chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 16 years old patient of unknown 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 subdermal injection, lot number N022980 with expiration date on 23-AUG-2019 (strength, dose and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8 degrees F for 33 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a 41 year old male patient referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 0.65 ml, for prophylaxis (route of administration, lot # and expiration date were not reported). The patient was told that he needed to be vaccinated against chickenpox in order to work on a medical facility. It was stated that the patient's physician prescribed the vaccine.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, No adverse event, Oral administration complication
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 2 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-APR-2018, the patient was vaccinated with a dose of ROTATEQ orally, for prophylaxis (route, lot # and expiration date were not reported). Immediately after vaccine administration, the patient spit out the dose of ROTATEQ. No known adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 02-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in 31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815: US-009507513-1804USA003816: US-009507513-1804USA003817: US-009507513-1804USA003818: US-009507513-1804USA003819: US-009507513-1804USA003820: US-009507513-1804USA003821: US-009507513-1804USA003822: US-009507513-1804USA003823: US-009507513-1804USA003824.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 03-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 05-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in 31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiple temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815: US-009507513-1804USA003817: US-009507513-1804USA003818: US-009507513-1804USA003819: US-009507513-1804USA003820: US-009507513-1804USA003821: US-009507513-1804USA003822: US-009507513-1804USA003823: US-009507513-1804USA003824: US-009507513-1804USA003769.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 20-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 20-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 20-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003815; US-009507513-1804USA003769.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in 31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815: US-009507513-1804USA003816: US-009507513-1804USA003817: US-009507513-1804USA003818: US-009507513-1804USA003819: US-009507513-1804USA003821: US-009507513-1804USA003822: US-009507513-1804USA003823: US-009507513-1804USA003824: US-009507513-1804USA003769.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 26-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (lot # N013992 with an expiration date in 27-JAN-2019), for prophylaxis, (dose and frequency were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 22-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (lot # N013992 with an expiration date in 27-JAN-2019), for prophylaxis, (dose and frequency were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003824; US-009507513-1804USA003769.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 02-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (lot # N013992 with an expiration date in 27-JAN-2019), for prophylaxis, (dose and frequency were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003769.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 06-APR-2018, the patient was vaccinated with a properly stored, but expired dose of VAQTA (lot # N012324, expiry date 05-APR-2018) for prophylaxis. No adverse effects were reported. No product quality complaint was present.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 09 week old infant. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 06-APR-2018, the patient was vaccinated with a properly stored expired dose of ROTATEQ vial, lot # M031805 (expiry date: 07-MAR-2018) orally (dosage not reported) for prophylaxis (expired vaccine used). No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Bedridden, Blood pressure abnormal, Fatigue, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: My son received the GARDASIL 9 vaccine and has been very ill since, cannot even attend school. Bedridden most days and since the vaccine developed a nervous system disorder by the name of Postural Orthostatic Tachycardia Syndrome. Since injection his symptoms include uncontrolled sweating, unsteady blood pressure, racing heart, syncope and near syncope, migraines, extreme fatigue, all over body pain.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Malaise, Migraine, Pain, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: My son received the GARDASIL 9 vaccine and has been very ill since, cannot even attend school. Bedridden most days and since the vaccine developed a nervous system disorder by the name of Postural Orthostatic Tachycardia Syndrome. Since injection his symptoms include uncontrolled sweating, unsteady blood pressure, racing heart, syncope and near syncope, migraines, extreme fatigue, all over body pain.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Presyncope, Syncope
Clinical narrative: My son received the GARDASIL 9 vaccine and has been very ill since, cannot even attend school. Bedridden most days and since the vaccine developed a nervous system disorder by the name of Postural Orthostatic Tachycardia Syndrome. Since injection his symptoms include uncontrolled sweating, unsteady blood pressure, racing heart, syncope and near syncope, migraines, extreme fatigue, all over body pain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Influenza, Injection site pain, Pain
Clinical narrative: Received 1 dose SHINGRIX IM L deltoid -> immediate pain at site, significant for 5 minutes. Body aches began hours later. On AM of 4/6/18, low grade fever, body aches, extreme fatigue, injection site pain; Symptoms helped by several doses of ADVIL 400 mg. We administered 10 other doses of SHINGRIX. Most had injection site pain, some body aches. Another 79 y/o man had same body aches, flu symptoms > 24 hr p vaccine I do not believe GSK's incidence of side effects of 6% is accurate. This vaccine has problems. I would never take another dose and cannot give any more to my patients.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Received 1 dose SHINGRIX IM L deltoid -> immediate pain at site, significant for 5 minutes. Body aches began hours later. On AM of 4/6/18, low grade fever, body aches, extreme fatigue, injection site pain; Symptoms helped by several doses of ADVIL 400 mg. We administered 10 other doses of SHINGRIX. Most had injection site pain, some body aches. Another 79 y/o man had same body aches, flu symptoms > 24 hr p vaccine I do not believe GSK's incidence of side effects of 6% is accurate. This vaccine has problems. I would never take another dose and cannot give any more to my patients.
Sex: F
Vaccine: HPV4
Symptoms: Blood cholesterol normal, Blood glucose normal, Glycosylated haemoglobin normal, Hypersensitivity, Muscle tightness
Clinical narrative: I received the second dose of the GARDASIL vaccine March 26th, I was encouraged to receive the vaccine by my PCP and the nurse that administered the vaccine, though the nurse continue to urge me to get the second vaccination after I expressed to her that I didn't like how I felt after the first vaccination. She said that all of her daughters had the vaccination (all 3) and that I should get it to protect against HPV and cancer. A week later April 2nd, I noticed a large rash develop on my left upper arm, small red bumps appear on my hands and additionally another rash (slightly bruised) develop on my left leg by my knee. I've been excessively itchy, and have felt tingling all over my body and sharp shooting pains all over my body that range from my shoulders, down my arms, into my hands, down my legs into my feet. I went back to the Dr. on April 5th to inquire about the rash and the bumps and the tingling, and the nurse practitioner said I was basically healthy due to the lab work done on March 26th and that it was probably allergies and tension in the muscle in my shoulders causing the issues. She checked my reflexes which were good, but did not do any additional tests to see what the tingling and shooting pain (which I'm still experiencing as I type this) comes from.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Paraesthesia, Pruritus, Rash, Rash erythematous
Clinical narrative: I received the second dose of the GARDASIL vaccine March 26th, I was encouraged to receive the vaccine by my PCP and the nurse that administered the vaccine, though the nurse continue to urge me to get the second vaccination after I expressed to her that I didn't like how I felt after the first vaccination. She said that all of her daughters had the vaccination (all 3) and that I should get it to protect against HPV and cancer. A week later April 2nd, I noticed a large rash develop on my left upper arm, small red bumps appear on my hands and additionally another rash (slightly bruised) develop on my left leg by my knee. I've been excessively itchy, and have felt tingling all over my body and sharp shooting pains all over my body that range from my shoulders, down my arms, into my hands, down my legs into my feet. I went back to the Dr. on April 5th to inquire about the rash and the bumps and the tingling, and the nurse practitioner said I was basically healthy due to the lab work done on March 26th and that it was probably allergies and tension in the muscle in my shoulders causing the issues. She checked my reflexes which were good, but did not do any additional tests to see what the tingling and shooting pain (which I'm still experiencing as I type this) comes from.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Patient reports developing rash on torso, arms, and legs on 4/4. Was seen in an urgent care facility and reports that the provider at that facility questioned if the patient had ever had the measles.  The patient reported receiving the MMR vaccine on 3/3. Patient reports taking BENADRYL for itch with relief. Reports rash still present on 4/10 but not spreading.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Blood thyroid stimulating hormone, Electroencephalogram, Full blood count, Metabolic function test, Thyroxine free
Clinical narrative: Whole body tremors/shaking x 30 minutes on 11/28/2017 and 4/9/2018. Not consistent with seizure, although we are trying to figure out if it is a seizure.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Whole body tremors/shaking x 30 minutes on 11/28/2017 and 4/9/2018. Not consistent with seizure, although we are trying to figure out if it is a seizure.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I developed shingles on my back and waist. Went to my family doctor and to the pharmacy where it was administered. I had originally had the first shingles vaccine five years previously.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: I developed shingles on my back and waist. Went to my family doctor and to the pharmacy where it was administered. I had originally had the first shingles vaccine five years previously.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had pain, swelling and burning of arm and shoulder beyond what would be expected from pneumococcal vaccination.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm started swelling and turning red...very painful about 2 hours after vaccine administered.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's historical therapies included PREVNAR 13 on 09-AUG-2016. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-AUG-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On 27-FEB-2018, the patient was vaccinated again with the second dose of PNEUMOVAX 23, 0.5 ml, intramuscularly, lot# N025563 and expiration date: 08-APR-2019. There were no adverse effects reported.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Guillain-Barre syndrome
Clinical narrative: This spontaneous retrospective pregnancy report was received from the nurse practitioner via a company representative and refers to a female patient of unknown age. There was no information regarding the patient's concomitant medications, drug reactions and allergies provided. On an unknown date (reported as "when she was young"), the patient was vaccinated with a dose of GARDASIL for prophylaxis (route of administration, lot number and expiration date were not provided). On an unknown date after administration, the patient believed she experienced Guillain-Barre syndrome. It was reported that the patient was a mother at the reporting time, however the representative was not able to clarify if the patient became pregnant after receiving GARDASIL or if she was ever pregnant. The outcome of the Guillain-Barre syndrome was unknown. The relatedness between the event and GARDASIL was not provided. Upon internal review, the event of Guillain-Barre syndrome was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 17 year old patient (gender not reported). Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, frequency and route not reported), lot # N020943 (expiry date: 26-OCT-2018) instead of VARIVAX (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis (wrong drug administered). No adverse effects were reported. No additional information was provided. A product quality complaint (PQC) was not filed.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 19 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 07-FEB-2018, the patient started therapy with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). On 09-MAR-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported) and on 06-APR-2018, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). No adverse effects reported.
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Local reaction, Musculoskeletal pain, Myalgia, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported for a 74-year-old African American female patient that received PREVNAR 13, via an unspecified route of administration in arm on 17Nov2017 to at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced severe local reaction and a lot of swelling initially on an unknown date. 48 hours later, she had severe muscle pain. Over time, the pain travelled to the shoulder and up to her jaw. Even today (on 06Apr2018) she had limited movement in the arm that the shot was given in. The outcome of the events was unknown. Information about lot/ batch number has been request in follow-up.
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported for a 74-year-old African American female patient that received PREVNAR 13, via an unspecified route of administration in arm on 17Nov2017 to at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced severe local reaction and a lot of swelling initially on an unknown date. 48 hours later, she had severe muscle pain. Over time, the pain travelled to the shoulder and up to her jaw. Even today (on 06Apr2018) she had limited movement in the arm that the shot was given in. The outcome of the events was unknown. Information about lot/ batch number has been request in follow-up.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain, swelling and redness at the injection site. Clinical outcome of the adverse events was unknown at time of this report.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: No treatment. Severe pain in left upper arm. Cannot lay on left side. Cannot lift left arm above 90 degrees without sharp pain. Pain is the same as the time of injection.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain
Clinical narrative: No treatment. Severe pain in left upper arm. Cannot lay on left side. Cannot lift left arm above 90 degrees without sharp pain. Pain is the same as the time of injection.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Joint range of motion decreased
Clinical narrative: 10/2017-Pain and itching in injection shot noticed immediately. As of today, April 10, 2018, pain and itching has increased. On and off limited range of motion noticed December 2017, until current. The limited range of motion is ongoing everyday at this point and causes severe pain.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram head normal, Dysaesthesia, Dyspnoea, Dyspraxia, Hypersensitivity
Clinical narrative: PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Laboratory test normal, Paraesthesia, Parkinsonian gait
Clinical narrative: PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Anxiety, Blood test normal, Computerised tomogram normal, Dizziness, Dyspnoea
Clinical narrative: PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram normal, Fatigue, Gait disturbance, Headache, Immobile
Clinical narrative: PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Mobility decreased, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Palpitations, Slow speech, Speech disorder, Vaccination complication
Clinical narrative: PT. developed asymmetrical dysesthesia and paresthesia in both arms with difficulty breathing at times as well as verbal dyspraxia which also was transient, rigid gait-seen at local ER, CT of head normal, all labs drawn WNL, neurology consult assessed as hypersensitivity reaction. Of note, PT. Had tonic arm movements when eliciting patella reflex, however, no LP has been performed to date.
Age: 66.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Injection site pain
Clinical narrative: Severe night shoulder pain at vaccine site.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress
Clinical narrative: Inconsolable for 2 hours approx. 4 hours after immunizations calmed with comfort measures and TYLENOL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling at site of DTaP injection.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Herpes simplex test negative, Polymerase chain reaction positive, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient developed Varicella Zoster (Shingles) in the Left T1 distribution. Zoster rash in clusters along the left T1 dermatome developed on 4/8/18, patient was seen and evaluated in the emergency room and followed up in our office on 4/10/18. No medications administered as patient was otherwise asymptomatic. During the ER visit Infectious disease was consulted and agreed with plan to defer starting acyclovir as patient did not have pain or itching and we did not want to suppress immunogenicity of the vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Skin exfoliation
Clinical narrative: Severe Rash starting on abdomen and slowly continuing over entire body over the course of 1 month. The rash did not itch until skin started to slough off. Last of sloughing ended around ankles about 2 weeks ago. After my research on vaccine, I found out that neomycin was in the family of NEOSPORIN. Years ago, I had a suspected reaction to NEOSPORIN cream and have never used it since. In previous years, I have received flu shots w/no adverse events.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Tremor
Clinical narrative: Seizure, generalized shaking, lasted less than 2 minutes.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, C-reactive protein increased, Computerised tomogram, Injection site erythema, Injection site oedema
Clinical narrative: BY NOON THE DAY AFTER INJECTION, DEVELOPED FEVER, ARM PAIN, COULDN'T LIFT ARM OR BEND ELBOW. VOMITED X 1. EXAM AT ER REVEALED TENDER AREA OF ERYTHEMA OF LEFT LATERAL ARM NEAR DELTOID MUSCLE. WARM TO TOUCH, ELEVATED WBC AND CRP. CT SCAN SHOWED LOCALIZED EDEMA, TACHYCARDIC.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Localised oedema, Mobility decreased, Pain in extremity
Clinical narrative: BY NOON THE DAY AFTER INJECTION, DEVELOPED FEVER, ARM PAIN, COULDN'T LIFT ARM OR BEND ELBOW. VOMITED X 1. EXAM AT ER REVEALED TENDER AREA OF ERYTHEMA OF LEFT LATERAL ARM NEAR DELTOID MUSCLE. WARM TO TOUCH, ELEVATED WBC AND CRP. CT SCAN SHOWED LOCALIZED EDEMA, TACHYCARDIC.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm, Tachycardia, Tenderness, Vomiting
Clinical narrative: BY NOON THE DAY AFTER INJECTION, DEVELOPED FEVER, ARM PAIN, COULDN'T LIFT ARM OR BEND ELBOW. VOMITED X 1. EXAM AT ER REVEALED TENDER AREA OF ERYTHEMA OF LEFT LATERAL ARM NEAR DELTOID MUSCLE. WARM TO TOUCH, ELEVATED WBC AND CRP. CT SCAN SHOWED LOCALIZED EDEMA, TACHYCARDIC.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: BY NOON THE DAY AFTER INJECTION, DEVELOPED FEVER, ARM PAIN, COULDN'T LIFT ARM OR BEND ELBOW. VOMITED X 1. EXAM AT ER REVEALED TENDER AREA OF ERYTHEMA OF LEFT LATERAL ARM NEAR DELTOID MUSCLE. WARM TO TOUCH, ELEVATED WBC AND CRP. CT SCAN SHOWED LOCALIZED EDEMA, TACHYCARDIC.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In September 2017, the patient was vaccinated the first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). In November 2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). In January 2018, the patient was vaccinated with the third dose of GARDASIL 9, intramuscularly, lot# N015089 and expiration date: 20-OCT-2019 (dose was not reported). There was no adverse effect reported.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from an office manager who is a licensed social worker and refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of an adult formulation of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This literature marketed report has been received from the authors of the published literature article. This report was a retrospective cohort study and refers to 91 female patients who reached age 11 years while enrolled and who were aged 1522 years at any time during the study period. Additionally, female enrollees had evidence of sexual activity (as determined using the 2012 Healthcare Effectiveness Data and Information Set definition) at any time from age 11 years to the end of the study period. No information on the patients' concurrent conditions, medical history and concomitant medications was reported. However, the patients did not experience genital warts prior to this study and had not had any diagnosis code for immunocompromised state or cancer. On unknown dates, the patients were vaccinated with three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dosage, routes of administration, lot numbers and expiration dates were not provided). On unknown dates, over 6-month after the final vaccine dose, the patients experienced genital warts. The outcome of the events was unknown. The authors of the article considered occurrence of genital warts to be lack of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) effectiveness.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N020015 and expiration date 17-JUL-2019 for prophylaxis, reconstituted with properly stored Merck sterile diluent with lot # N026286 and expiration date 06-FEB-2020. The administered dose of vaccine experienced the temperature excursion of -9 degrees C to 8 degrees C (7C) Celsius for 41 hours, and -14 degrees C to -10 degrees C (-9.6C) Celsius for 5 hours 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA004211; US-009507513-1804USA004212; US-009507513-1804USA004213; US-009507513-1804USA004214; US-009507513-1804USA004215; US-009507513-1804USA004216.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N020015 and expiration date 17-JUL-2019 for prophylaxis, reconstituted with properly stored Merck sterile diluent with lot # N026286 and expiration date 06-FEB-2020. The administered dose of vaccine experienced the temperature excursion of -9 degrees C to 8 degrees C (7C) Celsius for 41 hours, and -14 degrees C to -10 degrees C (-9.6C) Celsius for 5 hours 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA003156.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N020015 and expiration date 17-JUL-2019 for prophylaxis, reconstituted with properly stored Merck sterile diluent with lot # N026286 and expiration date 06-FEB-2020. The administered dose of vaccine experienced the temperature excursion of -9 degrees C to 8 degrees C (7C) Celsius for 41 hours, and -14 degrees C to -10 degrees C (-9.6C) Celsius  for 5 hours 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA003156.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Asthenia, Dizziness, Hypotension, Nausea, Pallor
Clinical narrative: After receiving the vaccines patient turn pale, weak, dizzy, with nausea and needed help to stand. This happened about 5-10 minutes after the vaccine administration. The patient was taken to Hospital, where they determine upon arrival that the patient has low blood pressure so they administer 9 NSS (1000ml) draining a full drip.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Asthenia, Dizziness, Dysstasia, Fall, Feeling abnormal
Clinical narrative: After receiving the vaccines patient turn pale, weak, dizzy, with nausea and needed help to stand. This happened about 5-10 minutes after the vaccine administration. The patient was taken to Hospital, where they determine upon arrival that the patient has low blood pressure so they administer 9 NSS (1000ml) draining a full drip.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Hypotension, Pallor, Syncope, Vomiting
Clinical narrative: After receiving the vaccines patient turn pale, weak, dizzy, with nausea and needed help to stand. This happened about 5-10 minutes after the vaccine administration. The patient was taken to Hospital, where they determine upon arrival that the patient has low blood pressure so they administer 9 NSS (1000ml) draining a full drip.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness around 13 inches in diameter at the injection site in the lower part of the arm. Painful, itchy and hot. Pt. had some ringing in his ears for 30 seconds. Treatm: BENADRYL, Prednisone and cool compress.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Tinnitus
Clinical narrative: Swelling and redness around 13 inches in diameter at the injection site in the lower part of the arm. Painful, itchy and hot. Pt. had some ringing in his ears for 30 seconds. Treatm: BENADRYL, Prednisone and cool compress.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling in arm of the injection.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Lymphadenitis
Clinical narrative: Initially right deltoid area redness and swelling, and progressed to a cellulitis and associated right axillary adenitis. Required oral antibiotics.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Injection site oedema
Clinical narrative: Patient received vaccination of TDAP on 04/02/2018 and was kept in clinic after vaccination to be monitored per policy for 15-20 minutes and did not report a reaction and was released. Patient had started getting flu-like symptoms six hours later with fever/chills, nausea, headache, and dizziness. The left deltoid was given the immunization, and the area was hot and tender to the touch with mild edema.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Patient received vaccination of TDAP on 04/02/2018 and was kept in clinic after vaccination to be monitored per policy for 15-20 minutes and did not report a reaction and was released. Patient had started getting flu-like symptoms six hours later with fever/chills, nausea, headache, and dizziness. The left deltoid was given the immunization, and the area was hot and tender to the touch with mild edema.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Mucosal inflammation, Scab, Skin ulcer
Clinical narrative: Patient developed sores after her first SHINGRIX injection (in the nostrils, ear, and one breast). This developed a few days after the injection. She states the sores crusted and healed over a period of a few weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Patient reported heart palpitations that started the day after receiving the vaccination. She says they lasted for approximately 6 hours. She felt fine afterwards and reported no future issues. The patient reported this adverse event approximately 1 week after it happened.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Pain
Clinical narrative: Employee reports symptom 24 hours post vaccination of headache, body aches, malaise, fever and pain, soreness and redness at site of injection.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Employee reports symptom 24 hours post vaccination of headache, body aches, malaise, fever and pain, soreness and redness at site of injection.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Leverage, chills, fatigue.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 74-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 3rd April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional information was received as follows: On 5th April 2018, the patient was seen in the emergency room. The health care professional was unsure if the patient was admitted.