chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUX, MENB
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Feeling cold, Headache
Clinical narrative: This is a spontaneous case reported by other non- health professional to VAERS (VAERS ID: 769776) initially retrieved on 15-Jan-2019, concerning a 16-year-old, adolescent female patient. The patient's medical history included exercise induced asthma, neurocardiogenic syncope and the patient is allergic to penicillin. The patient had flu like illness a couple of weeks before. The patient's concomitant medications included MYORISAN, MONO-LINYAH for unknown indications. On 07-Sep-2018, the patient was administered INN flu vaccine seasonal (route of administration: injection NOS (reported as syringe), anatomical location, dose, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day the patient was also administered non-company suspect vaccine TRUMENBA frequency: 2, route of administration: intramuscular, anatomical location: left arm, dose, batch number and expiry date: not reported) for unknown indication. On the same day after fifteen minutes of vaccination the patient experienced stomach ache and a strange sensation on the back of her neck. The patient went home and ten minutes later the stomach ache went away but the patient started shaking and felt really cold. She got a very bad headache and also had vomiting. The headache was very severe, and it lasted for around thirty minutes. The patient took Ibuprofen for headache which decreased the intensity of the headache from severe to mild which she had previously. The patient also reported that she felt weak and tired all evening. The outcome of the events (shaking, feeling cold, feelings of weakness, stomach ache, tiredness, vomiting) was reported as unknown, and outcome of the event headache was recovering (as the intensity of the event headache decreased from severe to mild after medication). The reporter assessed the case as non-serious. Reporter's Comments: A 16- year-old female patient experienced stomach ache, tremor, cold, headache, vomiting, asthenia, fatigue on the same day after receiving the INN flu vaccine seasonal and co suspect vaccine TRUMENBA. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between suspect vaccine and the events.
Age: 16.0
Sex: F
Vaccine: FLUX, MENB
Symptoms: Sensory disturbance, Tremor, Vomiting
Clinical narrative: This is a spontaneous case reported by other non- health professional to VAERS (VAERS ID: 769776) initially retrieved on 15-Jan-2019, concerning a 16-year-old, adolescent female patient. The patient's medical history included exercise induced asthma, neurocardiogenic syncope and the patient is allergic to penicillin. The patient had flu like illness a couple of weeks before. The patient's concomitant medications included MYORISAN, MONO-LINYAH for unknown indications. On 07-Sep-2018, the patient was administered INN flu vaccine seasonal (route of administration: injection NOS (reported as syringe), anatomical location, dose, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day the patient was also administered non-company suspect vaccine TRUMENBA frequency: 2, route of administration: intramuscular, anatomical location: left arm, dose, batch number and expiry date: not reported) for unknown indication. On the same day after fifteen minutes of vaccination the patient experienced stomach ache and a strange sensation on the back of her neck. The patient went home and ten minutes later the stomach ache went away but the patient started shaking and felt really cold. She got a very bad headache and also had vomiting. The headache was very severe, and it lasted for around thirty minutes. The patient took Ibuprofen for headache which decreased the intensity of the headache from severe to mild which she had previously. The patient also reported that she felt weak and tired all evening. The outcome of the events (shaking, feeling cold, feelings of weakness, stomach ache, tiredness, vomiting) was reported as unknown, and outcome of the event headache was recovering (as the intensity of the event headache decreased from severe to mild after medication). The reporter assessed the case as non-serious. Reporter's Comments: A 16- year-old female patient experienced stomach ache, tremor, cold, headache, vomiting, asthenia, fatigue on the same day after receiving the INN flu vaccine seasonal and co suspect vaccine TRUMENBA. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between suspect vaccine and the events.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Cough, Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 769844), concerning a 50-year-old, adult, female patient. The patient's medical history included celiac disease. The patient's concomitant medications included CONCERTA. The patient was allergic to AZITHROMAX, corn, and seeded berries. The patient did not have any ill conditions at the time of vaccination. On 07-Sep-2018, the patient was administered INN Flu vaccine seasonal [dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. The patient was also administered non-company suspect vaccine Pneumo [route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. On the same day (07-Sep-2018), after vaccination, the patient was experienced high fever, malaise, wheezing, chills, coughing, nausea, dry heaving, dizziness, headache, sore throat, patient head felt weird, swollen lymph nodes under arm where flu shot was administered, and the patient was unable to sit up and stand. The patient felt very ill and almost called an ambulance. The patient took BENADRYL at the time of events onset and patient also felt some of the events were related to allergy. The patient reported that BENADRYL did nothing on resolving symptoms. The patient reported that intensity of the events was severe (reported as this was not a mild response but severe). The outcome of the events was recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 50-year-old, female patient experienced high fever, malaise, wheezing, chills, cough, nausea, dry heaving, dizziness, headache, sore throat, patient's head felt weird, swollen lymph nodes under arm where flu shot was administered, and the patient was unable to sit up and stand, same day after vaccination with INN Flu vaccine seasonal and co-suspect vaccine Pneumo. The company assessed the causality of the events as related considering the plausible temporal relationship between the events and the suspect vaccine.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Lymphadenopathy, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 769844), concerning a 50-year-old, adult, female patient. The patient's medical history included celiac disease. The patient's concomitant medications included CONCERTA. The patient was allergic to AZITHROMAX, corn, and seeded berries. The patient did not have any ill conditions at the time of vaccination. On 07-Sep-2018, the patient was administered INN Flu vaccine seasonal [dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. The patient was also administered non-company suspect vaccine Pneumo [route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. On the same day (07-Sep-2018), after vaccination, the patient was experienced high fever, malaise, wheezing, chills, coughing, nausea, dry heaving, dizziness, headache, sore throat, patient head felt weird, swollen lymph nodes under arm where flu shot was administered, and the patient was unable to sit up and stand. The patient felt very ill and almost called an ambulance. The patient took BENADRYL at the time of events onset and patient also felt some of the events were related to allergy. The patient reported that BENADRYL did nothing on resolving symptoms. The patient reported that intensity of the events was severe (reported as this was not a mild response but severe). The outcome of the events was recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 50-year-old, female patient experienced high fever, malaise, wheezing, chills, cough, nausea, dry heaving, dizziness, headache, sore throat, patient's head felt weird, swollen lymph nodes under arm where flu shot was administered, and the patient was unable to sit up and stand, same day after vaccination with INN Flu vaccine seasonal and co-suspect vaccine Pneumo. The company assessed the causality of the events as related considering the plausible temporal relationship between the events and the suspect vaccine.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Posture abnormal, Pyrexia, Retching, Wheezing
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 769844), concerning a 50-year-old, adult, female patient. The patient's medical history included celiac disease. The patient's concomitant medications included CONCERTA. The patient was allergic to AZITHROMAX, corn, and seeded berries. The patient did not have any ill conditions at the time of vaccination. On 07-Sep-2018, the patient was administered INN Flu vaccine seasonal [dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. The patient was also administered non-company suspect vaccine Pneumo [route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication. On the same day (07-Sep-2018), after vaccination, the patient was experienced high fever, malaise, wheezing, chills, coughing, nausea, dry heaving, dizziness, headache, sore throat, patient head felt weird, swollen lymph nodes under arm where flu shot was administered, and the patient was unable to sit up and stand. The patient felt very ill and almost called an ambulance. The patient took BENADRYL at the time of events onset and patient also felt some of the events were related to allergy. The patient reported that BENADRYL did nothing on resolving symptoms. The patient reported that intensity of the events was severe (reported as this was not a mild response but severe). The outcome of the events was recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 50-year-old, female patient experienced high fever, malaise, wheezing, chills, cough, nausea, dry heaving, dizziness, headache, sore throat, patient's head felt weird, swollen lymph nodes under arm where flu shot was administered, and the patient was unable to sit up and stand, same day after vaccination with INN Flu vaccine seasonal and co-suspect vaccine Pneumo. The company assessed the causality of the events as related considering the plausible temporal relationship between the events and the suspect vaccine.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Product administered at inappropriate site, Swelling, Tenderness
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 769846) and initially retrieved on 15-Jan-2019, concerning a 27-year-old adult, female patient. The patient did not have any allergies. On 01-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. It was reported that the vaccine was administered in the shoulder joint instead of the deltoid muscle. On 08-Sep-2018, seven days after vaccination, the patient experienced radiant heat, 2-inch diameter raised redness that was sensitive to the touch. On an unspecified date, the patient made an office visit. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 27-year-old female patient experienced erythema, sensation of heat, and tenderness seven days after the administration of INN Flu Vaccine Seasonal in the shoulder joint instead of the deltoid muscle (coded as: product administered at inappropriate site). The company assessed the causality of events - erythema, sensation of heat and tenderness as related to the suspect vaccine due to plausible temporal relationship between the events and suspect vaccine and the event - product administered at inappropriate site as not related due to accidental nature of the event.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 769848), concerning a 52-year-old, adult, female patient. The patient had allergy to amoxicillin. The patient's concomitant medications included levothyroxine, escitalopram and zolpidem for unknown indications. On 05-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: reported 1, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, the patient was also administered non-company co-suspect vaccine SHINGRIX [dose: reported as 1, route of administration: intramuscular, anatomical location, batch number, expiry date, trade name, manufacturer: not reported] for unknown indication. On same day, within approximately 4-6 hours after vaccination, the patient experienced injection site pain and redness. Approximately 12 hours after vaccination, the patient experienced low-grade fever, flu like ache and fatigue, which lasted for 3 days. The outcome of the events was recovered (on an unspecified date). The reporter assessed this case as non-serious. Reporter's Comments: A 52-year-old female patient experienced Flu-like aches, Influenza like illness, fatigue, injection site pain, injection site erythema and pyrexia, within 24 hours after administration of suspect vaccine INN Flu Vaccine seasonal and co-suspect vaccine SHINGRIX. The causality of the events was assessed as related to suspect vaccine due to plausible temporal relationship between the events and suspect vaccine and causal role of suspect vaccine cannot be ruled out.
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Nov-2018 by Seqirus from VAERS (VAERS ID: 770205), concerning an adult female patient of an unspecified age. The patient's historical condition included breast cancer (reported that, the patient didn't get any vaccine or bloodwork done in right arm). The patient's historical drugs included Herpes zoster live-attenuated vaccine (reported as ZVL received 5 years before the reporting date) and flu vaccine. The patient received flu vaccine every year but did not always experience tenderness. On an unspecified date, the patient was administered Influenza Vaccine, (anatomical location: left arm, dose: unknown, route of administration, manufacturer, trade name, batch number and expiry date: not reported) for prophylaxis. On an unspecified date, less than a year after receiving vaccination, the patient experienced tenderness. At the time of the report, the outcome of the event was unknown. It was unknown if the reporter considered the tenderness to be related to Influenza vaccine. The reporter assessed the case as non-serious. Reporter's Comments: An adult female patient of an unspecified age developed tenderness on an unspecified day (less than a year) after receiving INN Flu Vaccine Seasonal. The causality of the events was unassessable due to the lack of information regarding the onset latency.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Dry skin, Feeling hot, Swelling face
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 770323), concerning a 60-year-old, adult, male patient. The patient had no historical conditions, allergies and current illness. The patient's concomitant medications included: Multivitamin and fish oil for unknown indications. On 07-Sep-2018 (reported as Friday), the patient was administered INN flu vaccine seasonal (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day after vaccination (reported as in the day), the patient's face was hot and over the weekend the facial skin was very dry, and the face had some mild puffiness. It was reported that, there was nothing serious. The patient was not completely sure whether the puffiness was from the vaccine. But the patient reported this, as he felt that, it was the only cause of the facial dryness and puffiness that he can think of as a cause. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Reporter's Comments: A 60-year-old male patient developed puffiness face, skin warm and dry skin face on the same day after receiving INN flu vaccine seasonal. The company assessed the causality of the events as related due to plausible temporal relationship between suspect vaccine and the events.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS (VAERS ID: 770424) and initially retrieved on 15-Jan-2019, concerning a 65-year-old, elderly female patient. The patient's current condition included osteoarthritis knee. The patient had no known allergies. The concomitant medications included duloxetine, magnesium glycinate, fish oil, NEXIUM, ibuprofen and oestrogen NOS with progesterone (low dose compounded) for unknown indications. On 30-Aug-2018, the patient was administered INN Flu Vaccine Seasonal [anatomical location: right arm, dose, route of administration: unknown, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On the same day the patient was also administered a non-company co-suspect vaccine, PNEUMOVAX (route of administration: intramuscular, anatomical location: left deltoid, dose: unknown, batch number and expiry date: not reported) for an unknown indication. On 31-Aug-2018, one day after vaccination, in the morning, the patient's left arm was extremely sore, and the right was less sore. The patient performed an aerobic and light weight lifting workout over an hour and a half. About 15 minutes prior to the conclusion of the workout, the patient had an onset of dizziness which was quickly followed by severe myalgia and generalized joint pain. The left deltoid was swollen, acutely painful and firm. The joint symptoms rapidly progressed in severity and persisted for 2 full days. The patient developed a circular area of erythema approximately 4 inches wide on the left deltoid, PNEUMOVAX injection site. The joint pains subsided by day 4, but the injection site on the left arm was still painful to touch and red on day 5. The patient had no fever. The patient was recovering from joint pain. The patient had not recovered from dizziness, pain in extremity, myalgia, injection site swelling, injection site pain, injection site redness and injection site induration. The reporter assessed the case as non-serious. Reporter's Comments: A 65-year-old, female patient experienced joint pain, dizziness, pain in extremity, myalgia, injection site swelling, injection site pain, injection site redness and injection site induration, one day after the administration of the suspect vaccine INN Flu Vaccine Seasonal and co-suspect vaccine PNEUMOVAX. The company assessed the causality of the events joint pain, dizziness, pain in extremity and myalgia as related due to plausible temporal relationship between the events and the suspect vaccine. The company assessed the causality of the events injection site swelling, injection site pain, injection site redness and injection site induration as not related due to occurrence of the event at the site of the co-suspect vaccine, PNEUMOVAX.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS (VAERS ID: 770424) and initially retrieved on 15-Jan-2019, concerning a 65-year-old, elderly female patient. The patient's current condition included osteoarthritis knee. The patient had no known allergies. The concomitant medications included duloxetine, magnesium glycinate, fish oil, NEXIUM, ibuprofen and oestrogen NOS with progesterone (low dose compounded) for unknown indications. On 30-Aug-2018, the patient was administered INN Flu Vaccine Seasonal [anatomical location: right arm, dose, route of administration: unknown, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On the same day the patient was also administered a non-company co-suspect vaccine, PNEUMOVAX (route of administration: intramuscular, anatomical location: left deltoid, dose: unknown, batch number and expiry date: not reported) for an unknown indication. On 31-Aug-2018, one day after vaccination, in the morning, the patient's left arm was extremely sore, and the right was less sore. The patient performed an aerobic and light weight lifting workout over an hour and a half. About 15 minutes prior to the conclusion of the workout, the patient had an onset of dizziness which was quickly followed by severe myalgia and generalized joint pain. The left deltoid was swollen, acutely painful and firm. The joint symptoms rapidly progressed in severity and persisted for 2 full days. The patient developed a circular area of erythema approximately 4 inches wide on the left deltoid, PNEUMOVAX injection site. The joint pains subsided by day 4, but the injection site on the left arm was still painful to touch and red on day 5. The patient had no fever. The patient was recovering from joint pain. The patient had not recovered from dizziness, pain in extremity, myalgia, injection site swelling, injection site pain, injection site redness and injection site induration. The reporter assessed the case as non-serious. Reporter's Comments: A 65-year-old, female patient experienced joint pain, dizziness, pain in extremity, myalgia, injection site swelling, injection site pain, injection site redness and injection site induration, one day after the administration of the suspect vaccine INN Flu Vaccine Seasonal and co-suspect vaccine PNEUMOVAX. The company assessed the causality of the events joint pain, dizziness, pain in extremity and myalgia as related due to plausible temporal relationship between the events and the suspect vaccine. The company assessed the causality of the events injection site swelling, injection site pain, injection site redness and injection site induration as not related due to occurrence of the event at the site of the co-suspect vaccine, PNEUMOVAX.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 771394), concerning a female patient of an unspecified age. In past the patient received 3 strain flu vaccine (reported as last year) and had smaller arms and got bruising and soreness at the injection site after her flu vaccines each year. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration: injection Nos (SYR), anatomical location: unk, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On an unspecified date, following vaccination, the patient experienced injection site bruising and soreness at injection site. The outcome of the events was unknown. The reporter assessed this case as non-serious. This case is linked with 201900544 due to same patient. Reporter's Comments: A female patient of an unspecified age experienced injection site bruising and pain, on an unspecified date after administration of INN Flu Vaccine. The causality of the events was assessed as related due to site specific occurrence of the reactions.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This is a non-serious spontaneous case reported by other non-health professional to VAERS (VAERS ID: 771394) and initially retrieved on 15-Jan-2019, concerning a female patient of unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On an unspecified date, after vaccination, the patient had smaller arms (as reported), developed bruising and experienced soreness at the injection site after her flu vaccines each year. The outcome of the events was not reported. This case is linked to case: 201900543 (same patient). Reporter's Comments: A female patient of unspecified age experienced injection site bruising and injection site pain after administration of INN Flu Vaccine Seasonal. The company assessed the causality of the events as unassessable due to lack of onset latency.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 771565), concerning a 67-year-old, elderly female patient. On 17-Sep-2017, the patient was administered Influenza Vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On 17-Sep-2017, soon after the flu shot (reported as 18-Sep-2017), the patient developed shoulder pain. The patient went through physical therapy and was still doing exercises at home. On an unspecified date, the patient made an office visit. At the time of the report, the outcome of the event was not reported. The reporter assessed the case as non-serious. Reporter's Comments: A 67-year-old female patient developed shoulder pain, on the same day after receiving INN flu vaccine seasonal. The company assessed the causality of the event as related due to plausible temporal relationship between suspect vaccine and the event.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 771703) and initially retrieved on 15-Jan-2019, concerning a female patient of an unspecified age. The patient's historical condition included genital herpes since 1980. On an unspecified date, the patient was administered Influenza vaccine (anatomical location: arm, dose, route of administration: Unknown, batch number, manufacturer, trade name and expiry date: not reported) for prophylaxis. On an unspecified date, reported as the same evening or the next day after vaccination, the patient experienced muscle soreness in the vaccinated arm. It was also reported that the patient had limited information regarding the flu vaccine. On an unspecified date, the patient had recovered from the event. The reporter assessed the case as non-serious. Reporter's Comments: A female patient of an unspecified age developed muscle soreness, on the same or next day after the administration of INN Flu Vaccine Seasonal. The company assessed the causality of the events as related due the plausible temporal relationship between the event and the suspect vaccine.
Age: 75.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fall, Fatigue
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 772120) and initially retrieved on 15-Jan-2019, concerning a 75-year-old elderly, male patient. The patient's historical condition included pain behind the right knee. The historical drugs included DEMEROL and fentanyl (reported as fentanal). The current conditions included diabetes and heart disease. The concomitant medications included hydrochlorothiazide, GLUCOPHAGE, HUMALOG, LANTUS, CRESTOR, PRINIVIL and aspirin for unknown indications. On 07-Sep-2018, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. The non-company co-suspect vaccine included SHINGRIX [dose: frequency reported as 1, route of administration, anatomical location, batch number and expiry date: not reported] for unknown indication. On the same day, after vaccination, the patient experienced extreme muscle weakness in legs and arms, felt very weak on both sides. The patient had a lot of difficulty walking, the patient had to hold on to walls and doorway to go to bathroom and was very unsteady. The patient experienced strong chills, body shaking and teeth chattering for over an hour. Patient had extreme pain behind right knee and could barely bend his left leg. When the patient tried to get back into bed, legs gave out and the patient fell. The patient did not have enough strength in legs to roll over or in arms to get up. Patient took a lot of effort to use arms just to sit up but had to lean against bed. Finally, the patient had wife call 911. Patient lost most of Saturday (as reported) and would wake for only about 1 to 2 hours then felt exhausted and went back to sleep. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 75-year-old male patient experienced arthralgia, chills, fall, fatigue, gait disturbance, asthenia, muscular weakness and tremor on the same day after administration of INN Flu Vaccine Seasonal. The non-company co-suspect vaccine included SHINGRIX. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events.
Age: 75.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Gait disturbance, Mobility decreased, Muscular weakness, Tremor
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 772120) and initially retrieved on 15-Jan-2019, concerning a 75-year-old elderly, male patient. The patient's historical condition included pain behind the right knee. The historical drugs included DEMEROL and fentanyl (reported as fentanal). The current conditions included diabetes and heart disease. The concomitant medications included hydrochlorothiazide, GLUCOPHAGE, HUMALOG, LANTUS, CRESTOR, PRINIVIL and aspirin for unknown indications. On 07-Sep-2018, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. The non-company co-suspect vaccine included SHINGRIX [dose: frequency reported as 1, route of administration, anatomical location, batch number and expiry date: not reported] for unknown indication. On the same day, after vaccination, the patient experienced extreme muscle weakness in legs and arms, felt very weak on both sides. The patient had a lot of difficulty walking, the patient had to hold on to walls and doorway to go to bathroom and was very unsteady. The patient experienced strong chills, body shaking and teeth chattering for over an hour. Patient had extreme pain behind right knee and could barely bend his left leg. When the patient tried to get back into bed, legs gave out and the patient fell. The patient did not have enough strength in legs to roll over or in arms to get up. Patient took a lot of effort to use arms just to sit up but had to lean against bed. Finally, the patient had wife call 911. Patient lost most of Saturday (as reported) and would wake for only about 1 to 2 hours then felt exhausted and went back to sleep. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 75-year-old male patient experienced arthralgia, chills, fall, fatigue, gait disturbance, asthenia, muscular weakness and tremor on the same day after administration of INN Flu Vaccine Seasonal. The non-company co-suspect vaccine included SHINGRIX. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 772122), concerning a 59-year-old, adult, female patient. The patient had no historical conditions. It was reported that, the patient gets the flu shot every year and never had a reaction. The patient had no allergies. The patient's current conditions included: mild cold two weeks prior to vaccination. The patient's concomitant medications included Escitalopram, Bupropion hydrochloride and Lamotrigine (reported as Generic of LEXAPRO, WELLBUTRIN And LAMICTAL) for unknown indications. On 18-Sep-2018, the patient was administered INN flu vaccine seasonal (influenza vaccine, influenza virus vaccine polyvalent, route of administration: injection NOS (reported as SYR), dose, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day, the patient was also administered non-company suspect product SHINGRIX [varicella zoster vaccine RGE (CHO), frequency: reported as 1, route of administration: intramuscular, anatomical location: left arm, dose, batch number and expiry date: not reported] for an unknown indication. On the same day after vaccination, the patient developed very sore throat, swollen glands, fatigue and body aches. On an unspecified day, the patient made an office visit. The patient went to the doctor and she was given a prescription for penicillin. The doctor looked at her throat and said it doesn't look like she had a strep throat. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Reporter's Comments: A 59-year-old female patient developed sore throat, swollen glands, fatigue and general body pain on the same day after receiving INN flu vaccine seasonal and co-suspect vaccine: SHINGRIX. The company assessed the causality of the events as related due to plausible temporal relationship between suspect vaccine and the events. However, the role of the co-suspect vaccine cannot be ruled out.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling of body temperature change, Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Pain
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 27-Dec-2018 by Seqirus from VAERS (VAERS ID: 772174), concerning a 33-year-old, adult, male patient. The patient's medical history included history of auto-immune skin reactions and no relevant allergies. The patient had no concomitant medications at the time of vaccination. No current illness was reported at the time of vaccination. On 10-Sep-2018, in the morning (as reported), the patient was administered INN Flu Vaccine Seasonal (patient reported the vaccine as Afluria trivalent but the patient do not know the vaccine which was administered) [influenza vaccine, influenza virus vaccine polyvalent, dose: 0.5 ml (frequency reported as unknown), route of administration: Injection (reported as SYR), anatomical location: right arm, batch number, trade name, manufacturer, expiry date: not reported] for an unknown indication. On 11-Sep-2018, at 2 am, within 24 hours after vaccination, the patient woke up with severe pain in all limbs. Patient alternated between feeling hot and cold with a likely fever. Limb pain relieved with ibuprofen. Had significant pain with movement for the next three days. Experienced muscle weakness throughout body but most prominently in the forearms. The patient had great pain even with lifting objects less than 20 pounds. Some pain even in operating door handles or a steering wheel. On 13-Sep-2018 and 17-Sep-2018, the patient underwent physical examination for bilateral sensation and muscle strength (with presumed neurological functioning). The results were normal. On an unspecified day in Sep-2018, by third day (as reported), the patient experienced some numbness in the hands. By fourth day (as reported), the pain was mostly relieved, but the muscle weakness lingered. After one week, the patient reported that he had about 80 percent strength in arms. On an unspecified date, the patient had a physician office visit. On an unspecified date in Sep-2018 (reported as back to normal at about day 9), the patient was recovered from the events. The reporter assessed this case as non-serious. Reporter's Comments: A 33-year-old, male patient, experienced pain in extremity, fever, feeling of body temperature change, within 24 hours after vaccination and pain upon movement, hypoesthesia, muscular weakness and impaired daily activities, within a week after administration of INN flu vaccine. The company assessed the causality of the events as related to suspect vaccine considering the plausible temporal relationship between the events and the suspect vaccine.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 27-Dec-2018 by Seqirus from VAERS (VAERS ID: 772174), concerning a 33-year-old, adult, male patient. The patient's medical history included history of auto-immune skin reactions and no relevant allergies. The patient had no concomitant medications at the time of vaccination. No current illness was reported at the time of vaccination. On 10-Sep-2018, in the morning (as reported), the patient was administered INN Flu Vaccine Seasonal (patient reported the vaccine as Afluria trivalent but the patient do not know the vaccine which was administered) [influenza vaccine, influenza virus vaccine polyvalent, dose: 0.5 ml (frequency reported as unknown), route of administration: Injection (reported as SYR), anatomical location: right arm, batch number, trade name, manufacturer, expiry date: not reported] for an unknown indication. On 11-Sep-2018, at 2 am, within 24 hours after vaccination, the patient woke up with severe pain in all limbs. Patient alternated between feeling hot and cold with a likely fever. Limb pain relieved with ibuprofen. Had significant pain with movement for the next three days. Experienced muscle weakness throughout body but most prominently in the forearms. The patient had great pain even with lifting objects less than 20 pounds. Some pain even in operating door handles or a steering wheel. On 13-Sep-2018 and 17-Sep-2018, the patient underwent physical examination for bilateral sensation and muscle strength (with presumed neurological functioning). The results were normal. On an unspecified day in Sep-2018, by third day (as reported), the patient experienced some numbness in the hands. By fourth day (as reported), the pain was mostly relieved, but the muscle weakness lingered. After one week, the patient reported that he had about 80 percent strength in arms. On an unspecified date, the patient had a physician office visit. On an unspecified date in Sep-2018 (reported as back to normal at about day 9), the patient was recovered from the events. The reporter assessed this case as non-serious. Reporter's Comments: A 33-year-old, male patient, experienced pain in extremity, fever, feeling of body temperature change, within 24 hours after vaccination and pain upon movement, hypoesthesia, muscular weakness and impaired daily activities, within a week after administration of INN flu vaccine. The company assessed the causality of the events as related to suspect vaccine considering the plausible temporal relationship between the events and the suspect vaccine.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Facial pain, Rash
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 772420) and initially retrieved on 15-Jan-2019, concerning a 70-year-old, elderly, female patient. On 19-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: reported as OF1A1817, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day after vaccination, patient experienced rash covering chest and pain in the face. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 70-year-old female patient experienced rash and facial pain on the same day after administration of suspect vaccine INN Flu Vaccine Seasonal. The company assessed the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Injection site haemorrhage
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 772441) and initially retrieved on 15-Jan-2019, concerning a 33-year-old, adult female pregnant patient. The patient's historical conditions included chronic obstructive pulmonary disease (COPD), hepatitis B and hepatitis C. The patient did not have any current illness. The patient was allergic to TEGRETOL and codeine. The concomitant medication included RITALIN for unknown indication. On 01-Sep-2018, the pregnant patient was administered INN Flu Vaccine Seasonal (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day, after vaccination, the patient had consistent bleeding from shot location for hours. The patient did not undergo any laboratory tests. The outcome of the events was unknown. The patient's due date was 15-Dec-2018. The reporter assessed the case as non-serious. Reporter's Comments: A 33-year-old female pregnant patient had injection site haemorrhage on the same day after administration of INN Flu Vaccine Seasonal. The company assessed the causality of the event- injection site haemorrhage as related to the suspect vaccine due to plausible temporal relationship and the event- exposure during pregnancy as not related due to special situation.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: This is a spontaneous case reported by other non-health professional to VAERS (VAERS ID: 772487) and initially retrieved on 15-Jan-2019, concerning a 60-year-old, adult female patient. The patient's current conditions included high blood pressure and cholesterol (reported as medical history). The concomitant medications included hydrochlorothiazide, levothyroxine, metoprolol, NIFEDICAL, potassium chloride and simvastatin for unknown indications. On 19-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (route of administration: injection (reported as SYR), anatomical location: right arm, dose, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day the patient was also administered a non-company suspect vaccine, SHINGRIX [frequency: 1, route of administration: injection (reported as SYR), anatomical location: left arm, dose, batch number and expiry date: not reported] for an unknown indication. On 20-Sep-2018, 24 hours after vaccination, the patient developed fever of 100 F and diarrhea. The fever subsided 12 hours later, and the diarrhoea subsided after one episode. The patient was recovering from the events. The reporter assessed the case as non-serious. Reporter's Comments: A 60-year-old, female patient developed fever and diarrhoea, one day after the administration of suspect vaccine INN Flu Vaccine Seasonal and non-company co-suspect vaccine SHINGRIX. The company assessed the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events and causal role of suspect vaccine cannot be ruled out.
Sex: F
Vaccine: FLUX, PNC13, PPV
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: This is spontaneous case, reported by a other health professional (nurse) to VAERS (VAERS ID: 772497) and initially retrieved on 15-Jan-2019, concerning a female patient of unknown age. The patient's relevant medical history and concomitant medications were not reported. On an unknown date, the patient was administered INN Flu Vaccine Seasonal (anatomical location: arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, the patient was also administered non-company co-suspect vaccines PREVNAR 13 [anatomical location: arm, dose, route of administration, batch number and expiry date] and PNEUMOVAX [anatomical location: arm, dose, route of administration, batch number and expiry date] for unknown indications. The vaccines were administered in separate arms. On an unknown date, after receiving the vaccines, the patient's heart rate went up to about 130 and had difficulty breathing. The outcome of the events was unknown. The reporter assessed this case as non-serious. Reporter's Comments: A female patient of unknown age experienced heart rate increased and difficulty breathing on an unspecified date after administration of INN Flu Vaccine Seasonal and non-company suspect vaccines PREVNAR 13 and PNEUMOVAX. The company assessed the causality of the events as unassessable due to lack of information regarding the onset latency between the vaccine and the events. The causal role of the non-company suspect vaccines PREVNAR 13 and PNEUMOVAX cannot be ruled out completely.
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This non-serious spontaneous case, reported by other healthcare professional to VAERS (VAERS ID: 772842) and initially retrieved on 31-Dec-2018 by Seqirus, concerning a male patient of unspecified age. On an unspecified date, the patient was administered INN flu vaccine seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On an unspecified date after vaccination, the patient experienced swelling and redness at the vaccination site. At the time of this report, the outcome of the events was not reported. This case was linked to 201806397 (same patient). Reporter's Comments: A male patient of unspecified age experienced swelling and redness at the vaccination site after administration of INN flu vaccine seasonal. The causality of the events was taken as unassessable due to lack of onset latency between the event and suspect vaccine.