chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS Id: 690923) on 10-Jul-2017, concerning a 09-year-old female patient. The subject's historical condition included asthma. On 20-Nov-2008, the patient was administered with INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose: 1 (as reported), route of administration, anatomical location, batch number, expiry date, manufacturer, trade name: not reported). On the same day, the patient was also administered with VARIVAX (dose: 1 (as reported), route of administration, anatomical location, batch number, expiry date: not reported). On 02-Jul-2016, after 7 years 7 months 13 days, the patient had herpes zoster with associated symptom such as painful unilateral rash, which lasted less than 4 week. It was unknown, whether treatment was received. The outcome of the event was recovered. Reporter's comment: The health authority assessed the report as non-serious.
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Allergy test positive, Discomfort, Food allergy, Gastrointestinal disorder, Gluten sensitivity
Clinical narrative: This initial spontaneous case received on 10-Jul-2017, via health authority (VAERS ID: 690928) reported by other non-health and concerns a 6 months old female (infant) patient. The patient had no family history of food allergy. On 25-Oct-2012, the patient was administered with INN Flu Vaccine (dose: 0 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On the same day, the patient was administered with HEXAVAX (dose:2 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer, indication was not reported), pneumococcal vaccine(dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer) and rotavirus vaccine (dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On 26-Oct-2012, after administration of INN Flu Vaccine Seasonal, the patient developed severe rash all over body and gastrointestinal issues (gi issues as reported). The patient consulted multiple doctors and no diagnosis was concluded. On an unspecified date, the patient stopped vaccinations. The event rash continued, severe itchy and uncomfortable, gastrointestinal issues persisted. Food allergy testing was performed later, the results of which were that, the patient was allergic to soy, corn, dairy, shellfish, wheat, gluten, sesame, peanut and to name a few. Outcome of the events (rash generalised, pruritus, food allergy, milk allergy, gluten sensitivity, gastrointestinal disorder, discomfort) was not recovered. The health authority assessed this case as non-serious. Significant case correction received on 26-Jul-2017: The "as determined" causality was updated from related to not related.
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Milk allergy, Pruritus, Rash generalised
Clinical narrative: This initial spontaneous case received on 10-Jul-2017, via health authority (VAERS ID: 690928) reported by other non-health and concerns a 6 months old female (infant) patient. The patient had no family history of food allergy. On 25-Oct-2012, the patient was administered with INN Flu Vaccine (dose: 0 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On the same day, the patient was administered with HEXAVAX (dose:2 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer, indication was not reported), pneumococcal vaccine(dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer) and rotavirus vaccine (dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On 26-Oct-2012, after administration of INN Flu Vaccine Seasonal, the patient developed severe rash all over body and gastrointestinal issues (gi issues as reported). The patient consulted multiple doctors and no diagnosis was concluded. On an unspecified date, the patient stopped vaccinations. The event rash continued, severe itchy and uncomfortable, gastrointestinal issues persisted. Food allergy testing was performed later, the results of which were that, the patient was allergic to soy, corn, dairy, shellfish, wheat, gluten, sesame, peanut and to name a few. Outcome of the events (rash generalised, pruritus, food allergy, milk allergy, gluten sensitivity, gastrointestinal disorder, discomfort) was not recovered. The health authority assessed this case as non-serious. Significant case correction received on 26-Jul-2017: The "as determined" causality was updated from related to not related.
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Allergy test positive, Discomfort, Food allergy, Gastrointestinal disorder, Milk allergy
Clinical narrative: This initial spontaneous case received on 10-Jul-2017, via health authority (VAERS ID: 690928) reported by other non-health and concerns a 6 months old female (infant) patient. The patient had no family history of food allergy. On 25-Oct-2012, the patient was administered with INN Flu Vaccine (dose: 0 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On the same day, the patient was administered with HEXAVAX (dose:2 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer, indication was not reported), pneumococcal vaccine(dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer) and rotavirus vaccine (dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On 26-Oct-2012, after administration of INN Flu Vaccine Seasonal, the patient developed severe rash all over body and gastrointestinal issues (gi issues as reported). The patient consulted multiple doctors and no diagnosis was concluded. On an unspecified date, the patient stopped vaccinations. The event rash continued, severe itchy and uncomfortable, gastrointestinal issues persisted. Food allergy testing was performed later, the results of which were that, the patient was allergic to soy, corn, dairy, shellfish, wheat, gluten, sesame, peanut and to name a few. Outcome of the events (rash generalised, pruritus, food allergy, milk allergy, gluten sensitivity, gastrointestinal disorder, discomfort) was not recovered. The health authority assessed this case as non-serious. Significant case correction received on 26-Jul-2017: The "as determined" causality was updated from related to not related.
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Pruritus, Rash generalised
Clinical narrative: This initial spontaneous case received on 10-Jul-2017, via health authority (VAERS ID: 690928) reported by other non-health and concerns a 6 months old female (infant) patient. The patient had no family history of food allergy. On 25-Oct-2012, the patient was administered with INN Flu Vaccine (dose: 0 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On the same day, the patient was administered with HEXAVAX (dose:2 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer, indication was not reported), pneumococcal vaccine(dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer) and rotavirus vaccine (dose: 1 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer). On 26-Oct-2012, after administration of INN Flu Vaccine Seasonal, the patient developed severe rash all over body and gastrointestinal issues (gi issues as reported). The patient consulted multiple doctors and no diagnosis was concluded. On an unspecified date, the patient stopped vaccinations. The event rash continued, severe itchy and uncomfortable, gastrointestinal issues persisted. Food allergy testing was performed later, the results of which were that, the patient was allergic to soy, corn, dairy, shellfish, wheat, gluten, sesame, peanut and to name a few. Outcome of the events (rash generalised, pruritus, food allergy, milk allergy, gluten sensitivity, gastrointestinal disorder, discomfort) was not recovered. The health authority assessed this case as non-serious. Significant case correction received on 26-Jul-2017: The "as determined" causality was updated from related to not related.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Nodule, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from Other Non-Healthcare Professional via health authority (VAERS ID: 690983) on 10-Jul-2017, concerns a 57-year-old adult female patient. Subject's concomitant medication included: unspecified blood pressure medication. On 17-Oct-2016, the subject was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 27-Oct-2016, the subject experienced pain at the spot of injection site, knot about a size of a dime was seen and upon touching at the site, the pain was unbearable. The pain from the shoulder travelled up to fingers. Patient was unable to put her arm over head as it was constantly hurting her. The patient put on heat but it didn't help. It's been 6 months and was still not better and some days she thinks it as worsened. At the time of this report, outcome of the events was not reported. The health authority assessed the report as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tenderness
Clinical narrative: This initial spontaneous case, was received from Other Non-Healthcare Professional via health authority (VAERS ID: 690983) on 10-Jul-2017, concerns a 57-year-old adult female patient. Subject's concomitant medication included: unspecified blood pressure medication. On 17-Oct-2016, the subject was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 27-Oct-2016, the subject experienced pain at the spot of injection site, knot about a size of a dime was seen and upon touching at the site, the pain was unbearable. The pain from the shoulder travelled up to fingers. Patient was unable to put her arm over head as it was constantly hurting her. The patient put on heat but it didn't help. It's been 6 months and was still not better and some days she thinks it as worsened. At the time of this report, outcome of the events was not reported. The health authority assessed the report as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from Other Non-Healthcare Professional via health authority (VAERS ID: 690983) on 10-Jul-2017, concerns a 57-year-old adult female patient. Subject's concomitant medication included: unspecified blood pressure medication. On 17-Oct-2016, the subject was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 27-Oct-2016, the subject experienced pain at the spot of injection site, knot about a size of a dime was seen and upon touching at the site, the pain was unbearable. The pain from the shoulder travelled up to fingers. Patient was unable to put her arm over head as it was constantly hurting her. The patient put on heat but it didn't help. It's been 6 months and was still not better and some days she thinks it as worsened. At the time of this report, outcome of the events was not reported. The health authority assessed the report as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Head discomfort
Clinical narrative: This non-serious initial spontaneous case, was received on 10-Jul-2017 from other non-health professional via health authority (VAERS: 691411), concerning a 56-year-old female adult patient. The patient had no current illness and medical history. The patient's concomitant medications included aspirin and vitamins, supplements taken daily. On 19-Apr-2017, the patient was vaccinated with the influenza vaccine (dose: 1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number, expiry date, trade name, manufacture name: not reported). On same day, after vaccination, the patient experienced dizziness and fullness of head. The patient drank water and rested in bed and was reported that when her head was in still position she felt fine but when she moved her head, dizziness returned. The patient slept and as soon as she woke up, the dizziness lessened but stated that she was still driven by head movement. The event dizziness was lessened over the course of time and completely recovered on 20-Apr-2017 at 17:00 hours and the event fullness of head was recovered on an unspecified date. Reporter's comment: The health authority assessed the report as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This initial spontaneous case was received from other non-health professional via health authority (VAERS Id: 691624) on 10-Jul-2017, concerning a patient of unspecified age and gender. Patient's medical history and concomitant medications was not reported. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (anatomical location, route of administration, dose, trade name, batch number, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed influenza A, considered it as a vaccination failure. Patient's laboratory data and corrective treatment were not reported. The outcome of the event was not reported. Reporter's comment: A patient experienced influenza A after receiving flu shot. This was a case of suspected vaccination failure as the information regarding confirmatory test (PCR and serology) were not reported). Time to onset was not reported and information regarding patients medical history, tolerance to previous vaccinations, ongoing medical condition and dose number of flu vaccine was also not reported. Additional information regarding PCR/serological tests would be required to further assess the case. Based upon available information the role of the vaccine can not be assessed.
Sex: F
Vaccine: MNQ, TDAP, FLUX, MEN, TDAP
Symptoms: Brain operation, Electroencephalogram, Seizure
Clinical narrative: This serious initial spontaneous case, was received via health authority (VAERS ID- 691835) on 10-Jul-2017, concerning a 11-year-old female patient. The patient had no medical history. The patient did not receive any concomitant medication. On an unspecified date, the patient was administered with influenza vaccine (route of administration: dose: 3 (as reported), intramuscular, anatomical location: arm, batch number, expiry date, manufacturer, trade name and indication: not reported). On an unspecified date, the patient was also administered with meningococcal vaccine and TDAP (route of administration: intramuscular, anatomical location: arm, dose, batch number, expiry date, manufacturer, trade name, anatomical location and indication: not reported). On 15-Aug-2013, the patient had seizures. On an unspecified date, the patient was hospitalized and stayed for 20 days (prolonged hospitalization). The patient's multiple EEGs (electroencephalogram) was performed and result was not provided. The patient underwent unspecified brain surgeries. The patient was treated with multiple medications (unspecified). The outcome of the event was not recovered. Reporter's comment: The health authority assessed the report as serious (Hospitalization and Disability).
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site dryness, Injection site erythema, Rash erythematous, Rash pruritic
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 692048) on 10-Jul-2017, concerning a 05-year-old male patient. The patient had history of similar skin-related vaccine reactions (during previous vaccinations). The patient's current condition included asthma, the concomitant medication included VENTOLIN and FLOVENT. On 07-Dec-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the subject was administered with Hepatitis A vaccine (dose: 0 route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), DTAP+IPV, (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), Measles vaccine + Mumps vaccine + Rubella vaccine + Varicella zoster vaccine (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch n umber, expiry date: not reported). On the same day evening, the patient's skin surrounding the vaccinated area, became red and raised specifically on right thigh, but also circular area 8 inches in diameter beyond the vaccine site. The red bumps worsened in the presence of warm water. AVEENO lotion was used to calm skin by minimizing bath times. One month later also rash continued and worsened on his right and left thigh. It was red, itchy, raised with pimple-like bumps (didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by the time, but stopped increasing). Nearly after five months post-vaccine the patient had dry patchy skin around the vaccine site on both legs. The right leg (more severe reaction) had the affected area about 4 inches in diameter. At the time of this report, the patient was recovering from the events. Reporter's comment: The health authority assessed the report as non-serious.
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 692048) on 10-Jul-2017, concerning a 05-year-old male patient. The patient had history of similar skin-related vaccine reactions (during previous vaccinations). The patient's current condition included asthma, the concomitant medication included VENTOLIN and FLOVENT. On 07-Dec-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the subject was administered with Hepatitis A vaccine (dose: 0 route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), DTAP+IPV, (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), Measles vaccine + Mumps vaccine + Rubella vaccine + Varicella zoster vaccine (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch n umber, expiry date: not reported). On the same day evening, the patient's skin surrounding the vaccinated area, became red and raised specifically on right thigh, but also circular area 8 inches in diameter beyond the vaccine site. The red bumps worsened in the presence of warm water. AVEENO lotion was used to calm skin by minimizing bath times. One month later also rash continued and worsened on his right and left thigh. It was red, itchy, raised with pimple-like bumps (didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by the time, but stopped increasing). Nearly after five months post-vaccine the patient had dry patchy skin around the vaccine site on both legs. The right leg (more severe reaction) had the affected area about 4 inches in diameter. At the time of this report, the patient was recovering from the events. Reporter's comment: The health authority assessed the report as non-serious.
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash erythematous, Vaccination site dryness
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 692048) on 10-Jul-2017, concerning a 05-year-old male patient. The patient had history of similar skin-related vaccine reactions (during previous vaccinations). The patient's current condition included asthma, the concomitant medication included VENTOLIN and FLOVENT. On 07-Dec-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the subject was administered with Hepatitis A vaccine (dose: 0 route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), DTAP+IPV, (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), Measles vaccine + Mumps vaccine + Rubella vaccine + Varicella zoster vaccine (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch n umber, expiry date: not reported). On the same day evening, the patient's skin surrounding the vaccinated area, became red and raised specifically on right thigh, but also circular area 8 inches in diameter beyond the vaccine site. The red bumps worsened in the presence of warm water. AVEENO lotion was used to calm skin by minimizing bath times. One month later also rash continued and worsened on his right and left thigh. It was red, itchy, raised with pimple-like bumps (didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by the time, but stopped increasing). Nearly after five months post-vaccine the patient had dry patchy skin around the vaccine site on both legs. The right leg (more severe reaction) had the affected area about 4 inches in diameter. At the time of this report, the patient was recovering from the events. Reporter's comment: The health authority assessed the report as non-serious.
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 692048) on 10-Jul-2017, concerning a 05-year-old male patient. The patient had history of similar skin-related vaccine reactions (during previous vaccinations). The patient's current condition included asthma, the concomitant medication included VENTOLIN and FLOVENT. On 07-Dec-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the subject was administered with Hepatitis A vaccine (dose: 0 route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), DTAP+IPV, (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch number, expiry date: not reported), Measles vaccine + Mumps vaccine + Rubella vaccine + Varicella zoster vaccine (dose: 0, route of administration: SYR (as reported), anatomical location: leg, batch n umber, expiry date: not reported). On the same day evening, the patient's skin surrounding the vaccinated area, became red and raised specifically on right thigh, but also circular area 8 inches in diameter beyond the vaccine site. The red bumps worsened in the presence of warm water. AVEENO lotion was used to calm skin by minimizing bath times. One month later also rash continued and worsened on his right and left thigh. It was red, itchy, raised with pimple-like bumps (didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by the time, but stopped increasing). Nearly after five months post-vaccine the patient had dry patchy skin around the vaccine site on both legs. The right leg (more severe reaction) had the affected area about 4 inches in diameter. At the time of this report, the patient was recovering from the events. Reporter's comment: The health authority assessed the report as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pruritus generalised
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 692156) on 10-Jul-2017, concerning a female patient of unspecified age. The patient's current condition included bipolar disorder, depression, loss of weight, pre-cancerous cells and the concomitant medications included XYZAL for respiratory allergic conditions. No other concomitant medications were reported. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration (SYR, as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, following the vaccination, the patient developed redness in the face and itching all over. Lab data and corrective treatment were not reported. The outcome of the events was not reported. The health authority assessed the report as non-serious. Significant case correction received on 26-Jul-2017: The "as determined causality" of the events was updated from related to unassessable.
Age: 6.0
Sex: M
Vaccine: DTAP, FLUX, DTAP, FLUX
Symptoms: Administration site pain, Administration site swelling, Injection site erythema
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 692225) on 10-Jul-2017, concerning a 6-year-old male patient. On 07-Apr-2017, the patient was administered with INN Flu Vaccine Seasonal "trade name, batch number, manufacturer: not reported" (anatomical location: left arm, route of administration: intramuscular and dose: 1 (as reported)). On the same day, the patient was administered with DTAP (anatomical location: left arm, route of administration: intramuscular and dose: 2 (as reported)). On 08-Apr-2017, the patient experienced redness, swelling and pain at the administration site. The outcome of the events was recovered. Reporter's comment: The health authority assessed the report as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Induration, Pain, Pyrexia, Swelling, Tremor
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 692513) on 10-Jul-2017, concerning a 52-year-old female patient. The patient's historical condition included possible lupus. The patient had no current illness. On 27-Apr-2017, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer, trade name and indication: not reported) and Pneumococcal vaccine polyvalent (dose, route of administration, anatomical location, batch number, expiry date and indication: not reported). On the same day, after vaccination, the patient experienced fever, swelling, whole body pain and felt hard travelled towards his elbow, under arm and inside armpit with body shakes. The outcome of the events was not recovered. The health authority assessed the report as non-serious. Significant case correction received on 26-Jul-2017: The event- description as reported was changed for the events from "pain/whole body pain" to "Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes, fever whole body pain", "swelling" to "Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes" and "induration" to "Pain swelling, hard traveling towards elbow, under arm and inside armpit with body shakes". The "as determined causality" was changed from related to unassessable.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Pyrexia, Swelling, Tremor
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 692513) on 10-Jul-2017, concerning a 52-year-old female patient. The patient's historical condition included possible lupus. The patient had no current illness. On 27-Apr-2017, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer, trade name and indication: not reported) and Pneumococcal vaccine polyvalent (dose, route of administration, anatomical location, batch number, expiry date and indication: not reported). On the same day, after vaccination, the patient experienced fever, swelling, whole body pain and felt hard travelled towards his elbow, under arm and inside armpit with body shakes. The outcome of the events was not recovered. The health authority assessed the report as non-serious. Significant case correction received on 26-Jul-2017: The event- description as reported was changed for the events from "pain/whole body pain" to "Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes, fever whole body pain", "swelling" to "Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes" and "induration" to "Pain swelling, hard traveling towards elbow, under arm and inside armpit with body shakes". The "as determined causality" was changed from related to unassessable.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise, Pharyngitis streptococcal, Seizure, Syncope
Clinical narrative: This initial serious spontaneous case was received via health authority from other non-health professional (VAERS ID: 693292) on 19-Jul-2017, concerning a 10-year-old male patient. Patient's medical history and current conditions were reported as none. On 11-Nov-2016, the patient was administered with INN Flu Vaccine Seasonal (anatomical location, route of administration (reported as: SYR), dose, trade name, batch number, manufacturer: not reported). Prior to the occurrence of the event, the patient was in good health. On the same day after vaccination, the patient felt sick for several weeks. On an unspecified date in January, the patient started fainting when he developed streptococcal pharyngitis (as reported: strep). On an unspecified date in March, the patient started experiencing full of seizures. Outcome of the events was not recovered. Reporter's comment: The health authority assessed the events as non-serious.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: This is non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID; 693961) on 19-Jul-2017, concerning a 33-year-old male patient. The patient's medical history, current illness and concomitant medications were not reported. On an unspecified date, the patient was administered with INN (anatomical location, route of administration, dose, trade name, batch number, manufacture: not reported) for an unknown indication. On an unspecified date, after the vaccination, the patient had nausea and vomiting. These details were provided by the patient to a medical centre, when he declined the influenza vaccine as he experienced these events in the past to influenza vaccination. The details about when these side effects occurred was not provided. Since the patient stated that he had adverse event from influenza vaccine, the primary care physician entered as an allergy into system. The outcome of the events was recovered. The health authority assessed the report as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Crying, Eyelid oedema, Lip swelling
Clinical narrative: This initial spontaneous case, was received on 19-Jul-2017 via health authority (VAERS ID: 694197), reported by other non-health professional and concerns a 5-year-old female patient. Patient's medical history and current illness was not reported. On 01-Aug-2016, the patient received INN Flu Vaccine Seasonal (dose: 2 (as reported), route of administration, anatomical site, batch number, trade name, manufacturer was not reported). On 12-May-2017, 9 months 12 days, after administration of INN Flu Vaccine Seasonal, it was reported that, after returning from the airport, at 2:30 pm, one of the parent noticed the patient lying on the floor in the living room and crying. Both the eyes of the patient were swollen very badly, eyes closed and not able to open. Her lips were also swollen. On 13-May-2017 (Saturday), in the afternoon, the patient's eyes were swollen shut and lips as well. It was reported that, the patient would consult a holistic doctor. Outcome of the events crying, eyelid oedema and lip swelling was not yet recovered. The health authority assessed this case as non-serious.
Sex: M
Vaccine: DTAP, FLUX, HEPA, DTAP, FLUX, HEPA
Symptoms: Erythema, Hypersomnia, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious initial spontaneous case was received from other non health professional via health authority (VAERS ID: 694198) on 19-Jul-2017, concerning a male patient of age 18 months (1.50, as reported). The patient had no current illness and medical history. The patient's concomitant medications included: TYLENOL for unknown indication. On 12-May-2107, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, subject was administered with DTaP and Hepatitis A vaccine whose dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). The patient developed large hives and rash around his left armpit stretching over ribcage and also large hives was randomly presented on his arms and legs. The injected leg also had large rash all around it. The patient's belly button had a bright red pimply rash and his ears turned bright red and warm. The patient was quite lethargic, (thought due to exhaustion) and slept for several hours more than normal. The patient used BENADRYL and within 24 hours most of the symptoms had gone down. His hives were much improved, but the injected leg remained swollen, covered with rash and warmth. It was reported that he was still a bit "off" and sleeps more than usual, even without the BENADRYL. Following the reaction, a very weak streptococcus test returned positive. The patient was not recovered from the events injection site swelling, injection site rash, Injection site warmth, hypersomnia and was still recovering from all other events and the outcome for the event streptococcus test returned positive was unknown. Health authority assessed this report as non-serious. Significant case correction received on 11-Aug-2017: As determined listedness for the event (Injection site warmth) was corrected from listed to unlisted in flu vaccine egg subunit+MF59 NVD and unlisted to listed in flu vaccine egg subunit NVD.
Sex: M
Vaccine: DTAP, FLUX, HEPA, DTAP, FLUX, HEPA
Symptoms: Lethargy, Rash, Rash erythematous, Skin warm, Streptococcus test positive
Clinical narrative: This non-serious initial spontaneous case was received from other non health professional via health authority (VAERS ID: 694198) on 19-Jul-2017, concerning a male patient of age 18 months (1.50, as reported). The patient had no current illness and medical history. The patient's concomitant medications included: TYLENOL for unknown indication. On 12-May-2107, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, subject was administered with DTaP and Hepatitis A vaccine whose dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). The patient developed large hives and rash around his left armpit stretching over ribcage and also large hives was randomly presented on his arms and legs. The injected leg also had large rash all around it. The patient's belly button had a bright red pimply rash and his ears turned bright red and warm. The patient was quite lethargic, (thought due to exhaustion) and slept for several hours more than normal. The patient used BENADRYL and within 24 hours most of the symptoms had gone down. His hives were much improved, but the injected leg remained swollen, covered with rash and warmth. It was reported that he was still a bit "off" and sleeps more than usual, even without the BENADRYL. Following the reaction, a very weak streptococcus test returned positive. The patient was not recovered from the events injection site swelling, injection site rash, Injection site warmth, hypersomnia and was still recovering from all other events and the outcome for the event streptococcus test returned positive was unknown. Health authority assessed this report as non-serious. Significant case correction received on 11-Aug-2017: As determined listedness for the event (Injection site warmth) was corrected from listed to unlisted in flu vaccine egg subunit+MF59 NVD and unlisted to listed in flu vaccine egg subunit NVD.
Sex: M
Vaccine: DTAP, FLUX, HEPA, DTAP, FLUX, HEPA
Symptoms: Urticaria
Clinical narrative: This non-serious initial spontaneous case was received from other non health professional via health authority (VAERS ID: 694198) on 19-Jul-2017, concerning a male patient of age 18 months (1.50, as reported). The patient had no current illness and medical history. The patient's concomitant medications included: TYLENOL for unknown indication. On 12-May-2107, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, subject was administered with DTaP and Hepatitis A vaccine whose dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). The patient developed large hives and rash around his left armpit stretching over ribcage and also large hives was randomly presented on his arms and legs. The injected leg also had large rash all around it. The patient's belly button had a bright red pimply rash and his ears turned bright red and warm. The patient was quite lethargic, (thought due to exhaustion) and slept for several hours more than normal. The patient used BENADRYL and within 24 hours most of the symptoms had gone down. His hives were much improved, but the injected leg remained swollen, covered with rash and warmth. It was reported that he was still a bit "off" and sleeps more than usual, even without the BENADRYL. Following the reaction, a very weak streptococcus test returned positive. The patient was not recovered from the events injection site swelling, injection site rash, Injection site warmth, hypersomnia and was still recovering from all other events and the outcome for the event streptococcus test returned positive was unknown. Health authority assessed this report as non-serious. Significant case correction received on 11-Aug-2017: As determined listedness for the event (Injection site warmth) was corrected from listed to unlisted in flu vaccine egg subunit+MF59 NVD and unlisted to listed in flu vaccine egg subunit NVD.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Joint crepitation, Sleep disorder
Clinical narrative: This initial spontaneous case received from other non-health care professional, via regulatory authority (VAERS ID: 695134) on 09-Aug-2017, concerning a 44-year-old male patient. The patient had no relevant medical history. The patient's concomitant medications included ADDERALL and omeprazole. On 26-Oct-2016, the patient had received influenza vaccine (dose: (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day, after vaccination, the patient had a dull pain at injection site. Pain was extreme when slept on the left side and kept him awake until the pain subsides (reported as about 1 hour after he moved to right shoulder), which happened every night. On some unspecified date, after 2 months, the symptoms had worsened. The patient also had minor popping/crackling sounds when rotating his arm. The patient mentioned that he consulted doctor on an unspecified date in January. On an unspecified date, the patient felt more pain than usual and experienced pain in upper left arm. The outcome of the events was not recovered. The health authority assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 695261) on 09-Aug-2017, concerning a 29-year-old female patient. The patient had no current illness. The patient's concomitant medication included citalopram for an unknown indication. On 29-Sep-2016, the patient was administered with INN Flu Vaccine (route of administration: intramuscular, anatomical location: right arm, dose, batch number, manufacturer, trade name and expiry date: not reported). On the same day, immediately after the vaccine, the patient had a throbbing pain in her right upper arm, where the shot was given. It was reported that, the patient had a constant pain in her right upper arm since vaccination and was unable to move her arm straight above her shoulder without hurting. She received OTC (over the counter), pain medications and was prescribed muscle relaxers, which did not help the patient. The outcome of the event was not recovered. The health authority assessed the report as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Mobility decreased, Musculoskeletal pain
Clinical narrative: This non-serious initial spontaneous case was received via health authority (VAERS ID: 695828) on Aug-2017, concerning a 32-year-old female patient. The patient was pregnant in the past. The patient had no current illness. Concomitant medication included: CELEXA for unknown indication. On 24-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: 3 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On 28-Feb-2017, 4 days after vaccination, the patient experienced soreness in shoulder/persistent shoulder soreness, limited mobility and loss of strength. It was reported, that the patient was scheduled to visit physical medicine department on 30-May-2017. Outcome of the events was not reported. Health authority assessed this report as non-serious.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult female patient. The patient had no problem with food/egg or insects and other immunizations. On 01-Oct-2014, the patient received INN (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name manufacturer and indication was not reported). On the same day, the patient noticed red, watery, itchy eyes and throat within one to two hours of vaccination. No swelling was observed and the patient could swallow. It was reported that, the patient had no cough, wheezing, rashes or GI symptoms. The symptoms lasted for one day and cleared on its own without medical attention or medication. It was reported that, the patient completely recovered from the events (eye pruritus, lacrimation increased, ocular hyperemia and throat irritation). The health authority assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Throat irritation
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult female patient. The patient had no problem with food/egg or insects and other immunizations. On 01-Oct-2014, the patient received INN (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name manufacturer and indication was not reported). On the same day, the patient noticed red, watery, itchy eyes and throat within one to two hours of vaccination. No swelling was observed and the patient could swallow. It was reported that, the patient had no cough, wheezing, rashes or GI symptoms. The symptoms lasted for one day and cleared on its own without medical attention or medication. It was reported that, the patient completely recovered from the events (eye pruritus, lacrimation increased, ocular hyperemia and throat irritation). The health authority assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Throat irritation
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult female patient. The patient had no problem with food/egg or insects and other immunizations. On 01-Oct-2014, the patient received INN (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name manufacturer and indication was not reported). On the same day, the patient noticed red, watery, itchy eyes and throat within one to two hours of vaccination. No swelling was observed and the patient could swallow. It was reported that, the patient had no cough, wheezing, rashes or GI symptoms. The symptoms lasted for one day and cleared on its own without medical attention or medication. It was reported that, the patient completely recovered from the events (eye pruritus, lacrimation increased, ocular hyperemia and throat irritation). The health authority assessed the case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult female patient. The patient had no problem with food/egg or insects and other immunizations. On 01-Oct-2014, the patient received INN flu vaccine seasonal and within one to two hours of vaccination, the patient noticed red, watery, itchy eyes and throat. These symptoms lasted for one day and cleared on its own without medical attention or medication. On an unspecified date in 2015, the patient received influenza virus vaccine polyvalent (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name, manufacturer and indication was not reported). On the same day, within one hour after vaccination, the patient noticed mild itchy eyes without any discharge or redness and had mild itchy throat. No swelling or rashes were observed. The symptoms lasted for a day, cleared on its own without any medication attention or medication. On an unspecified date in 2015, the patient completely recovered from the events (eye pruritus, throat irritation). The health authority assessed the events (eye pruritus, throat irritation) as non-serious.