chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 31-Dec-2018 by Seqirus from VAERS (VAERS ID: 772855), concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported) for an unknown indication. On an unspecified date, after vaccination, the patient experienced mild soreness in arm. The outcome of the event was not reported. This case is linked with 201806391 due to same patient. Reporter's Comments: A female patient of unspecified age experienced mild soreness in arm after administration of INN flu vaccine. The causality of the event was considered as unassessable due to lack of information on onset latency.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Heart rate increased
Clinical narrative: This is a spontaneous case reported by other non-health professional to VAERS (VAERS ID: 772877) and initially retrieved on 15-Jan-2019, concerning a 55-year-old, adult, female patient. The patient was allergic to erythromycin, NEOSPORIN, amoxicillin and PERCOCET. The patient did not have any current illness. On 22-Sep-2018, 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. The non-company co-suspect vaccine included SHINGRIX [dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 4fS5N and expiry date: not reported) for an unknown indication. On the same day after vaccination, patient experienced fast heartbeat for about 15 minutes, chills and shivering for about 10 minutes, and fatigue which lasted the rest of the evening. The outcome of the events- fast heartbeat and chills was recovered and event- fatigue was not recovered. The reporter assessed the case as non-serious. Reporter's Comments: A 55-year-old female patient experienced increased heartbeat, chills and fatigue on the same day after 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, PPV
Symptoms: Asthma, Condition aggravated, Feeling abnormal
Clinical narrative: This is a serious spontaneous case, reported by other non-health professional (consumer) to VAERS (VAERS ID: 773059) and initially retrieved on 15-Jan-2019, concerning a female patient of unknown age. The patient's concurrent conditions included asthma (since unspecified date). 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, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, the patient was also administered a non-company suspect vaccine Pneumococcal vaccine [pneumonia vaccine, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, the patient thought that she was going to die and told that vaccines triggered asthma. On an unspecified date (reported as a month before ) the time of reporting she got better. The outcome of the events was recovering. Reporter's Comments: A female patient of unknown age with concurrent condition of asthma experienced her asthma aggravated and felt abnormal, on an unspecified day after administration of INN Flu Vaccine. The case lacks information regarding vaccination details, onset latency between the vaccination and reported event of asthma aggravated, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported case and was assessed as unassessable. The event of feeling abnormal could be alternately explained by underlying condition of asthma which got aggravated. The sponsor assessed the reported event as not related due to the alternative more plausible cause for the event rather than suspect vaccine. The pneumococcal vaccine was considered as non-company suspect product. The company assessed the case as serious (medically significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
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: 773086), concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On an unspecified date, after vaccination, the patient experienced reaction as soreness in arm. The outcome of the event was not reported. The reporter assessed this case as non-serious. This case is cross-linked to the case: 201900488 (same patient). Reporter's Comments: A female patient of an unspecified age experienced soreness in the arm, on an unspecified time after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information on the onset latency.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Hyperaesthesia, Immediate post-injection reaction, Malaise, Nasal congestion
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: 773086), concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On an unspecified date, after vaccination, the patient experienced reaction as soreness in arm. The outcome of the event was not reported. The reporter assessed this case as non-serious. This case is cross-linked to the case: 201900488 (same patient). Reporter's Comments: A female patient of an unspecified age experienced soreness in the arm, on an unspecified time after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information on the onset latency.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nausea, Pain, Pain in extremity
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: 773086), concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On an unspecified date, after vaccination, the patient experienced reaction as soreness in arm. The outcome of the event was not reported. The reporter assessed this case as non-serious. This case is cross-linked to the case: 201900488 (same patient). Reporter's Comments: A female patient of an unspecified age experienced soreness in the arm, on an unspecified time after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information on the onset latency.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 773086), concerning a 70-year-old, elderly, female patient. In past the patient received flu vaccine and experienced soreness in arm. The patient's current condition included pressure in eyes (reported as medical history). The patient's concomitant medication included Timolol eye drops for unknown indication. The patient was allergic to all seafood, fish, red meat, bananas, avocado, spinach and zucchini. On 21-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: reported as 1, route of administration: injection (reported as SYR), anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, immediately after vaccination, the patient had soreness in arm of vaccination. About 2 hours later, the patient experienced skin sensitivity. About 10 hours later, the patient experienced chills and total soreness. The patient felt like she was hit by a truck. The patient also experienced nausea, and nasal stuffiness. The patient returned to former wellness about 20-24 hours later. The outcome of the events was recovered. The reporter assessed this case as non-serious. This case is linked with 201900489 due to same patient. Reporter's Comments: A 70 year old female patient experienced soreness in arm, immediately after vaccination of INN Flu vaccine, and also experienced, about 2 hours later skin sensitivity, about 10 hours later chills and total soreness, and on the same day nausea, malaise and nasal stuffiness. The causality of the events was assessed as related to suspect vaccine due to plausible temporal relationship between the events and suspect vaccine.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Hyperaesthesia, Immediate post-injection reaction, Malaise, Nasal congestion
Clinical narrative: This is a spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 773086), concerning a 70-year-old, elderly, female patient. In past the patient received flu vaccine and experienced soreness in arm. The patient's current condition included pressure in eyes (reported as medical history). The patient's concomitant medication included Timolol eye drops for unknown indication. The patient was allergic to all seafood, fish, red meat, bananas, avocado, spinach and zucchini. On 21-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: reported as 1, route of administration: injection (reported as SYR), anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, immediately after vaccination, the patient had soreness in arm of vaccination. About 2 hours later, the patient experienced skin sensitivity. About 10 hours later, the patient experienced chills and total soreness. The patient felt like she was hit by a truck. The patient also experienced nausea, and nasal stuffiness. The patient returned to former wellness about 20-24 hours later. The outcome of the events was recovered. The reporter assessed this case as non-serious. This case is linked with 201900489 due to same patient. Reporter's Comments: A 70 year old female patient experienced soreness in arm, immediately after vaccination of INN Flu vaccine, and also experienced, about 2 hours later skin sensitivity, about 10 hours later chills and total soreness, and on the same day nausea, malaise and nasal stuffiness. The causality of the events was assessed as related to suspect vaccine due to plausible temporal relationship between the events and suspect vaccine.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 773086), concerning a 70-year-old, elderly, female patient. In past the patient received flu vaccine and experienced soreness in arm. The patient's current condition included pressure in eyes (reported as medical history). The patient's concomitant medication included Timolol eye drops for unknown indication. The patient was allergic to all seafood, fish, red meat, bananas, avocado, spinach and zucchini. On 21-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: reported as 1, route of administration: injection (reported as SYR), anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, immediately after vaccination, the patient had soreness in arm of vaccination. About 2 hours later, the patient experienced skin sensitivity. About 10 hours later, the patient experienced chills and total soreness. The patient felt like she was hit by a truck. The patient also experienced nausea, and nasal stuffiness. The patient returned to former wellness about 20-24 hours later. The outcome of the events was recovered. The reporter assessed this case as non-serious. This case is linked with 201900489 due to same patient. Reporter's Comments: A 70 year old female patient experienced soreness in arm, immediately after vaccination of INN Flu vaccine, and also experienced, about 2 hours later skin sensitivity, about 10 hours later chills and total soreness, and on the same day nausea, malaise and nasal stuffiness. The causality of the events was assessed as related to suspect vaccine due to plausible temporal relationship between the events and suspect vaccine.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: This is a spontaneous case from United States, reported by other healthcare professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 773321), concerning a 33-year-old, adult, female patient. The patient current conditions included: Urinary tract infection (UTI), Kidney infection, hypothyroidism and Blood infection (E. Coli). The patient had allergy to hydrocodone. The patient's concomitant medication included: ARMOUR THYROID (thyroid) and Prenatal vitamins (minerals nos, vitamins nos) for unknown indications. On 23-Sep-2018, the patient was administered INN flu vaccine seasonal (influenza vaccine, influenza virus vaccine polyvalent, route of administration: unknown, anatomical location: unknown, dose, frequency, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the next day after vaccination, the patient at the injection site developed large welt, about 2.5 inches in diameter. It was red, itchy, warm to touch, and the area was sore. 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 33-year-old female patient developed injection site warmth, injection site redness, injection site urticaria, injection site itching and injection site pain on the next day after receiving INN flu vaccine seasonal. The company assessed the causality of the events as related due to anatomical site specific reactions and plausible temporal relationship between suspect vaccine and the events.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This is a spontaneous case from United States, reported by other healthcare professional to VAERS and initially retrieved on 15-Jan-2019 by Seqirus from VAERS (VAERS ID: 773321), concerning a 33-year-old, adult, female patient. The patient current conditions included: Urinary tract infection (UTI), Kidney infection, hypothyroidism and Blood infection (E. Coli). The patient had allergy to hydrocodone. The patient's concomitant medication included: ARMOUR THYROID (thyroid) and Prenatal vitamins (minerals nos, vitamins nos) for unknown indications. On 23-Sep-2018, the patient was administered INN flu vaccine seasonal (influenza vaccine, influenza virus vaccine polyvalent, route of administration: unknown, anatomical location: unknown, dose, frequency, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the next day after vaccination, the patient at the injection site developed large welt, about 2.5 inches in diameter. It was red, itchy, warm to touch, and the area was sore. 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 33-year-old female patient developed injection site warmth, injection site redness, injection site urticaria, injection site itching and injection site pain on the next day after receiving INN flu vaccine seasonal. The company assessed the causality of the events as related due to anatomical site specific reactions and plausible temporal relationship between suspect vaccine and the events.
Age: 29.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This is spontaneous case, reported by other non-health professional (consumer) to VAERS (VAERS ID: 773322) and initially retrieved on 15-Jan-2019, concerning a 29-year-old adult female patient. The patient's current conditions included chronic pain, asthma, high blood pressure, depression, anxiety and arthritis (reported as medical history). The patient's concomitant medications included ADVAIR, Albuterol, losartan, NORVASC, SINGULAIR, ZYRTEC, SEASONIQUE, CYMBALTA, ZANAFLEX, XANAX and NORCO for unknown indications. The patient was allergic to penicillin and SYMBICORT. On 11-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [anatomical location: dose: frequency reported as 1, anatomical location: left arm, route of administration: injection NOS (reported as SYR), batch number, expiry date, trade name, manufacturer: not reported) and non-company suspect vaccine TDAP [dose: frequency reported as 2, anatomical location: right arm, route of administration: injection NOS (reported as SYR), batch number, expiry date, trade name, manufacturer: not reported) for an unknown indications. On the same day, right away after vaccinations, TDAP injection site (right arm) was started to itch and turned red. On 12- Sep-2018, 1 day after vaccinations, the patient developed a large golf ball sized lump at the injection site. The outcome of the events was not recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 29-Year-old female experienced injection site erythema, injection site mass and injection site pruritus after administration of INN Flu Vaccine Seasonal and co-suspect vaccine TDAP. The company assessed the causality of the events (Injection site erythema and Injection site pruritus) as not related to the suspect vaccine as these events occurred where TDAP vaccine was given (right arm). The causality of the event (injection site mass) was unassessable to the suspect vaccine as anatomical location was unspecified where injection site mass developed (right arm or left arm).
Age: 17.0
Sex: M
Vaccine: FLUX, MENB
Symptoms: Feeling abnormal, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous case reported by a physician to VAERS (VAERS ID: 773468) and initially retrieved on 15-Jan-2019, concerning a 17-year-old, adolescent male patient. The patient had no historical and current condition. The patient did not receive concomitant medication. On 19-Sep-2018, the patient was administered Influenza vaccine [dose, route of administration, anatomical location: unknown, batch number, manufacturer, trade name and expiry date: not reported] for immunization. On the same day the patient also received a non-company suspect vaccine, TRUMENBA [dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: arm, batch number: S60256 and expiry date: not reported] for immunization. On 20-Sep-2018, the patient felt miserable for 48 hours. On an unspecified date in Sep-2018 after vaccination, the patient developed a fever of 101.9, the site had pain and pain in his arm. Therapeutic measures were taken as a result of the events and included treatment with ADVIL. The ADVIL didn't help, so then he took TYLENOL. On 22-Sep-2018, the patient had recovered from the event feeling miserable (reported as for 48 hours). The outcome of other events was unknown. The reporter assessed the case as non-serious and causality of the events as related (reported as could be a relationship). Reporter's Comments: A 17-year-old, male patient developed a fever, injection site pain, pain and pain in arm unspecified days after vaccination and felt miserable, one day after the administration of the suspect vaccine INN Flu Vaccine Seasonal and co-suspect vaccine TRUMENBA. The company assessed the causality of the events injection site pain, fever, pain in arm and feeling miserable as related due to site-specific reaction (injection site) and plausible temporal relationship between the events and the suspect vaccine.
Age: 35.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 773509) and initially retrieved on 15-Jan-2019, concerning a 35-year-old, adult, male patient. The patient's historical condition included keratoconus and tinnitus. The patient did not have any relevant allergies and current illness. The patient did not take any concomitant medications at the time of vaccination. On 11-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 ADACEL [dose, route of administration, anatomical location, batch number and expiry date: not reported] for unknown indication. On the same day, patient experienced increased tinnitus in ears. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 35-year-old male patient experienced increased tinnitus in ears on the same day after administration of suspect vaccine INN Flu Vaccine Seasonal and non-company co-suspect vaccine ADACEL. The company assessed the causality of the event, condition aggravated, as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the event and causal role of suspect vaccine cannot be ruled out. The company assessed the causality of the event, tinnitus, as not related to the suspect vaccine as the event was patient's historical condition.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 773524) and initially retrieved on 15-Jan-2019, concerning a 60-year-old adult, female patient. The patient had no allergies. The patient's current illness included gastroesophageal reflux disease (GERD), Irritable bowel syndrome (IBS) and chronic pancreatitis.  The concomitant medications included ZENPEP, hyoscyamine, PREVACID, fish oil, calcium, B12 and METAMUCIL for unknown indications. On 24-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (route of administration: injection Nos (reported as SYR), anatomical location: left arm, dose, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day after vaccination, the patient experienced pain in entire left arm extending into hand and fingers, left upper back pain, fever 101.5 (unit unspecified), body aches and extreme headache. The next day, patient experienced nausea. The outcome of the events was not recovered. The reporter assessed the case as non-serious. Reporter's Comments: A 60-year-old female patient experienced back pain, headache, injection site pain, pain, pain in extremity and fever on the same day after the administration of INN Flu Vaccine Seasonal. The patient experienced nausea the next day. 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: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 773524) and initially retrieved on 15-Jan-2019, concerning a 60-year-old adult, female patient. The patient had no allergies. The patient's current illness included gastroesophageal reflux disease (GERD), Irritable bowel syndrome (IBS) and chronic pancreatitis.  The concomitant medications included ZENPEP, hyoscyamine, PREVACID, fish oil, calcium, B12 and METAMUCIL for unknown indications. On 24-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (route of administration: injection Nos (reported as SYR), anatomical location: left arm, dose, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the same day after vaccination, the patient experienced pain in entire left arm extending into hand and fingers, left upper back pain, fever 101.5 (unit unspecified), body aches and extreme headache. The next day, patient experienced nausea. The outcome of the events was not recovered. The reporter assessed the case as non-serious. Reporter's Comments: A 60-year-old female patient experienced back pain, headache, injection site pain, pain, pain in extremity and fever on the same day after the administration of INN Flu Vaccine Seasonal. The patient experienced nausea the next day. 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: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Blood glucose decreased, Dizziness, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 773836) and initially retrieved on 15-Jan-2019, concerning a 67-year-old, elderly female patient. The patient had no historical and current conditions. The patient was allergic to sulfa drugs. The patient did not receive any concomitant medications. On 26-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location: unknown, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day the patient was also administered non-company suspect vaccine PREVNAR 13 [frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: T78674, dose and expiry date: not reported] for an unknown indication. After the flu vaccination, the patient had no complaints, however after the administration of PREVNAR 13, the patient felt light headedness. After sitting with the patient several minutes and providing her with water and crackers (as reported), the patient began to slump down while sitting, eyes rolled back, her leg was slightly twitching and experienced syncope. The reporter was able to catch the patient and the patient's husband helped to hold her while the reporter checked her pulse. The patient's pulse was fine and never had any issues in breathing or swallowing. The patient reported that, she felt shaky and thought her blood sugar was low when she regained consciousness. The patient then had another snack and left the pharmacy in a wheel chair to prevent a fall while walking to her car. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 67-year-old, female patient developed dizziness, eyes rolling, muscle twitching, blood glucose decreased, nervousness and syncope, immediately after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported events and lack of any underlying conditions, the company conservatively assessed the events as possibly related to suspect vaccine. Despite temporal association between vaccination and event of posture abnormal, the clinical course suggests the reported syncope and dizziness as a more plausible explanation for the event. Hence, the company assessed the causality as not related to suspect vaccine. However, the co-administered pneumococcal vaccine was considered noncompany co-suspect in this case. The company assessed the event syncope as serious (medically significant).
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Muscle twitching, Nervousness, Posture abnormal, Syncope, Wheelchair user
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 773836) and initially retrieved on 15-Jan-2019, concerning a 67-year-old, elderly female patient. The patient had no historical and current conditions. The patient was allergic to sulfa drugs. The patient did not receive any concomitant medications. On 26-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location: unknown, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day the patient was also administered non-company suspect vaccine PREVNAR 13 [frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: T78674, dose and expiry date: not reported] for an unknown indication. After the flu vaccination, the patient had no complaints, however after the administration of PREVNAR 13, the patient felt light headedness. After sitting with the patient several minutes and providing her with water and crackers (as reported), the patient began to slump down while sitting, eyes rolled back, her leg was slightly twitching and experienced syncope. The reporter was able to catch the patient and the patient's husband helped to hold her while the reporter checked her pulse. The patient's pulse was fine and never had any issues in breathing or swallowing. The patient reported that, she felt shaky and thought her blood sugar was low when she regained consciousness. The patient then had another snack and left the pharmacy in a wheel chair to prevent a fall while walking to her car. The outcome of the events was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 67-year-old, female patient developed dizziness, eyes rolling, muscle twitching, blood glucose decreased, nervousness and syncope, immediately after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported events and lack of any underlying conditions, the company conservatively assessed the events as possibly related to suspect vaccine. Despite temporal association between vaccination and event of posture abnormal, the clinical course suggests the reported syncope and dizziness as a more plausible explanation for the event. Hence, the company assessed the causality as not related to suspect vaccine. However, the co-administered pneumococcal vaccine was considered noncompany co-suspect in this case. The company assessed the event syncope as serious (medically significant).
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Decreased appetite, Dizziness, Fatigue, Night sweats, Pyrexia
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: 773998), concerning a 72-year-old, elderly, female patient. The patient's current condition included macular degeneration (reported as medical history). The patient was a part of age-related eye disease study (AREDS). On 24-Sep-2018, the patient was administered Influenza vaccine (dose, route of administration: unknown, anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, the patient was also administered SHINGRIX (dose, route of administration, anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, 12 hrs after vaccination, the patient began experiencing fever (body temperature 100.2/ Fahrenheit), fatigue, night sweats, loss of appetite and dizziness. The outcome of the events was not recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 72-year-old female patient experienced fever, fatigue, night sweats, loss of appetite and dizziness, 12 hrs after administration of INN Flu Vaccine and SHINGRIX. The causality of the events was assessed as related to suspect vaccine due to plausible temporal relationship between the events and suspect vaccine. The causal role of co-suspect vaccine cannot be ruled out.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This is a spontaneous case, reported by a physician to VAERS (VAERS ID: 774043) and initially retrieved on 15-Jan-2019, concerning a patient of an unspecified age and gender. On an unspecified date in the past, the patient had received an unspecified influenza vaccine and had experienced anaphylaxis. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for prophylaxis. On an unspecified date after vaccination, the patient experienced anaphylaxis. The outcome of the event was unknown. This case is linked to 201900534 (same patient). The reporter assessed this case as serious (medically significant). Reporter's Comments: A patient of unspecified age and gender experienced anaphylactic reaction, on an unspecified date after receipt of INN flu vaccine seasonal. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Considering the plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the causal role of suspect vaccine cannot be ruled out. Hence, company assessed the event as possibly related to suspect vaccine.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This is a spontaneous serious case, reported by a physician to VAERS (VAERS ID: 774043) and initially retrieved on 15-Jan-2019, concerning a patient of unknown age and gender. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unknown date, after vaccination, the patient experienced anaphylaxis. The outcome of the event was unknown. This case is linked to 201900533 (same patient). Reporter's Comments: A patient of unspecified age and gender experienced anaphylactic reaction, unspecified date after receipt of INN Flu vaccine seasonal. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Considering the plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the causal role of suspect vaccine cannot be ruled out. Hence, company assessed the event as possibly related to suspect vaccine. The company assessed this case as serious (medically significant).
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Neurological symptom
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 774083) and initially retrieved on 15-Jan-2019, concerning a 64-year-old, adult male patient. The patient's historical condition included Guillain-Barre syndrome at the age of 18. On 21-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (dose: unknown, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day after vaccination, the patient developed possible Guillain Barre Syndrome (GBS) with progressive weakness of the extremities and left sided numbness. On an unspecified date, the patient was hospitalised for 7 days. The patient was treated with intravenous immunoglobulin therapy (reported as 1 week out s/p). There was an improvement in the neurological symptoms of the patient but with residual hand and leg weakness. The patient was recovering from the events. The reporter assessed this case as serious (hospitalisation). Reporter's Comments: A 64-year-old male patient with history of Guillain Barre Syndrome (GBS), had diagnosis of GBS with symptoms starting on the same day after vaccination with INN flu vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Although the exact details regarding onset latency between vaccination to onset of symptoms to diagnosis of GBS is not mentioned, the company conservatively considered the event as related to suspect vaccine.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Nasal congestion
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 774288) and initially retrieved on 15-Jan-2019, concerning a 31-year-old, adult female patient. The patient did not have any medical history, current illness and allergies. The patient did not take any medications at the time of vaccination. On unknown dates in the past, the patient was administered Flu vaccination [unspecified, dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported] for unknown indications. On 26-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [route of administration: Injection NOS (reported as SYR), anatomical location: right arm, dose, batch number and expiry date: not reported] for an unknown indication. Right after the injection, the patient took TYLENOL as done with every previous flu vaccination in the past. On the same day after the administration of vaccine and the day after, the patient experienced swelling and extreme soreness in entire right upper arm, much greater than any previous injection. On 29-Sep-2018 (reported as three days after) the patient had extreme fatigue, full body aches, headache, nausea, nasal congestion, and low grade fever. The outcome of the events was not recovered. The reporter assessed the case as non-serious. Case re-opened for completion of full data entry: 15-Jan-2019. Reporter's Comments: A 31-year-old female patient experienced pain in arm and swelling arm on the same day and fatigue, headache, nasal congestion, nausea, ache and fever three days after the administration of INN Flu Vaccine Seasonal on right arm. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the events and suspect vaccine.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 774288) and initially retrieved on 15-Jan-2019, concerning a 31-year-old, adult female patient. The patient did not have any medical history, current illness and allergies. The patient did not take any medications at the time of vaccination. On unknown dates in the past, the patient was administered Flu vaccination [unspecified, dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported] for unknown indications. On 26-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [route of administration: Injection NOS (reported as SYR), anatomical location: right arm, dose, batch number and expiry date: not reported] for an unknown indication. Right after the injection, the patient took TYLENOL as done with every previous flu vaccination in the past. On the same day after the administration of vaccine and the day after, the patient experienced swelling and extreme soreness in entire right upper arm, much greater than any previous injection. On 29-Sep-2018 (reported as three days after) the patient had extreme fatigue, full body aches, headache, nausea, nasal congestion, and low grade fever. The outcome of the events was not recovered. The reporter assessed the case as non-serious. Case re-opened for completion of full data entry: 15-Jan-2019. Reporter's Comments: A 31-year-old female patient experienced pain in arm and swelling arm on the same day and fatigue, headache, nasal congestion, nausea, ache and fever three days after the administration of INN Flu Vaccine Seasonal on right arm. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the events and suspect vaccine.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site 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: 774428), concerning a 53-year-old, adult, male patient. The patient had no current illness. The patient historical conditions included: coronary artery disease and procedure included insertion of cardiac stent. The patient had no known allergies and current illness. The patient's concomitant medication included: Prilosec [omeprazole] for an unknown indication. On 27-Sep-2018, the patient was administered INN flu vaccine seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location: left deltoid (reported as left arm), dose, frequency, route of administration, 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 Pneumococcal Vaccine Polyvalent (pneumococcal vaccine poly V, anatomical location: left deltoid (reported as left arm), dose, frequency, route of administration, batch number and expiry date: not reported] for an unknown indication. The patient stated that, he received the pneumococcal and flu vaccine both in left deltoid (explicitly coded as vaccine administered at inappropriate site). On the next day after vaccination, the patient's left upper arm was reddened and painful. The patient states that, he received the vaccine at his work through services provided by the pharmacy. On an unspecified day, the patient made an office visit. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious.; Reporter's Comments: A 53-year-old male patient developed injection site pain and injection site redness on the next day after receiving INN flu vaccine seasonal and co-suspect vaccine: Pneumococcal vaccine polyvalent on the same arm (coded as vaccine administered at inappropriate site). The company assessed the causality of the event vaccine administered at inappropriate site as not related to the suspect vaccine due to the accidental nature of the event. The company assessed the causality of the events injection site pain and injection site redness as related due to plausible temporal relationship between suspect vaccine and the events.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS (VAERS ID: 774463) and initially retrieved on 15-Jan-2019, concerning a 2-year-old, infant, female patient. The patient had no allergies and current illness. The patient's current conditions included: Type 1 diabetes and Hashimoto's disease. The patient's concomitant medications included: insulin and UNITHROID for unknown indications. On 28-Sep-2018, the patient was administered INN Flu Vaccine Seasonal (frequency reported as 1, route of administration: intramuscular, anatomical location: right leg, dose, batch number, trade name, manufacturer and expiry date: not reported) (reported as Influenza, Quadrivalent (P-free) for an unknown indication. On the next day after vaccination, around 2 PM, the patient experienced muscle pain, headache, stomach ache, and fever. At the time of the report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Reporter's Comments: A 2-year-old, female patient developed muscle pain, headache, stomach ache and fever on the next 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: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Fatigue, Grip strength decreased, Headache, Hemiparesis
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS (VAERS ID: 774467) and initially retrieved on 15-Jan-2019, concerning 46-year-old adult female patient. The patient's medical history included irritable bowel syndrome. The patient had gluten sensitivity. The patient's concomitant medication included Multivitamin (vitamins NOS) for an unknown indication. On an unspecified date in 2015, the patient was administered an Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication and experienced severe headache, significant fatigue, blurred vision, aches and chills. On an unspecified date in Oct-2016 (reported as Thursday), the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. The patient experienced significant soreness, headache, tremor on the left hand, mild left sided (full body) weakness and was unable to walk without assistance, maintain items held in left hand or sustain left arm in a raised position and was giving out of the left knee at times marking disability. On an unspecified date in 2017, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date in 2017, after receiving the vaccine, the patient experienced severe headache, significant fatigue, blurred vision, aches and chills. The outcome of the events was not reported. This case is cross linked to 201900546 and 201900547 (same patient). Reporter's Comments: An 46-year-old female patient of developed severe headache, significant fatigue, blurred vision, aches and chills on an unspecified day after receiving INN Flu Vaccine Seasonal. The company assessed the causality of the events as unassessable due to lack of event onset latency.