redness at injection site and around area also arm hurts all the way down to hand.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient was noted to be limping within 12 hours following the vaccine then the following morning (24 hours) following the vaccine he was noted to have left thigh redness and swelling. He took scheduled benadryl as per doctor instructions and was seen in the office at 48 hours following the vaccine - redness and swelling consistent with allergic reaction but now walking improved. Advised scheduled claritin for another 24 hours and followup by phone next day.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site. Pt's wife called the next day to report symptoms and was instructed to use heat on site. TYLENOL pain and BENADRYL for itching.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness and warmth to left arm. Patient was seen in the ER the evening of injection and was prescribed Zantac and Benadryl and to use ice.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion, Vomiting
Clinical narrative: Mother calls and reports patient that on evening of administration of flu vaccine (12/06/17)  patient began throwing up at 1130PM and at 530 AM 12/7/17 had a witnessed febrile seizure. Per mother patient does have a h/o one former febrile seizure. Per Pediatrician, report needed to be placed through VAERS.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Agitation, Body temperature increased, Coxsackie viral infection, Emotional distress, Irritability
Clinical narrative: Received MMR, Var, Hep A on Tues., 11/21/17 Wed am was agitated and fussy, inconsolable, temp 105.5. Symptoms have continued x 5 days off and on. Foster mom also noted he has had staring spells off and on. No reaction at site of injections. Highest temp 101.5. Seen in office 11-28-17 diagnosed with coxsackie illness.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Staring
Clinical narrative: Received MMR, Var, Hep A on Tues., 11/21/17 Wed am was agitated and fussy, inconsolable, temp 105.5. Symptoms have continued x 5 days off and on. Foster mom also noted he has had staring spells off and on. No reaction at site of injections. Highest temp 101.5. Seen in office 11-28-17 diagnosed with coxsackie illness.
Age: 67.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Cardiac failure congestive
Clinical narrative: On 8-12-16 (has no record of this event-no hospital report) Patient called stating he went to the hospital and they told him he had CHF from PREVENAR 13.
Sex: U
Vaccine: RV1
Symptoms: Dysphagia, Gastrostomy
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of swallowing difficult in a patient who received ROTARIX. Previously administered products included ROTARIX vaccine (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of ROTARIX. On an unknown date, unknown after receiving ROTARIX, the patient experienced swallowing difficult. On an unknown date, the outcome of the swallowing difficult was unknown. It was unknown if the reporter considered the swallowing difficult to be related to ROTARIX. Additional details were provided as follows: The patient received 2 doses of ROTARIX and subsequently had a gastrostomy tube (g-tube) placed. The lot number and expiration date was unknown. The reporter stated that the patient was having difficulty swallowing. No further information was provided.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Hand-foot-and-mouth disease, Urticaria
Clinical narrative: Patient developed hives while at babysitter. Called doctor office and wanted child to be seen. Dr. diagnosed child with hand, foot, and mouth disease and started amoxicillin and told father to give her BENADRYL.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, Body temperature increased, Fatigue, Headache, Injection site discomfort
Clinical narrative: Within 12 hours developed T101.7, local shot site pain, achiness, fatigue and headache. Seen the next day in the office Exam: Local shot site pain hurt greatest discomfort is over distal Tricuspid. Fatigue w/ diffuse abdominal pain but no other localized findings.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Within 12 hours developed T101.7, local shot site pain, achiness, fatigue and headache. Seen the next day in the office Exam: Local shot site pain hurt greatest discomfort is over distal Tricuspid. Fatigue w/ diffuse abdominal pain but no other localized findings.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt received injection of PNEUMOVAX approximately at 14:41 on 12/5/17 and same day in the late evening hour pt developed reaction at site (swelling from deltoid to elbow and feverish).
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Patient stated that the morning after receiving the vaccine she woke up with hives covering her entire torso, buttock and legs. By mid-morning they had started to decrease and by afternoon the hives were basically resolved. She has stated she has never had this type of reaction to an influenza vaccine before and she did not use or take anything different that night other than receive the influenza vaccine.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient complaining of soreness and stiffness in right arm a day after getting the immunization. States it started towards the back of the shoulder (deltoid) and has now progressed to the side of shoulder where shot was administered.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who referred to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M033335, expiration date 11-OCT-2017 (dose, anatomical location and route of administration were not mentioned) for prophylaxis. No adverse effects were reported. The nurse was able to add that the patient has a history of high blood pressure. The nurse was also able to share that the patient was showing no adverse reactions in regards to receiving expired vaccine. The patient has been contacted by the nurse to schedule a re-vaccination. The patient declined at this time and preferred to what until the holidays would be over.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 22-NOV-2017, the patient was inadvertently vaccinated with an expired ZOSTAVAX lot # M036297 with an expiration date 14-NOV-2017 for prophylaxis. There was no adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # N021571 with expiration date 29-APR-2020 or lot# N021475 with expiration date: 31-JAN-2020 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days, through 6 cycles multiple temperature excursions were involved. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003734.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# N011867 and expiration date: 08-NOV-2018 or lot# N014946 and expiration date: 01-FEB-2017 or lot# N020688 and expiration date: 09-MAR-2019 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days. Through 6 cycles multiple temperature excursions were involved. There were no previous temperature excursions. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# N011867 and expiration date: 08-NOV-2018 or lot# N014946 and expiration date: 01-FEB-2017 or lot# N020688 and expiration date: 09-MAR-2019 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days. Through 6 cycles multiple temperature excursions were involved. There were no previous temperature excursions. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# N011867 and expiration date: 08-NOV-2018 or lot# N014946 and expiration date: 01-FEB-2017 or lot# N020688 and expiration date: 09-MAR-2019 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days. Through 6 cycles multiple temperature excursions were involved. There were no previous temperature excursions. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003734.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
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 pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX lot # N014630, expiration date 11-AUG-2019 (also reported as 11-MAY-2019) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA003734:
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a Consumer (Patient's mother) on 16- Oct -2017. This case involves a 9-year-old female patient who was vaccinated with a single dose of INFLUENZA QUADRIVAL A-B VACCINE (FLU SHOT) (batch number: U5913BA, expiry date, dose, form, route and dose in series was not reported) via in the left arm on an unknown date. (Reported as Thursday at 4:00). Concomitant medications were not reported. On an unknown date, three hours following the vaccination, the patients had reaction where her arm (left) became increasingly red and swollen from her shoulder to her elbow. It was reported that on an unknown date on Saturday she could barely get her shirt on, and by Saturday the swelling had increased such that her elbow was not defined, and the swelling moved to her forearm. It was also red and itchy in her triceps area, but she had no hives and no other reaction anywhere else. Patient's mother treated her with IBUPROFEN (Motrin) after shot, because she said her arm hurt, then with DIPHENHYDRAMINE HYDROCHLORIDE (Benedryl) orally and topically Friday through Sunday. Lab data was not reported. Other corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 20 Oct 2017. This case involves a 51-year-old female patient who was vaccinated with one dose of FLUZONE QUADRIVALENT (Batch number: UT5954KA, Expiry date: 30-Jun-2018, dose and dose in series was not reported) intramuscularly in left deltoid on 11-Oct-2017. Patient medical history was not reported. The patient denied injury or previous history of back issues. Concomitant medications were not reported. (It was reported as no other vaccines were administered by the patient). On 13-Oct-2017, two days following the vaccination, the patient developed incapacitating back pain, the pain was limited to lower back and lower extremities. Relevant lab tests were not reported. Patient received corrective treatment with ibuprofen (Advil), naproxen sodium (Aleve), paracetamol (Tylenol), ice, heat and foam roller but had no relief from any of those medications. The outcome of the event Low back pain was recovering (reported as back pain has remained, improved, but is still noticeable) and the outcome of Pain of lower extremities was unknown. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: Initial unsolicited report received from a nurse on 03-Nov-2017. This case involves a 10-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number: UT5911MA) in right deltoid via intramuscular route on 01-Nov-2017. The patient's has no history of bleeding disorders or other medical problems, only seasonal allergies. The patient's concomitant medications were not reported. On 02-Nov-2017, one day following the vaccination, the patient's injection site started to ooze blood. It was reported that they put on a bandaid and it stopped but, overnight the bleeding started again. It's only a small amount but, they were concerned it's still bleeding days later. Nurse advised to have evaluated for hematoma at the injection site. The patient's laboratory data and corrective treatment were not reported. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Urticaria
Clinical narrative: Felt lightheaded immediately. Over course of 2 Hrs increased lightheaded, nausea, hives over trunk. Seen in ED.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and heat at injection site.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Allergy test positive, Bacterial test negative, Clostridium test, Culture stool, Differential white blood cell count normal
Clinical narrative: Hematochezia - Child exclusively breastfed. First dose ROTATEQ administered 10/6/17 and onset hematochezia 10/16/17 initially thought to be sensitivity to mom's diet. Mom's diet restricted (even though allergy testing revealed no obvious allergy, only slight sensitivity to cow's milk) and bloody stools resolved. Second dose ROTATEQ administered 12/5/17 and hematochezia returned 12/6/17 without any change to mom's diet.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Full blood count normal, Giardia test negative, Haematochezia, Metabolic function test normal, Parasite stool test negative
Clinical narrative: Hematochezia - Child exclusively breastfed. First dose ROTATEQ administered 10/6/17 and onset hematochezia 10/16/17 initially thought to be sensitivity to mom's diet. Mom's diet restricted (even though allergy testing revealed no obvious allergy, only slight sensitivity to cow's milk) and bloody stools resolved. Second dose ROTATEQ administered 12/5/17 and hematochezia returned 12/6/17 without any change to mom's diet.
Age: 0.17
Sex: M
Vaccine: RV5, RV5
Symptoms: Rotavirus test, Salmonella test negative
Clinical narrative: Hematochezia - Child exclusively breastfed. First dose ROTATEQ administered 10/6/17 and onset hematochezia 10/16/17 initially thought to be sensitivity to mom's diet. Mom's diet restricted (even though allergy testing revealed no obvious allergy, only slight sensitivity to cow's milk) and bloody stools resolved. Second dose ROTATEQ administered 12/5/17 and hematochezia returned 12/6/17 without any change to mom's diet.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Haematoma, Limb mass, Pain, Sleep disorder, Swelling
Clinical narrative: Patient stated on 12.2.17 that he was still experiencing pain and swelling from the flu shot he received in September. He said he has a golf ball size lump that seems to be getting worse in his arm. He has visited the hospital was diagnosed with a hematoma. He said he does not have any problems with his shoulder or any problems with range of motion but he is still in pain and unable to sleep on his right arm.
Age: 27.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Blood test, Cardiac monitoring, Cellulitis, Chest X-ray, Dehydration
Clinical narrative: I woke up Friday night around 11:00 pm with extreme pain left upper arm and body aches. Went to a stand-alone ER. The doctor told us it was just severe inflammation and gave me an anti-inflammatory injection, hydrocodone, and an Rx for TYLENOL 3. Over the next 36 hours or so I took the TYLENOL 3 around the clock and it didn't seem to do much other than put me to sleep. I got worse over the course of time and by Sunday, 11/26/2017, around 2:45 pm, I went to a hospital ER with extreme pain to my left arm, swelling and redness covering the entirety of the upper left arm, high heart rate and blood pressure, extreme headache anytime I moved, body aches, severely dehydrated, and a fever of 102.7. A chest x-ray and blood test was ran. My WBC was at 29 and I was diagnosed with cellulitis of the left arm. I was admitted to the hospital, put on morphine, ibuprofen, and an IV antibiotic and fitted with a heart monitor. I was hesitantly released Tuesday evening, 11/28/2017 with an Rx of BACTRIM and Ibuprofen, told to watch my temperature and if I were to start running one, to contact my doctor immediately or come back to the ER. I still have the reddish/purple stain looking mark on my arm from the infection.
Age: 27.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Heart rate increased, Hypertension, Infection, Inflammation
Clinical narrative: I woke up Friday night around 11:00 pm with extreme pain left upper arm and body aches. Went to a stand-alone ER. The doctor told us it was just severe inflammation and gave me an anti-inflammatory injection, hydrocodone, and an Rx for TYLENOL 3. Over the next 36 hours or so I took the TYLENOL 3 around the clock and it didn't seem to do much other than put me to sleep. I got worse over the course of time and by Sunday, 11/26/2017, around 2:45 pm, I went to a hospital ER with extreme pain to my left arm, swelling and redness covering the entirety of the upper left arm, high heart rate and blood pressure, extreme headache anytime I moved, body aches, severely dehydrated, and a fever of 102.7. A chest x-ray and blood test was ran. My WBC was at 29 and I was diagnosed with cellulitis of the left arm. I was admitted to the hospital, put on morphine, ibuprofen, and an IV antibiotic and fitted with a heart monitor. I was hesitantly released Tuesday evening, 11/28/2017 with an Rx of BACTRIM and Ibuprofen, told to watch my temperature and if I were to start running one, to contact my doctor immediately or come back to the ER. I still have the reddish/purple stain looking mark on my arm from the infection.
Age: 27.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: I woke up Friday night around 11:00 pm with extreme pain left upper arm and body aches. Went to a stand-alone ER. The doctor told us it was just severe inflammation and gave me an anti-inflammatory injection, hydrocodone, and an Rx for TYLENOL 3. Over the next 36 hours or so I took the TYLENOL 3 around the clock and it didn't seem to do much other than put me to sleep. I got worse over the course of time and by Sunday, 11/26/2017, around 2:45 pm, I went to a hospital ER with extreme pain to my left arm, swelling and redness covering the entirety of the upper left arm, high heart rate and blood pressure, extreme headache anytime I moved, body aches, severely dehydrated, and a fever of 102.7. A chest x-ray and blood test was ran. My WBC was at 29 and I was diagnosed with cellulitis of the left arm. I was admitted to the hospital, put on morphine, ibuprofen, and an IV antibiotic and fitted with a heart monitor. I was hesitantly released Tuesday evening, 11/28/2017 with an Rx of BACTRIM and Ibuprofen, told to watch my temperature and if I were to start running one, to contact my doctor immediately or come back to the ER. I still have the reddish/purple stain looking mark on my arm from the infection.
Age: 27.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia, Skin discolouration, Ultrasound scan, White blood cell count increased
Clinical narrative: I woke up Friday night around 11:00 pm with extreme pain left upper arm and body aches. Went to a stand-alone ER. The doctor told us it was just severe inflammation and gave me an anti-inflammatory injection, hydrocodone, and an Rx for TYLENOL 3. Over the next 36 hours or so I took the TYLENOL 3 around the clock and it didn't seem to do much other than put me to sleep. I got worse over the course of time and by Sunday, 11/26/2017, around 2:45 pm, I went to a hospital ER with extreme pain to my left arm, swelling and redness covering the entirety of the upper left arm, high heart rate and blood pressure, extreme headache anytime I moved, body aches, severely dehydrated, and a fever of 102.7. A chest x-ray and blood test was ran. My WBC was at 29 and I was diagnosed with cellulitis of the left arm. I was admitted to the hospital, put on morphine, ibuprofen, and an IV antibiotic and fitted with a heart monitor. I was hesitantly released Tuesday evening, 11/28/2017 with an Rx of BACTRIM and Ibuprofen, told to watch my temperature and if I were to start running one, to contact my doctor immediately or come back to the ER. I still have the reddish/purple stain looking mark on my arm from the infection.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Rt arm had turned red and swollen felt like she had a fever but she did not.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site warmth
Clinical narrative: Patient received vaccine on 11/08/2017. She came to the pharmacy on 11/09/2017 because the injection site was hot and she was having chills. She was advised to take TYLENOL and put ice in around the injection site.
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Joint swelling, Pruritus, Swelling, Urticaria
Clinical narrative: This was the first PROQUAD Vaccine, but the second MMR and Varicella. He woke up in the morning 7:30am with welts on his face (around cheeks, eyes, ears), arms, legs. Some looked like bug bites others were about 3-5 inches- They were raised welts that felt swollen. There was itchiness around his ankles. Later in the afternoon around 12pm I noticed swelling around his ankles.
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Hypersensitivity
Clinical narrative: This was the first PROQUAD Vaccine, but the second MMR and Varicella. He woke up in the morning 7:30am with welts on his face (around cheeks, eyes, ears), arms, legs. Some looked like bug bites others were about 3-5 inches- They were raised welts that felt swollen. There was itchiness around his ankles. Later in the afternoon around 12pm I noticed swelling around his ankles.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62 year old female patient. The patient's concomitant medications and pertinent medical history were not provided. The patient had a drug reaction or allergy to codeine. She had no illnesses at the time of vaccination. On 06-NOV-2017, the patient was vaccinated with her first dose of ZOSTAVAX, lot # N015627 with expiration date on 04-JUL-2018, subcutaneously for shingles prevention (dose and vaccination site were not reported). The ZOSTAVAX was reconstituted with sterile diluent (dose, lot # and expiration date were not reported). On 06-NOV-2017, reported as "later that evening", the patient developed itching at the ZOSTAVAX injection site. On 08-NOV-2017, the patient developed a raised bump that was 2 inches in diameter (reported also "2 inches long red bump"), that was painful to the touch and slightly itchy. The patient stated that the bump was warm to touch. The patient did not seek medical attention. No laboratory diagnostics were performed and no treatment was given for the events. The outcome of "raised bump that was 2 inches in diameter, that was painful to touch and slightly itchy" was reported as not recovered/not resolved (reported also as unknown). The outcome of "red bump" and "bump was warm to touch" was unknown. The relatedness between the events and ZOSTAVAX was not assessed by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69-year-old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 16-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection via intramuscular route, lot # N022703 with expiration date on 27-FEB-2019 (dose was not reported).  On the same night, the patient experienced pain with no redness or swelling. At the time of the report, the patient did not recover from the event. The relatedness between the event and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via sale rep and described the occurrence of hives in a patient who received FLULAVAL Quadrivalent. On an unknown date, the patient received FLULAVAL Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FLULAVAL Quadrivalent, the patient experienced hives. The patient was treated with steroids NOS. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. No further information was provided. The case was linked with US2017GSK182464, reported by the same reporter.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg pain in a patient who received FLULAVAL Quadrivalent. On an unknown date, the patient received FLULAVAL Quadrivalent. On an unknown date, unknown after receiving FLULAVAL Quadrivalent, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were unknown. It was unknown if the reporter considered the leg pain and back pain to be related to FLULAVAL Quadrivalent. Additional details were reported as follows: No health care professional information provided. The FLULAVAL Quadrivalent was administered to an 8 or 9 year old patient. After received FLULAVAL Quadrivalent, the patient experienced leg and back pain. On 30th November 2017, the patient visited and Endocrinologist and was back at the doctor's office. GSK representative stated that she will call back with more detailed information after the doctors visit today. No additional information provided.
Age: 1.92
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Injection site cellulitis, Injection site pain, Oedema
Clinical narrative: Cellulitis to Left thigh began 12/5/17. ER visit at 12AM 12/6/17 for fever Tmax 103 and increasing warmth, redness, swelling. Also increasing pain in left leg. Discharge to home with BACTRIM and CLEOCIN x 10 days.
Age: 1.92
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Swelling, Ultrasound scan abnormal, X-ray limb normal
Clinical narrative: Cellulitis to Left thigh began 12/5/17. ER visit at 12AM 12/6/17 for fever Tmax 103 and increasing warmth, redness, swelling. Also increasing pain in left leg. Discharge to home with BACTRIM and CLEOCIN x 10 days.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incomplete course of vaccination, Therapeutic response decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapeutic response decreased in a child male patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine, and Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased and incomplete course of vaccination. On an unknown date, the outcome of the therapeutic response decreased and incomplete course of vaccination were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional information was reported as follows: The healthcare professional who was a physician was called on behalf of her son. The patient was previously vaccinated with Hepatitis B (unknown brand) with a 3 dose series as a baby and on an unknown date, the patient's hepatitis B titer was recorded as low. So the Healthcare professional was asking if they need to repeat the 3 dose series of Hepatitis B. After receiving 1st dose of Hepatitis B vaccine in July 2017, the patient did not receive 2nd dose of Hepatitis B vaccine which led to incomplete course of vaccination. The healthcare professional was asking if they need to restart the Hepatitis B series since it was longer than the recommended intervals. No further information was provided.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever 101.4 the next day lasting 7 to 8 hours. Resolved after with no other symptoms.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Agitation, Eczema, Irritability, Pyrexia, Rash
Clinical narrative: Two days post vaccine patient developed a small rash in the center of her chest. 4-5 days post injection she became very agitated and unsettled, (waking every hour in the night). 5 days post injection her disposition was very fussy and fever started to climb from 101.5-104.0 within an hours time. She was brought to the hospital ER and evaluated for mild rash and fever. She was discharged and prescribed topical ointment for rash (Dx ringworm) and TYLENOL and MOTRIN regimen to be administered q4h. Patient's fever went back up to 103.9 the night of the 5/6 day post injection she was taken to our PC Pediatrician and evaluated and told she had eczema and a mild virus. We were prescribed a topical steroid which was filled and not picked up or applied. 6/7 days post injection a physician explained that she was having a reaction to her injection. On days 6-9 (today) she has continued to maintain a high fever of 100.-103 pm and 99.9-101am. Her rash has since spread head to toe and she has welts on her arms, hands, face, legs and feet. Her fever on day 9 (today) was normal in the am. Rash is still present.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash generalised, Urticaria, Vaccination complication, Viral infection
Clinical narrative: Two days post vaccine patient developed a small rash in the center of her chest. 4-5 days post injection she became very agitated and unsettled, (waking every hour in the night). 5 days post injection her disposition was very fussy and fever started to climb from 101.5-104.0 within an hours time. She was brought to the hospital ER and evaluated for mild rash and fever. She was discharged and prescribed topical ointment for rash (Dx ringworm) and TYLENOL and MOTRIN regimen to be administered q4h. Patient's fever went back up to 103.9 the night of the 5/6 day post injection she was taken to our PC Pediatrician and evaluated and told she had eczema and a mild virus. We were prescribed a topical steroid which was filled and not picked up or applied. 6/7 days post injection a physician explained that she was having a reaction to her injection. On days 6-9 (today) she has continued to maintain a high fever of 100.-103 pm and 99.9-101am. Her rash has since spread head to toe and she has welts on her arms, hands, face, legs and feet. Her fever on day 9 (today) was normal in the am. Rash is still present.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Nausea, Vomiting
Clinical narrative: Patient had nausea and vomiting on Friday and throughout the weekend and had no appetite on Monday. The patient's doctor was informed of the reaction on Monday morning.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction
Clinical narrative: Patient indicated swelling and redness at/near the site of injection, extending down towards the elbow of the left arm. The injection site was unremarkable other than redness of the skin. The skin of the affected area was warm to the touch and the patient reported soreness near the site of injection as well as possibly some sensitivity in the related inflamed skin.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient indicated swelling and redness at/near the site of injection, extending down towards the elbow of the left arm. The injection site was unremarkable other than redness of the skin. The skin of the affected area was warm to the touch and the patient reported soreness near the site of injection as well as possibly some sensitivity in the related inflamed skin.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Urticarial rash on forearms and upper chest which started that evening patient got flu shot. It wasn't treated until the next afternoon when patient came to clinic reporting an itchy rash. Diphenhydramine 25mg. and hydrocortisone topical 1% cream were used to treat the symptoms. Patient took another dose of diphenhydramine 25mg. at home and continued to use hydrocortisone lotion. The next morning patient reported great improvement in symptoms, although some rash is still present. (12/7/2017).
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm
Clinical narrative: 11-30-2017 developed redness the size of fingertip to wrist. Mother circled the redness with a pen and it went beyond the line, denies fever, pain or vomiting. Mother spoke with a hospital resident on the day that she worked and was advised to just watch the area. 12-4-2017 the area is still warm to touch but the redness has went down and has no other complaints.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Arm was swollen, red and feverish to touch from injection site all the way to the elbow area by the following day. Patient was also running a fever of 102 degrees.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain, Dizziness, Loss of consciousness, Urinary incontinence, Vomiting
Clinical narrative: Patient is a participant in a study. On 12/06/17, patient completed a routine plasma donation during which 880 mL plasma was collected and 500 mL saline was administered. Donation was followed by a dose of Td Adsorbed (MassBiologics). This was her 5th dose of Td vaccine over the course of 1 year. She had received all doses at an interval of not more often than every 90 days. Following vaccination, Patient remained in the center for 30 minutes to be observed for adverse events. Approx 30 minutes post-dose, she complained of lightheadedness and subsequently had a loss of consciousness > 60 seconds during which time she had a loss of bladder control. Upon regaining consciousness, she complained of abdominal pain and vomited x 2. She was provided with comfort care (including assistance to lie down, water, and a snack) per our SOP and monitored throughout. Patient recovered fully approx. 30 minutes after the onset of symptoms. Patient was assisted to the floor by staff when she lost consciousness, so no head injury occurred. Patient contacted the center after arriving home and notified the staff she had vomited once more, but was able to retain fluids and was resting. The site nurse reached out to patient on 12/07/17. At this time, patient reports all symptoms have completely subsided. She took a shower, rested, and has been feeling well. She has eaten a meal and not had a return of symptoms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Mobility decreased
Clinical narrative: Patient states that she had a bruise that persisted for a few weeks after injection. Injection site pain seems to increase in intensity over time and has persisted for over a month. Some loss of movement has also been noted.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: As per mother's voicemail that was left on Tuesday afternoon. Patients arm, site of injection, has  gotten red, and some swelling with some pain to site.