chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case was initially received on 22-Oct-2015. The case report was received from a Health Professional and concerns a 63 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. No other vaccines 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 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 result manually as appropriate.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a 38 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Nov-2014, Batch no: 10749221A, Route of administration: Intramuscular, Dose: no information provided. No additional drugs suspected. On Nov-2014, after starting treatment with AFLURIA the patient experienced Nausea three times, Vomiting three times. Action taken: Discontinued. No treatment in office for reaction.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 06-Oct-2015 - 06-Oct-2015, batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, the patient inadvertently administered expired AFLURIA PFS. The reporter stated that she heard no complaints from any of the 10 patients. She also confirmed that no patients were pregnant. For relevant test results see appropriate report section. Reporter's assessment.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 26 years old male. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report section. The patient received AFLURIA on 09-Oct-2015 - 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA. For relevant test results see appropriate report section. Reporter's assessment.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Received PNEUMOVAX 23 (R) deltoid at 11:30 am. 4:30 pm pt reported gradual px. 9:30 pm area red and hot. Woke up by pain during night. 6:30 am redness spread to bicep and itchy was given KEFLEX at OV. ER: PEPCID and BENADRYL.
Age: 84.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Left upper arm redness/warmth -> cellulitis.
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a adult male patient who received Flu Season TIV Dresden. Co-suspect products included VIOMYCIN and polymyxin b. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose, VIOMYCIN at an unknown dose and frequency and polymyxin b at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced allergic reaction. The action taken with VIOMYCIN was unknown. The action taken with polymyxin b was unknown. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The patient received Flu vaccine and experienced allergic reaction to that. The patient mentioned he had an allergy to VIOMYCIN or polymyxin b and was just wondering if it would be safe to get the PREVNAR 13.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Exfoliative rash, Rash
Clinical narrative: Crusty scaly rash on both extremities and lower abdomen no rash on face.
Age: 1.15
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Pt. had a reaction to varicella vaccine on (L) upper thigh. Welt returned to (L) thigh after 8 days, post vaccine. Fever also returned.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Fall, Head injury, Mouth injury, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Approximately 3 minutes after receiving HPV #2 and BEXSERO #1 patient went from talking to fainting, falling off exam table hitting mouth/head on floor.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Tooth fracture
Clinical narrative: Approximately 3 minutes after receiving HPV #2 and BEXSERO #1 patient went from talking to fainting, falling off exam table hitting mouth/head on floor.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Ear pain, Nervousness, Pain in extremity
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 63 years old female patient. Weight: not provided. Height: not provided. The patient received Influenza (Seasonal) (no brand name). No additional drugs suspected. On an unknown date, after starting treatment with Influenza (Seasonal) (no brand name) the patient experienced Eyes blurry / Vision blurred, [Weak areas intensified / Weak], dizzy / Dizziness, Nervous extremely / Nervousness, More floaters / Vitreous floaters, Weak areas intensified / Weak [, dizzy] / Asthenia, Ears hurt / Ear pain, Legs hurt / Pain in extremity, Teeth hurt-need crowns / Toothache.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Toothache, Vision blurred, Vitreous floaters
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 63 years old female patient. Weight: not provided. Height: not provided. The patient received Influenza (Seasonal) (no brand name). No additional drugs suspected. On an unknown date, after starting treatment with Influenza (Seasonal) (no brand name) the patient experienced Eyes blurry / Vision blurred, [Weak areas intensified / Weak], dizzy / Dizziness, Nervous extremely / Nervousness, More floaters / Vitreous floaters, Weak areas intensified / Weak [, dizzy] / Asthenia, Ears hurt / Ear pain, Legs hurt / Pain in extremity, Teeth hurt-need crowns / Toothache.
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Rash
Clinical narrative: This spontaneous case was initially received on 25-Sep-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. On an unspecified date "4 or 5 years ago" the patient received Flu vaccine (manufacturer and batch number not provide). The patient and reporter did not know which brand flu vaccine the patient received. No additional drugs suspected. On an unknown date, after starting treatment with Flu vaccine the patient experienced Nausea, Rash. For relevant test results see appropriate report section. Reporter's assessment.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case was initially received on 23-Sep 2015. The case report was received from a Health Professional and concerns a 62 year old female patient. The patient has a medical history of Diverticulitis and Colitis. The patient received AFLURIA on 21-Sep-2015, Batch no: U55006, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left deltoid. No additional drugs suspected. On Sep-2015, after starting treatment with AFLURIA the patient experienced Injection site tender and painful. On 21-Sep-2015, after starting treatment with AFLURIA the patient experienced Arm got hard to touch, Mark about 3 inches round [and hot when I touch it] (injection site), Arm is also red, [Mark about 3 inches round and] hot when I touch it (injection site) /Hot injection site, Hard injection site, Left arm is itchy, Itchy at injection site. The patient has received a flu shot before but is unsure if it was AFLURIA. The patient missed last year's flu shot but has gotten it the 2 years previous. This is the first time she has had a reaction like this. Reporter's assessment: Non serious.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Drug administered to patient of inappropriate age, Injection site pain
Clinical narrative: This spontaneous case was initially received on 22-Sep-2015. The case report was received from a Health Professional and concerns a 4 years 5 months old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 22-Sep-2015 - 22-Sep-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, in the right deltoid. The AFLURIA was inadvertently administered to a patient who was 4.5 years old. No additional drugs suspected. On Sep-2015, after treatment with AFLURIA the patient experienced crying from pain from the injection. The patient appeared to be fine - no flushing or anaphylaxis. Action taken: not provided. Event treatment: not provided. For relevant test results see appropriate report section. Reporter's assessment: The reporter reported the term 'off-label use' and assessed the events as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed health authority report (initial receipt: 21-Sep-2015) concerns a 50 year old female patient. On 20-Sep-2015, the patient received intramuscular AFLURIA (batch number U56606) that had a temperature excursion prior to administration and reached 50 degree F for about an hour. (Medication error). There was no adverse event reported other than the temperature excursion. The outcome was reported as recovered. Reporter's comments: The reporter assessed the event as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 18-Sep-2015) concerns a 63 year old female patient. On 15-Sep-2015, the patient received intramuscular AFLURIA (batch number U54906) at 0.5 ml. On 16-Sep-2015 (the following day), the patient experienced swelling near the injection site. The symptoms that developed at the injection site: a 3 inch diameter area that became red, swollen, itchy, warm and hard. The affected area got bigger on 17-Sep-2015. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: This spontaneous case was initially received on 16-Sep-2015. The case report was received from a Health Professional and concerns a 59 years old female patient who was not taking any medications that would increase her likelihood of bleeding, nor did she have any medical conditions that would increase her risk of bleeding. The patient stated that she "bruises easily" after being administered the vaccine. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA for indication protection against seasonal influenza on 13-Sep-2015 - 13-Sep-2015, Batch no: U54506, Route of administration: Intramuscular, Dose: 0.5 ml once. AFLURIA was stored correctly and the indication for use was approved as per the Product Information leaflet. Additional suspect drug (s): No additional drug suspected. Reaction (s)/event (s) and outcome: On 13-Sep-2015, immediately after AFLURIA administration the patient began bleeding profusely from the site (injection site) and completely soaked a bandage applied to the site within three seconds (non serious, outcome: Recovered/ Resolved). The bleeding resolved spontaneously on the same day. Action taken: AFLURIA was discontinued.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous medically confirmed (initial receipt 01-Sep-2015) concerns a 29-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) 0.5 mL once via intramuscular route of administration. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious and reported the term 'Medication error'. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-Sep-2015) concerns an 88 year old male patient. On the 10-Sep-2015, the patient received AFLURIA (batch number not reported) for the prevention of influenza. The patient received one injection and it was a 1mL dose in the left arm, instead of 0.5 mL. The patient was fine and had no complaints. It was an overdose. No treatment was received. Outcome was recovered.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Axillary pain, Injected limb mobility decreased, Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: This non-serious consumer report (initial receipt 08-Sep-2015) concerns a 62 year old female patient who had no remarkable relevant patient history and no known drug allergies. On the 02-Oct-2014, the patient received AFLURIA (batch number not reported) 0.5 ml via the intramuscular route in the left deltoid. It was a pre-filled syringe and the 2014-2015 formulation. On the 04-Oct-2014, she complained about lumps under her left arm. On the 06-Oct-2014, she saw her MD (Medical Doctor) for swelling and lumps under her left arm that extended all over under the arm. The MD believed it could be due to the flu shot, but wanted her to get additional diagnostic evaluation. The patient had an ultrasound on the 07-Oct-2014 on her left axillary. The image result showed multiple lymph nodes, enlarged, none of pathological appearance, left axillary adenopathy observed consistent with that of reactive lymph nodes, a likely response to the flu shot. On the 07-Oct-2014, the patient went to the MD for follow-up and she explained that the imaging results concluded it was due to the flu shot and there was improvement. The MD recommended ibuprofen and warm compresses for the lumps and the lumps slowly started to be less painful and eventually went away in about three weeks from this medical appointment. The patient could not move the arm during this time and it was very painful. Even though the lumps ended up shrinking, they were painful. This cause impaired mobility. The lumps extended under the arm to the breast area. Outcome was not reported. Reporter comments: The reporter stated that the imaging results concluded it was due to the flu shot.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Sep-3015) concerns a 46-year-old male patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, once for protection against seasonal influenza. No adverse reaction occurred after the administration. the outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 43-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, once for protection against seasonal influenza. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-serious spontaneous medically confirmed report (initial receipt 01-Sep-2015) concerns a 45-year-old male patient. On 01-Sep-2015, the patient inadvertently received 0.5 mL total of an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015), a medication error. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious, and assessed the event as a medication error. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This  medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 44-year female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA, (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA. The patient was revaccinated with FLUZONE Quadrivalent (49281-415-88, batch number UI439AA) on 16-Sep-2015 in left deltoid. No averse events reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 46-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, which was medication error. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 43-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at dose of 0.5 ml. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 41-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 46-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, once for protection against seasonal influenza. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reported assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: AFLURIA was stored correctly. The reporter assessed the event as unrelated to AFLURIA. The patient was revaccinated with FLUZONE (batch number UI439AA) on 10-Sep-2015 in the right deltoid. No adverse effects reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Tension headache
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Non Health Professional and concerns a 64 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: Intramuscular, Dose: Administered: ??-Nov-2015. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced More tired, severe headaches, and tension headaches. Reporter's assessment: The headaches went away and now she gets unrelated tension headaches that she insists had no connective with AFLURIA.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015  16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting/treatment with AFLURIA the patient experienced Fever, Chills, Headache, Vomiting. No antipyretic treatment administered. For relevant test results see appropriate report section.
Sex: U
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Pyrexia
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting treatment with AFLURIA the patient experienced Fever, Headache, Chills. For relevant test results see appropriate report section.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting treatment with AFLURIA the patient experienced Fever/Temperature of 101.8 degree F, and chills. Event treatment: Over the counter paracetamol. Reporter's assessment: The reporter considers events related to AFLURIA.
Sex: U
Vaccine: FLU3
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015 - 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting/treatment with AFLURIA the patient experienced Fever (oral temperature of 101 Degree F), Headache, Nausea, Vomiting. For relevant test results see appropriate report section. Reporter's assessment:
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting treatment with AFLURIA the patient experienced dizziness, headache, and vomiting. Event Treatment: The patient did not treat the events. Reporter's assessment: none stated.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015 - 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 8 hours after starting/treatment with AFLURIA the patient experienced Fever of 102 degree F, Chills. Event treatment: No treatment. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events related to the suspect drug.
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Rash
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. The patient received AFLURIA on unknown dates, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 8 hours after starting treatment with AFLURIA the patient experienced fatigue, nausea, and rash on torso. Event treatment: The patient did not treat the events. Reporter's assessment: The reporter considered the events non serious.
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Headache, Migraine, Pyrexia
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. the case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015 - 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 8 hours after starting/treatment with AFLURIA the patient experienced Migraine-like headache, Fatigue, Fever 101 Degree F, headache. Event treatment: Ibuprofen. For relevant test results see appropriate report section. Reporter's Assessment:
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 4 hours after starting treatment with AFLURIA the patient experienced Severe swollen reaction, (Swelling) extends down the arm down to patient's fingers/Swollen arm and fingers, Swelling started at the injection site. Event treatment: Prednisolone taper. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events related to suspect drug.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Oct-2015) concerns a 3 year old male patient. On 15-Oct-2015 at 17:00, the patient received intramuscular AFLURIA (batch number not reported). (inappropriate age of vaccine administration). The reporter did not know the current status of the patient. The outcome was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Incorrect product storage, No adverse event, Prenatal screening test
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 16-Oct-2015) concerns a female pregnant patient. On an unknown date, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). On an unknown date, the pregnant patient received the excursioned vaccine. The vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported. Additional information received from HCP on 26-Feb-2016: The patient had two previous pregnancies and did not have a stillbirth, miscarriage, a birth defect or congenital anomaly in any of the previous pregnancies. On 09-Sep-2015, the patient received the excursioned AFLURIA (batch number U55406) 0.5 ml via the intramuscular route of administration. The estimated date of delivery was 07-Jul-2015. There was no evident of a defect/adverse finding from a prenatal test, and no adverse pregnancy outcome/miscarriage.
Age: 54.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Non Health Professional and concerns a 54 years old patient with unknown gender. Weight: not provided, Height: not provided. The patient received Flu shot (Influenza Vaccine). Additional suspect drug: PNEUMOVAX. On an unknown date, after starting treatment with Flu shot the patient experienced soreness in the arm where the vaccines were administered. Reporter's assessment: none stated.
Age: 51.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Non Health Professional and concerns a 51 years old patient with unknown gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Flu shot on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Administered in Sep 2015. Additional suspect drug: PNEUMOVAX, Indication: not provided. On Sep-2015, after starting/treatment with Flu shot the patient experienced Soreness in the arm where the vaccines were administered. For relevant test results see appropriate report section. Reporter's assessment:
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, Injection site pain, Limb discomfort, Pain, Syringe issue
Clinical narrative: This spontaneous case was initially received on 15-Oct-2015. The case report was received from a Health Professional and concerns a 53 year old female patient. The patient received AFLURIA on 15-Oct-2015, Batch no: U54906, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm. No additional drugs suspected. On 15-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Discomfort in context of arm, Normally the plunger goes in easily / A lot of resistance on the stopper, Some of the serum came out when the needle was withdrawn from the arm, Revaccinated the patient, Patient was in a lot of pain (injection site)/Pain level from the first injection was 5 out of 10 (injection site) /Throbbing (arm pain at injection site)/Pain at injection site. No swelling was observed by the pharmacist. Resistance in plunger has not been noted from other PFS in the box or other lots. The pharmacist revaccinated the patient in her right arm per CDC recommendation. The second injection was administered without problem and the patient tolerated it fine. The pharmacist recommended the patient take ibuprofen for the discomfort. Reporter's assessment: Non serious. Case correction (31-Mar-2016): AE 4 re-coded.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Fatigue, Influenza, Injection site pain, Insomnia
Clinical narrative: This spontaneous consumer report (initial receipt 09-Dec-2015) concerns a 50 year old female patient. The patient had no medical history except that she had two children. She also confirmed that she was not pregnant or breastfeeding while on AFLURIA. This was the first time she had received the flu shot. On 04-Dec-2015, the patient received AFLURIA (batch number not reported) in the left arm. On 02-Dec-2015, she had also received hepatitis A vaccine (manufacturer and batch number not reported) and typhoid vaccine injection (manufacturer and batch number not reported). Each shot was given in different arm. After receiving AFLURIA, later that night, she go a 'little case of flu' in which she felt tired and achy. Her arm was painful and bruised. This lasted for 1.5 days. The patient could not sleep during that time and took acetaminophen which helped her sleep. She stated that by 5 pm, the next day, she felt 100% fine. The soreness at the injection site went away. The next couple of days, she felt achy on the left. She felt pain on the back side of her arm and also felt neck pain. She could not provide and exact date but stated that she was achy all the time. The patient further stated it to be getting worse. to self treat her left arm, the patient was moving it around to keep it mobile. She stated it was difficult to move though. The outcome was reported as resolved as of 11-Dec-2015. It went away on its own without any type of treatment.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 09-Dec-2015) concerns a 50 year old female patient. The patient had no medical history except that she had two children. She also confirmed that she was not pregnant or breastfeeding while on AFLURIA. This was the first time she had received the flu shot. On 04-Dec-2015, the patient received AFLURIA (batch number not reported) in the left arm. On 02-Dec-2015, she had also received hepatitis A vaccine (manufacturer and batch number not reported) and typhoid vaccine injection (manufacturer and batch number not reported). Each shot was given in different arm. After receiving AFLURIA, later that night, she go a 'little case of flu' in which she felt tired and achy. Her arm was painful and bruised. This lasted for 1.5 days. The patient could not sleep during that time and took acetaminophen which helped her sleep. She stated that by 5 pm, the next day, she felt 100% fine. The soreness at the injection site went away. The next couple of days, she felt achy on the left. She felt pain on the back side of her arm and also felt neck pain. She could not provide and exact date but stated that she was achy all the time. The patient further stated it to be getting worse. to self treat her left arm, the patient was moving it around to keep it mobile. She stated it was difficult to move though. The outcome was reported as resolved as of 11-Dec-2015. It went away on its own without any type of treatment.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 15-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 15-Oct-2015, Batch no:.U59208, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 15-Oct-2015, after starting treatment with AFLURIA the patient experienced Received an IM dose of AFLURIA on 15Oct2015 that was exposed to temperatures up to 48 degrees F for 12 hours/Administered vaccine exposed outside of recommended storage conditions/Medication error, AFLURIA exposed to temperatures up to 48 degree F for 12 hours/Vaccine exposed outside of recommended storage conditions. For relevant test results see appropriate report section. Reporter's assessment. Additional information received on 19-Nov-2015. The patient was 56 years old and female. VAERS ID: 638325.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chills, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: This spontaneous case was initially received on 15-Oct-2015. The case report was received from Health Professional and concerns a 62 year old female patient. The patient received AFLURIA on 14-Oct-2015 - 14-Oct-2015, Batch no: U58107, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm. No additional drugs suspected. On 14-Oct-2015, 2 to 3 hours after starting treatment with AFLURIA the patient experienced headache, chills. Upon walking on the morning of 15-Oct-2015, after starting treatment with AFLURIA the patient experienced arm is very sore/Pain (from the left side of neck) down through the left arm (injected arm), numbness from left shoulder to the fingertips, pain from the left side of neck (down through the left arm (injected arm), Anxiety in chest, feels relatively cool now and not warm, which is unusual, tingling from left shoulder or the fingertips. The patient is not sure if the anxiety is due to the injection or a reaction to the experience. The patient advises that she is waiting to hear back from her doctor's office for an appointment time. Reporter's assessment: Not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case was initially received on 15-Oct-2015. The case report was received from Health Professional and concerns a 62 year old female patient. The patient received AFLURIA on 14-Oct-2015 - 14-Oct-2015, Batch no: U58107, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm. No additional drugs suspected. On 14-Oct-2015, 2 to 3 hours after starting treatment with AFLURIA the patient experienced headache, chills. Upon walking on the morning of 15-Oct-2015, after starting treatment with AFLURIA the patient experienced arm is very sore/Pain (from the left side of neck) down through the left arm (injected arm), numbness from left shoulder to the fingertips, pain from the left side of neck (down through the left arm (injected arm), Anxiety in chest, feels relatively cool now and not warm, which is unusual, tingling from left shoulder or the fingertips. The patient is not sure if the anxiety is due to the injection or a reaction to the experience. The patient advises that she is waiting to hear back from her doctor's office for an appointment time. Reporter's assessment: Not reported.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 15-Oct-2015. The case report was received from a Health Professional and concerns a male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, the patient received expired AFLURIA vaccine from multidose vial (non serious, outcome: Unknown). Action taken: not provided. Event treatment: not provided. Rechallenge/Dechallenge information: not provided. For relevant test results see appropriate report section. Reporter's assessment: not provided.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 41 year old patient (gender unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 41 year old patient (gender unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Sex: U
Vaccine: MENB
Symptoms: Induration
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of induration in a 16-year-old patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced induration. On an unknown date, the outcome of the induration was unknown. The reporter considered the induration to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 59 year old female patient with antihistamine allergy, who was reporting on herself. The patient had no pertinent medical history. In 2008 (reported as "8 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not provided), however the patient was not sure if it was indeed ZOSTAVAX vaccine. Concomitant therapies included acyclovir. On unknown dates, the patient has broken out at least three times since the vaccine was given. No treatment for the event was given and no lab diagnostic studies were performed. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as the patient did not wish her physician to be contacted.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. On 05-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included metformin, simvastatin (manufacturer unknown), losartan potassium (+) hydrochlorothiazide (manufacturer unknown), glipizide, levothyroxine sodium (manufacturer unknown), citalopram and canagliflozin. On 05-May-2016, the patient developed an itchy, red rash that is about 3 inches long at the injection site following the administration of ZOSTAVAX. The patient received hydrocortisone cream and BENADRYL. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacist contact. No product quality issue was involved. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.