chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a physician via call. This case involves a patient who experienced high fever, while he/she received vaccine FLUZONE HIGH DOSE. The patients 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 unknown administration site. On an unknown date, the patient experienced a non-serious high fever (fever) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was high fever. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 81 years old male patient who experienced sore arm and rapid heart rate, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On 18-Oct-2018, the patient experienced a non-serious sore arm (pain in arm) and rapid heart rate (heart rate increased) one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included was on 18-Oct pulse rate was 87, on 19-Oct pulse rate was 92, on 20-Oct pulse rate was 90, on 21-Oct pulse rate was 92, on 22-Oct pulse rate was 92, on 23-Oct pulse rate was 95, on 24-Oct pulse rate was 60 and on 25-Oct pulse rate was 62. Final diagnosis was rapid heart rate and sore arm. It was not reported if the patient received a corrective treatment. On 24-Oct-2018, the patient recovered from the events. List of documents held by sender: none.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299807, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794 and 2018SA299809 (same reporter). This case involves 76 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794 and 2018SA299809 (cluster). This case involves 94 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794 and 2018SA299809 (cluster). This case involves 82 years old female (height reported as 63.5) patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 82 years old female (height 65 and weight: 148) patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 71 years old female patient (height: 67 and weight: 204) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 66 years old female patient (height: 70.5 and weight: 205 lbs) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 66 years old female patient (height: 64.75, weight: 137) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299814, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 77 years old female patient (height: 68 weight: 196 lbs) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old female patient who received an expired dose of 0.5 mL ACT-HIB (frequency once) lot UI805AA via intramuscular route in the right thigh on 26-Oct-2018. The patient's medical history and concomitant medications were not reported. Concomitant medications included MMR for Immunisation; and PREVNAR 13 for Immunisation. It was an actual medication error case due to expired vaccine used. It was reported that the patient had not any bad reaction and had no treatment. 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 and Module VI of the 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: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 62 years old female patient who she received 0.5 ml of vaccine FLUZONE HIGH DOSE (batch number: UJ031AA) (expiry date and dose in series were not reported) via intramuscular route in the left deltoid on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included SHINGRIX for Immunization. It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose. No adverse event was reported. 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
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old female patient who experienced bad itching rash across her chest, while she received vaccine FLUZONE QUADRIVALENT. The patients past vaccination included FLUZONE QIV in 2003 with no adverse reaction. The patients past medical history, concomitant medication and family history were not provided. The patient did not receive any vaccine, other than suspect. On 22-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date and dose not reported via unknown route in the left deltoid. On unknown date, the patient developed a non-serious bad itching rash across her chest (rash pruritic) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was 4 days affected by it and did not want anything to touch the rash. It was not painful just itchy. It is getting better now. The patient did report this to her doctor. Lab data was not provided. Final diagnosis was bad itching rash across her chest. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for bad itching rash across her chest. List of documents held by sender- none.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 years old male patient and reported that Flublok Quadrivalent given to a 15 years male patient, while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 25-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1816 and expiry date: 20-Jun-2018) (dose in series and route was not reported) in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if 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.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old female patient who received an expired fifth dose of 0.5 mL DAPTACEL (frequency once) lot C5065AA expiry date: 08-Oct-2018 via unknown route in the left deltoid on 26-Oct-2018. The patient's medical history and concomitant medications were not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; POLIO VACCINE INACT (IPV) for Immunisation; and MMR for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that, patient did not had side effects. 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 and Module VI of the 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: 76.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 77 years old male patient who received vaccine FLUBLOK QIV instead of vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 07-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date not reported via unknown route in the right arm instead of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported. It was an actual medication error due to wrong vaccine administered. It was reported that patient received FLUBLOK, but he wanted to get to receive FLUZONE HIGH DOSE, a nurse administered to him. The patient did not experience 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
Symptoms: Injection site erythema, Injection site swelling, Pain, Tenderness
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult female patient who experienced large surface area of redness and swelling at the injection site, still has tenderness when raising arm several weeks after injection and still has tenderness when raising arm several weeks after injection, while she received vaccine FLUZONE QUADRIVALENT. 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 QUADRIVAL A-B VACCINE lot number, expiry date not reported. On an unknown date, patient developed a non-serious large surface area of redness and swelling at the injection site (vaccination site inflammation), still has tenderness when raising arm several weeks after injection (tenderness), still has tenderness when raising arm several weeks after injection (limb discomfort) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. Final diagnosis was still has tenderness when raising arm several weeks after injection, still has tenderness when raising arm several weeks after injection and large surface area of redness and swelling at the injection site. It was not reported if the patient received a corrective treatment. The event outcome is reported as Unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: After receiving Men B she states arm was immediately sore at site of the injection, also for the first couple of days and then for the first week after the injection. She now complains of Sharp pain of upper mid arm when she lifts something heavy or extends arm. She states is a non-consistent sharp pain. States when she changes position pain goes away. Referred to Primary Care Provider for evaluation of symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Feeling hot
Clinical narrative: Patient states that in the afternoon after receiving vaccines she could not get off her couch without assistance. She said she was achy, dizzy, extreme fatigue and headache. She had chills but head felt hot. She did not  take temperature. She was able to get up around 10 AM the next morning. She experience diarrhea the  day after vaccines. She said it took her 3 to 4 days to feel normal.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Pain
Clinical narrative: Patient states that in the afternoon after receiving vaccines she could not get off her couch without assistance. She said she was achy, dizzy, extreme fatigue and headache. She had chills but head felt hot. She did not  take temperature. She was able to get up around 10 AM the next morning. She experience diarrhea the  day after vaccines. She said it took her 3 to 4 days to feel normal.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Impaired healing, Injection site reaction, Pain in extremity
Clinical narrative: Poor healing at injection site with bruising and pain to upper arm post three weeks after vaccine administration.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Electrocardiogram, Pleurisy, X-ray
Clinical narrative: Flu Shot = Quad, not sure of manufacturer Adverse event currently diagnosed as pleurisy by ER.   Today I have appointment with Pneumologist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt experienced about 1 inch of redness, induration, heat, pain and itching to injection site within 24 hours of vaccination.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Erythema, Headache, Malaise, Peripheral swelling
Clinical narrative: Mom called office reporting that child did not feel well, eat well, and had swelling and redness to upper arm for several days following the vaccination. She also reported that her child complained of a headache for 2 weeks following the vaccine.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Blood test, Borrelia test negative, Computerised tomogram head, Electrocardiogram
Clinical narrative: Sunday(10/28/2018) about 3 days later after the vaccine I developed numbness on the right side of my lips,. On Monday (10/29/2018) I went to Medical Center were I underwent a series of tests and the medical staff concluded I developed Bell's Palsy.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia oral, Neurological examination
Clinical narrative: Sunday(10/28/2018) about 3 days later after the vaccine I developed numbness on the right side of my lips,. On Monday (10/29/2018) I went to Medical Center were I underwent a series of tests and the medical staff concluded I developed Bell's Palsy.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced soreness in arm and tingling in hand. Patienr reported to doctor who said it was most likely from shot and should go away.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Injection site rash, Rash pustular
Clinical narrative: Rash on right upper arm. Initially has pustules that became blisters overnight. No fevers. Monitor for now. May consider starting antibiotics if it continues to spread.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient was vaccinated at her place of employment by EHS team. Patient reported to EHS staff several mins after vaccination  the site was red. Patient used an ice pack to left deltoid and returned two hours later and Left deltoid at the site of injection appeared swollen 3in x3in circular area, slightly itchy, small area of hardness at injection site, warm to touch, redness, no tracking, no cellulitis noted. PCP treated with BENADRYL.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: Had 12M PE and imms on 10/23, Monday mom noted a few bumps/rash on random parts of body, tuesday a few more bumps head to toe in random spots, yesterday got better, much less spots, today all spots have resolved, today temp 101.5 rectal, no other new sx, will send to clinic for advice.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Sudden death
Clinical narrative: Patient received immunization on 10/15/18 and passed away the next morning on 10/16/18. He had multiple other comorbidities, but death was sudden.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Patient was given flu shot in her right deltoid - she states she feels like the shot was given high in the arm. She states, she has had pain in the arm, can't raise the arm and can't sleep on her right side ever since the vaccine was administered. Advised her to see her HCP.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Extra dose administered, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large localized reaction at site of vaccine injections (left thigh). Redness, swelling, warmth, and itching. Started approx. 24 hrs. after vaccination. Redness and swelling spread over next 24 hours. Redness approx. 8 x 10 cm in diameter. Parents applied ice and gave OTC CLARITIN. At visit on 11/1/2018, I prescribed diphenhydramine 12.5 mg/5 mL, give 2.5 mL every 4-6 hrs as needed for itch and swelling. Also notable: the Hepatitis A vaccine and DTaP vaccine given on 10/30/18 were extra, unnecessary vaccines. They were given in error because of lack of previous vaccination records. After the incident it was noted from past records that he had already received DTaP #4 and Hepatitis A #2. The patient also received the annual influenza vaccine in the right thigh, and this area also had a small localized reaction with redness and mild swelling of about 3-4 cm.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Local reaction
Clinical narrative: Large localized reaction at site of vaccine injections (left thigh). Redness, swelling, warmth, and itching. Started approx. 24 hrs. after vaccination. Redness and swelling spread over next 24 hours. Redness approx. 8 x 10 cm in diameter. Parents applied ice and gave OTC CLARITIN. At visit on 11/1/2018, I prescribed diphenhydramine 12.5 mg/5 mL, give 2.5 mL every 4-6 hrs as needed for itch and swelling. Also notable: the Hepatitis A vaccine and DTaP vaccine given on 10/30/18 were extra, unnecessary vaccines. They were given in error because of lack of previous vaccination records. After the incident it was noted from past records that he had already received DTaP #4 and Hepatitis A #2. The patient also received the annual influenza vaccine in the right thigh, and this area also had a small localized reaction with redness and mild swelling of about 3-4 cm.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date 31st May 2019) for prophylaxis. On 16th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema and injection site swelling. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient visited the doctor, the day before reporting and brought medicine that cause her additional expenses.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-FEB-2015, the patient received ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient had her first of five shingles outbreaks on 21-JUN-2015; second outbreak again on 02-AUG-2015; third outbreak on 25-MAY-2016; fourth outbreak on 23-SEP-2016 and her fifth outbreak on 30-APR-2017. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak on 21-JUN-2015; shingles outbreak on 02-AUG-2015; shingles outbreak on 25-MAY-2016; shingles outbreak on 23-SEP-2016 and shingles outbreak on 30-APR-2017 were considered to be disabling.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-NOV-2011, the ZOSTAVAX was administered to the patient (lot number, dosage and route of administration not provided). On or about 26-SEP-2017, the patient was treated by a physician for repetitive shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 31-OCT-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M043836, expiration date 17-JUN-2018, orally (dose was not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Syringe issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number TA422, expiry date 30th June 2019) for prophylaxis. This case was associated with a product complaint. On 11th October 2018 11:30, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 11th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain, syringe issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the pharmacist for herself. The patient received FLULAVAL QUADRIVALENT on the left deltoid. The patient believed that there was more air in the FLULAVAL QUADRIVALENT syringes this year than in previous years. The patient was an experienced user of the product. On the day of reporting her facility had a flu vaccination clinic for staff. The patient noted the unusual amount of air in syringe, as well as, experienced pain during the vaccination and could feel the vaccine being injected. The patient reported that the syringes are filled 1/3 to 1/2 with air and the rest of the space was product. The patient indicated that she had not experienced this with previous vaccinations with the product. The patient did not ask for replacement of the product. However, she wanted to report this in case there was a quality issue. The patient provided the lot number of another syringe which appears the same, batch number 4MA57 and expiry date 11th June 2019. The patient was initially speaking with a representative in Medical Information but she reports that they were unable to tell her this was acceptable. The patient provided two pictures of the syringe to GSK. The patient did not want to send a sample of one of the FLULAVAL syringes because all doses were allocated and felt that the pictures she emailed would be sufficient. This case has been linked with the case US2018185712 and US2018GSK197109, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Syringe issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. This case was associated with a product complaint. On 11th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 11th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint and syringe issue. On an unknown date, the outcome of the injection site pain, pharmaceutical product complaint and syringe issue were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the pharmacist for her colleague. The age at vaccination was not reported. The patient noted the unusual amount of air in syringe, as well as, experienced pain during the vaccination and could feel the vaccine being injected. The reporter did not provide more information about colleague at the time of reporting. This case has been linked with the case US2018185671 and US2018GSK197109, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vertigo
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 66-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number C9275, expiry date 31st May 2019) for prophylaxis. On 9th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 10th October 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced nausea and vertigo. On 11th October 2018, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the vertigo was recovered/resolved. It was unknown if the reporter considered the nausea and vertigo to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The events were bad enough that the patient was sent home from work early. It resolved later that evening. The patient had denied permission to contact their physician.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia, Sjogren's disease, hypothyroidism and white blood cell count low. Previously administered products included ZOSTAVAX. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had fibromyalgia, Sjogren's disease, hypothyroidism, low white blood cell count and weakened immune system (all conditions prior to receive SHINGRIX vaccine). After receiving SHINGRIX, the patient experienced fever, flu-like symptoms and did not feel well for a few days. The patient's injection site was also swollen and very painful such that she could not move it. The contact details of the physician were provided. For tolerance to the 2nd dose of SHINGRIX, refer case US2018GSK194539.