chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: This spontaneous case was initially received on 30-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 78 year old female patient. The patient does not have any drug allergies. The patient received Influenza vaccine on unknown dates, Batch no: not provided, Route of administration: Unknown, Site: Left arm. Additional suspect drug(s): KEYTRUDA, Route: Central intravenous, Dose: 2 mg/kg, Indication: Stage IV melanoma, Site: Right arm. On an unknown date, after starting treatment with Influenza vaccine the patient experienced Rash on her upper right arm. The pharmacist reports that one week after the first dose of pembrolizumab, the patient returned to her physician because she had developed a rash on her upper right arm. No treatment was given. The patient returned to her physician's office on 18-Nov-2015 to receive her second dose of pembrolizumab. Prior to the infusion it was noted by the physician that the rash looked worse, however, the pembrolizumab was still administered. The patient will be treated with hydrocortisone cream and diphenhydramine. The pharmacist also reported that the patient received an influenza vaccination "a couple of weeks ago" in the left arm (unspecified manufacturer, unspecified date). The pharmacist reports the patient's rash is a pre-existing condition which periodically appears then disappears. Pharmacist further explained that prior to starting pembrolizumab therapy, the patient "has always had a rash that comes and goes on her arm". On the day the patient was scheduled to received her first dose of pembrolizumab, she did not have a rash. The first dose was administered and at an unspecified time the rash "reappeared" on her arm and "it currently seems to be getting worse". Reporter's assessment: Not reported. The pharmacist does not believe the reaction (rash) is from the flu shot. The pharmacist states the flu shot was administered in the left arm, but the rash is in the right arm. The right arm is also where the patient gets her KEYTRUDA, which may cause rash. He states he last spoke to the patient 28-Nov-15 and the rash has not gotten any worse. He believes the rash is from the KEYTRUDA or the patient's disease state of melanoma.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Decreased appetite, Dizziness, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Initial information regarding a clinical sponsored solicited case was received on 19-May-2016 from the patient via the Patient Support Program. This case concerns a 63 years old female patient who experienced cold 19 days after receiving treatment with PRALUENT and unknown duration after receiving influenza vaccine. No information on any concomitant drugs, past medications or concurrent conditions was reported. Medical history: atherosclerosis of arteries and extremities. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown) for an unknown indication. On 27-Apr-2016, patient commenced alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date: unspecified) for Mixed hyperlipidemia delivered via alirocumab prefilled pen. Patient reported that she was sick right now; she caught a cold on 16-May-2016. She did take the flu shot. Her whole body was hurting and she had no appetite. All this started about Monday, 16-May-2016. Reportedly, her throat started hurting. On Tuesday she felt lightheaded and stopped up. She took her last injection on 11-May-2016. Action taken: Drug Withdrawn NOS. the therapy was withdrawn on 11-May-2016. Corrective treatment: Not reported. Outcome: Unknown. Reporter causality: Not reported with influenza vaccine and unknown with alirocumab. Company causality: Not associated.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Type V hyperlipidaemia
Clinical narrative: Initial information regarding a clinical sponsored solicited case was received on 19-May-2016 from the patient via the Patient Support Program. This case concerns a 63 years old female patient who experienced cold 19 days after receiving treatment with PRALUENT and unknown duration after receiving influenza vaccine. No information on any concomitant drugs, past medications or concurrent conditions was reported. Medical history: atherosclerosis of arteries and extremities. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown) for an unknown indication. On 27-Apr-2016, patient commenced alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date: unspecified) for Mixed hyperlipidemia delivered via alirocumab prefilled pen. Patient reported that she was sick right now; she caught a cold on 16-May-2016. She did take the flu shot. Her whole body was hurting and she had no appetite. All this started about Monday, 16-May-2016. Reportedly, her throat started hurting. On Tuesday she felt lightheaded and stopped up. She took her last injection on 11-May-2016. Action taken: Drug Withdrawn NOS. the therapy was withdrawn on 11-May-2016. Corrective treatment: Not reported. Outcome: Unknown. Reporter causality: Not reported with influenza vaccine and unknown with alirocumab. Company causality: Not associated.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Malaise, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Initial information regarding a clinical sponsored solicited case was received on 19-May-2016 from the patient via the Patient Support Program. This case concerns a 63 years old female patient who experienced cold 19 days after receiving treatment with PRALUENT and unknown duration after receiving influenza vaccine. No information on any concomitant drugs, past medications or concurrent conditions was reported. Medical history: atherosclerosis of arteries and extremities. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown) for an unknown indication. On 27-Apr-2016, patient commenced alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date: unspecified) for Mixed hyperlipidemia delivered via alirocumab prefilled pen. Patient reported that she was sick right now; she caught a cold on 16-May-2016. She did take the flu shot. Her whole body was hurting and she had no appetite. All this started about Monday, 16-May-2016. Reportedly, her throat started hurting. On Tuesday she felt lightheaded and stopped up. She took her last injection on 11-May-2016. Action taken: Drug Withdrawn NOS. the therapy was withdrawn on 11-May-2016. Corrective treatment: Not reported. Outcome: Unknown. Reporter causality: Not reported with influenza vaccine and unknown with alirocumab. Company causality: Not associated.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Initial information regarding a clinical sponsored solicited case was received on 19-May-2016 from the patient via the Patient Support Program. This case concerns a 63 years old female patient who experienced cold 19 days after receiving treatment with PRALUENT and unknown duration after receiving influenza vaccine. No information on any concomitant drugs, past medications or concurrent conditions was reported. Medical history: atherosclerosis of arteries and extremities. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown) for an unknown indication. On 27-Apr-2016, patient commenced alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date: unspecified) for Mixed hyperlipidemia delivered via alirocumab prefilled pen. Patient reported that she was sick right now; she caught a cold on 16-May-2016. She did take the flu shot. Her whole body was hurting and she had no appetite. All this started about Monday, 16-May-2016. Reportedly, her throat started hurting. On Tuesday she felt lightheaded and stopped up. She took her last injection on 11-May-2016. Action taken: Drug Withdrawn NOS. the therapy was withdrawn on 11-May-2016. Corrective treatment: Not reported. Outcome: Unknown. Reporter causality: Not reported with influenza vaccine and unknown with alirocumab. Company causality: Not associated.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was initially received on 14-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 41 years old male patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 14-Nov-2015, Batch no: T50707, Route of administration: Intramuscular, Dose: 0.5 ml. AFLURIA was stored correctly and the indication for used approved as per the Product Information leaflet. No additional drugs suspected. On an unknown date after starting treatment with AFLURIA the patient experienced Given expired AFLURIA. No adverse reaction was reported due to AFLURIA. The reporter reported the term 'Medication error' and assessed the event as non-serious.
Age: 30.0
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(n) Health Professional and concerns a(n) 30 years old male patient. Weight: 240 pounds, Height: 74 inches. The patient received AFLURIA on 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.
Age: 29.0
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(n) Health Professional and concerns a(n) 29 years old male patient. Weight: 240 pounds, Height: 74 inches. The patient received AFLURIA on 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.
Age: 33.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Increased swelling, redness, itching. Treatment: Antibiotic and Steroid pills.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Discomfort, Pain, Rash
Clinical narrative: Patient presented to our health clinic with c/o a rash on his bilateral arms, back, and waistband areas of his body. Describes as mild discomfort of itching and stinging pain (#3/10 scale). DENIES: headache, fever, chills, chest pain, shortness of breath, difficulty breathing, swelling of face/tongue, abdominal pain, nausea, vomiting, or myalgia.
Age: 65.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema
Clinical narrative: Pt received Boostrix, and Prevnar 13 IM injections, and several days after injection reported redness at the injection site, and said it was migrating down towards her elbow. On 6/1 she reported that the migration
Age: 23.0
Sex: F
Vaccine: MMR, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: MMR vaccine powder lot #L032181 exp 8/25/17 was mixed with Menveo liquid conjugate lot #X15019 exp 10/2017.
Sex: U
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: This spontaneous case was initially received on 23-Dec-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. On an unspecified date, the patient received AFLURIA. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced respiratory issues (non serious, outcome: Unknown). Reporter's assessment: n/a.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Overdose
Clinical narrative: This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Non Health Professional and concerns a 14 years old male patient. The patient received AFLURIA on 25-Nov-2015 - 25-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml and received a second dose on 25-Nov-2015- 25-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. On 25-Nov-2015, the patient accidently received two AFLURIA vaccines today. Reporter's assessment: Non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle haemorrhage
Clinical narrative: This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Health Professional and concerns a 35 year old female patient. The patient received AFLURIA on 04-Nov-2015 - 4-November-2015, Batch no: U58908, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 04-Nov-2015, 1 day after starting treatment with AFLURIA the patient experienced Arm pain near injection site/Pain in context of arm. On an unknown date, after starting treatment with AFLURIA the patient experienced Intramuscular hematoma. Pharmacist suggested that the patient try oral ibuprofen. Reporter's assessment: Non serious.
Sex: U
Vaccine: FLUX, VARCEL
Symptoms: Adverse event
Clinical narrative: This spontaneous case was initially received on 02-FEB-2016. 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 medications and therapy dates refers to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): On an unspecified date, the patient received Flu vaccine . Indication not provided. Additional Suspect drug(s): ZOSTAVAX, Indication: Not provided. Reaction(s)/Event(s) and outcome: On an unknown date, after starting/treatment with flu vaccine the patient experienced an unspecified adverse event (non serious, outcome: Unknown). Action to be take: Details manually to be entered. Event treatments: 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: n/a
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This spontaneous case was initially received on 03-FEB-2016. The case report was received from a Health Professional and concerns a male patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): On an unspecified date, the patient received AFLURIA (batch number: "U54004"). Indication not reported. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced a reaction after receiving AFLURIA (non serious, outcome: Unknown). Event treatment: The patient received prednisone for treatment. Follow up received 09-FEB-2016 from pharmacist: Reporter's Assessment: The reporter's pharmacy facility  carry FLUZONE and ALFURIA and stated that it was possible there was mix up in the brand of vaccine documented, but cannot confirm this. The probability of this happening is low.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Round red rash present at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash, Rash vesicular, Skin exfoliation
Clinical narrative: Round red rash present at injection site.
Age: 55.0
Sex: F
Vaccine: MMR, PPV, TDAP
Symptoms: Arthralgia, Cellulitis, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 55 year old female c/o itching, swelling, and pain on left arm that radiates to wrist x 2 days. Patient was given Tdap, MMR, and PNUPs on left arm on 05/26/2016. Was seen by NP on 06/02/2016 and diagnosed with Cellulitis of left arm, approx. 25cm x 7cm. NP referred patient to Urgent care for further evaluation and treatment.
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Induration, Skin warm, Swelling, Tenderness
Clinical narrative: Large area of swelling.  It is indurated, hot to touch and tender.  Site is about 2.5-3 inches wide and long.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Throwing up every fifteen to thirty minutes. Not projectile. Lasted a few hours. I think it has finally stopped. Also had a runny nose (did not previously have before the immunizations).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: AT INJECTION SITE ARM BEGAN TO SWELL AND GET WARM. The swelling and redness didn't leave for about 3 weeks. The affected area stayed between elbow and shoulder on the back of the arm. Also patient noticed a red rash on abdomen about week after injection.
Age: 60.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Hep #3 vaccine administered 12 days after Hep #2 was administered.  NO adverse effects noted or reported.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Fatigue, Tinnitus
Clinical narrative: EMPLOYEE GRADUALLY COMPLAINED OF FATIGUE, MILD CONFUSION AND RINGING IN HER EARS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation on the trunk, face and arm on the side of vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Apnoea, Circulatory collapse, Disorientation, Feeling abnormal, Incontinence
Clinical narrative: Within 1 minute of vaccine being given, client was slumped in the chair, unconscious and moaned very loudly x 2. Client then apneic, RN observed client to begin posturing with no tonic clonic movements observed; client was also incontinent. Client's pupils were dilated. Posturing continued for approximately 60-90 seconds until 0.15mg epinephrine was given at approximately 08:50 and oxygen applied 15 LPM, and then client regained consciousness within about 20 seconds and stopped posturing. Client was a little dazed and not oriented for about 5 minutes. A few minutes later, after sitting client up, client vomited. Client was then oriented x 3 and conversant. Paramedics then arrived and began client care. See vitals below. Client taken by EMS at 9:20 am. 8:52 am - BP 98/60 approximated two minutes after Epi, (no BP taken prior to Epi.) Pulse 60. RR apneic initially then approx 6/min. 8:54 am - BP 118/74. Pulse 100. O2 99%. RR 6/min. 8:57 am- BP 108/68. Pulse 87 and regular. Lugns CTA, unlabored, skin pale, warm dry. O2 99%. RR: 12/min. Assessment: Syncope followed by incontinence and posturing lasting approx 60-120 seconds, symptoms resolved within 10-20 seconds of epinephrine injection. Mother denies history of syncope with vaccines, nor seizure activity. Signs/sxs consistent with cardiovascular collapse and subsequent posturing.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Moaning, Mydriasis, Posture abnormal, Posturing
Clinical narrative: Within 1 minute of vaccine being given, client was slumped in the chair, unconscious and moaned very loudly x 2. Client then apneic, RN observed client to begin posturing with no tonic clonic movements observed; client was also incontinent. Client's pupils were dilated. Posturing continued for approximately 60-90 seconds until 0.15mg epinephrine was given at approximately 08:50 and oxygen applied 15 LPM, and then client regained consciousness within about 20 seconds and stopped posturing. Client was a little dazed and not oriented for about 5 minutes. A few minutes later, after sitting client up, client vomited. Client was then oriented x 3 and conversant. Paramedics then arrived and began client care. See vitals below. Client taken by EMS at 9:20 am. 8:52 am - BP 98/60 approximated two minutes after Epi, (no BP taken prior to Epi.) Pulse 60. RR apneic initially then approx 6/min. 8:54 am - BP 118/74. Pulse 100. O2 99%. RR 6/min. 8:57 am- BP 108/68. Pulse 87 and regular. Lugns CTA, unlabored, skin pale, warm dry. O2 99%. RR: 12/min. Assessment: Syncope followed by incontinence and posturing lasting approx 60-120 seconds, symptoms resolved within 10-20 seconds of epinephrine injection. Mother denies history of syncope with vaccines, nor seizure activity. Signs/sxs consistent with cardiovascular collapse and subsequent posturing.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Vomiting
Clinical narrative: Within 1 minute of vaccine being given, client was slumped in the chair, unconscious and moaned very loudly x 2. Client then apneic, RN observed client to begin posturing with no tonic clonic movements observed; client was also incontinent. Client's pupils were dilated. Posturing continued for approximately 60-90 seconds until 0.15mg epinephrine was given at approximately 08:50 and oxygen applied 15 LPM, and then client regained consciousness within about 20 seconds and stopped posturing. Client was a little dazed and not oriented for about 5 minutes. A few minutes later, after sitting client up, client vomited. Client was then oriented x 3 and conversant. Paramedics then arrived and began client care. See vitals below. Client taken by EMS at 9:20 am. 8:52 am - BP 98/60 approximated two minutes after Epi, (no BP taken prior to Epi.) Pulse 60. RR apneic initially then approx 6/min. 8:54 am - BP 118/74. Pulse 100. O2 99%. RR 6/min. 8:57 am- BP 108/68. Pulse 87 and regular. Lugns CTA, unlabored, skin pale, warm dry. O2 99%. RR: 12/min. Assessment: Syncope followed by incontinence and posturing lasting approx 60-120 seconds, symptoms resolved within 10-20 seconds of epinephrine injection. Mother denies history of syncope with vaccines, nor seizure activity. Signs/sxs consistent with cardiovascular collapse and subsequent posturing.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: My daughter has a very bad rash on half of her body.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient called and said she noticed a raised and red spot that felt feverish the day after the ZOSTAVAX shot. I told her to monitor it and if it gets worse go seek medical attention.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral mucosal blistering
Clinical narrative: This spontaneous case was initially received on 05-JAN-2016. This case report was received from a(n) Health Professional and concerns a(n) 59 years old male patient. Weight: 224 pounds. Height: 5'7 inches. Concurrent medical condition(s), medical and drug history: The patient had a medical history of Drug reaction/allergies: penicillin. The follow drug history information was reported: Penicillin (indication: -, Reaction; Drug reaction/allergy). 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. Indication not reported on 07-DEC-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: no information provided. Additional suspect drug(s): ZOSTAVAX, Batch: L029484, start date 07-DEC-2015). Indication: Prevention of shingles. On 15-DEC-2015 to 22-DEC-2015, the patient received ZOSTAVAX (batch L029484). Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Shingle outbreak on roof of mouth which was confirmed by the doctor (non serious, outcome: Recovered/Resolved), Blisters on the roof of his mouth (non serious, outcome: Recovered/Resolved). Action taken: N/A. Event treatment: The doctor recommended a mouthwash and told to take l-lysine. Rechallenge/Dechallenge information: N/A. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The doctor assessed the causality as certain/highly probably in relation to ZOSTAVAX, and the events as non-serious.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pyrexia, Somnolence
Clinical narrative: This spontaneous case was initially received on 28-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 years old female patient. Weight: 160 pounds, Height: 64 inches. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Neomycin allergy and Potassium allergy. 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 17-OCT-2015 - 17-OCT-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 17-OCT-2015, after starting/treatment with AFLURIA the patient experienced Site injection pain/Pain at site (injection) (non serious, outcome: Not Recovered/Not Resolved). On 18-OCT-2015, after starting/treatment with AFLURIA the patient experienced Tiredness/Felt very tired (non serious, outcome: Not Recovered/Not Resolved), Felt very sleepy (non serious, outcome: Not Recovered/Not Resolved). On 19-OCT-2015, after starting/treatment with AFLURIA the patient experienced Felt feverish (warm to touch) (non serious, outcome: Not Recovered/Not Resolved). Redness at the site (injection (non serious, outcome: Not Recovered/Not Resolved). Action taken: discontinued. Event treatment: 21-OCT-2015 applied topical diphenhydramine cream. For relevant test results see appropriate report section.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 05-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 26 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received ALFURIA on 05-NOV-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular: Dose: 0.6 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) outcome: On 05-NOV-2015 08:45, after starting/treatment with AFLURIA the patient experienced AFLURIA pre-filled syringe that was left out for 9 hours and reached room temperature (first excursion) was administered (non serious outcome: Unknown). On an unknown date, after starting/treatment with ALFURIA the patient experienced AFLURIA pre-filled syringe that was left out for 8  hours and reached room temperature (first excursion)/Temperature excursion occurred (non serious, outcome: Unknown). Reporter's assessment: Not reported.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case was initially received on 17-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) elderly male patient in his seventies. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received an unspecified flu vaccine on unknown dates, batch no: not provided, Route of administration: Unknown, Dose: no information provided. Additional suspect drug(s): PNEUMOVAX23, batch no: Unknown. Reaction(s)/event(s) and outcome: On an unknown date after starting/treatment with an unspecified flu vaccine, the patient experienced Redness at the injection site (non serious, outcome: Unknown) and Swelling at the injection site (non serious, outcome: Unknown). The events occurred 6 days after receiving PNEUMOVAX23. The patient received the unspecified flu vaccine "within the last few weeks". Reporter's assessment: Not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Pain, Throat irritation
Clinical narrative: Not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site nerve damage
Clinical narrative: This medically confirmed health authority report (initial receipt 23-NOV -2016) concerns a 29 year old female patient. On an unspecified date, the patient received influenza seasonal vaccine (manufacturer and batch number not reported).  On an unspecified date, the patient reported that the injection hit the nerve. The outcome was not reported. Linked case: 2016059213 (same patient). Case correction 08-MAR-2016: LLT for AE 1"injection hit nerve" re-coded to "injection site nerve damage", case downgraded to non serious.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous case was initially received on 16-NOV-2015. This case report was received from a(n) Health Professional and concerns a(n) 40 years old female patient. The patient received AFLURIA, batch number: not provided) last year and no complaints were reported post-vaccination. Weight: not provided, Height: not provided. For concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction9s)/event(s): The patient received AFLURIA for indication Active immunization against influenza disease caused by influenza subtypes A and type B present int he vaccine on 30-OCT-2015 - unknown stop date. Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, AFLURIA was stored correctly. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Pain in the arm/Pain is limited to the arm of the injections site (non serious, outcome: Unknown, Pain worsens when lifting objects and reaching over her head (non serious, outcome: Unknown). Reporter's assessment: n/a
Sex: U
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dyspepsia, Fatigue, Injection site pruritus, Musculoskeletal pain
Clinical narrative: This spontaneous case was initially received on 299-OCT-2015. The case report was received from a(n) Non 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 for indication not provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Shoulder pain/Shoulder was in pain (non serious, outcome: Unknown), Heartburn (non serious, outcome: Unknown), Fatigue/Fatigued (non serious, outcome: Unknown), Injection site itching/injection site itched very badly (non serious, outcome Unknown), stomach upset (non serious, outcome Unknown). Rechallenge/Dechallenge information: not applicable. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site vesicles
Clinical narrative: This spontaneous case was initially received on 05-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 61 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 05-NOV-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Lot: "U50007".  Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 05-NOV-2015, after starting/treatment with AFLURIA the patient experienced Skin near injection site bubbled up "like a TB bubble"/skin in the area was bubbled/Skin bubbled at injection site (non serious, outcome: Unknown), Bleed at injection site/Bleeding at injection site (non serious, outcome: Unknown), Described site as red (injection site)/Redness at injection site (non serious, outcome: Unknown). Reporter's assessment: Not reported.
Age: 33.0
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(n) Health Professional and concerns a(n) 33 years old male patient. Weight: 240 pounds, Height: 74 inches. 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 09-OCT-2015 - 09-OCT-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 09-OCT-2015, the patient received an IM dose of expired AFLURIA (non serious, outcome: Unknown). (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: Not provided.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 05-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 21 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 05-NOV-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) outcome: On 05-NOV-2015 08:45, after starting/treatment with AFLURIA the patient experienced AFLURIA pre-filled syringe that was  left out for 8 hours and reached room temperature (first excursion) was administered (non serious, outcome: Unknown). On an unknown date, after starting/treatment with AFLURIA the patient experienced AFLURIA pre-filled syringe that was left out for 8 hours and reached room temperature (first excursion)/Temperature excursion occurred (non serious, outcome: Unknown). Reporter's assessment: Not reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This spontaneous case was initially received on 29-OCT-2015. The case report was received from a(n) Non Health Professional and concerns a(n) 70 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 28-OCT-2015 - 28-OCT-2015, Batch no: U54205, Route of administration: not provided, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 29-AUG-2015, after starting/treatment with AFLURIA the patient experienced Pain at the injection site that feels like she has been "punched in the arm" in the area where she got the injection (non serious, outcome: Not Recovered/Not Resolved) and cannot sleep due to pain on left side (non serious, outcome): Not Recovered/Not Resolved. Action taken: Drug withdrawn. Event treatment: nothing seems to be helping with pain. Rechallenge/Dechallenge information: not applicable. For relevant test results see appropriate report section. Reporter's assessment: Not provided.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous case was initially received on 02-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 35 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 30-OCT-2015 - 30-OCT-2015, Batch no: U56306, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: The AFLURIA vaccine shipment was received at the pharmacy on 26-OCT-2015. The pharmacy thought it may be frozen so segregated it in the refrigerator so it would not be dispensed. On an unknown date, the patient was administered with one vaccine from quarantined syringes (temperature excursion occurred - frozen) (non serious outcome: Unknown), (non serious, outcome: unknown) Action taken: not provided Event treatment: Referred to the PCP (primary care physician) and recommended repeat vaccination per CDC. Rechallenge/Dechallenge information not provided. For relevant tests results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The Health Professional considered the event(s) Administered one vaccine from quarantined syringes, Temperature excursion occurred - frozen as non-serious and causality of unlikely in relation to AFLURIA.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case was initially received on 24-NOV-2015. The case report was received from a(n) 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. Suspect drug(s), timing and condition surrounding the onset of reaction(s)/event(s): The patient received AFLURIA. Indication not provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, the patient received AFLURIA, batch number: not provided) from the boarding home for the mentally disabled. The patient then went to a pharmacy and got the flu shot again. No adverse reactions experienced. The patient's doctor was aware of the event. No further information available. The outcome was reported as recovered. 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 HCP reporter reported "overdose".  Case correction (08-MAR-2016) AE 2 "overdose" deleted.
Age: 69.0
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous case was initially received on 20-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 69 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received an Unspecified influenza vaccine on unknown dates, Batch no: not provided, Route of administration:  Unknown, Dose: no information provided. Additional suspect drug(s): On the same day, the patient also received ZOSTAVAX. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with Unspecified influenza vaccine the patient experienced redness of the arm (non serious, outcome: Unknown) Reporter's assessment: Not reported.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
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. Reporter comments: 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.
Age: 51.0
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 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. The patient received AFLURIA on 20-Oct-2015- unknown stop date, Batch no: U569076, route of administration: Intramuscular, Dose: no information provided. No additional drugs suspected. 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. On 20-Oct-2015, after starting treatment with AFLURIA the patient experienced vaccine administered to the patient after the temperature excursion. The patient did not complain of adverse reactions.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dyspepsia, Fatigue, Injection site pruritus, Musculoskeletal pain
Clinical narrative: This spontaneous case was initially received on 29-Oct-2015. The case report was received from a Non 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 19-Oct-2015 - 19-Oct-2015. Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 19-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced shoulder pain/Shoulder was in pain, Heartburn, Fatigue/Fatigued, Injection site itching/Injection site itched very badly, Stomach upset. Action taken: discontinued. Dechallenge/Rechallenge: not applicable. For relevant test results see appropriate report section. Report's assessment: the reporter considered events non serious.
Age: 24.0
Sex: F
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 25 years old female patient. Weight: 240 pounds, Height: 74 inches. 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 for indication protection against seasonal influenza virus on 09-Oct-2015 - 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected.
Age: 33.0
Sex: F
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 33 years old female patient. Weight: 240 pounds, Height: 74 inches. 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 for indication Protection against seasonal influenza virus on 09-Oct-2015 -09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous 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. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication protection against seasonal influenza virus on unknown dates, Batch no: U57507, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced administered an AFLURIA dose that was exposed to temperatures down to 34 F for about two hours/medication error (non serious, outcome: Resolved). No adverse reaction has been reported since administration. Action taken: discontinued. 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#.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Drug administration error
Clinical narrative: This spontaneous case was initially received on 28-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 unspecified Influenza Vaccine. Additional suspect drug(s): PNEUMOVAX and ZOSTAVAX. On an unknown date, the patient received PNEUMOVAX and unspecified flu vaccine at the same time, in the same arm about an inch way (non serious, outcome: Unknown). For relevant test results see appropriate report section.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: This spontaneous case was initial received on 07-Dec-2015. The case report was received from a Health Professional and concerns an 17 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 for indication protection against seasonal influenza on 18-Nov-2014 -18-Nov-2014, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. AFLURIA was stored correctly. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting/ treatment with AFLURIA the patient experienced Localized swelling in deltoid (non serious, outcome: Recovered/Resolved). For relevant test results see appropriate report section.