chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Cranial nerve paralysis, Eye movement disorder
Clinical narrative: The patient's eye turning caller is not sure which eye it is; This spontaneous report was received from a nurse referring to a 4-year-old male patient. The patient's pertinent medical history was reported as none. No known drug allergies (NKDA). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (QUADRACEL).   On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot # and expiration date were not reported) subcutaneously (SQ) for prevention.  On an unspecified date in 2020, the patient's parents started to notice his eye turning (strabismus) (caller was not sure which eye it was). No pain. The health care professional (HCP) recommend to go to eye doctor, and the eye doctor was going to follow up with a magnetic resonance imaging (MRI). His mother took him to a new pediatrician. It was unknown if any treatment was given. The outcome of strabismus was unknown, the patient's present status was reported as stable.   The HCP considered this event was a side effects of getting vaccine, so the causality between the suspect vaccine and the event was considered as related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Strabismus, Vaccination complication
Clinical narrative: The patient's eye turning caller is not sure which eye it is; This spontaneous report was received from a nurse referring to a 4-year-old male patient. The patient's pertinent medical history was reported as none. No known drug allergies (NKDA). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (QUADRACEL).   On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot # and expiration date were not reported) subcutaneously (SQ) for prevention.  On an unspecified date in 2020, the patient's parents started to notice his eye turning (strabismus) (caller was not sure which eye it was). No pain. The health care professional (HCP) recommend to go to eye doctor, and the eye doctor was going to follow up with a magnetic resonance imaging (MRI). His mother took him to a new pediatrician. It was unknown if any treatment was given. The outcome of strabismus was unknown, the patient's present status was reported as stable.   The HCP considered this event was a side effects of getting vaccine, so the causality between the suspect vaccine and the event was considered as related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Corrective lens user, Eye movement disorder, Magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Strabismus
Clinical narrative: The patient's eye turning caller is not sure which eye it is; This spontaneous report was received from a nurse referring to a 4-year-old male patient. The patient's pertinent medical history was reported as none. No known drug allergies (NKDA). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (QUADRACEL).   On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot # and expiration date were not reported) subcutaneously (SQ) for prevention.  On an unspecified date in 2020, the patient's parents started to notice his eye turning (strabismus) (caller was not sure which eye it was). No pain. The health care professional (HCP) recommend to go to eye doctor, and the eye doctor was going to follow up with a magnetic resonance imaging (MRI). His mother took him to a new pediatrician. It was unknown if any treatment was given. The outcome of strabismus was unknown, the patient's present status was reported as stable.   The HCP considered this event was a side effects of getting vaccine, so the causality between the suspect vaccine and the event was considered as related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: VIth nerve paralysis
Clinical narrative: The patient's eye turning caller is not sure which eye it is; This spontaneous report was received from a nurse referring to a 4-year-old male patient. The patient's pertinent medical history was reported as none. No known drug allergies (NKDA). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (QUADRACEL).   On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot # and expiration date were not reported) subcutaneously (SQ) for prevention.  On an unspecified date in 2020, the patient's parents started to notice his eye turning (strabismus) (caller was not sure which eye it was). No pain. The health care professional (HCP) recommend to go to eye doctor, and the eye doctor was going to follow up with a magnetic resonance imaging (MRI). His mother took him to a new pediatrician. It was unknown if any treatment was given. The outcome of strabismus was unknown, the patient's present status was reported as stable.   The HCP considered this event was a side effects of getting vaccine, so the causality between the suspect vaccine and the event was considered as related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Strabismus
Clinical narrative: The patient's eye turning caller is not sure which eye it is; This spontaneous report was received from a nurse referring to a 4-year-old male patient. The patient's pertinent medical history was reported as none. No known drug allergies (NKDA). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (QUADRACEL).   On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot # and expiration date were not reported) subcutaneously (SQ) for prevention.  On an unspecified date in 2020, the patient's parents started to notice his eye turning (strabismus) (caller was not sure which eye it was). No pain. The health care professional (HCP) recommend to go to eye doctor, and the eye doctor was going to follow up with a magnetic resonance imaging (MRI). His mother took him to a new pediatrician. It was unknown if any treatment was given. The outcome of strabismus was unknown, the patient's present status was reported as stable.   The HCP considered this event was a side effects of getting vaccine, so the causality between the suspect vaccine and the event was considered as related.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Paraesthesia, Tremor
Clinical narrative: felt bad; felt very cold; buzzy feeling on abdomen and all the way down her side; Multiple sclerosis hug- tightness around waist; lower limbs weak; paresthesia; malaise/did not feel well; lower limbs shaky; Initial information regarding an unsolicited valid non-serious case was received from a physician via The Agency (Reference number- 00329886) and transmitted to Sanofi on 23-Oct-2020.  This case involves a 66 year old female patient who felt bad (feeling abnormal), felt very cold (feeling cold), buzzy feeling on abdomen and all the way down her side (vibratory sense increased), multiple sclerosis hug- tightness around waist (band sensation), lower limbs weak (muscular weakness), paresthesia, malaise/did not feel well (malaise) and lower limbs shaky (tremor), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Multiple sclerosis.  On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination   On 14-Oct-2020 (Wednesday), the patient received a dose of suspect PNEUMOVAX and dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (weekend), the patient started complaining of malaise and felt bad (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date (at night), she felt very cold and had to put heat on. Ever since then, she developed a multiple sclerosis hug- tightness around waist, a paresthesia, buzzy feeling on abdomen all the way down her side. She claimed that she did not feel well and her lower limbs were weak and shaky (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter is not sure if these are side effects that may have been caused by the mix of vaccines given in the past month.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Band sensation, Chest discomfort, Condition aggravated, Euphoric mood, Feeling abnormal
Clinical narrative: felt bad; felt very cold; buzzy feeling on abdomen and all the way down her side; Multiple sclerosis hug- tightness around waist; lower limbs weak; paresthesia; malaise/did not feel well; lower limbs shaky; Initial information regarding an unsolicited valid non-serious case was received from a physician via The Agency (Reference number- 00329886) and transmitted to Sanofi on 23-Oct-2020.  This case involves a 66 year old female patient who felt bad (feeling abnormal), felt very cold (feeling cold), buzzy feeling on abdomen and all the way down her side (vibratory sense increased), multiple sclerosis hug- tightness around waist (band sensation), lower limbs weak (muscular weakness), paresthesia, malaise/did not feel well (malaise) and lower limbs shaky (tremor), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Multiple sclerosis.  On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination   On 14-Oct-2020 (Wednesday), the patient received a dose of suspect PNEUMOVAX and dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (weekend), the patient started complaining of malaise and felt bad (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date (at night), she felt very cold and had to put heat on. Ever since then, she developed a multiple sclerosis hug- tightness around waist, a paresthesia, buzzy feeling on abdomen all the way down her side. She claimed that she did not feel well and her lower limbs were weak and shaky (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter is not sure if these are side effects that may have been caused by the mix of vaccines given in the past month.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Flank pain, Herpes zoster, Hypoaesthesia eye, Malaise, Multiple sclerosis
Clinical narrative: felt bad; felt very cold; buzzy feeling on abdomen and all the way down her side; Multiple sclerosis hug- tightness around waist; lower limbs weak; paresthesia; malaise/did not feel well; lower limbs shaky; Initial information regarding an unsolicited valid non-serious case was received from a physician via The Agency (Reference number- 00329886) and transmitted to Sanofi on 23-Oct-2020.  This case involves a 66 year old female patient who felt bad (feeling abnormal), felt very cold (feeling cold), buzzy feeling on abdomen and all the way down her side (vibratory sense increased), multiple sclerosis hug- tightness around waist (band sensation), lower limbs weak (muscular weakness), paresthesia, malaise/did not feel well (malaise) and lower limbs shaky (tremor), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Multiple sclerosis.  On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination   On 14-Oct-2020 (Wednesday), the patient received a dose of suspect PNEUMOVAX and dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (weekend), the patient started complaining of malaise and felt bad (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date (at night), she felt very cold and had to put heat on. Ever since then, she developed a multiple sclerosis hug- tightness around waist, a paresthesia, buzzy feeling on abdomen all the way down her side. She claimed that she did not feel well and her lower limbs were weak and shaky (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter is not sure if these are side effects that may have been caused by the mix of vaccines given in the past month.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Pain, Pain in extremity, Sensory disturbance
Clinical narrative: felt bad; felt very cold; buzzy feeling on abdomen and all the way down her side; Multiple sclerosis hug- tightness around waist; lower limbs weak; paresthesia; malaise/did not feel well; lower limbs shaky; Initial information regarding an unsolicited valid non-serious case was received from a physician via The Agency (Reference number- 00329886) and transmitted to Sanofi on 23-Oct-2020.  This case involves a 66 year old female patient who felt bad (feeling abnormal), felt very cold (feeling cold), buzzy feeling on abdomen and all the way down her side (vibratory sense increased), multiple sclerosis hug- tightness around waist (band sensation), lower limbs weak (muscular weakness), paresthesia, malaise/did not feel well (malaise) and lower limbs shaky (tremor), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Multiple sclerosis.  On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination   On 14-Oct-2020 (Wednesday), the patient received a dose of suspect PNEUMOVAX and dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (weekend), the patient started complaining of malaise and felt bad (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date (at night), she felt very cold and had to put heat on. Ever since then, she developed a multiple sclerosis hug- tightness around waist, a paresthesia, buzzy feeling on abdomen all the way down her side. She claimed that she did not feel well and her lower limbs were weak and shaky (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter is not sure if these are side effects that may have been caused by the mix of vaccines given in the past month.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Band sensation, Feeling abnormal, Feeling cold, Malaise, Muscular weakness
Clinical narrative: felt bad; felt very cold; buzzy feeling on abdomen and all the way down her side; Multiple sclerosis hug- tightness around waist; lower limbs weak; paresthesia; malaise/did not feel well; lower limbs shaky; Initial information regarding an unsolicited valid non-serious case was received from a physician via The Agency (Reference number- 00329886) and transmitted to Sanofi on 23-Oct-2020.  This case involves a 66 year old female patient who felt bad (feeling abnormal), felt very cold (feeling cold), buzzy feeling on abdomen and all the way down her side (vibratory sense increased), multiple sclerosis hug- tightness around waist (band sensation), lower limbs weak (muscular weakness), paresthesia, malaise/did not feel well (malaise) and lower limbs shaky (tremor), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Multiple sclerosis.  On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination   On 14-Oct-2020 (Wednesday), the patient received a dose of suspect PNEUMOVAX and dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (weekend), the patient started complaining of malaise and felt bad (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date (at night), she felt very cold and had to put heat on. Ever since then, she developed a multiple sclerosis hug- tightness around waist, a paresthesia, buzzy feeling on abdomen all the way down her side. She claimed that she did not feel well and her lower limbs were weak and shaky (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter is not sure if these are side effects that may have been caused by the mix of vaccines given in the past month.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Paraesthesia, Tremor, Vibratory sense increased
Clinical narrative: felt bad; felt very cold; buzzy feeling on abdomen and all the way down her side; Multiple sclerosis hug- tightness around waist; lower limbs weak; paresthesia; malaise/did not feel well; lower limbs shaky; Initial information regarding an unsolicited valid non-serious case was received from a physician via The Agency (Reference number- 00329886) and transmitted to Sanofi on 23-Oct-2020.  This case involves a 66 year old female patient who felt bad (feeling abnormal), felt very cold (feeling cold), buzzy feeling on abdomen and all the way down her side (vibratory sense increased), multiple sclerosis hug- tightness around waist (band sensation), lower limbs weak (muscular weakness), paresthesia, malaise/did not feel well (malaise) and lower limbs shaky (tremor), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Multiple sclerosis.  On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination   On 14-Oct-2020 (Wednesday), the patient received a dose of suspect PNEUMOVAX and dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (weekend), the patient started complaining of malaise and felt bad (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date (at night), she felt very cold and had to put heat on. Ever since then, she developed a multiple sclerosis hug- tightness around waist, a paresthesia, buzzy feeling on abdomen all the way down her side. She claimed that she did not feel well and her lower limbs were weak and shaky (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter is not sure if these are side effects that may have been caused by the mix of vaccines given in the past month.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: rash on the front and back of her chest, legs and hands; throat tightness; hard to breath; coughing; chills; shaking; fever; was tired; blood shot eyes; bruised injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 297828 ?, expiry date 30th June 2021) for prophylaxis.   Concurrent medical conditions included asthma and fruit allergy (allergic to pineapple).   On 26th October 2020 10:00, the patient received the 1st dose of FluLaval Tetra 2020-2021 season (intramuscular) .5 ml. On 26th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site bruising (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required) and bloodshot eye (serious criteria clinically significant/intervention required). On 26th October 2020 02:00, the patient experienced throat tightness (serious criteria clinically significant/intervention required), difficulty breathing (serious criteria clinically significant/intervention required) and cough (serious criteria clinically significant/intervention required). On 27th October 2020, the patient experienced generalized rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 26th October 2020, the outcome of the throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness and bloodshot eye were recovered/resolved. On 27th October 2020, the outcome of the generalized rash was recovered/resolved. On an unknown date, the outcome of the injection site bruising was recovered/resolved.   It was unknown if the reporter considered the injection site bruising, throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness, bloodshot eye and generalized rash to be related to FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient received her first flu vaccine and on same day at approximately 2pm she started having throat tightness, coughing, and it was hard to breath. These symptoms resolved by 7pm same day and in the evening she had chills, fever, blood shot eyes and was tired, these all resolved that night while in bed.  On 27th October 2020, she developed a rash on the front and back of her chest, legs and hands. The patient took some Benadryl and these symptoms resolved that day after a few hours. She stated that on the day of vaccination, she had a bruised injection site that lasted a few days and resolved. The reporter did not consent to follow up.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Wheezing
Clinical narrative: rash on the front and back of her chest, legs and hands; throat tightness; hard to breath; coughing; chills; shaking; fever; was tired; blood shot eyes; bruised injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 297828 ?, expiry date 30th June 2021) for prophylaxis.   Concurrent medical conditions included asthma and fruit allergy (allergic to pineapple).   On 26th October 2020 10:00, the patient received the 1st dose of FluLaval Tetra 2020-2021 season (intramuscular) .5 ml. On 26th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site bruising (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required) and bloodshot eye (serious criteria clinically significant/intervention required). On 26th October 2020 02:00, the patient experienced throat tightness (serious criteria clinically significant/intervention required), difficulty breathing (serious criteria clinically significant/intervention required) and cough (serious criteria clinically significant/intervention required). On 27th October 2020, the patient experienced generalized rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 26th October 2020, the outcome of the throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness and bloodshot eye were recovered/resolved. On 27th October 2020, the outcome of the generalized rash was recovered/resolved. On an unknown date, the outcome of the injection site bruising was recovered/resolved.   It was unknown if the reporter considered the injection site bruising, throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness, bloodshot eye and generalized rash to be related to FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient received her first flu vaccine and on same day at approximately 2pm she started having throat tightness, coughing, and it was hard to breath. These symptoms resolved by 7pm same day and in the evening she had chills, fever, blood shot eyes and was tired, these all resolved that night while in bed.  On 27th October 2020, she developed a rash on the front and back of her chest, legs and hands. The patient took some Benadryl and these symptoms resolved that day after a few hours. She stated that on the day of vaccination, she had a bruised injection site that lasted a few days and resolved. The reporter did not consent to follow up.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Injection site bruising
Clinical narrative: rash on the front and back of her chest, legs and hands; throat tightness; hard to breath; coughing; chills; shaking; fever; was tired; blood shot eyes; bruised injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 297828 ?, expiry date 30th June 2021) for prophylaxis.   Concurrent medical conditions included asthma and fruit allergy (allergic to pineapple).   On 26th October 2020 10:00, the patient received the 1st dose of FluLaval Tetra 2020-2021 season (intramuscular) .5 ml. On 26th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site bruising (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required) and bloodshot eye (serious criteria clinically significant/intervention required). On 26th October 2020 02:00, the patient experienced throat tightness (serious criteria clinically significant/intervention required), difficulty breathing (serious criteria clinically significant/intervention required) and cough (serious criteria clinically significant/intervention required). On 27th October 2020, the patient experienced generalized rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 26th October 2020, the outcome of the throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness and bloodshot eye were recovered/resolved. On 27th October 2020, the outcome of the generalized rash was recovered/resolved. On an unknown date, the outcome of the injection site bruising was recovered/resolved.   It was unknown if the reporter considered the injection site bruising, throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness, bloodshot eye and generalized rash to be related to FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient received her first flu vaccine and on same day at approximately 2pm she started having throat tightness, coughing, and it was hard to breath. These symptoms resolved by 7pm same day and in the evening she had chills, fever, blood shot eyes and was tired, these all resolved that night while in bed.  On 27th October 2020, she developed a rash on the front and back of her chest, legs and hands. The patient took some Benadryl and these symptoms resolved that day after a few hours. She stated that on the day of vaccination, she had a bruised injection site that lasted a few days and resolved. The reporter did not consent to follow up.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia, Pyrexia, Rash, Throat tightness, Tremor
Clinical narrative: rash on the front and back of her chest, legs and hands; throat tightness; hard to breath; coughing; chills; shaking; fever; was tired; blood shot eyes; bruised injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 297828 ?, expiry date 30th June 2021) for prophylaxis.   Concurrent medical conditions included asthma and fruit allergy (allergic to pineapple).   On 26th October 2020 10:00, the patient received the 1st dose of FluLaval Tetra 2020-2021 season (intramuscular) .5 ml. On 26th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site bruising (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required) and bloodshot eye (serious criteria clinically significant/intervention required). On 26th October 2020 02:00, the patient experienced throat tightness (serious criteria clinically significant/intervention required), difficulty breathing (serious criteria clinically significant/intervention required) and cough (serious criteria clinically significant/intervention required). On 27th October 2020, the patient experienced generalized rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 26th October 2020, the outcome of the throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness and bloodshot eye were recovered/resolved. On 27th October 2020, the outcome of the generalized rash was recovered/resolved. On an unknown date, the outcome of the injection site bruising was recovered/resolved.   It was unknown if the reporter considered the injection site bruising, throat tightness, difficulty breathing, cough, chills, tremor, fever, tiredness, bloodshot eye and generalized rash to be related to FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient received her first flu vaccine and on same day at approximately 2pm she started having throat tightness, coughing, and it was hard to breath. These symptoms resolved by 7pm same day and in the evening she had chills, fever, blood shot eyes and was tired, these all resolved that night while in bed.  On 27th October 2020, she developed a rash on the front and back of her chest, legs and hands. The patient took some Benadryl and these symptoms resolved that day after a few hours. She stated that on the day of vaccination, she had a bruised injection site that lasted a few days and resolved. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: next day patient felt warm and his arm was red around the injection site and went down to his elbow
Age: 1.17
Sex: M
Vaccine: MMR, PNC13
Symptoms: Blood test normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: My son had a fever saturday morning October 31st. Later that day my son had a febrile Seizure. He was rushed to the hospital.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pruritus
Clinical narrative: I had numb lips, tongue and arms itchy all over within about 15 minutes of the shot. 10 days later I am still very itchy and cannot get relief
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Feeling hot
Clinical narrative: Diarrhea, weakness, shaky feeling on the inside of my  body, feverish on the inside of body but not hot to the touch on the out side and no temperature,  tired, lightheaded, for one day. Redness and swelling at injection site, left arm very sore and tender to the touch , hurts to move it , lift it , or lay on it in bed for three days so far. .
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Nervousness, Pain
Clinical narrative: Diarrhea, weakness, shaky feeling on the inside of my  body, feverish on the inside of body but not hot to the touch on the out side and no temperature,  tired, lightheaded, for one day. Redness and swelling at injection site, left arm very sore and tender to the touch , hurts to move it , lift it , or lay on it in bed for three days so far. .
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Diarrhea, weakness, shaky feeling on the inside of my  body, feverish on the inside of body but not hot to the touch on the out side and no temperature,  tired, lightheaded, for one day. Redness and swelling at injection site, left arm very sore and tender to the touch , hurts to move it , lift it , or lay on it in bed for three days so far. .
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion/ one dose of VARIVAX was administered this morning; This spontaneous report was received from an office manager regarding an unspecified patient of unknown age and gender.  Information n unspecified medical history, concomitant medications, drug reactions, or allergies was not provided. On the morning of 05-OCT-2020, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection once for prophylaxis (strength, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported).  The dose had undergone a temperature excursion of 6 to 14 degrees Fahrenheit (F) for 45 minutes as detected by a data logger. There was not a previous temperature excursion. The involved lot numbers were reported as T010312 (expiration date 24-MAR-2022), T000697 (expiration date 07-JAN-2022), and T001311 (expiration date 24-MAR-2022); however, the reporter was not sure which was administered to the patient. Lot number T001311 was determined to be invalid for varicella virus vaccine live.  Follow-up information has been received from the reporting office manager on 22-OCT-2020, stating that the patient was a 12-month-old male. The reporter confirmed the lot number of the administered varicella virus vaccine live (oka/merck) (VARIVAX) was T000697, which underwent an elevated temperature in the freezer.   This case was previously considered non-valid due to the lack of patient identifiers, but upon receipt of follow-up, it was determined to be valid.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient received a dose of PROQUAD at 11 months and 10 days of age, and a second dose of PROQUAD at 12 months and 1 day of age; A patient received a dose of PROQUAD at 11 months and 10 days of age, and a second dose of PROQUAD at 12 months and 1 day of age; This spontaneous report was received from a physician referring to a 11-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 26-APR-2019 (at 11 months and 10 days of age), the patient was vaccinated with the first does of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously for prophylaxis (lot # and expiration date were not reported) (product administered to patient of inappropriate age).   On 17-MAY-2019 (at 12 months and 1 day of age), the patient was vaccinated with the second does of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously for prophylaxis (lot # and expiration date were not reported) (inappropriate schedule of product administration).
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Feeling abnormal, Flushing, Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: all over achiness; hypersensitivity; she didn't "feel right."; tenderness; Flushed; skin sensitive; Chills; Inappropriate schedule of vaccine administered; This spontaneous report was received from a registered nurse via a field representative and an office nurse referring to a 25 years old female patient. The patient had no pertinent medical history and no concomitant medications. Information about drug reactions/ allergies was not provided. The patient did not get a flu shot and did not start any new medications.  On 24-APR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R024264 with expiration date 29-OCT-2019; dose was not reported) intramuscularly in the left deltoid for prophylaxis. On 27-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R009614 with expiration date 30-NOV-2020; dose was not reported) intramuscular in the right deltoid for prophylaxis. On 08-OCT-2020 around 10:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S010729 with expiration date 01-DEC-2021, a dose) intramuscularly in the left deltoid for prophylaxis (reported as cervical cancer prevention) (inappropriate schedule of vaccine administered).  On 09-OCT-2020 around 14:00, the patient presented back to the practice with all over achiness, tenderness and hypersensitivity, and she didn't feel right. On the same day, the patient experienced skin sensitive, chills and flushed. The patient did not experience rash or fever in this situation. The patient had taken actions for events of all over achiness, skin sensitive, chills and flushed. It was unknow if treatment was given for other events. On 10-OCT-2020 (reported in 24 hours), the events of all over achiness, skin sensitive, chills and flushed was recovered. The outcome of other events was unknown. The office nurse considered the events of all over achiness, skin sensitive, chills and flushed was related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The causality between other events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for return/evaluation. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Registered Nurse; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Sensitive skin, Tenderness
Clinical narrative: all over achiness; hypersensitivity; she didn't "feel right."; tenderness; Flushed; skin sensitive; Chills; Inappropriate schedule of vaccine administered; This spontaneous report was received from a registered nurse via a field representative and an office nurse referring to a 25 years old female patient. The patient had no pertinent medical history and no concomitant medications. Information about drug reactions/ allergies was not provided. The patient did not get a flu shot and did not start any new medications.  On 24-APR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R024264 with expiration date 29-OCT-2019; dose was not reported) intramuscularly in the left deltoid for prophylaxis. On 27-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R009614 with expiration date 30-NOV-2020; dose was not reported) intramuscular in the right deltoid for prophylaxis. On 08-OCT-2020 around 10:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S010729 with expiration date 01-DEC-2021, a dose) intramuscularly in the left deltoid for prophylaxis (reported as cervical cancer prevention) (inappropriate schedule of vaccine administered).  On 09-OCT-2020 around 14:00, the patient presented back to the practice with all over achiness, tenderness and hypersensitivity, and she didn't feel right. On the same day, the patient experienced skin sensitive, chills and flushed. The patient did not experience rash or fever in this situation. The patient had taken actions for events of all over achiness, skin sensitive, chills and flushed. It was unknow if treatment was given for other events. On 10-OCT-2020 (reported in 24 hours), the events of all over achiness, skin sensitive, chills and flushed was recovered. The outcome of other events was unknown. The office nurse considered the events of all over achiness, skin sensitive, chills and flushed was related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The causality between other events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for return/evaluation. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Registered Nurse; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Product storage error, Recalled product administered
Clinical narrative: Improperly stored vaccine administered - recalled; RECOMBIVAX HB that was recalled; This spontaneous report has been received from nurse regarding a 10-week old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled improperly stored dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 mL, lot # T00798 for prophylaxis and expiration date 01-NOV-2022 (dose and route of administration were not reported).  This report is one from multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA009823: US-009507513-2010USA009831: US-009507513-2010USA009853: US-009507513-2010USA010090: US-009507513-2010USA010095: US-009507513-2010USA010216: US-009507513-2010USA010884: