chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: Information has been received from a physician via company representative, concerning a male patient of an unknown age. There was no information about patient's medical history, previously drug reactions or allergies, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (strength, dose number, anatomical location, route of administration, lot number and expiration date were not provided), for human papillomavirus (HPV) prevention. Then, on an unspecified date, the patient began to experience "hives and trouble breathing"; the physician reported that the patient was having an anaphylactic reaction; therefore, the patient was sent to emergency room, and unspecified treatment was given. It was unknown if laboratory diagnostics or studies were performed. At the time of report, the patient was recovered since an unknown date. The causal relationship between the adverse event and GARDASIL 9 was not provided. The reporter physician considered the anaphylactic reaction as a life threatening event and upon internal review, the anaphylactic reaction was considered a medically significant event.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Myalgia, Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of decreased arm swing in a adult female patient who received SHINGRIX. The patient's past medical history included shingles. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced decreased arm swing, arm discomfort and pain in arm. On an unknown date, the outcome of the decreased arm swing was unchanged and the outcome of the arm discomfort was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the decreased arm swing, arm discomfort and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had the SHINGRIX vaccine and within 5 minutes she experienced pain in her left arm. Within two days the patient experienced a loss of range of motion in her left arm. The patient described the feeling as when she overextends her arm, she got a pinching feeling and she could no longer reach back to zip or unzip her clothing. The patient claimed that the pharmacy already reported her experience to the CDC. The time of her vaccination was around 3:30 PM. The patient also reported that she had never been hospitalized other than for her previous pregnancies and she was in good health and takes no medications. The patient worked out and was very healthy.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Movement disorder, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of decreased arm swing in a adult female patient who received SHINGRIX. The patient's past medical history included shingles. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced decreased arm swing, arm discomfort and pain in arm. On an unknown date, the outcome of the decreased arm swing was unchanged and the outcome of the arm discomfort was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the decreased arm swing, arm discomfort and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had the SHINGRIX vaccine and within 5 minutes she experienced pain in her left arm. Within two days the patient experienced a loss of range of motion in her left arm. The patient described the feeling as when she overextends her arm, she got a pinching feeling and she could no longer reach back to zip or unzip her clothing. The patient claimed that the pharmacy already reported her experience to the CDC. The time of her vaccination was around 3:30 PM. The patient also reported that she had never been hospitalized other than for her previous pregnancies and she was in good health and takes no medications. The patient worked out and was very healthy.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 56-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 11th April 2018 12:30, the patient received SHINGRIX. On 11th April 2018 22:30, 10 hrs after receiving SHINGRIX, the patient experienced chest tightness, cough, rigors, tremor and headache. On an unknown date, the outcome of the chest tightness was not recovered/not resolved and the outcome of the cough, rigors, tremor and headache were recovered/resolved. It was unknown if the reporter considered the chest tightness, cough, rigors, tremor and headache to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported (patient) that he received a SHINGRIX vaccination and developed a tightness in his chest, a headache in his temples, a cough and chills with shaking. The symptom were resolved by the time he woke up, and then the tightness in his chest started around 9 AM on the day of reporting.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral coldness, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 56-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 11th April 2018 12:30, the patient received SHINGRIX. On 11th April 2018 22:30, 10 hrs after receiving SHINGRIX, the patient experienced chest tightness, cough, rigors, tremor and headache. On an unknown date, the outcome of the chest tightness was not recovered/not resolved and the outcome of the cough, rigors, tremor and headache were recovered/resolved. It was unknown if the reporter considered the chest tightness, cough, rigors, tremor and headache to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported (patient) that he received a SHINGRIX vaccination and developed a tightness in his chest, a headache in his temples, a cough and chills with shaking. The symptom were resolved by the time he woke up, and then the tightness in his chest started around 9 AM on the day of reporting.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Cough, Headache, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 56-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 11th April 2018 12:30, the patient received SHINGRIX. On 11th April 2018 22:30, 10 hrs after receiving SHINGRIX, the patient experienced chest tightness, cough, rigors, tremor and headache. On an unknown date, the outcome of the chest tightness was not recovered/not resolved and the outcome of the cough, rigors, tremor and headache were recovered/resolved. It was unknown if the reporter considered the chest tightness, cough, rigors, tremor and headache to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported (patient) that he received a SHINGRIX vaccination and developed a tightness in his chest, a headache in his temples, a cough and chills with shaking. The symptom were resolved by the time he woke up, and then the tightness in his chest started around 9 AM on the day of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a adult female patient who received SHINGRIX. Concurrent medical conditions included asthma. Concomitant products included methotrexate. On 5th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced cold sores and rash. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the cold sores and rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported this information to VAERS as well. The age at vaccination was not reported. The patient received SHINGRIX vaccine on right arm. The pharmacist reported that the patient had a breakout of cold sores and developed a rash around her neck. A few days after that, she started getting a rash above her eyelid. The rash was between her eyebrow and eyelid. The rash around the patient's neck had resolved and the cold sores were still present. It was unknown if the rash above her eyelid was still present. The patient was taking many medications, but the reporter did not have the list available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid rash, Oral herpes, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a adult female patient who received SHINGRIX. Concurrent medical conditions included asthma. Concomitant products included methotrexate. On 5th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced cold sores and rash. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the cold sores and rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported this information to VAERS as well. The age at vaccination was not reported. The patient received SHINGRIX vaccine on right arm. The pharmacist reported that the patient had a breakout of cold sores and developed a rash around her neck. A few days after that, she started getting a rash above her eyelid. The rash was between her eyebrow and eyelid. The rash around the patient's neck had resolved and the cold sores were still present. It was unknown if the rash above her eyelid was still present. The patient was taking many medications, but the reporter did not have the list available.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Lymphadenopathy, Myalgia, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concurrent medical conditions included hairy cell leukemia. On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, enlargement of lymph nodes and muscle pain. On an unknown date, the outcome of the injection site pain and muscle pain were recovering/resolving and the outcome of the injection site swelling was unknown and the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the injection site pain, injection site swelling, enlargement of lymph nodes and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered pharmacist. Concomitant medications included Steroids. The patient SHINGRIX in the left deltoid. The patient experienced injection site pain with swelling and bulging, muscle pain, and swollen lymph nodes.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concurrent medical conditions included hairy cell leukemia. On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, enlargement of lymph nodes and muscle pain. On an unknown date, the outcome of the injection site pain and muscle pain were recovering/resolving and the outcome of the injection site swelling was unknown and the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the injection site pain, injection site swelling, enlargement of lymph nodes and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered pharmacist. Concomitant medications included Steroids. The patient SHINGRIX in the left deltoid. The patient experienced injection site pain with swelling and bulging, muscle pain, and swollen lymph nodes.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, HEPA, MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old male patient. The patient's number of brothers and sisters was reported as one. The patient was inadvertently simultaneously administered a dose of PROQUAD (rHA) from lot N025718, expiry date 17-MAR-2019 subcutaneous in right thigh and a dose of M-M-R II (rHA) from lot N013868, expiry date 04-MAY-2019 on 16-APR-2018 subcutaneous in right thigh, instead of M-M-R II and VARIVAX (wrong drug administered)(incorrect dose administered). Other suspect therapies included VAQTA from lot N020689 intramuscular in left thigh. Concomitant therapies included Sterile Diluent. No adverse effects reported. There was no temperature excursion as a result of a reading from a digital data logger.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old male patient. The patient's number of brothers and sisters was reported as one. The patient was inadvertently simultaneously administered a dose of PROQUAD (rHA) from lot N025718, expiry date 17-MAR-2019 subcutaneous in right thigh and a dose of M-M-R II (rHA) from lot N013868, expiry date 04-MAY-2019 on 16-APR-2018 subcutaneous in right thigh, instead of M-M-R II and VARIVAX (wrong drug administered)(incorrect dose administered). Other suspect therapies included VAQTA from lot N020689 intramuscular in left thigh. Concomitant therapies included Sterile Diluent. No adverse effects reported. There was no temperature excursion as a result of a reading from a digital data logger.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: About a month after the booster shot I noticed pretty severe joint pain around the knees. After standing all day the pain was excruciating with ice and ibuprofen being of little to. I relied. Pain occurred daily for about three months but did subside.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: Soreness in arm the next day. Went away after a couple of weeks. About 3-4 days after receiving the shot, I developed pretty extreme jaw tension that has lasted 1 month later. It's a daily thing. Some days it seems to be a little better, and then the next day, it feels like body builder hands on pushing in on either side of my jaw joints. PCP confirms its not tmj. Nothing else had changed in my life around the time it started. I wear a night guard so it wasn't from grinding teeth at night. I've never experienced anything like this before.
Sex: M
Vaccine: VARZOS
Symptoms: Sjogren's syndrome
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously, for vaccination (strength, dose, lot # and expiration date were not reported). On an unspecified date, the patient was diagnosed with a mild case of shingles (herpes zoster). The patient sought medical attention but it was unknown if any treatment was given for the adverse experience or if any laboratory study was performed. At the reporting time, the outcome of herpes zoster was unknown. The causality assessment between herpes zoster and ZOSTAVAX was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. The patient had no pertinent medical history. On 17-APR-2018, the patient was vaccinated with a first dose of GARDASIL 9 for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). There were no concomitant medications. On 17-APR-2018, the patient felt a little faint and lightheaded but not enough to pull over while driving home. She was also having some stomach discomfort but was not sure if it wasn't from something she ate. The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was reported as not recovered/not resolved. Causality assessment was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-APR-2018, the patient was inadvertently administered an expired dose of RECOMBIVAX HB, intramuscular injection, lot # L048236 and expiration date on 31-MAR-2018, for prophylaxis (dose and anatomical location were not reported). No temperature excursion was involved and no adverse effects were reported.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included PROQUAD for prophylaxis and sterile diluent (MERCK STERILE DILUENT) (dose, anatomical location, lot# and expiration date were not reported for all the aforementioned vaccines and diluent). On 13-APR-2018, the patient received both vaccines: VARIVAX and PROQUAD at the same visit by mistake. Additionally, no adverse effects were noted.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old female patient. On 03-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in April-2018, the patient was inadvertently vaccinated with ZOSTAVAX vial 19400 plaque-forming unit (PFU), lot # N014942 (expiry date: 02-FEB-2018), subcutaneously (deltoid) for prophylaxis (dose not reported) instead of VARIVAX (wrong vaccine administered and expired vaccine used). The patient attempted to conceive at this time however, the patient was not pregnant at this time. No adverse events. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. The patient's historical drugs included PREVNAR. Medical history was not reported. Concurrent conditions included cancer. On 23-APR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date and route of administration was not provided) at a dose of 1 injection given to an unknown arm for immunisation. Concomitant medications included unspecified cancer treatment. On 23-APR-2018 sometime after the patient was vaccinated, she could not move the vaccinated arm (vaccination site movement impairment). The patient took unspecified doses of TYLENOL to relieve the symptoms. The patient visited physician to seek medical attention. The outcome of vaccination site movement impairment was unknown. Causality assessment was not provided by the reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old female patient. On 11-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010458:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old female patient. On 13-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010458:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient. On 13-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored Merck sterile diluent (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA010458.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old female patient. On 18-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010458:
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Encephalitis post immunisation
Clinical narrative: On 19APR2018 the Sponsor identified this case during data reconciliation activities. A 20 year-old female received immunization with ACAM2000 and 11 days later developed encephalitis. Medical history was positive for dizziness/fainting spells, numbness and/or paralysis. Concomitant medications or other vaccines were not reported. On 08Apr2010, the female received ACAM2000. On 19Apr2010 'encephalitis following immunization procedures' was reported. Diagnostics such as lumbar puncture and magnetic resonance imaging of the spinal cord were not performed. No further information was provided. This information was retrieved during surveillance activities; therefore, a causality assessment was not provided.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Blood pressure decreased, Disorientation, Syncope
Clinical narrative: The patient experienced a syncope event lasting <5 seconds a few minutes after receiving the vaccines, his blood pressure dropped to 70s/50s, student appeared slightly disoriented.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Feeling hot, Hypotonia, Nausea, Syncope
Clinical narrative: Patient fainted after receiving vaccines. Patient was calm and and did very well during process. After receiving vaccines, patient went limp in chair. RN held patient up and fanned patient and applied cold washcloth to patient's neck. Patient came to quickly and felt nauseous and hot. Patient did not vomit and improved with water and cooling down. Mother at side. Patient had never passed out and was surprised he did as he was not scared of needles and had tattoos. RN monitored patient for 15 minutes without adverse events or reactions. Mother was driving.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Mass, Pain
Clinical narrative: Painful lump.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, chills, site swollen and warm to touch.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong patient received medication
Clinical narrative: Accidentally administered to wrong pt. MA went into the pt's room and asked whether their name was (correct patient's name). Pt confirmed, so injection was administered. Discovered upon leaving the room that it was administered to wrong pt. Pt notified/effects discussed between pt and NP. MD and office manager notified. Process change in place to prevent from happening again. Need to verify pt TELLS US their name/DOB prior to administration.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Headche, malaise, lightheadedness on day #1 (day vaccine was given). Fever to 102.3 F and presyncope on day #2. Resolution of sx around 4 am on Day #3.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Presyncope, Pyrexia
Clinical narrative: Headche, malaise, lightheadedness on day #1 (day vaccine was given). Fever to 102.3 F and presyncope on day #2. Resolution of sx around 4 am on Day #3.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Office Manager refers to a 04 year old male patient. The patient's relevant medical history and concurrent condition were not reported. On 09-APR-2018, the patient was vaccinated with a dose of expired PROQUAD injection lot # M041083 (expired date: 04-APR-2018), 0.5 ml once for prophylaxis (expired vaccine used). Concomitant therapy included sterile diluent (DILUENT MRK INJ) which was used to reconstitute. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005644:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot reported as: N026814; Expiry date: 15-JUL-2020 and lot reported as: N021572; Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Office Manager refers to a 04 year old male patient. The patient's relevant medical history and concurrent condition were not reported. On 09-APR-2018, the patient was vaccinated with a dose of expired PROQUAD injection lot # M041083 (expired date: 04-APR-2018), 0.5 ml once for prophylaxis (expired vaccine used). Concomitant therapy included sterile diluent (DILUENT MRK INJ) which was used to reconstitute. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA004507:
Age: 4.0
Sex: F
Vaccine: FLU4, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Nurse regarding a 4-year old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. It was reported that the patient was well child at the time of vaccination. On 13-APR-2018 the patient was vaccinated with first dose (reported as one) ROTATEQ (Lot # N022174 dose 1, oral at private doctor's office or hospital with public funds) for prophylaxis (drug administered to patient of inappropriate age). Other suspect therapies included FLUZONE (lot # U182AE dose 1 through intramuscular) for prophylaxis on 13-APR-2018. There was no temperature excursion occur because of a reading from digital data logger. It was reported that the medication error occurred at the time of dispensing (Drug dispensing error). No adverse effect reported. No product quality compliant (PQC) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office administrator refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (manufacturer unknown) was properly stored and which was used for reconstitution of VARIVAX. On 23-APR-2018, the patient was vaccinated with improperly stored VARIVAX (0.5 ml, once) (lot# N027628 and expiration date: 04-OCT-2019) subcutaneously at a temperature from -9 degree Celsius (C) to 8 C (plus 0.3 C) for 1 hour 13 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. Lot number [N027628] has been verified to be a valid lot number for VARIVAX.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling and pain where he had given the injection on an unspecified date and it lasted like a month with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and PNEUMOVAX 23 at unknown dose, both via unspecified route of administration for immunization at a hospital. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the pneumonia shot the day before (unspecified date) and the next day, on an unspecified date, the patient experienced a reaction described as feeling weak and diarrhea. The patient did not know if the "pneumonia shot" was PREVNAR 13 or PNEUMOVAX 23, just that she got a "pneumonia shot" (pending clarification). Outcome of the events was unknown. Information on batch and lot numbers has been requested.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 15-month-old male patient received PREVNAR 13 on 20Apr2018 at single dose for immunisation. Medical history included ear infection from 13Apr2018, and cold. Concomitant medication included CIPRO for ear infection at 0.3 percent a couple times a day. The patient received some vaccinations at the doctors visit one of which was pneumococcal 13-val conj vac (dipht crm197 protein) and this morning he did have a fever upon waking up (21Apr2018). Treatment included TYLENOL in the morning and subsequently Ibuprofen as well. Lab work was none. Event outcome was recovered.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Acarodermatitis, Blister, Cheilitis, Pruritus, Rash papular
Clinical narrative: DOS 4-10-17 onset 2 days prior with papular lesions to lip and thigh progressing to vesicular Blisters/itchy- rhinorrhea -scabies lesions on exam.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash vesicular, Rhinorrhoea
Clinical narrative: DOS 4-10-17 onset 2 days prior with papular lesions to lip and thigh progressing to vesicular Blisters/itchy- rhinorrhea -scabies lesions on exam.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The patient's initials, gender, or date of birth were unknown. The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid and experienced cellulitis below the injection site for longer than five days. This was all information provided by the reporter and the field representative had very limited information.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Confusional state, Fall, Musculoskeletal discomfort, Myalgia
Clinical narrative: Fever, myalgias, generalized weakness (fell a couple of times). Reports that evening - some discomfort shoulder and also generalized upper body achiness. Next morning - husband went to wake pt and found her on the floor, husband reports she was confused as well -had not even been able to call for help. Needed assistance to get her up off the floor - reportedly 'fainted' again later that morning when 'trying to exercise' (unwitnessed). She was admitted for IVF hydration and observation. Following day she felt improved, cleared by PT to go home as was ambulating independently. Pt and husband reports temp up to 101.Symptoms resolved as quickly as they came on.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: Fever, myalgias, generalized weakness (fell a couple of times). Reports that evening - some discomfort shoulder and also generalized upper body achiness. Next morning - husband went to wake pt and found her on the floor, husband reports she was confused as well -had not even been able to call for help. Needed assistance to get her up off the floor - reportedly 'fainted' again later that morning when 'trying to exercise' (unwitnessed). She was admitted for IVF hydration and observation. Following day she felt improved, cleared by PT to go home as was ambulating independently. Pt and husband reports temp up to 101.Symptoms resolved as quickly as they came on.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had some side effect after vaccination (unspecified). The patient a question about Shingles vaccine. She wondered if in tests, the side effects were better, worse or the same with the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown date. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and local swelling. On an unknown date, the outcome of the influenza-like symptoms and local swelling were unknown. It was unknown if the reporter considered the influenza-like symptoms and local swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection pain in a 69-year-old female patient who received SHINGRIX. Concomitant products included LOVAZA, Pneumococcal Vaccine, Vitamin D3 and unknown Osteoporosis Medication. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with BENADRYL (NOS). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included vitamin B. Two days prior to the reporting the patient received SHINGRIX in left deltoid and a pneumonia vaccine in right deltoid. The next morning the patient experienced redness, pain and swelling at both injection sites and both arms. The patient had taken BENADRYL as well as used warm compresses and this had not helped. The patient went back to the pharmacy and was referred to see her doctor. The patient would be contacting her doctor on the day of reporting. The patient had denied permission to contact their physician.
Sex: M
Vaccine: FLU4, TTOX
Symptoms: Feeling abnormal, Immunisation reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of immunization reaction in a adult male patient who received Influenza vaccine Quadrivalent. Co-suspect products included Tetanus Shot. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and Tetanus Shot at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent, the patient experienced immunization reaction. On an unknown date, the outcome of the immunization reaction was unknown. It was unknown if the reporter considered the immunization reaction to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The age at vaccination was not reported. The patient reported that, he felt iffy a day or two after his tetanus and flu shots. The patient described this iffy feeling as a mild immune response to the injections. A manufacturer or brand name was unknown. The patient declined to proceed with safety report.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Severe headache. Dizziness. Pain ln joints of left leg. Weakness in left leg. Symptoms started around 6:00pm 4/23 and abated around 5:00pm 4/25. Headache was severe for approximately 46 hours, with a very small amount of relief after taking otc medications (tylenol, ibuprofen), but relief was not complete and did not last. Dizziness was intermittent- she experienced the dizziness the worst when walking or standing. She had sever leg pain for about 12 hours.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Muscular weakness, Pain in extremity, Swelling
Clinical narrative: Severe headache. Dizziness. Pain ln joints of left leg. Weakness in left leg. Symptoms started around 6:00pm 4/23 and abated around 5:00pm 4/25. Headache was severe for approximately 46 hours, with a very small amount of relief after taking otc medications (tylenol, ibuprofen), but relief was not complete and did not last. Dizziness was intermittent- she experienced the dizziness the worst when walking or standing. She had sever leg pain for about 12 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Redness swelling pain at site of injection, muscle aches, headache, upset stomach, fatigue, shivering. Took TYLENOL twice on second day. Symptoms except soreness abated third day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Redness swelling pain at site of injection, muscle aches, headache, upset stomach, fatigue, shivering. Took TYLENOL twice on second day. Symptoms except soreness abated third day.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site cellulitis, Laboratory test, Pain, Swelling
Clinical narrative: Symptoms: Red, Pain, Swelling, Spreading (continues to spread today) after ER visit yesterday. Course in ER: TORADOL for pain IV; Ultrasound and lab work; Diagnosis: Cellulitis Left upper arm; Traced arm with marker; Antibiotic and TYLENOL ordered.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Ultrasound scan
Clinical narrative: Symptoms: Red, Pain, Swelling, Spreading (continues to spread today) after ER visit yesterday. Course in ER: TORADOL for pain IV; Ultrasound and lab work; Diagnosis: Cellulitis Left upper arm; Traced arm with marker; Antibiotic and TYLENOL ordered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling redness at injection site. Took ALEVE three times. Soreness continues on third day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: Patient reported flu like symptoms starting two hours after receiving the vaccination. Symptoms included: red, sore arm; fever (temp was not taken by patient); body aches; chills; sweating; nausea. The next morning of 4/24/18 pt was feeling better but not great. On 4/25/18 she felt back to normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reported flu like symptoms starting two hours after receiving the vaccination. Symptoms included: red, sore arm; fever (temp was not taken by patient); body aches; chills; sweating; nausea. The next morning of 4/24/18 pt was feeling better but not great. On 4/25/18 she felt back to normal.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: On 4/25 noticed reddness/mild yellow around shot area. On 4/26 area began to blister up. Redness on leg extending. No medications applied. No pain. Fever of 100.3 today and 100.8 yesterday. No other rashes/No previous rashes. Blister measured: 1.5 x 2.5. Redness measured: 14 x 12 cm.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Fatigue, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included Hodgkin's lymphoma. On 11th April 2018, the patient received SHINGRIX .5 ml. On 11th April 2018, 7 hrs after receiving SHINGRIX, the patient experienced sleeplessness, general body pain and fatigue. On 12th April 2018, the patient experienced dry mouth. On an unknown date, the outcome of the sleeplessness, dry mouth, general body pain and fatigue were unknown. It was unknown if the reporter considered the sleeplessness, dry mouth, general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The reporter reported adverse reactions which were experienced by her husband. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain and fatigue. The patient's wife stated that everything that husband was experiencing they were told prior to receiving vaccine that he may experience, but she wanted to report reactions to the company. The patient had denied permission to contact their physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 57-year-old female patient who receive SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema, local swelling and pain localized. On an unknown date, the outcome of the localized erythema, local swelling and pain localized were recovered/resolved. It was unknown if the reporter considered the localized erythema, local swelling and pain localized to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced redness and tender swelling near the elbow and not near the deltoid and lasted about 3 to 5 days. This case has been linked with case US2018GKS064287 and US2018GSK064280 reported by same reporter.