chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Sinusitis, Tinnitus
Clinical narrative: This medically confirmed health authority report (initial receipt 21-Apr-2016) concerns a 23 year old male patient. The patient has no medical history and had no illness at the time of vaccination. On 05-Feb-2015, the patient received an intramuscular injection of AFLURIA (batch number: not reported). Four days after receiving the injection, the patient began to experience a sore throat which progressed into a sinus infection by the next day and lasted for five days. On day 6, the patient began to experience dizziness, tinnitus, fever and aching joints. The night of day 7 the fever worsened at night and then broke and disappeared over the course of the next day, along with the joint aches and dizziness. On the 8th day the patient noticed an unidentified rash on the outer pinna of both ears that has continued without abate until the present (day 11). The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. VAERS ID: 622860.
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 25 year old female patient. The patient has no medical history and had no concomitant medications and no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 13-Aug-2015-unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Site: Left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 13-Aug-2015, 1 day after starting / treatment with AFLURIA the patient experienced Arm was incredibly painful the same night (non serious, outcome: Not Recovered / Not Resolved), lt (arm) felt stiff (non serious, outcome: Not Recovered / Not Resolved), lt (arm) hurt to move it (non serious, outcome: Not Recovered / Not Resolved), Thought my bicep was going to explode (non serious, outcome: Not Recovered / Not Resolved). Lab data: X-rays. Reporter's assessment: Non serious. Listedless: According to the Reference Safety Information, the events Arm was incredibly painful the same night, lt (arm) felt stiff, lt (arm) hurt to move it and Thought my bicep was going to explode are unlisted events of AFLURIA. Case Causality: Possible.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) 62 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surround the onset of reaction(s)/event(s): The patient received AFLURIA on 15-Feb-2016 - unknown stop date, Batch no: U50509, Route of administration: Intramuscular. Dose: 0.5 ml, site: right arm. Additional suspect drug(s): ZOSTAVAX, batch number L034726, route of administration: subcutaneous, site: left arm. Reaction(s)/event(s) and outcome: On 15-Feb-2016, 1 day after receiving AFLURIA the patient experienced warm, red, itchy area local to the injection site. The patient was advised to watch careful and take diphenhydramine. The outcome was unknown. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 623231.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 21-Apr-2016) concerns a 21 year old female patient. The patient has a medical history of allergic rhinitis and exercise-induced asthma. The patient has NKDA (no  known  drug  allergies). The patient is currently suffering from asthma. On 08-Feb-2016, the patient received an injection of AFLURIA,  batch number: U54205, route: unknown, site: left arm (LA).  On the same day, the patient received PNEUMOVAX, batch number: K019933, route: unknown, site: left arm (LA).  Both AFLURIA and PNEUMOVAX were administered to the left arm (medication error not explicitly reported). On 09-Feb-2016, the patient went to the ER (emergency  room)  the day after vaccination with (L) arm pain and swelling. The patient was diagnosed in the ER with cellulitis. The patient was treated with BACTRIM. The outcome was not recovered. Reporter comments: The health  authority  assessed  the events as  non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 56 year old female patient. Concomitant medical condition(s), medical and drug history: The patient has a medical history of Swelled up the year before the size of an egg (following administration unspecified vaccine). The following drug history information was reported: Vaccine not specified (Indication: -,Reaction: Swelled up the year before the size of an egg). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reactions(s)/events(s): The patient received AFLURIA on 14-Oct-2015 - unknown stop date, Batch no: U54506, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 16-Oct-2015, 3 days after starting / treatment with AFLURIA the patient experienced Excruciating pain in the left arm that the flu shot was given (non serious, outcome: Not Recovered / Not Resolved). Reporter's assessment: Non serious. Listedness: According to the Reference Safety Information, the event Excruciating pain in the left arm that the flu shot was given is a unlisted event of AFLURIA. Case Causality: Possible.
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Joint range of motion decreased, Pain in extremity
Clinical narrative: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 63 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Sulfa allergy. The following drug history information was reported: Sulfa (Indication: -, Reaction: Allergy). The patient's medical history is unknown. The patient had no current illness at the time of vaccination. It is uncertain as to whether the patient was on any concomitant medications at the time of vaccination, however, the patient last filled a script for rosuvastatin 5 mg on 23-Feb-2015. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 10-Oct-2015 - unknown stop date, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 20-Nov-2015, 6 weeks 0 days after starting / treatment with AFLURIA the patient experienced Painful and sore arm [with a knot at site of injection] (non serious, outcome: Unknown). [Painful and sore] arm with a knot at site of injection (non serious, outcome: Unknown), Limited range of motion in context of arm (non serious, outcome: Unknown). Patient states it occurred shortly after injection. On 20-Nov-2015, the patient went to the doctor at which time doctor told patient to take ibuprofen and use hot compress to alleviate the pain. Patient called on 03-Dec-2015 stating that it does not seem to be getting better, she will call with update. On 15-Feb-2016, doctor was called to see if any follow-up had been done on patient. Spoke to person who states patient called still complaining of pain and limited range of motion due to vaccination. Doctor has referred patient to physical medicine specialist. Doctor will inform us of any outcome. Lab data: Unknown. Treatment: Ibuprofen, hot compress. Reporter's assessment: Non serious. The Health Professional considered the event(s) Painful and sore arm [with a knot at site of injection], [Painful and sore] arm with a knot at site of injection, Limited range of motion in contest of arm as non-serious and possibly related. VAERS ID: 623301.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 35 year old male patient. The patient has no medical history and had no current illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 07-Nov-2015 - unknown stop date, Batch no: U56606, Dose no: 4, Route of administration: Intramuscular, Dose: 05 ml, Site: Left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 07-Nov-2015, 1 day after starting / treatment with AFLURIA the patient experienced All pain in shoulder area (deltoid) (non serious, outcome: Recovered/Resolved), Discomfort in context of shoulder area-deltoid (non serious, outcome: Recovered/Resolved), Intense pain upon initial injection (non serious, outcome: Recovered/Resolved). Subsequent pain and discomfort (in context of shoulder area-deltoid) lasted for approximately 10 weeks following vaccination. Reporter's assessment: Non serious. VAERS ID: 623407.
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Vaccination complication
Clinical narrative: This medically confirmed health authority report (initial receipt 21-Apr-2016) concerns a 49 year-old female  patient who had no current illness, and medical history of asthma and hypertension. Concurrent medications included montelukast, vitamin B6, plus a multivitamin, levothyroxine, budesonide/formoterol fumarate, tolterodine, levalbuterol, hydrochlorothiazide, and amlodipine. She received flu vaccine (thiomersal-free) in the past 2010-2013 without any problems. On 18-Apr-2014, her CBC record showed normal platelets, which was performed prior to her regular 2014 flu vaccine (received the flu vaccine on 23-Sep-2014). Reviewed CBC (complete blood count) results annually from 21-Mar-2011 to 18-Apr-2014 and the platelets were between 186-224 range. On 21-Sep-2015, the patient received AFLURIA vaccine injection ([thiomersal  containing], batch  number 11449211A) via the intramuscular route on the left arm. On 02-Oct-2015, the patient had a decreased platelet count. The patient had gone for routine physical and blood work and CBC (complete blood count) showed a low platelet count of 45. On 02-Nov-2015, the patient had a follow-up CBC with platelet drop to 28. She had followed up with a haematologist and there was a suspicion of reaction to flu vaccine. The outcome was not recovered. Reporter comments: The health authority assessed the case as non-serious. VAERS case ID: 623618. Seriousness: Serious. Medically significant. Listedness: Listed. Assessment according to the CCDS  for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product information, low platelet count is listed. Causality: Possible. Time to onset is within 2 weeks following vaccination. Patient had normal platelet count in recent years prior to vaccination. Of note, there was a further deterioration of platelet count at follow up 1 month later. Influenza vaccination can be associated with (transient) thrombocytopenia as a class effect from an immune mediated reaction. It is not known if patient experienced any other concurrent viral illness. In the absence of alternate cause such as  haematological malignancy and due to temporal association, influenza vaccination is considered causally attributable.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 62 year old female patient. The patient has no medical history. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 22-Feb-2016 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): ZOSTAVAX,  batch number: L036822, route: subcutaneous. Site: right arm. Reaction(s)/event(s) and outcome: On 26-Feb-2016, five days after vaccination, the patient experienced itching, redness and lump at the injection site. Reporter's assessment: The health authority assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain
Clinical narrative: Source of report and patient demography: This health authority care was initially on 21-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) 60 years old male patient. Weight: not provided; Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 07-Oct-2015 - unknown stop date, Batch no:, not provided, Route of administration: 'SYR', Dose: 0.5 ml, Site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 08-Oct-2015, the patient developed persistent pain immediately after injection unlike prior years flu shots. Pain continued since injection date and worsened. The pain ranged from 5-10 with limited range of movement. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 625203.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bone pain, Chills, Vomiting
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) 31 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset reaction(s)/event(s): The patient received AFLURIA on 29-Sep-2015 - unknown stop date, Batch no: U57707, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 29-Sep-2015, 1 day after vaccination, the patient experienced severe chills, bone aches, vomiting and body weakness. The outcome was recovered. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 625282.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) 32 years old female patient. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Graves disease. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 07-Dec-2010 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, site: Unknown. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 07-Dec-2010, 1 day after starting / treatment with ALFURIA the patient experienced Hives on chest abdomen and arms (non serious, outcome: Recovered / Resolved). For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the event as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Neuralgia, Pain in extremity
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 49 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of IBS (irritable bowel syndrome), GERD (gastroesophageal reflux disease) and Hay fever. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 15-Oct-2015 - unknown stop date, Batch no: U59508, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 18-Oct-2015, 4 days after starting / treatment with AFLURIA the patient's Entire arm was filled with intense pain (non serious, outcome: Not Recovered / Not Resolved), Left shoulder was filled with intense pain (non serious, outcome: Not Recovered / Not Resolved), Shooting nerve pain (non serious, outcome: Not Recovered / Not Resolved), Injection site pain (non serious, outcome: Not Recovered / Not Resolved). The patient had x-rays taken of the shoulder and collection of venous blood on 24-Nov-2015. Event treatment: The patient massaged and iced the areas. The patient had been in physicial therapy for the past 2 months, neuromuscular re-education, ultrasound therapy. Reporter's assessment: Non serious. The health authority reported the symptom: injection site pain. Listedness: According to the Reference Safety Information, the events Shooting nerve pain and injection site pain are listed events of AFLURIA, the events Entire arm was filled with intense pain and Left shoulder was filled with intense pain are unlisted events of AFLURIA. Case Causality: Possible.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Loss of personal independence in daily activities, Tooth infection, Tremor
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) 68 years old male patient. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Cough, Dry mouth and Nausea. The following drug history information was reported: Lisinopril (Indication: -,Reaction: Cough), Doxazosin (Indication: -, Reaction: Dry mouth) and Nicotine patch (Indication:-,Reaction: Nausea). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 14-Oct-2015-unknown stop date, Batch no:, "174085", Route of administration: Unknown, Dose: 0.5 ml, Site: Left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 15-Oct-2015, 2 days after receiving AFLURIA the patient had one week of cough, chills and shakes which kept him home for a week. The patient reported that the dentist was treating him for a dental infection with an antibiotic which he started this week and that yesterday he was doing a lot of coughing all day. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. Listedness: According to the Reference Safety Information, the event Chills is a listed event of AFLURIA, the events Shakes, Cough and Dental infection are unlisted events of AFLURIA. Case Causality: Possible.
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Source of report and patient demography: This health authority care was initially received on 21-Apr-2016. The case report was received from a(n) Health Professional and concerns a(n) 38 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 14-Oct-2015 - unknown stop date, Batch no: U59408, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 14-Oct-2015, the patient experienced severe pain in the left arm causing difficulty with tasks as putting on jacket and difficulty sleeping at night. The patient was trying to treat with Ibuprofen. The outcome was not recovered. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling, Peripheral swelling, Rash macular
Clinical narrative: Source of report and patient demography This health authority case was initially received on 09-May-2016. The case report was received from a Health Professional and concerns a 52 year old female patient. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 10-Mar-2016 - unknown stop date, Batch no: U55906, Route of administration: intramuscular, Dose: 0.5 ml, dose no: 2, site: left arm (LA). Additional suspect drug(s): ADACEL, Batch no: U5298AA, Route: intramuscular, indication: not provided, Site: Left arm (LA). AFLURIA and ADACEL both administered to the left arm. Reaction(s)/events(s) and outcome: On 10-Mar-2016, 1 day after starting / treatment with AFLURIA the patient experienced 5 x 5 cm raised swollen bump inside the arm, [the area was from injection site] all the way to inner arm (non serious, outcome: Not recovered / not resolved), 5 x 5 cm raised swollen bump [inside the arm, the area was] from injection siite [all the way to inner arm] (non serious, outcome: not recovered / not resolved), Blotchy skin (non serious, outcome: not recovered / not resolved). Event treatment: Diphenhydramine. Reporter's assessment: Non serious.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This health authority case was initially received on 09-May-2016. The case report was received from a(n) Health Professional and concerns a(n) 39 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 05-Apr-2016 - unknown stop date, Batch no: U51209, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 05-Apr-2016, 1 day after starting / treatment with AFLURIA the patient experienced Shaking (non serious, outcome: Unknown), Mild fever (non serious, outcome: Unknown), Chills (non serious, outcome: Unknown). For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: This health authority case was initially received on 09-May-2016. The case report was received from a Health Professional and concerns a 37 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Mild pollen allergy. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 30-Oct-2015 - unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 30-Oct-2015, immediately after being vaccinated the patient began to cough. This lasted for a few moments and resolved once back in the area about 1 mile away. Approximately less than 30 min later he felt a numbness/fullness to his right nostril as if stuffy. Over the next 2 hours, the numbness worsened to the right side of his face along the jaw and tongue (as if he went to dentist). The patient denied any difficulty speaking, chewing, swallowing and no number to neck/eye/ear. He denied difficulty moving jaw/facial/neck muscles. This sensation and nasal fullness resolved by 21:00 when he went to bed. On the morning of 31-Oct-2015, the patient awoke with a dull 1/10 headache over frontal sinuses that persisted all day resolving later that evening. He again denied any fevers, chills, nausea and vomiting (n/v), visual disturbances, tinnitus, weakness, rash, neck pain or any systemic like symptoms. Headache (HA) was not like past migraine headaches - not as severe and different location. He advised he ate 2 homemade breakfast sandwiches with ginger tea which he had had before and since without reaction. He denied any new detergents, deodorants, food groups, trauma, odor exposure, or recent exercise prior to/after vaccination. The outcome was reported as recovered. Report's assessment: Non serious. The health authority reported the symptoms: headache, immediate post-injection reaction. VAERS ID: 630986.
Sex: M
Vaccine: FLU3
Symptoms: Nasal congestion
Clinical narrative: This health authority case was initially received on 09-May-2016. The case report was received from a Health Professional and concerns a 37 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Mild pollen allergy. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 30-Oct-2015 - unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 30-Oct-2015, immediately after being vaccinated the patient began to cough. This lasted for a few moments and resolved once back in the area about 1 mile away. Approximately less than 30 min later he felt a numbness/fullness to his right nostril as if stuffy. Over the next 2 hours, the numbness worsened to the right side of his face along the jaw and tongue (as if he went to dentist). The patient denied any difficulty speaking, chewing, swallowing and no number to neck/eye/ear. He denied difficulty moving jaw/facial/neck muscles. This sensation and nasal fullness resolved by 21:00 when he went to bed. On the morning of 31-Oct-2015, the patient awoke with a dull 1/10 headache over frontal sinuses that persisted all day resolving later that evening. He again denied any fevers, chills, nausea and vomiting (n/v), visual disturbances, tinnitus, weakness, rash, neck pain or any systemic like symptoms. Headache (HA) was not like past migraine headaches - not as severe and different location. He advised he ate 2 homemade breakfast sandwiches with ginger tea which he had had before and since without reaction. He denied any new detergents, deodorants, food groups, trauma, odor exposure, or recent exercise prior to/after vaccination. The outcome was reported as recovered. Report's assessment: Non serious. The health authority reported the symptoms: headache, immediate post-injection reaction. VAERS ID: 630986.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 22-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) 51 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. No other vaccine was administered concomitantly with AFLURIA. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 20-Oct-2015 - unknown stop date, Batch no: U569076, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 20-Oct-2015, after starting/treatment with AFLURIA the patient experienced Vaccines reached a maximum temperature of 46.2 Degree F for a duration of 24 hours (non serious outcome: Unknown). On 20-Oct-2015, after starting/treatment with AFLURIA the patient experienced Vaccine administered to the patient after the temperature excursion (non serious, outcome: Unknown). The patient did not complain of adverse reactions. Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Vaccines reached a maximum temperature of 46.2 Degree F for a duration of 24 hours and Vaccine administered to the patient after the temperature excursion are unlisted events of AFLURIA. Case Causality: Unassessable/unclassifiable due to insufficient information. Additional information received from the regulator on 22-Aug-2016: The regulator reported the term 'no adverse event' (non-serious, outcome: unknown).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 02-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-Oct-2015 - 01-Oct-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-Oct-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 ml/Overdose (non-serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Medication error (non serious, outcome: Unknown). Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage. Follow-up information received from health authority on 20-Jun-2016: The regulator considered the events 'incorrect dose administered' and 'medication error' as non-serious. Case correction received 22-Sep-2016: The events 'medication error' and 'incorrect dose administered' were deleted. The event 'Patient received a 1 ml dose of AFLURIA, instead of 0.5 ml/Overdose' was re-coded to LLT 'accidental overdose' (special circumstance: medication error - drug administration error).
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Local reaction, Pertussis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641877) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 28-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M004116 (expiration date: 12-OCT-2017) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL batch/lot # U5247BA, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5155BA, intramuscularly in the right arm for prophylaxis. On 29-JUN-2016, the patient had a localized reaction to immunized right arm (local reaction) and probable pertussis. The patient visited ER. The outcome of local reaction and pertussis was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641900) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 13-JUN-2016 the patient was vaccinated with the first dose GARDASIL 9 lot # L045700 (dose, frequency and lot expiration dates were not reported), route: unknown, in the right arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5185BA, dose 1, route: unknown, in the right arm for prophylaxis. On 15-JUN-2016, the patient's right arm was warm, red, swollen and tender to the touch which was the reaction to GARDASIL 9. The outcome of erythema, tenderness, skin warm and was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642182) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's medical history, lab data and prior vaccinations were not reported. Patient's other medication included PANADOL tablets. Patient had no current illness. On 01-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 3, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with MENVEO lot/batch # M15079, unknown dose number, intramuscularly in the right arm, VARIVAX lot # M000995, dose 2, via subcutaneous route, in the left arm and TRUMENBA lot/batch # M74089, unknown dose number, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, patient had diarrhoea, vomiting, rash, fever, body pain, nausea and headache. The outcome of all the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642182) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's medical history, lab data and prior vaccinations were not reported. Patient's other medication included PANADOL tablets. Patient had no current illness. On 01-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 3, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with MENVEO lot/batch # M15079, unknown dose number, intramuscularly in the right arm, VARIVAX lot # M000995, dose 2, via subcutaneous route, in the left arm and TRUMENBA lot/batch # M74089, unknown dose number, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, patient had diarrhoea, vomiting, rash, fever, body pain, nausea and headache. The outcome of all the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Full blood count, Peripheral swelling, Pyrexia, Rash generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642183) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old male patient. Information on the patient's medical history, other medications and prior vaccinations were not reported. Information on the patient's current illness was reported as none. Patient's lab data included complete blood count (CBC). On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with meningococcal vaccine (unspecified)(MENINGOCOCCAL VACCINE (UNSPECIFIED)) lot/batch # M15077A, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 06-JUL-2016, the patient had rash in entire body, fever, swelling on the left forearm. The outcome of all the events were reported as not recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Induration, Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642414) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old female patient. Information on the patient's medical history, other medications, lab data and prior vaccinations were not reported. Information on the patient's concurrent illnesses was reported as none. On 24-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 1, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with MENACTRA lot/batch # US244AA, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, after 12 hours of vaccination the patient developed symptoms of lip swelling and tingling. It was slightly itchy and the left side swelled more as compared to the right side. Patient felt hard. The outcome of all the events was reported as recovered. The patient required emergency room visit. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient had no other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 09-JUL-2016, the patient was vaccinated with GARDASIL 9, (route, site, dose number, dose, frequency and lot number unknown) for prophylaxis and the same day patient was extremely tired, had headache and high fever. On an unknown date, the patient had an emergency room (ER) visit. The outcome of fatigue, pyrexia and headache was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 05-MAY-2016, the patient was vaccinated with GARDASIL 9, (route of administration reported as needle and syringe (not specified)) (site, dose number, dose, frequency, lot and lot expiration date unknown) for prophylaxis. On 02-JUN-2016, the patient had painful lump at injection site with swelling and redness. The outcome of injection site erythema, injection site swelling and injection site mass was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Decreased appetite, Dizziness, Fatigue, Moaning, Pyrexia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient had no other medications, current illnesses and medical history and the patient's prior vaccinations was not reported. On 06-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M011117 and expiration date: 07-DEC-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number: 1, vaccinated date: 06-JUL-2016, intramuscularly in the left arm, lot # 9GE5D; (dose, frequency and lot expiration date unknown), HAVRIX dose number: 1, vaccinated date: 06-JUL-2016, intramuscularly in the right arm, lot # KT54C; (dose, frequency and lot expiration date unknown) and MENVEO dose number: 1, vaccinated date: 06-JUL-2016, intramuscularly in the left arm, lot # M15098; (dose, frequency and lot expiration date unknown). On 07-JUL-2016, the patient had high fever of 104.5, some shaking and moaning, had little interest in eating, fatigue and dizziness. The patient was administered with Motrin to reduce fever. The fever stayed above 103 for 48 hours and fever broke after 72 hours. The patient remained fatigue and light headed (dizziness) for another two days and the patient had little interest in eating. Lab data reported as the patient was too sick to take to the doctor. After five days later the patient was still recovering. The outcome of decreased appetite, tremor, pyrexia, moaning, fatigue and dizziness was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient had no other medications, current illnesses and medical history and the patient's prior vaccinations was not reported. On 06-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M011117 and expiration date: 07-DEC-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number: 1, vaccinated date: 06-JUL-2016, intramuscularly in the left arm, lot # 9GE5D; (dose, frequency and lot expiration date unknown), HAVRIX dose number: 1, vaccinated date: 06-JUL-2016, intramuscularly in the right arm, lot # KT54C; (dose, frequency and lot expiration date unknown) and MENVEO dose number: 1, vaccinated date: 06-JUL-2016, intramuscularly in the left arm, lot # M15098; (dose, frequency and lot expiration date unknown). On 07-JUL-2016, the patient had high fever of 104.5, some shaking and moaning, had little interest in eating, fatigue and dizziness. The patient was administered with Motrin to reduce fever. The fever stayed above 103 for 48 hours and fever broke after 72 hours. The patient remained fatigue and light headed (dizziness) for another two days and the patient had little interest in eating. Lab data reported as the patient was too sick to take to the doctor. After five days later the patient was still recovering. The outcome of decreased appetite, tremor, pyrexia, moaning, fatigue and dizziness was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Feeling abnormal, Gaze palsy, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643505). This spontaneous report refers to a 16 year old male patient. The patient had no current illnesses, medical history and other medications. On 15-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L016428 (expiry date: 30-JUL-2017), dose 3, route : unknown in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5187AA, dose 2, route: unknown in the left arm. On 15-JUL-2016, patient's parent stated that after GARDASIL 9 shot was administered to patient's right arm, their son's eyes shifted to the right and froze, then his arms went stiff, bent into his chest with his fists closed. His head tilted to the right and he got highly visible goose bumps all over his arms and legs. He was unresponsive to voice prompts, his eyes remained open and he shook a little. The nurse laid him back on the bed. They tried to talk to him, but he was still unresponsive. Within a few minutes, patient immediately came to senses and started to sit up frantically, not knowing what just happened. The nurse asked him some questions, to which he answered one incorrectly, she had him lay back down and they explained what happened to him. Then patient said that he didn't feel very good and nurse put an alcohol pad near his nose to help with his nausea. Then before he could sit up quick enough, he vomited all over himself. When he got completely upright, the nurse gave him a trash can and he vomited some more in it. After sitting and laying and drinking sips of water, along with cold wet towels on his forehead and neck, the nurse asked him to stand and sit in the chair directly across from bed. He did so very slowly and after sitting for a few minutes, he vomited again in the trash can about 3 or 4 times. Prior to this visit, patient had not been sick and hasn't been sick with anything since the winter time and that was just a mild cold. He did have a small bowl of froot loops about an hour and a half prior to the visit. Once home, patient walked very slowly to get inside. Patient's parents cleaned him up and he immediately laid on the couch and fell asleep. He has no temperature but is extremely lethargic. He complained of slight headache and nausea. It was almost 16:00 on 15-JUL-2016, at the time of report. The outcome of all the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.