chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Muscular weakness, Pain, Tremor, Vision blurred
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.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Walking aid user
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.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Fatigue, Headache, Pain, Vision blurred
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.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Fatigue, Grip strength decreased, Headache, Hemiparesis
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 774467) and initially retrieved on 15-Jan-2019, concerning an adult female patient of an unspecified age. On an unspecified date in 2015, 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 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 was cross-linked to the cases: 201900548 and 201900546 due to same patient. Reporter's Comments: An adult female patient experienced headache, significant fatigue, blurred vision, aches and chills, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality was unassessable due to lack of information regarding onset latency of the events.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Muscular weakness, Pain, Tremor, Vision blurred
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 774467) and initially retrieved on 15-Jan-2019, concerning an adult female patient of an unspecified age. On an unspecified date in 2015, 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 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 was cross-linked to the cases: 201900548 and 201900546 due to same patient. Reporter's Comments: An adult female patient experienced headache, significant fatigue, blurred vision, aches and chills, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality was unassessable due to lack of information regarding onset latency of the events.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Walking aid user
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 774467) and initially retrieved on 15-Jan-2019, concerning an adult female patient of an unspecified age. On an unspecified date in 2015, 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 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 was cross-linked to the cases: 201900548 and 201900546 due to same patient. Reporter's Comments: An adult female patient experienced headache, significant fatigue, blurred vision, aches and chills, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality was unassessable due to lack of information regarding onset latency of the events.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Fatigue, Headache, Pain, Vision blurred
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 774467) and initially retrieved on 15-Jan-2019, concerning an adult female patient of an unspecified age. On an unspecified date in 2015, 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 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 was cross-linked to the cases: 201900548 and 201900546 due to same patient. Reporter's Comments: An adult female patient experienced headache, significant fatigue, blurred vision, aches and chills, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality was unassessable due to lack of information regarding onset latency of the events.
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 01-Jan-2019 by Seqirus from VAERS (VAERS ID: 775017), concerning a male child patient of unspecified age. On an unspecified date, the patient was administered INN flu vaccine seasonal [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported] for an unknown indication. On an unspecified date, after vaccination, the patient's arm became red, swollen and warm. The outcome of the events was not reported. This case is linked to 201900079 due to same patient. Reporter's Comments: A male patient of unspecified age developed skin warm, redness and swelling arm on an unspecified date after administration of INN flu vaccine seasonal. The company assessed the causality of the events as unassessable, due to the lack of onset latency.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous case from, reported by other non-health professional to VAERS (VAERS ID: 776446) and initially retrieved on 18-Jan-2019, concerning an elderly female patient of an unspecified age. The patient had influenza vaccine in the past for an unknown indication and developed bump or redness at the injection site. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, route of administration: injection (reported as SYR), dose, anatomical location: unknown, batch number, expiry date, trade name and manufacturer: not reported] for prophylaxis. On an unspecified date after vaccination, the patient developed injection site erythema and injection site swelling. The outcome of the events was unknown. The reporter assessed the case as non-serious. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Influenza vaccine. Reporter's Comments: An elderly female patient of an unspecified age developed injection site erythema and injection site swelling, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality of the events was unassessable due to lack of information on onset latency.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS (VAERS ID: 776446) and initially retrieved on 18-Jan-2019, 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 developed a bump or redness at the injection site. The outcome of the events was not reported. This case was linked to the case: 201900591 (same patient). Reporter's Comments: A female patient of an unspecified age developed a lump and redness at the injection site, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality of the events was unassessable due to lack of information regarding onset latency.
Age: 32.0
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 776803) and initially retrieved on 18-Jan-2019, concerning a 32-year-old, adult patient of an unspecified gender. The patient was allergic to ibuprofen. The concomitant medication included prenatal vitamins for unknown indication. On 21-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [dose: unknown, route of administration: injection (reported as SYR), anatomical location: arm, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On the same day after vaccination, the patient was not being able to lift arm. The outcome of the event was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 32-year-old adult patient of an unspecified gender was not being able to lift arm on the same day after the administration of INN Flu Vaccine Seasonal. The company assessed the causality as related due to plausible temporal relationship between the suspect vaccine and the event.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This is a spontaneous case, reported by a pharmacist to VAERS (VAERS ID: 776855) and initially retrieved on 18-Jan-2019, concerning a female patient of unspecified age. On an unspecified date (reported as years ago), the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported) for prophylaxis. On an unspecified date, after the vaccination, the patient got really sick. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious and considered the causality of the event as related to the suspect vaccine. Reporter's Comments: A female patient of unknown age experienced sickness after an unspecified period of time after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information regarding the vaccination date and onset latency of the event.
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: This is a non-serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 01-Jan-2019 by Seqirus from VAERS (VAERS ID: 777140), concerning a female 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, expiry date, manufacturer and trade name: not reported] for an unknown indication. On an unspecified date, after vaccination, the patient experienced little swelling and recovered from it. The outcome of the event was recovered on an unspecified date. Reporter's Comments: A female patient of unspecified age developed swelling on an unspecified date after administration of INN flu vaccine seasonal. The company assessed the causality of the event as unassessable, due to the lack of onset latency.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 777294), concerning an elderly patient (age 84 or 85 years, as reported) male patient. On 28-Sep-2018, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for unknown indication. On the same day, at 3 pm, the patient also administered SHINGRIX (dose: reported as 2, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported) for prophylaxis. On 02-Oct-2018, 4 days after vaccination, the patient experienced pain in arm where SHINGRIX was administered. The patient's injected arm was sore when he raised it. It was reported that the patient was aware about a possible side effect but stated that he was surprised that it started 4 days after he received the SHINGRIX. The patient was referred to healthcare professional. The outcome of the events was not recovered. The reporter assessed this case as non-serious. Reporter's Comments: An elderly male patient experienced pain in arm and pain upon movement, 4 days after administration of suspect vaccine INN Flu Vaccine and co-suspect vaccine SHINGRIX. The company assessed the causality of the events as not related, as the events occurred on the left arm where co-suspect SHINGRIX was administered.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Enuresis, Micturition urgency, Paralysis
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 777372) and initially retrieved on 18-Jan-2019, concerning a 77-year-old, elderly male patient. The patient was a former smoker and did not have any known drug allergy (NKDA). The concomitant medications included Aspirin, carvedilol, finasteride, furosemide, isosorbide mononitrate ER, lisinopril, tizanidine, ergocalciferol, oxycodone-acetaminophen, potassium chloride, allopurinol, pravastatin sodium, glimepiride, KEFLEX, gabapentin, PLAVIX and pravasta (as reported) for unknown indications. On 13-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [route of administration, anatomical location; unknown, dose, batch number, expiry date, trade name, manufacturer: not reported] and non-company suspect vaccine Zoster (route of administration, anatomical location: unknown, dose, batch number, expiry date: not reported] for unknown indications. On 14-Sep-2018, 1 day after vaccination, patient woke up around midnight with an urge to urinate and felt paralyzed and was too weak to get up. The patient wet the bed several times before regaining enough strength to get up and remained weak for 24 hours. The outcome of the events was recovered on an unspecified in 2018. The reporter assessed the case as non-serious. Reporter's Comments: A 77-year-old male patient experienced paralysis with weakness one day after vaccination with INN flu vaccine and Zoster vaccine (co-suspect). Considering the plausible temporal relationship between vaccination to paralysis, the company assessed causality of paralysis as related to suspect vaccine and zoster vaccine was considered as co-suspect. The elderly patient was already on treatment with finasteride, indicating possibility of benign prostatic hypertrophy. Hence, the event urinary urgency was assessed as not related to suspect vaccine. The event enuresis can be explained by paralysis and urinary urgency, hence considered not related to suspect vaccine. The company assessed the case as serious (medically significant).
Age: 78.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Somnolence
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 777465), concerning a 78-year-old, elderly female patient. On 05-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [dose, anatomical location, route of administration, batch number, trade name, manufacturer and expiry date: not reported] for prophylaxis. The patient was also administered non-company suspect vaccine SHINGRIX [dose (reported as 1), anatomical location, route of administration, batch number and expiry date: not reported] for prophylaxis. On 06-Sep-2018, 1 day after vaccination (reported as next day morning), the patient experienced decreased appetite, sleepiness and upset stomach. The patient experienced the symptoms for one full day. On an unspecified date, the outcome of the events (decreased appetite, sleepiness and upset stomach) were recovered. The patient also reported that the events were related to SHINGRIX vaccine. On an unspecified date, the outcome of the events was recovered. The reporter assessed this case as non-serious. Reporter's Comments: A 78-year-old female patient experienced abdominal discomfort, decreased appetite and sleepiness, one day after vaccination with suspect vaccine INN flu vaccine seasonal and co-suspect SHINGRIX vaccine. The company assessed the causality of the events as related considering the plausible temporal relationship between the events and the suspect vaccine. The causal role of the suspect vaccine cannot be rule out.
Sex: M
Vaccine: FLUX
Symptoms: Alopecia
Clinical narrative: This is a non-serious spontaneous case reported by other health professional to VAERS (VAERS ID: 777488) initially retrieved on 28-Dec-2018, concerning an infant male patient of an 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 hair loss (alopecia) which was in just small circle. The outcome of the event was not reported. This case is cross-linked to the case: 201806309 (same patient). Reporter's Comments: An infant male patient of an unspecified age experienced hair loss, unspecified days after the administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information regarding onset latency.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose, Headache, Influenza virus test, Loss of consciousness, Pulmonary function test
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 777574) and initially retrieved on 18-Jan-2019, concerning a 06-year-old, male child. The patient's current condition included Streptococcus sore throat and was allergic to tobacco. On 10-Oct-2018, the patient was administered INN Flu Vaccine Seasonal [route of administration: injection (reported as SYR), anatomical location: right arm, dose: unknown, batch number, manufacturer, trade name and expiry date: not reported] for an unknown indication. On the same day after vaccination, the patient experienced headache ache and passed out. The patient also experienced fever all night and the next day. The patient was taken to emergency room (ER) twice. On unspecified dates, flu swab, respiratory test, streptococcus test and sugar test were performed, and the results were not reported. The patient had not recovered from the events. The reporter assessed the case as non-serious. Reporter's Comments: A 6-year-old male patient with concurrent medical condition Streptococcus sore throat experienced headache, fever and loss of consciousness, on the same day after receipt of INN Flu vaccine seasonal. Considering the plausible temporal relationship between vaccination and reported events and plausible systemic response to vaccine, the causality of suspect vaccine cannot be ruled out. Hence, company assessed the events as possibly related to suspect vaccine. The underlying Streptococcus sore throat is considered as the confounding factor. The company assessed the event 'loss of consciousness' as serious (medically significant).
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Streptococcus test
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 777574) and initially retrieved on 18-Jan-2019, concerning a 06-year-old, male child. The patient's current condition included Streptococcus sore throat and was allergic to tobacco. On 10-Oct-2018, the patient was administered INN Flu Vaccine Seasonal [route of administration: injection (reported as SYR), anatomical location: right arm, dose: unknown, batch number, manufacturer, trade name and expiry date: not reported] for an unknown indication. On the same day after vaccination, the patient experienced headache ache and passed out. The patient also experienced fever all night and the next day. The patient was taken to emergency room (ER) twice. On unspecified dates, flu swab, respiratory test, streptococcus test and sugar test were performed, and the results were not reported. The patient had not recovered from the events. The reporter assessed the case as non-serious. Reporter's Comments: A 6-year-old male patient with concurrent medical condition Streptococcus sore throat experienced headache, fever and loss of consciousness, on the same day after receipt of INN Flu vaccine seasonal. Considering the plausible temporal relationship between vaccination and reported events and plausible systemic response to vaccine, the causality of suspect vaccine cannot be ruled out. Hence, company assessed the events as possibly related to suspect vaccine. The underlying Streptococcus sore throat is considered as the confounding factor. The company assessed the event 'loss of consciousness' as serious (medically significant).
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 777652), concerning a female patient of unspecified age. On an unspecified date, the patient was administered INN flu vaccine seasonal (route of administration: injection NOS (reported as SYR), anatomical location: unknown, dose, batch number, trade name, manufacturer and expiry date: not reported) for immunization. The patient was also administered non-company suspect vaccine PREVNAR 13 (route of administration: injection NOS (reported as SYR), anatomical location: unknown, dose, batch number and expiry date: not reported) for immunization. It was reported that both the vaccines were administered at the same site (explicitly coded as drug administration error). On an unspecified date, after vaccination the patient experienced redness and pain on touching. The outcome of the events redness and tenderness was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A female patient of unspecified age experienced redness and tenderness on an unspecified day after administration of the suspect vaccine INN Flu Vaccine Seasonal and co-suspect vaccine PREVNAR 13 in the same site. The causality of the events redness and tenderness was taken as unassessable due to lack of information regarding the onset latency of the events. The company assessed the causality of the event drug administration error as not related to the suspect vaccine considering the accidental nature of the event.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 778211), concerning a female patient of an unspecified age. The patient always responded to the shots by experiencing a sore arm within 24 to 48 hours after vaccination. On an unspecified day, the patient was administered INN flu vaccine seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) for prophylaxis. On an unspecified day (reported as less than a week), after vaccination, the patient experienced pain in arm. The patient had recovered from the event. The reporter assessed the case as non-serious.; Reporter's Comments: A female patient of unspecified age with a history of pain in arn after unspecified shots, experienced pain in arm less than a week after receiving INN flu vaccine seasonal. The company assessed the causality of the event as related due to plausible temporal relationship between the event and suspect vaccine.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 778226) and initially retrieved on 18-Jan-2019, concerning a 56-year-old, adult female patient. On 29-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, dose: unknown, route of administration, anatomical location, batch number, manufacturer, trade name, expiry date: not reported] for an unknown indication. On the same day after vaccination, the patient experienced extreme chills, vomiting and headache for 24 hours. The patient also experienced muscle ache and joint pain and felt almost like a severe flu. The outcome of the events was not reported. The reporter assessed the case as non-serious. Reporter's Comments: A 56-year-old, female patient experienced extreme chills, vomiting, headache, muscle ache, joint pain and flu like illness on the same day after the administration of INN Flu Vaccine Seasonal. The company assessed the causality of the events as related due to plausible temporal relationship between the events and the suspect vaccine.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 778226) and initially retrieved on 18-Jan-2019, concerning a 56-year-old, adult female patient. On 29-Sep-2018, the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, dose: unknown, route of administration, anatomical location, batch number, manufacturer, trade name, expiry date: not reported] for an unknown indication. On the same day after vaccination, the patient experienced extreme chills, vomiting and headache for 24 hours. The patient also experienced muscle ache and joint pain and felt almost like a severe flu. The outcome of the events was not reported. The reporter assessed the case as non-serious. Reporter's Comments: A 56-year-old, female patient experienced extreme chills, vomiting, headache, muscle ache, joint pain and flu like illness on the same day after the administration of INN Flu Vaccine Seasonal. The company assessed the causality of the events as related due to plausible temporal relationship between the events and the suspect vaccine.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Influenza like illness
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 778329), concerning a 61-year-old, adult female patient. On 17-Sep-2018, at 02:30, the patient was administered INN flu vaccine seasonal [route of administration and anatomical location: unknown, dose, batch number, expiry date, manufacturer and trade name: not reported] for an unknown indication and on the same day, the patient was administered non-company suspect product Varicella Zoster vaccine live [dose: (frequency reported as 1) route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported] for prophylaxis. On the same day, after vaccination, the patient experienced sore arm, pain in arm and headache. A couple of hours later, the patient experienced body aches, general body pain, fatigue, shivering. It was reported that less than a day after SHINGRIX vaccine, the patient felt like flu. The patient was on bed for 24 hours. Approximately 24 hours after, the patient was recovered from all the symptoms. The patient felt very cold when she went to bed and had to put on socks and blankets. The outcome of the events was recovered on an unknown date. The reporter assessed this case as non-serious. Reporter's Comments: A 61-year-old female patient developed pain in arm and influenza like illness, on the same day after administration of INN flu vaccine seasonal and Varicella zoster vaccine live. 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. The Varicella zoster vaccine live is considered as co-suspect.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 778329), concerning a 61-year-old, adult female patient. On 17-Sep-2018, at 02:30, the patient was administered INN flu vaccine seasonal [route of administration and anatomical location: unknown, dose, batch number, expiry date, manufacturer and trade name: not reported] for an unknown indication and on the same day, the patient was administered non-company suspect product Varicella Zoster vaccine live [dose: (frequency reported as 1) route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported] for prophylaxis. On the same day, after vaccination, the patient experienced sore arm, pain in arm and headache. A couple of hours later, the patient experienced body aches, general body pain, fatigue, shivering. It was reported that less than a day after SHINGRIX vaccine, the patient felt like flu. The patient was on bed for 24 hours. Approximately 24 hours after, the patient was recovered from all the symptoms. The patient felt very cold when she went to bed and had to put on socks and blankets. The outcome of the events was recovered on an unknown date. The reporter assessed this case as non-serious. Reporter's Comments: A 61-year-old female patient developed pain in arm and influenza like illness, on the same day after administration of INN flu vaccine seasonal and Varicella zoster vaccine live. 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. The Varicella zoster vaccine live is considered as co-suspect.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 778563), concerning a 57-year-old, adult female patient. The patient's historical vaccine included flu vaccine. The patient had no current illness but was allergic to sulfa drugs. On 10-Oct-2018, the patient was administered INN flu vaccine seasonal (dose, route of administration and anatomical location: unknown, frequency, batch number, trade name, manufacturer and expiry date: not reported) for an unknown indication. On the next day, after vaccination, the patient developed generalized urticaria without shortness of breath (reported as SOB). At the time of the report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 57-year-old female patient developed generalized urticaria on the next 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.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 778630), concerning a 68-year-old elderly female patient. The patient's historical vaccine included flu vaccine and experienced sore arm. On an unspecified day, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location: unknown, frequency, batch number, trade name, manufacturer and expiry date: not reported) for prophylaxis. On an unspecified day, after vaccination, the patient experienced pain in arm. The outcome of the event was unknown. The reporter assessed the case as non-serious. Reporter's Comments: A 68-year-old female patient with a history of sore arm after flu vaccination, experienced pain in arm on an unspecified day after receiving INN flu vaccine seasonal. The company assessed the causality of the event as unassessable due to lack of onset latency between the vaccination and the event.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case reported by other non-healthcare professional to VAERS and initially retrieved on 18-Jan-2019 by Seqirus from VAERS (VAERS ID: 778630), concerning a female patient of an 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 soreness in arm. At the time of this report, the outcome of the event was not reported. The reporter assessed the case as non-serious. This case is cross-linked to the case: 201900615 (same patient).; Reporter's Comments: A female patient of unspecified age experienced soreness in arm on an unspecified day after receiving INN flu vaccine seasonal. The causality of the event was unassessable due to lack of onset latency.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 779194) and initially retrieved on 18-Jan-2019, concerning a 04-year-old, child female patient. On an unknown date, the patient was administered INN Flu Vaccine Seasonal (anatomical location: thigh, dose, frequency, route of administration, batch number and expiry date were not reported) for an unknown indication. On an unspecified date after vaccination, the patient developed severe injection site swelling, erythema, pain and induration. The patient's mother took the patient for evaluation to her paediatrician and conservative management was recommended. The patient did not have any systemic allergic symptoms. The swelling, erythema, pain, and induration subsided within 5 days and the outcome of the events was reported as recovering. The reporter assessed the case as non-serious. This case is linked to 201900617 owing to same patient. Reporter's Comments: A 04-year-old female patient developed Injection site reaction on an unspecified period after administration of suspect vaccine INN Flu Vaccine Seasonal. The company assessed the causality of the events as related considering plausible temporal relationship between events and suspect vaccine and vaccination site specific reactions.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Back pain, Dyspnoea, Injection site pain, Neck pain
Clinical narrative: This is a non-serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 01-Jan-2019 by Seqirus from VAERS (VAERS ID: 780006), concerning a 46-year-old, adult, male patient. The patient's medical history included sleep apnoea and no relevant allergies were reported. The patient reported that he got flu shot annually without exception and never experienced any symptoms in the past. The concomitant medications included possible oral candidiasis and concomitant medications included ZANTAC, ZYRTEC, fish oil, glucosamine/chondroitin, anti-candida supplement (as reported) for unknown indication. On 15-Oct-2018, the patient was administered Influenza Vaccine (reported as quadrivalent vaccine) (dose: reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number, frequency, trade name, manufacturer and expiry date: not reported) for unknown indication. On 16-Oct-2018, 1 day after vaccination, the patient reported that he experienced severe pain in the upper left shoulder and back, near the base of the neck. On 17-Oct-2018, at night, the patient experienced shortness of breath and reported that his lungs felt clear, but he felt some resistance while breathing deeply. Also, slight soreness in the abdomen and right lung was observed. The patient complained that he got winded suddenly when he tried to jog even a short distance and while he walked fast. The outcome of the events was not recovered.  The reporter assessed this case as non-serious. Reporter's Comments: A 46-year-old, male patient experienced back pain, neck pain and injection site pain, 1 day after vaccination and shortness of breath, abdominal pain and pulmonary pain, 2 days after vaccination with INN Flu Vaccine Seasonal. The company assessed the causality of the events as related considering the plausible temporal relationship between event and suspect vaccine.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Pulmonary pain
Clinical narrative: This is a non-serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 01-Jan-2019 by Seqirus from VAERS (VAERS ID: 780006), concerning a 46-year-old, adult, male patient. The patient's medical history included sleep apnoea and no relevant allergies were reported. The patient reported that he got flu shot annually without exception and never experienced any symptoms in the past. The concomitant medications included possible oral candidiasis and concomitant medications included ZANTAC, ZYRTEC, fish oil, glucosamine/chondroitin, anti-candida supplement (as reported) for unknown indication. On 15-Oct-2018, the patient was administered Influenza Vaccine (reported as quadrivalent vaccine) (dose: reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number, frequency, trade name, manufacturer and expiry date: not reported) for unknown indication. On 16-Oct-2018, 1 day after vaccination, the patient reported that he experienced severe pain in the upper left shoulder and back, near the base of the neck. On 17-Oct-2018, at night, the patient experienced shortness of breath and reported that his lungs felt clear, but he felt some resistance while breathing deeply. Also, slight soreness in the abdomen and right lung was observed. The patient complained that he got winded suddenly when he tried to jog even a short distance and while he walked fast. The outcome of the events was not recovered.  The reporter assessed this case as non-serious. Reporter's Comments: A 46-year-old, male patient experienced back pain, neck pain and injection site pain, 1 day after vaccination and shortness of breath, abdominal pain and pulmonary pain, 2 days after vaccination with INN Flu Vaccine Seasonal. The company assessed the causality of the events as related considering the plausible temporal relationship between event and suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Pruritus
Clinical narrative: This is a non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 01-Jan-2019 by Seqirus from VAERS (VAERS ID: 780721), concerning a female patient of unspecified age. On an unspecified date, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, frequency, trade name, manufacturer and expiry date: not reported for an unknown indication. On an unspecified date after vaccination, the patient experienced mild pruritus and rash at injection site. The outcome of the events was not reported. This case is linked to 201900244 reported in same patient. Reporter's Comments: A female patient of unspecified age experienced pruritus and rash at injection site, on an unspecified date after vaccination with INN Flu Vaccine Seasonal. The causality of the events was taken as unassessable due to lack of onset latency.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 01-Jan-2019 by Seqirus from VAERS (VAERS ID: 780812), concerning a female patient of unspecified age. The patient was allergic to thiomersal (since an unspecified date). On an unspecified date, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported for an unknown indication. On an unspecified date, after vaccination, the patient experienced swelling, redness and hot to touch. The outcome of the events was not reported. The reporter assessed this case as non-serious. This case is linked to 201900256 due to same patient. Reporter's Comments: A female patient of unspecified age developed skin warm, redness and swelling on an unspecified date after administration of INN flu vaccine seasonal. The company assessed the causality of the events as unassessable, due to the lack of onset latency.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This is a serious spontaneous case reported by other non-health professional to VAERS and initially retrieved on 01-Jan-2019, concerning a male patient of unspecified age. On an unspecified date, 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 an unspecified date, after taking flu shot the patient experienced flu. The outcome of the event was not reported. This case is linked to 201900038 (same patient). Reporter's Comments: A male patient of unspecified age experienced flu, unspecified period after receipt of INN flu vaccine. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event company assessed the causality as unassessable. The company assessed the event 'flu' as serious (medically significant).