chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Pain in arm at the injection site; This is a spontaneous case, initially received from pharmacist via Med Communication (reference number: SEQ20-00086) on 07-Jan-2020, concerning a 39-year-old, male patient.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not reported.  On 03-Dec-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261234, expiration date: 30-Jun-2020, anatomical location: arm, route of administration: not reported] for influenza prophylaxis.  On the same day, after receiving the vaccine, the patient developed pain in arm at the injection site.  At the time of this report, the patient did not recover from the event of pain in arm at the injection site.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: The event of pain in arm at the injection site was considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of pain in arm at the injection site was considered as related to Flucelvax Quadrivalent.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Emotional distress, Incorrect dose administered, Product use issue
Clinical narrative: Child was traumatized; Patient has only received half a dose, 0.25 ml of the Flucelvax Quadrivalent vaccine; Pharmacist was not able to push the vaccine all the way down; This is a spontaneous case, reported by a pharmacist to Med Communications (reference number: SEQ20-00089) on 07-Jan-2020, concerning a 12-year-old male patient.   The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 06-Jan-2020, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261219, expiry date: 30-Jun-2020, dose: 0.25 ml, route of administration: intramuscular, anatomical location: leg muscle] for prevention of seasonal influenza. The patient received half a dose because the pharmacist had not been able to push the vaccine all the way down (explicitly coded as Product use issue' and  Incomplete dose administered').  On the same day, after vaccine administration, re-administration was tried, but the patient was traumatized and because of that he did not receive the second half of a full dose.  At the time of initial reporting the outcome of 'emotional distress' was not reported.  This case was assessed as non serious.  The reporter did not provide the causality assessment to Flucelvax Quadrivalent.  Company comment: The patient experienced emotional distress after incorrect dose administered and the suspect product Flucelvax Quadrivalent use issue. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event emotional distress is assessed as related. Incorrect dose administered and product use issue were assessed as not related per company's conventions.; Sender's Comments: The patient experienced emotional distress after incorrect dose administered and the suspect product Flucelvax Quadrivalent use issue. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event emotional distress is assessed as related. Incorrect dose administered and product use issue were assessed as not related per company's conventions.
Sex: M
Vaccine: FLUA3
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Malaise
Clinical narrative: Got sick; This is a spontaneous case, reported by other non health professional (consumer) to Med Communications (reference number: SEQ20-00262) on 16-Jan-2020, concerning a male patient of unknown age.   The patient's medical history and concomitant medications were not provided.  On 17-Sep-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On 09-Jan-2020, 3 months and 23 days after Fluad administration, the patient got sick.  On an unspecified day in Jan-2020, the patient performed flu tests for A and B strains and the results for both strains were negative.  At the time of this report, the outcome of sickness was not reported.  The reporter did not provide causality assessment to Fluad (TIV).  This case is linked to case 202000168 due to the same reporter.  Case comment: The event of sickness was assessed as related to Fluad (TIV).; Sender's Comments: The event of sickness was assessed as related to Fluad (TIV).
Age: 4.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: After receiving the vaccine, the patient contracted flu; This is a spontaneous case, initially received from other health professional (nurse) via Agency (reference number: SEQ20-00291) on 17-Jan-2020, concerning a 4-year-old female patient.   The patient's medical history and concomitant medications were not reported.    On 17-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261204; expiry date: 26-Jun-2020; dose: 0.5 ml; route of administration: intramuscular; anatomical location: left arm deltoid] as influenza prophylaxis.   On 16-Jan-2020, approximately three months after vaccination, the patient contracted flu and was treated with Tamiflu (oseltamivir phosphate).  At the time of initial reporting, the outcome of event was not resolved.   The event of flu was considered serious due to the criterion of medical significance.   The reporter did not provide causality assessment.  Company comment: The patient experienced influenza three months after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza three months after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza B virus test positive, Malaise, Pyrexia
Clinical narrative: Influenza string B; This is a spontaneous case from initially received from other health professional (nurse) via agency (reference number: SEQ20-00382) on 27-Jan-2020, concerning a 9-year-old, female patient.   The patient's medical history was not provided. The patient had no concomitant medications.  On 28-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261204, and expiration date: 26-Jun-2020] for prevention of seasonal influenza.  On the same day, after vaccination, the patient underwent testing and was positive for influenza, string B. On 26-Jan-2020, the diagnosis was confirmed with symptoms of feeling sick and fever. The patient received a prescription for Tamiflu (oseltamivir phosphate).  At the time of this report, the outcome for the event of influenza, string B, was not reported.   Per company, the event of influenza, string B, was assessed as serious due to the criterion od medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced influenza on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is not compatible because the incubation period for flue is between one and four days. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as not related.; Sender's Comments: The patient experienced influenza on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is not compatible because the incubation period for flue is between one and four days. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as not related.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Broke out in hives; This is a spontaneous case initially received from other non-health professional via Med Communications (reference number: SEQ20-00433) on 29-Jan-2020 concerning a 74-year-old, male patient.   The patient's medical history included heart surgery, triple bypass and arthritis.   The patient's concomitant medications included atorvastatin, metoprolol, lisinopril, aspirin (acetylsalicylic acid), loratadine, cimetidine, hydroxyzine, Humira (adalimumab) and vitamin D, all used for unknown indications.   On 19-Sep-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number and expiry date: not reported] for prevention of seasonal influenza.    On the same day, the patient broke out in hives and it had affected him ever since, as reported.   The patient had taken antihistamines and prednisolone as a treatment.   At the time of the reporting, the patient did not recover from the event.  The case is linked with 202001402 (same reporter).   Company comment: The event of hives is considered as related to Fluad TIV.; Sender's Comments: The event of hives is considered as related to Fluad TIV.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Cough, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Flu like symptoms; Fever; Feeling unwell; Headache; Hip and shoulder pain; Body ache; Hip and shoulder pain; Got lots of phlegm in throat and a cough; This is a spontaneous case, reported by other non-health professional to Med Communications (reference number: SEQ20-00435) and initially received on 29-Jan-2020, concerning a 59-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included Vitamin D (non-specified) for unknown indication.  On 26-Jan-2020, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, batch number: 261200, expiration date: 30-Jun-2020, route of administration and anatomical location: not reported] for influenza prophylaxis.  On the same day, immediately after vaccination, the patient started feeling unwell, got lots of phlegm and cough, and had to continually clear her throat.   On 27-Jan-2020, one day after vaccination, the patient developed fever, typical flu like symptoms, headache, body ache, hip and shoulder pain. The patient went to the pharmacist, and also to her physician, who tested her for the flu. The test results were negative. The patient stated that she was feeling a bit better.  At the time of the initial reporting, the outcome of all events was not reported.   The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient experienced productive cough, pain, musculoskeletal pain, influenza like illness, headache, arthralgia, malaise and pyrexia after vaccination with the suspect product, Flucelcax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced productive cough, pain, musculoskeletal pain, influenza like illness, headache, arthralgia, malaise and pyrexia after vaccination with the suspect product, Flucelcax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza virus test negative, Malaise, Musculoskeletal pain, Pain, Productive cough
Clinical narrative: Flu like symptoms; Fever; Feeling unwell; Headache; Hip and shoulder pain; Body ache; Hip and shoulder pain; Got lots of phlegm in throat and a cough; This is a spontaneous case, reported by other non-health professional to Med Communications (reference number: SEQ20-00435) and initially received on 29-Jan-2020, concerning a 59-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included Vitamin D (non-specified) for unknown indication.  On 26-Jan-2020, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, batch number: 261200, expiration date: 30-Jun-2020, route of administration and anatomical location: not reported] for influenza prophylaxis.  On the same day, immediately after vaccination, the patient started feeling unwell, got lots of phlegm and cough, and had to continually clear her throat.   On 27-Jan-2020, one day after vaccination, the patient developed fever, typical flu like symptoms, headache, body ache, hip and shoulder pain. The patient went to the pharmacist, and also to her physician, who tested her for the flu. The test results were negative. The patient stated that she was feeling a bit better.  At the time of the initial reporting, the outcome of all events was not reported.   The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient experienced productive cough, pain, musculoskeletal pain, influenza like illness, headache, arthralgia, malaise and pyrexia after vaccination with the suspect product, Flucelcax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced productive cough, pain, musculoskeletal pain, influenza like illness, headache, arthralgia, malaise and pyrexia after vaccination with the suspect product, Flucelcax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms; Fever; Feeling unwell; Headache; Hip and shoulder pain; Body ache; Hip and shoulder pain; Got lots of phlegm in throat and a cough; This is a spontaneous case, reported by other non-health professional to Med Communications (reference number: SEQ20-00435) and initially received on 29-Jan-2020, concerning a 59-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included Vitamin D (non-specified) for unknown indication.  On 26-Jan-2020, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, batch number: 261200, expiration date: 30-Jun-2020, route of administration and anatomical location: not reported] for influenza prophylaxis.  On the same day, immediately after vaccination, the patient started feeling unwell, got lots of phlegm and cough, and had to continually clear her throat.   On 27-Jan-2020, one day after vaccination, the patient developed fever, typical flu like symptoms, headache, body ache, hip and shoulder pain. The patient went to the pharmacist, and also to her physician, who tested her for the flu. The test results were negative. The patient stated that she was feeling a bit better.  At the time of the initial reporting, the outcome of all events was not reported.   The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient experienced productive cough, pain, musculoskeletal pain, influenza like illness, headache, arthralgia, malaise and pyrexia after vaccination with the suspect product, Flucelcax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced productive cough, pain, musculoskeletal pain, influenza like illness, headache, arthralgia, malaise and pyrexia after vaccination with the suspect product, Flucelcax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: Diarrhoea; Fever; Patient has been feeling poorly; Sick; Headaches; Stomach pains; Body aches; This is a spontaneous case, reported by other non-health professional (consumer) to Med Communications (reference number: SEQ20-00530) on 05-Feb-2020, concerning a 43-year-old female patient.   The patient's medical history and concomitant medications were not provided.  On 09-Dec-2019, the patient was administered unspecified flu vaccine seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiry date: not reported) for prevention of seasonal influenza.  On the same day, after vaccination, the patient started to be sick. She was feeling poorly and developed stomach pain, diarrhoea, fever and headache.  On an unspecified day in Dec-2019, approximately a week and a half after vaccination, the patient started to have body aches.  Tamiflu (oseltamivir phosphate) was prescribed by patient's physician as a treatment for the events.  At the time of this report, the outcome of all events was not resolved. It was reported that the patient was still experiencing the symptoms of the events.  The case was assessed as non-serious.  The reporter did not provide causality assessment to unspecified flu vaccine seasonal.  Company comment: The patient experienced abdominal pain upper, pyrexia, diarrhoea, feeling abnormal, malaise and headache on the same day after receiving unspecified flu vaccine seasonal. The patient also developed pain (body aches) a week later. Chronology is plausible. More information regarding medical history is needed. With information available, causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: The patient experienced abdominal pain upper, pyrexia, diarrhoea, feeling abnormal, malaise and headache on the same day after receiving unspecified flu vaccine seasonal. The patient also developed pain (body aches) a week later. Chronology is plausible. More information regarding medical history is needed. With information available, causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Diarrhoea; Fever; Patient has been feeling poorly; Sick; Headaches; Stomach pains; Body aches; This is a spontaneous case, reported by other non-health professional (consumer) to Med Communications (reference number: SEQ20-00530) on 05-Feb-2020, concerning a 43-year-old female patient.   The patient's medical history and concomitant medications were not provided.  On 09-Dec-2019, the patient was administered unspecified flu vaccine seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiry date: not reported) for prevention of seasonal influenza.  On the same day, after vaccination, the patient started to be sick. She was feeling poorly and developed stomach pain, diarrhoea, fever and headache.  On an unspecified day in Dec-2019, approximately a week and a half after vaccination, the patient started to have body aches.  Tamiflu (oseltamivir phosphate) was prescribed by patient's physician as a treatment for the events.  At the time of this report, the outcome of all events was not resolved. It was reported that the patient was still experiencing the symptoms of the events.  The case was assessed as non-serious.  The reporter did not provide causality assessment to unspecified flu vaccine seasonal.  Company comment: The patient experienced abdominal pain upper, pyrexia, diarrhoea, feeling abnormal, malaise and headache on the same day after receiving unspecified flu vaccine seasonal. The patient also developed pain (body aches) a week later. Chronology is plausible. More information regarding medical history is needed. With information available, causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: The patient experienced abdominal pain upper, pyrexia, diarrhoea, feeling abnormal, malaise and headache on the same day after receiving unspecified flu vaccine seasonal. The patient also developed pain (body aches) a week later. Chronology is plausible. More information regarding medical history is needed. With information available, causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Flu swab tested positive for A strain; This is a spontaneous case, initially received from other health professional (nurse) via Company on 11-Feb-2020, concerning a 27-year old male patient.   The patient's current condition included asthma.   The patient's concomitant medications were not provided.   On 10-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0,5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261204 and expiration date: 26-Jun-2020] for influenza prophylaxis.    On 10-Feb-2020, the patient's flu swab was tested positive for A strain. The patient received Tamiflu (oseltamivir phosphate) as treatment medication.    At the time of this report, the outcome of the event was unknown.  The reporter did not provide causality assessment.  The event of flu' was assessed as serious due to criterion of medical significance, per company.  Company Comment: The event flu' was assessed as related to Flucelvax QIV.  Company comment: The patient developed Influenza after Flucelvax QIV was administered. Reportedly, four months after vaccination the patient's flu swab was tested positive for A strain. This is considered as lack of efficacy. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed Influenza after Flucelvax QIV was administered. Reportedly, four months after vaccination the patient's flu swab was tested positive for A strain. This is considered as lack of efficacy. Based on provided information, causal role of the suspect product is assessed as related.
Sex: M
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: Influenza; This is a spontaneous case, reported by other non-health professional to agency (reference number: SEQ20-00601) on 12-Feb-2020, concerning a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On 10-Oct-2019 at 15:45, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: right deltoid, batch number: 261204, dose and expiry date: not reported) for prevention of seasonal influenza.  On 10-Feb-2020, approximately four months after vaccination, the patient developed influenza although he received the vaccine.  On 13-Feb-2020, the patient fully recovered from influenza.   Per company, the event of influenza was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Follow up information received from other non-health professional on 13-Mar-2020: Additional reporter added. Flucelvax QIV details added [start date, route of administration, anatomical location and batch number]. The event of influenza updated [start and stop date added; outcome changed from not reported to recovered]. Narrative amended accordingly.   Company comment: The patient developed Influenza four months after vaccination with Flucelvax QIV. Chronology seems plausible. More information regarding medical history and diagnostic findings is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed Influenza four months after vaccination with Flucelvax QIV. Chronology seems plausible. More information regarding medical history and diagnostic findings is needed. Based on provided information, causal role of the suspect product is assessed as related.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash, Rash pruritic
Clinical narrative: Rashes with bumps starting on her legs and now on her belly, armpits /very itchy; Rashes with bumps starting on her legs and now on her belly, armpits /very itchy; This is a spontaneous case, reported from other non-health professional) via Med Communications (reference number: SEQ20-00615) on 13-Feb-2020, concerning a 71-year-old, female patient.  The patient's medical history included high cholesterol and allergies to neomicin and thimerosal.   The patient's concomitant medications included rosuvastatin, calcium, Fibercon (polycarbophil calcium), Baby aspirin (acetylsalicylic acid), iron and Centrum (unspecified minerals and vitamins) for an unknown indication.  On 10-Dec-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 260387 and expiry date: 30-Apr-2020] for an unknown indication.  On 31-Jan-2020, one month and 21 days after vaccination, the patient experienced rash on her legs which spread on belly and armpits and was very itchy. The patient visited a doctor who prescribed triamcinolone steroid cream for rash.  At the time of initial reporting, the outcome of events was not resolved.  This case was assessed as non-serious.  The reporter did not provide causality assessment to Fluad (TIV).  Company comment: The events of rash and pruritus was considered as related to the Fluad (TIV).; Sender's Comments: The events of rash and pruritus was considered as related to the Fluad (TIV).
Age: 10.0
Sex: U
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: Patient received Flucelvax Quadrivalent after temperature excursion; Patient received Flucelvax Quadrivalent after temperature excursion; This is a spontaneous case, initially received from other health professional via Med Communications (reference number: SEQ20-00509) on 14-Feb-2020, concerning a 10-year old patient of unspecified gender.   The patient's medical history and concomitant medications were not reported.   On an unknown date in 2019, the sticker on the box that contained Flucelvax Quadrivalent vaccine [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261228 and expiry date: not reported] turned red and showed that storage temperature was out of range, but it did not indicate when temperature excursion happened and how long it lasted. The first temperature excursion was confirmed (explicitly coded as Product storage error').  On 10-Nov-2019, there was another excursion at 10.9 degrees Celsius for undetermined time, potentially five hours.  On 11-Nov-2019, the patient was administered Flucelvax Quadrivalent [anatomical location: left deltoid, dose and route of administration,expiration date: not reported] for an unknown indication after temperature excursion (explicitly coded as Product administration error').  It was not reported whether the patient experienced an adverse event due to Flucelvax Quadrivalent administration.   This case is linked to cases 201907258, 202001725, 202001745, 202001746, 202001747, 202001748, 202001749, 202001750, 202001752, 202001753, 202001754, 202001755, 202001756, 202001757, 202001758, 202001759, 202001760, 202001761, 202001762, 202001763, 202001764, 202001765, 202001766, 202001767, 202001768, 202001769, 202001770, 202001771 and 202001772 (the same reporter).   Company comment: Reportedly, the patient was administered the suspect product Flucelvax Quadrivalent after two temperature excursions. It was not reported whether the patient experienced an adverse event. Product storage error and product administration error are assessed as not related per company's conventions.; Sender's Comments: Reportedly, the patient was administered the suspect product Flucelvax Quadrivalent after two temperature excursions. It was not reported whether the patient experienced an adverse event. Product storage error and product administration error are assessed as not related per company's conventions.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: Diagnozed with influenza strain A; This is a spontaneous case reported by other health professional (nurse) to Company (reference number: SEQ20-00664) and initially received on 18-Feb-2020, concerning a 44-year-old, female patient.  The patient did not have any medical history.  The patient did not take any concomitant medications.  On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, batch number: 261204, expiration date: 26-Jun-2020 and route of administration: intramuscular) as influenza prophylaxis.  On 10-Feb-2020, the patient was diagnosed with influenza strain A. The patient went to doctor and received Tamiflu (oseltamivir phosphate).  At the time of this report, the patient was recovering from the event.  The event of influenza was considered as serious due to criterion of medical significance, per company.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.  The case is linked to the case 202001856 due to same reporter.  Company comment: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: Diagnozed with influenza strain A; This is a spontaneous case , initially received from other health professional (nurse) via agency (reference number: SEQ20-00663) on 18-Feb-2020, concerning a 56-year-old, female patient.  The patient's current condition included diabetes.   The patient's concomitant medications were not provided.  On 10-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, batch number: 261204, expiration date: 26-Jun-2020 and route of administration: intramuscular) as influenza prophylaxis.  On 16-Feb-2020, 4 months and 6 days after vaccination, the patient was diagnosed with influenza strain A. The patient received Tamiflu (oseltamivir phosphate) as treatment medication.  At the time of this report, the patient did not recover from the event of influenza'.  The event of influenza' was assessed as serious due to criterion of medical significance, per company.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.   This case is linked to 2020001854 due to same reporter.  Company comment: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. Medical history of diabetes may have contributed to development of the event. No concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. Medical history of diabetes may have contributed to development of the event. No concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain, Chills, Dysphagia, Influenza, Malaise
Clinical narrative: Influenza B-strain/influenza A-strain; This is a spontaneous case reported by physician to agency (reference number: SEQ20-00662) and initially received on 18-Feb-2020, concerning a 18-year-old, male patient.  The patient's relevant medical history and concomitant medications were not reported.   On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, batch number: 261207, expiration date: Jun-2020 and anatomical location: not reported,) for prevention of seasonal influenza.  On 10-Jan-2020, 3 months and 2 days after the vaccination, the patient was diagnosed with influenza, B-strain.  On an unspecified date, after the first time the patient was diagnosed with influenza Tamiflu (oseltamivir) was prescribed.  On 12-Feb-2020, 4 months and 4 days after the vaccination, the patient was admitted to accidents and emergency (A&E) two times in that day, with abdominal pains, severe throat pain, difficulty swallowing, fever and chills. The patient was diagnosed with influenza A-strain.  At the time of this report, the patient had not recovered from the event of 'flu', it was reported that the patient was still sick with influenza.  The events of 'flu' was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: The patient experienced influenza 3 months and 2 days after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza 3 months and 2 days after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Influenza B-strain/influenza A-strain; This is a spontaneous case reported by physician to agency (reference number: SEQ20-00662) and initially received on 18-Feb-2020, concerning a 18-year-old, male patient.  The patient's relevant medical history and concomitant medications were not reported.   On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, batch number: 261207, expiration date: Jun-2020 and anatomical location: not reported,) for prevention of seasonal influenza.  On 10-Jan-2020, 3 months and 2 days after the vaccination, the patient was diagnosed with influenza, B-strain.  On an unspecified date, after the first time the patient was diagnosed with influenza Tamiflu (oseltamivir) was prescribed.  On 12-Feb-2020, 4 months and 4 days after the vaccination, the patient was admitted to accidents and emergency (A&E) two times in that day, with abdominal pains, severe throat pain, difficulty swallowing, fever and chills. The patient was diagnosed with influenza A-strain.  At the time of this report, the patient had not recovered from the event of 'flu', it was reported that the patient was still sick with influenza.  The events of 'flu' was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: The patient experienced influenza 3 months and 2 days after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza 3 months and 2 days after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Difficulty to lift right arm; Stiffness in right arm; Pain in right arm; This is a spontaneous case, initially received from other health professional (pharmacist) via Med Communications (reference number: SEQ20-00692) on 19-Feb-2020, concerning a 71-year-old, female patient.   The patient's medical history included that the patient received unspecified flu vaccine, Prevnar 13 (pneumococcal 13v conjugate vaccine) and Zostavax (varicella zoster vaccine live) in 2018 and no adverse events were reported after vaccines.  The patient's concomitant medications were not provided.   On 12-May-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, route of administration: intramuscularly (IM), anatomical location: left arm (LA), batch number: P100112490, expiry date: 11-Jun-2020 and dose: not reported) for unknown indication.  On the same day, the patient was administered Pneumovax 23 [pneumococcal vaccine polysacch 23v, route of administration: intramuscularly (IM), anatomical location: right arm (RA), batch number: R034248, expiry date and dose: not reported) to complete the pneumonia series recommendation.  On the same day, the patient experienced pain and stiffness in her arm. Patient was advised to use ice and take ibuprofen for the pain.   On unspecified date, the patient's pain subsided, but the arm was stiff, and it was difficult to move arm, two months later.   On unspecified day in Feb-2020, the patient visited physician who ordered physical therapy.  On 19-Feb-2020, the physician stated pain and stiffness were in the right arm.  On unspecified date, the outcome of event 'pain in arm' was resolved.  At the time of this report, the outcome of events 'stiffness' and 'mobility decreased' was not resolved.  The reporter did not provide the causality assessment to Afluria Quadrivalent.  Company comment: The patient experienced mobility decreased, musculoskeletal stiffness and pain in extremity after vaccination with the suspect product, Afluria Quadrivalent given in the left arm. Chronology is plausible. Non-company co-suspect vaccine Pneumovax 23 (pneumococcal vaccine polysacch 23v) was given in the right arm and on that arm, events appeared. Since these were localised events, causality between suspect product and the events is assessed as not related.; Sender's Comments: The patient experienced mobility decreased, musculoskeletal stiffness and pain in extremity after vaccination with the suspect product, Afluria Quadrivalent given in the left arm. Chronology is plausible. Non-company co-suspect vaccine Pneumovax 23 (pneumococcal vaccine polysacch 23v) was given in the right arm and on that arm, events appeared. Since these were localised events, causality between suspect product and the events is assessed as not related.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: Tested positive for string B of the flu after receiving the vaccine; This is a spontaneous case, initially received from other health professional (nurse) via agency (reference number: SEQ20-00724) on 25-Feb-2020, concerning a 56-year-old, male patient.   The patient's relevant medical history and concomitant medications were not reported.   On 10-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, batch number: 261204, expiration date: 26-Jun-2020, anatomical location: not reported] as prevention of seasonal influenza.  On the same day, after receiving the vaccine, the patient was tested positive for string B of the flu. The patient was prescribed anti influenza medicine Zona flu, as reported, however, it was unknown if the patient started treatment.  At the time of initial reporting, the patient was recovered from the event of influenza B virus infection'.   The event of influenza B virus infection' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 56-year-old male patient experienced influenza after vaccination with the suspect product Flucelvax QIV. Reportedly, on the same day after receiving the vaccine, the patient was tested positive for string B of the flu. Chronology seeems plausible. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as possibly related to the event.; Sender's Comments: A 56-year-old male patient experienced influenza after vaccination with the suspect product Flucelvax QIV. Reportedly, on the same day after receiving the vaccine, the patient was tested positive for string B of the flu. Chronology seeems plausible. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as possibly related to the event.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Agitation, Arthralgia, Cough, Influenza like illness, Lacrimation increased
Clinical narrative: Flu like symptoms; Sneezing; Watery eyes; Cough; Drainage; Body pain; Agitated; Viciously sick / Feeling sick; Fever; Joint pain; This is a spontaneous case, reported by a non-health professional to Med Communications (reference number: SEQW20-00138) on 12-Mar-2020, concerning a 63-year-old female patient.   The patient's medical history and concomitant medications were not provided.  On 18-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported] for influenza prophylaxis. After vaccination, the patient was fine.  On an unspecified date, an unknown amount of time after vaccination, the patient developed flu-like symptoms, sneezing, cough, watery eyes, drainage, fever, body pain and joint pain. It was reported that the patient got viciously sick/ was feeling sick. The patient did not see a physician and did not have any treatment.  At the time of this report, the patent was agitated.The outcome of the events was resolving as it was reported that the patient was feeling better.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 63-year-old female patient developed influenza like illness, sneezing, lacrimation increased, cough, rhinotthoea, pain, agitation, malaise, pyrexia and arthralgia after vaccination with the suspect product Flucelvax Quadrivalent for influenza prophylaxis.  Reportedly, an unknown amount of time after vaccination the patient developed. Chronology needs more clarification. At the time of this report, the patent was agitated. The patient's medical history and concomitant medications were not provided. With information presented, causality is assessed as possibly related for all events.; Sender's Comments: A 63-year-old female patient developed influenza like illness, sneezing, lacrimation increased, cough, rhinotthoea, pain, agitation, malaise, pyrexia and arthralgia after vaccination with the suspect product Flucelvax Quadrivalent for influenza prophylaxis.  Reportedly, an unknown amount of time after vaccination the patient developed. Chronology needs more clarification. At the time of this report, the patent was agitated. The patient's medical history and concomitant medications were not provided. With information presented, causality is assessed as possibly related for all events.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Pain, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Flu like symptoms; Sneezing; Watery eyes; Cough; Drainage; Body pain; Agitated; Viciously sick / Feeling sick; Fever; Joint pain; This is a spontaneous case, reported by a non-health professional to Med Communications (reference number: SEQW20-00138) on 12-Mar-2020, concerning a 63-year-old female patient.   The patient's medical history and concomitant medications were not provided.  On 18-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported] for influenza prophylaxis. After vaccination, the patient was fine.  On an unspecified date, an unknown amount of time after vaccination, the patient developed flu-like symptoms, sneezing, cough, watery eyes, drainage, fever, body pain and joint pain. It was reported that the patient got viciously sick/ was feeling sick. The patient did not see a physician and did not have any treatment.  At the time of this report, the patent was agitated.The outcome of the events was resolving as it was reported that the patient was feeling better.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 63-year-old female patient developed influenza like illness, sneezing, lacrimation increased, cough, rhinotthoea, pain, agitation, malaise, pyrexia and arthralgia after vaccination with the suspect product Flucelvax Quadrivalent for influenza prophylaxis.  Reportedly, an unknown amount of time after vaccination the patient developed. Chronology needs more clarification. At the time of this report, the patent was agitated. The patient's medical history and concomitant medications were not provided. With information presented, causality is assessed as possibly related for all events.; Sender's Comments: A 63-year-old female patient developed influenza like illness, sneezing, lacrimation increased, cough, rhinotthoea, pain, agitation, malaise, pyrexia and arthralgia after vaccination with the suspect product Flucelvax Quadrivalent for influenza prophylaxis.  Reportedly, an unknown amount of time after vaccination the patient developed. Chronology needs more clarification. At the time of this report, the patent was agitated. The patient's medical history and concomitant medications were not provided. With information presented, causality is assessed as possibly related for all events.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Injection site mass, Irritability
Clinical narrative: six days post vaccination, there is a large lump at injection site. warm and cold compresses has been applied since vaccination. my child is irritable from the lump. This is his third dose of this vaccine and has all required vaccines to date. He has not reacted to any vaccine such as this.