chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: erythema (5.5 cm) at Right upper anterior thigh; Swelling (6cm) at Right upper anterior thigh; Itching with or without contact; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from a healthcare professional via Health Authorities (under the reference 777803-1).  This case involves an eight years old female patient who experienced swelling (6cm) and erythema (5.5 cm) at right upper anterior thigh and itching with or without contact, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included drug hypersensitivity with KEFLEX. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Seasonal allergies.  Concomitant medications included MACROGOL 3350 (MIRALAX) (supplement, Multivitamin chewable).  On 11-Oct-2018, the patient received one dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB and Exp. Date 30-Jun-2019 via intramuscular route in the right thigh.  On 12-Oct-2018, the patient developed a non-serious erythema (5.5 cm) at right upper anterior thigh (injection site erythema), swelling (6cm) at right upper anterior thigh (injection site swelling) and itching with or without contact (injection site pruritus) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests not reported.    Final diagnosis was injection site erythema, injection site swelling and injection site pruritus.  It was not reported if the patient received a corrective treatment.  The patient had not recovered from all the events.  List of documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Lymph node pain
Clinical narrative: Sore lymph node in armpit; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from  non-healthcare professional via Health Authorities under reference 779240-1.  This case involves a 36 years old male patient who experienced sore lymph node in armpit, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Diabetes mellitus and Blood pressure diastolic increased. The patient's past medical treatment included Cephalexin and Percocet. At the time of the event, the patient had ongoing Nasopharyngitis and Hypersensitivity.  Concomitant medications were not reported.  On 14-Oct-2018, the patient received a one dosage form of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose in series were not reported) via intramuscular route in the left arm.  On 17-Oct-2018, the patient developed a non-serious sore lymph node in armpit (lymph node pain) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was sore lymph node in armpit.   The patient was treated with METFORMIN (METFORMIN), HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE), LOSARTAN (LOSARTAN), PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) , ATORVASTATIN (ATORVASTATIN), MULTIVITAMINS [VITAMINS NOS] (MULTIVITAMINS [VITAMINS NOS]), VITAMIN C [ASCORBIC ACID] (VITAMIN C [ASCORBIC ACID]), VITAMIN B COMPLEX (VITAMIN B COMPLEX), ZINC (ZINC), MAGNESIUM (MAGNESIUM), VANADIUM (VANADIUM), FISH OIL (FISH OIL) and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) on an unknown date..  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for sore lymph node in armpit.  Documents held by the sender: none.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness on skin surface about six inches long, 3 inches wide; chills; fever; Tenderness, soreness, in left shoulder; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from other healthcare professional via Health Authorities under reference 779465-1.  This case involves a 74 years old male patient who experienced chills, fever, tenderness, soreness, in left shoulder and redness on skin surface about six inches long, 3 inches wide, while he received vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and PNEUMOVAX.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included METOPROLOL and LISINOPRIL.  On 16-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ022AB and Exp. Date 18-Apr-2019 via intramuscular route in the left arm. On 16-Oct-2018, the patient received a second dose of suspect PNEUMOVAX not produced by Sanofi Pasteur lot RO18735 via intramuscular route in the left arm.  On 17-Oct-2018, the patient developed a non-serious chills, fever (pyrexia), tenderness, soreness, in left shoulder (injection site pain) and redness on skin surface about six inches long, 3 inches wide (erythema) one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX.  Other relevant tests not reported.    Final diagnosis was erythema, injection site pain, pyrexia and chills.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events.  List of documents held by sender- none.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Induration, Pain in extremity, Peripheral swelling
Clinical narrative: a lot of swelling with pain in deltoid area down to bicep; swelling travelled to forearm and decreased in other affected muscles; Arm ached a lot; a lot of swelling with pain in deltoid area down to bicep, arm was also very hard; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from  Health Authorities under reference 781722-1.  This case involves a 72 years old female patient who experienced a lot of swelling with pain in deltoid area down to bicep, swelling travelled to forearm and decreased in other affected muscles, arm ached a lot and a lot of swelling with pain in deltoid area down to bicep, arm was also very hard, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and PNEUMOVAX.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 19-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ042AB via intramuscular route in the left arm.  On 19-Oct-2018, the patient received a dose of suspect PNEUMOVAX not produced by Sanofi Pasteur lot R022249 via intramuscular route in the left arm.  On 19-Oct-2018, the patient developed a non-serious a lot of swelling with pain in deltoid area down to bicep (injection site pain), swelling travelled to forearm and decreased in other affected muscles (induration), arm ached a lot (pain in extremity) and lot of swelling with pain in deltoid area down to bicep, arm was also very hard (injection site swelling) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX.  No Lab data was reported.  Final diagnosis was Induration, Injection site pain, Injection site swelling and pain in extremity.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovered / Resolved on an unknown date for all the events.  Documents held by the sender: none.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Warm to the touch; sore; swollen; a little red; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from  Health Authorities under reference number 781831-1.  This case involves a 9 years old male patient who experienced warm to the touch, sore, swollen and a little red, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Current illness: No, History/ Allergies: No.  Concomitant medications were not reported.   On 23-Oct-2018, the patient received a six dosage form  of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ049AB, expiry date, dose in series were not reported) via intramuscular route in the right arm.  On 25-OctThe patient developed a non-serious warm to the touch (skin warm), sore (pain), swollen (swelling) and a little red (erythema) 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was a little red, swollen, sore and warm to the touch.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  Documents held by the sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Flu vaccine 0.5 ml dose administered at 10:05 am, not knowing previous dose at 8 am; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from other healthcare professional Health Authorities (under reference: 781899-1)  This case involves a three years old male patient who was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ041AA) via intramuscular route in left leg on 26-Oct-2018 without knowing the previous dose this am at 8 am.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's medical history and concomitant medications were not reported.  It was an actual medication error due to extra dose administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 6 month old female patient was administered a dose of Fluzone High Dose; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from an other health care professional via health authority (under reference number: 782801-1).   This case involves a six months old female patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ042AB via intramuscular route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was third dose DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) lot number: C5171AA via intramuscular route in left thigh, third dose HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) lot number: UI912AAA via intramuscular route in left thigh, third dose PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) lot number: W33491 via intramuscular route in right thigh and third dose ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) lot number: N029888 via oral route.  It was an actual medication error due to inappropriate age at vaccine administration. A 6 month old female patient was administered a dose of Fluzone High Dose  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Myalgia
Clinical narrative: Diarrhoea; Bad stomach cramps; chills; muscle ache; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from  Health Authorities under reference 784118-1.  This case involves a 71 years old male patient who experienced diarrhoea, bad stomach cramps, chills and muscle ache, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Atrial fibrillation, Current Illness: None and no known allergies.   On 03-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, dose in series and route of administration were not reported) in the right arm.  On 04-Nov-2018, the patient developed a non-serious diarrhea, bad stomach cramps (abdominal pain upper), chills and  muscle ache (myalgia) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was muscle ache, chills, bad stomach cramps and diarrhoea.   The patient was treated with WARFARIN (WARFARIN), ATORVASTATIN (ATORVASTATIN) and DILTIAZEM (DILTIAZEM) on an unknown date.  The patient outcome is reported as Unknown for all the events.  Documents held by the sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Hypoaesthesia, Injection site pain, Injection site paraesthesia, Mobility decreased
Clinical narrative: numbness; inability to lift arm; involuntary movement of arm after needle injection; extreme pain radiating from injection site down to hand; tingling; extreme pain radiating from injection site down to hand; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer of Health Authorities under reference 784199-1.  This case involves a 61 years old female patient who experienced numbness, inability to lift arm, involuntary movement of arm after needle injection, extreme pain radiating from injection site down to hand, tingling and extreme pain radiating from injection site down to hand, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included HYPERTENSION, Supraventricular tachycardia and Food allergy with Sunflower seeds.  The patient's past medical treatment included VALSARTAN, AMLODIPINE, CARVEDILOL and VIT D.  The patient's past vaccination(s), concomitant medication(s) and family history were not provided.  On 11-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ035AB) (expiry date, dose, dose in series and route was not reported) in the right arm. O  On 11-Oct-2018, on same day after the vaccination the patient experienced hypoaesthesia, dyskinesia, mobility decreased, pain in extremity, paraesthesia and injection site pain.   Relevant laboratory test results included:  Physiotherapy - On an unknown date: [Seen By physician 11/5/18. Referred for physical therapy]  Final diagnosis was hypoaesthesia, dyskinesia, mobility decreased, pain in extremity, paraesthesia and injection site pain.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as not recovered for all events.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: numbness; inability to lift arm; involuntary movement of arm after needle injection; extreme pain radiating from injection site down to hand; tingling; extreme pain radiating from injection site down to hand; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer of Health Authorities under reference 784199-1.  This case involves a 61 years old female patient who experienced numbness, inability to lift arm, involuntary movement of arm after needle injection, extreme pain radiating from injection site down to hand, tingling and extreme pain radiating from injection site down to hand, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included HYPERTENSION, Supraventricular tachycardia and Food allergy with Sunflower seeds.  The patient's past medical treatment included VALSARTAN, AMLODIPINE, CARVEDILOL and VIT D.  The patient's past vaccination(s), concomitant medication(s) and family history were not provided.  On 11-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ035AB) (expiry date, dose, dose in series and route was not reported) in the right arm. O  On 11-Oct-2018, on same day after the vaccination the patient experienced hypoaesthesia, dyskinesia, mobility decreased, pain in extremity, paraesthesia and injection site pain.   Relevant laboratory test results included:  Physiotherapy - On an unknown date: [Seen By physician 11/5/18. Referred for physical therapy]  Final diagnosis was hypoaesthesia, dyskinesia, mobility decreased, pain in extremity, paraesthesia and injection site pain.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as not recovered for all events.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Erythema; swelling; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a healthcare professional via the Health Authorities under reference (VAERS ID: 784756-1).  This case involves 8 years old female patient who experienced erythema and swelling, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Rhinitis allergic, Milk allergy, erythema with flu and other vaccines in same leg (Unsure age). The patient's past medical treatment included amoxicillin. The patient's past vaccination(s) and family history were not provided.  Concomitant medications included CETIRIZINE.   On 05-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ025AC via intramuscular route in the right arm.  On 05-Nov-2018, the patient developed a non-serious erythema and swelling, on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab tab performed.  Final diagnosis was swelling and erythema.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient had recovered from the events.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: aches in her upper trunk; Rash; hot to the touch; Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch); Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch); low grade fever; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from an other health care professional via health authority (under reference number: 784966-1).  This case involves a 46 years old female patient who experienced rash-raised red rash limited to her L arm, red and blotchy (hot to the touch), aches in upper trunk, and low grade fever, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA via intramuscular route in unknown administration site.  On 02-Nov-2018, the patient experienced a non-serious hot to the touch (skin warm), red and blotchy rash left arm (rash erythematous) (rash macular), aches in upper trunk (pain), rash and low grade fever (pyrexia) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was low grade fever, rash, aches in upper trunk, red and blotchy rash left arm and hot to the touch.   It was not reported if the patient received a corrective treatment.  The patient recovered from all the events at the time of report.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: aches in her upper trunk; Rash; hot to the touch; Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch); Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch); low grade fever; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from an other health care professional via health authority (under reference number: 784966-1).  This case involves a 46 years old female patient who experienced rash-raised red rash limited to her L arm, red and blotchy (hot to the touch), aches in upper trunk, and low grade fever, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA via intramuscular route in unknown administration site.  On 02-Nov-2018, the patient experienced a non-serious hot to the touch (skin warm), red and blotchy rash left arm (rash erythematous) (rash macular), aches in upper trunk (pain), rash and low grade fever (pyrexia) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was low grade fever, rash, aches in upper trunk, red and blotchy rash left arm and hot to the touch.   It was not reported if the patient received a corrective treatment.  The patient recovered from all the events at the time of report.  List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Pallor, Rash erythematous
Clinical narrative: 7 cm by 6 cm erythematous blanching raised rash surrounding injection site on right upper extrmity; 7 cm by 6 cm erythematous blanching raised rash surrounding injection site on right upper extrmity; 7 cm by 6 cm erythematous blanching raised rash surrounding injection site on right upper extrmity; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from other healthcare professional via Health Authorities (under the reference number: 785054-1).  This case involves a 6 years old female patient who experienced 7 cm by 6 cm erythematous blanching raised rash surrounding injection site on right upper extremity, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Current Illness: No.  Concomitant medications were not reported.   On 30-Oct-2018, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U4990CA via intramuscular route in the right arm.  On 01-NOV-2018, the patient developed a non-serious 7 cm by 6 cm erythematous blanching raised rash surrounding injection site on right upper extrmity (rash erythematous, pallor and injection site reaction), 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab data was reported.  Final diagnosis was rash erythematous, pallor and injection site reaction.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient had recovered from the events.  Documents held by the sender: none.
Sex: M
Vaccine: FLU4, UNK
Symptoms: Musculoskeletal pain
Clinical narrative: shoulder has been hurting intermittently; Initial information regarding an unsolicited valid serious case downloaded from the VAERS database received on 29-Mar-2019 from Other Health Care Professional via Health Authorities under reference 785228-1.  This case involves a 62 years old male patient who experienced shoulder has been hurting intermittently, while he received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] AND ZOSTER  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2018, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI996AB via intramuscular route in the right arm.  On 19-Sep-2018, the patient received a dose second  dose of suspect ZOSTER not produced by Sanofi Pasteur lot H547E via intramuscular route in the left arm.  On 07-Nov-2018, the patient developed a non-serious shoulder has been hurting intermittently (musculoskeletal pain) 1 month 19 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE and ZOSTER.  (Other relevant tests included no lab data.) Final diagnosis was shoulder has been hurting intermittently.  It was not reported if the patient received a corrective treatment.  The patient was not recovered from the events.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Cough, Diarrhoea, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Rhinorrhoea; cough; she had diarrhea; She has a hard red bump; She has a hard red bump.; She has a red bump. It was hot to touch; She also started to run a fever; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional via Health Authorities (under reference: 785310-1).  This case involves a 17 months old female patient who experienced rhinorrhea, cough, diarrhea injection site erythema, injection site induration, injection site warmth and fever, while she received vaccines HAVRIX and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2018, the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. On 07-Nov-2018, the patient received a dose of suspect HAVRIX not produced by Sanofi Pasteur lot number not reported.  On 07-Nov-2018, the patient developed a non-serious rhinorrhea, cough, diarrhea (diarrhoea), hard red bump (injection site erythema), hard red bump (injection site induration), red bump it was hot to touch (injection site warmth) and fever (pyrexia) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of HAVRIX.  (Other relevant tests included No lab data.) Final diagnosis was rhinorrhea, cough, diarrhea injection site erythema, injection site induration, injection site warmth and fever.  It was not reported if the patient received a corrective treatment.  The patient was unknown for all the event.  List of document held by sender: none.
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site warmth, Pyrexia, Rhinorrhoea
Clinical narrative: Rhinorrhoea; cough; she had diarrhea; She has a hard red bump; She has a hard red bump.; She has a red bump. It was hot to touch; She also started to run a fever; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional via Health Authorities (under reference: 785310-1).  This case involves a 17 months old female patient who experienced rhinorrhea, cough, diarrhea injection site erythema, injection site induration, injection site warmth and fever, while she received vaccines HAVRIX and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2018, the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. On 07-Nov-2018, the patient received a dose of suspect HAVRIX not produced by Sanofi Pasteur lot number not reported.  On 07-Nov-2018, the patient developed a non-serious rhinorrhea, cough, diarrhea (diarrhoea), hard red bump (injection site erythema), hard red bump (injection site induration), red bump it was hot to touch (injection site warmth) and fever (pyrexia) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of HAVRIX.  (Other relevant tests included No lab data.) Final diagnosis was rhinorrhea, cough, diarrhea injection site erythema, injection site induration, injection site warmth and fever.  It was not reported if the patient received a corrective treatment.  The patient was unknown for all the event.  List of document held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 56 years old patient given high dose flu shot; 56 years old patient given high dose flu shot; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from Other health care professional via Health Authorities under reference 787268-1.  This case involves a 56 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patients past medical history, concomitant medication and family history were not provided.   On 01-Oct-2018, the patient received a first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ029AA, expiry date not provided via intramuscular route in the left arm.  It was an actual medication error due to overdose and Inappropriate age at vaccine administration.  It was reported that 56 years old patient given high dose flu shot.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information regarding an unsolicited valid serious case downloaded from the VAERS database received on 29-Mar-2019 from Other Health Care Professional via Health Authorities (under the reference 787686-1). This case involves a 35 years old female patient who received a pediatric dose of vaccine FLUZONE. The patient's past medical history included Scoliosis, Depression, Anxiety and Arthropod sting. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation; KETOCONAZOLE; and PARAGARD. On 23-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AB via intramuscular route in the right arm. It was a case of actual medication error due to inappropriate age at vaccine administration as Pediatric dose given to adult patient. It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site erythema. redness on the left arm was described as about 3 inches in circumference; pain and arm soreness at the injection site; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer via Health Authorities under reference 787771-1.  This case involves female patient (age unknown) who experienced injection site erythema. redness on the left arm was described as about 3 inches in circumference and pain and arm soreness at the injection site, while she received vaccines SHINGRIX and INFLUENZA VACCINE.  The patients past medical history, concomitant medication and family history were not provided.   On 07-Sep-2018, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in the right arm. On 07-Sep-2018, the patient received injection of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in the left arm.  On 07-Sep-2018, the patient developed a non-serious injection site erythema. redness on the left arm was described as about 3 inches in circumference (injection site erythema) same day following the administration of INFLUENZA VACCINE and following the administration of SHINGRIX. On 07-Sep-2018, the patient developed a non-serious pain and arm soreness at the injection site (injection site pain) same day following the administration of INFLUENZA VACCINE and following the administration of SHINGRIX.  Lab data was not provided.  Final diagnosis was pain and arm soreness at the injection site and injection site erythema. redness on the left arm was described as about 3 inches in circumference.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for injection site erythema. redness on the left arm was described as about 3 inches in circumference and as Unknown for pain and arm soreness at the injection site.  List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Injection site reaction, Joint range of motion decreased
Clinical narrative: injection site pain; immidiate post-injection reaction; sub-deltoid bursa inflammation; joint range of motion decreased; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer of Health Authorities under reference 788504-1.   This case involves a 56 years old female patient who experienced sub-deltoid bursa inflammation, injection site pain, immidiate post-injection reaction and joint range of motion decreased, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment included LISINOPRIL, LEVOTHYROXINE, SINGULAIR, ALBUTEROL HFA and QVAR. The patient's past medical history, vaccination(s), concomitant medication(s) and family history were not provided. Thyroid and HTN were stable.   On 19-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left deltoid.  On 19-Oct-2018, on same day after the vaccination the patient experienced bursitis, joint range of motion decreased and injection site reaction. On 08-Nov-2018, 20 days after the vaccination the patient experienced injection site pain.  (Other relevant tests included no lab data.)  Final diagnosis was bursitis, joint range of motion decreased, injection site pain and injection site reaction.  The patient was treated with PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (PT).  The outcome of the events was reported as not recovered. On 27-Nov-2018, pain was not recovered.  List of documents held by sender: none.
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Fatigue, Limb discomfort, Pain in extremity, Pruritus generalised, Rash
Clinical narrative: fatigue; limb discomfort; pain in extremity; pruritus generalised; rash; urticaria; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer of Health Authorities under reference 788705-1.  This case involves a 58 years old female patient who experienced fatigue, limb discomfort, pain in extremity, pruritus generalised, rash and urticaria, while she received vaccines TWINRIX, BOOSTRIX and TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history included Hypertension, Insomnia, Arthralgia, Sinus disorder and Drug hypersensitivity with sulfa; codeine. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concurrent medication was reported.  Concomitant medications included LOSARTAN (LOSARTAN); LORATADINE (LORATADINE); IBUPROFEN (IBUPROFEN); and FISH OIL (FISH OIL) and multivitamins.  On 31-Oct-2018, the patient received 1st dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot N1K141M via intramuscular route in the left arm.  On 31-Oct-2018, the patient received 1st dose of suspect BOOSTRIX not produced by Sanofi Pasteur lot 33T42 via intramuscular route in the left arm.  On 31-Oct-2018, the patient received 1st dose of suspect TWINRIX not produced by Sanofi Pasteur lot 95KG9 via intramuscular route in the right arm.    On 31-Oct-2018, on same day after the vaccination the patient experienced fatigue, limb discomfort, pain in extremity, pruritus generalized, rash and urticaria.  It was reported that two appointments was arranged on 12/3/18 and 12/12/18  (Other relevant tests included no lab data.)  Final diagnosis was fatigue, limb discomfort, pain in extremity, pruritus generalized, rash and urticaria.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (CALADRYL [DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]), FAMOTIDINE (FAMOTIDINE) and HYDROXYZINE (HYDROXYZINE).  The outcome of the events was reported as recovered on an unknown date.  List of documents held by sender: none.
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Urticaria
Clinical narrative: fatigue; limb discomfort; pain in extremity; pruritus generalised; rash; urticaria; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer of Health Authorities under reference 788705-1.  This case involves a 58 years old female patient who experienced fatigue, limb discomfort, pain in extremity, pruritus generalised, rash and urticaria, while she received vaccines TWINRIX, BOOSTRIX and TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history included Hypertension, Insomnia, Arthralgia, Sinus disorder and Drug hypersensitivity with sulfa; codeine. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concurrent medication was reported.  Concomitant medications included LOSARTAN (LOSARTAN); LORATADINE (LORATADINE); IBUPROFEN (IBUPROFEN); and FISH OIL (FISH OIL) and multivitamins.  On 31-Oct-2018, the patient received 1st dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot N1K141M via intramuscular route in the left arm.  On 31-Oct-2018, the patient received 1st dose of suspect BOOSTRIX not produced by Sanofi Pasteur lot 33T42 via intramuscular route in the left arm.  On 31-Oct-2018, the patient received 1st dose of suspect TWINRIX not produced by Sanofi Pasteur lot 95KG9 via intramuscular route in the right arm.    On 31-Oct-2018, on same day after the vaccination the patient experienced fatigue, limb discomfort, pain in extremity, pruritus generalized, rash and urticaria.  It was reported that two appointments was arranged on 12/3/18 and 12/12/18  (Other relevant tests included no lab data.)  Final diagnosis was fatigue, limb discomfort, pain in extremity, pruritus generalized, rash and urticaria.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (CALADRYL [DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]), FAMOTIDINE (FAMOTIDINE) and HYDROXYZINE (HYDROXYZINE).  The outcome of the events was reported as recovered on an unknown date.  List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Feeling abnormal, Migraine
Clinical narrative: a week-long migraine; overall feeling horrible; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via health authority (under VAERS id: 789188-1).  This case involves a 33 years old female patient who experienced a week-long migraine and overall feeling horrible, while she received vaccine INFLUENZA VACCINE.  The patient's past medical history included Hypothyroidism, Migraine, Anxiety, Depression and Methylenetetrahydrofolate reductase gene mutation.  Concomitant medications were not reported.   On 02-Nov-2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On 02-Nov-2017, the patient developed a non-serious a week-long migraine (migraine) and overall feeling horrible (feeling abnormal) same day following the administration of INFLUENZA VACCINE.  No Lab data was reported.  Final diagnosis was overall feeling horrible and a week-long migraine.   The patient was treated with LEVOTHYROXINE (LEVOTHYROXINE), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CYPROHEPTADINE (CYPROHEPTADINE), ASCORBIC ACID, BETACAROTENE, CALCIUM CARBONATE, COLECALCIFEROL, DOCOSAHEXAENOIC ACID, FERROUS FUMARATE, FOLIC ACID, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, RIBOFLAVIN, THIAMINE MONONITRATE, TOCOPHERYL ACETATE, VITAMIN B12 NOS, ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), FISH OIL (FISH OIL) and MAGNESIUM (MAGNESIUM) on an unknown date..  The patient outcome is reported as Recovered / Resolved on an unknown date for both the events.  Documents held by the sender: none.
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Fall, Haemorrhage, Head injury, Loss of consciousness, Syncope
Clinical narrative: Initial information regarding an unsolicited valid serious case downloaded from the VAERS database received on 29-Mar-2019 from Health Authorities under reference 789220-1. This case involves a 17 years old male patient who fainted and fell on the floor from the standing position and had bleeding head, while he received vaccines FLUZONE QUADRIVALENT and BOOSTRIX. The patient had no current illness, past medical history or allergy. Past vaccination(s) and family history were not provided. No concomitant therapies were given. On 02-Dec-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ045AA via intramuscular route in the left arm. On 02-Dec-2018, the patient received a dose of suspect BOOSTRIX not produced by Sanofi Pasteur lot K5F5R via intramuscular route in the left arm. On 02-Dec-2018, the patient developed a serious fainted and fell on the floor from the standing position less than 2 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE and BOOSTRIX. This event was assessed as medically significant. On 02-Dec-2018, the patient fainted and fell on the floor from the standing position and had bleeding head less than 2 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE and BOOSTRIX. Case details: Patient was instructed to stay flat back position on the floor. After approximately 10 minutes, patient got up and sat on the chair in the waiting area while waiting for paramedic to arrive. Patient was given water and pharmacist pressed back bleeding head while mom and patient was talking. Patient wanted cold water to be poured over his head. Patient was doing well and paramedic arrived. Paramedic checked patient's vital sign and patient was taken to the emergency room. It was unknown if any lab test has been performed. Final diagnosis was fainted and fell on the floor from the standing position and head injury. It was not reported if the patient received a corrective treatment. The patient recovered from all the events (Patient regained consciousness in less than 30 seconds). List of documents held by send one. Sender's Comments: This case concerns an adolescent patient who presented with syncope after vaccination with FLUZONE QUADRIVALENT and BOOSTRIX. The time to onset is compatible and the events are expected with this vaccine. However, past history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: underdose/given a pediatric dose; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from Health Authorities under reference 790659-1.  This case involves a 14 years old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent], lot number: UT6259KA via intramuscular route in the left arm on 17-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to vaccine underdose.  A pediatric dose was given to a 14 year old. Patient was instructed to come back in for second injection.  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pain in her right arm; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from Health Authorities under reference 793061-1.  This case involves a 65 years old female patient who experienced pain in her right arm, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm.  On an unknown date, the patient developed a non-serious pain in her right arm (pain in extremity) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included No lab data reported.)  Final diagnosis was pain in her right arm.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for pain in her right arm.