chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare professional. This case involves an 83 years old patient who received vaccine FLUZONE HIGH DOSE in the gluteal instead of deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 17-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UJ000AA via unknown route in the gluteal instead of deltoid. It was case of actual medication due to Vaccine administered at inappropriate site. It was not reported that if any adverse event occurred 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: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case 09-month old female child patient who received 0.5 ml FLUZONE QUADRIVALENT (batch number UT6261LA, expiry date 30 June 2019, route not reported) in left thigh on 17 Sep 2018. It was a case of actual medication error due to vaccine overdose. No known reported symptoms. 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: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 83 years old female patient who received a dose of FLUZONE HIGH DOSE which was undergone a temperature excursion from being in transit too long and arrived 4 days later than expected. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 17-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ022AB expiry date: 18-Apr-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was not reported that any adverse event occurred 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.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient (also reported as 3 year 2 weeks) who recieved 0.25 ml vaccine, while he received vaccine FLUZONE. 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  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot UT6259NA via unknown route in unknown administration site. It was also a case of actual medication error due to vaccine underdose. It was unknown if patient experienced 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.
Age: 19.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: This spontaneous report was received from an office manager, via company representative and refers to a currently 19-year-old female patient. The patient did not have any medical history and drug reactions or allergies. Her concomitant medications included an unspecified meningococcal vaccine. On 16-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose not reported) lot # N035032 with expiration date: 24-SEP-2020, intramuscularly for prophylaxis. On an unknown date, the patient experienced tingling and poking sensations in her upper body. She contacted her physician but did not receive any treatment. None laboratory diagnostics nor studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and (GARDASIL 9) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. 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. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 25-OCT-2016, the patient was treated by a physician for herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Hyperhidrosis, Hypotension, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 18-year-old female patient who received BEXSERO (batch number 1684O1, expiry date unknown) for prophylaxis. On 7th September 2018 11:30, the patient received the 2nd dose of BEXSERO .5 ml. On 7th September 2018 14:30, 3 hrs after receiving BEXSERO, the patient experienced chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps. The patient was treated with ADVIL. On 8th September 2018, the outcome of the chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps were recovered/resolved. It was unknown if the reporter considered the chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps to be related to BEXSERO. Additional details were received as follows: The patient's physician asked the patient in general to have breakfast before coming in to the office to get BEXSERO vaccination. In morning at 11:30 o'clock, the patient came to receive her shot of BEXSERO in left thigh. The patient sit for 20 minutes after vaccination with BEXSERO for observation. The patient went home after vaccination, had lunch and at about 2:30 pm came back to the office. The patient had shaking chills, a spike in temperature fever of 103 degree F and the patient was feeling nauseated. The patient also had cramping on the left leg where she received the vaccine, and was diaphoretic. The patient had a bit of a low blood pressure. The patient had some swelling at the injection site. However, the patient had no wheezing, no hives, no respiratory distress. The patient was given food and ADVIL. The patient was also kept in the office. The patient then went home. The patient had a low grade fever that night. The patient was given popsicles with sugar. She took ADVIL again at home. The day after vaccination, the patient was fine and had recovered from all the symptoms. This case was linked with case US2018165454, reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Muscle spasms, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 18-year-old female patient who received BEXSERO (batch number 1684O1, expiry date unknown) for prophylaxis. On 7th September 2018 11:30, the patient received the 2nd dose of BEXSERO .5 ml. On 7th September 2018 14:30, 3 hrs after receiving BEXSERO, the patient experienced chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps. The patient was treated with ADVIL. On 8th September 2018, the outcome of the chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps were recovered/resolved. It was unknown if the reporter considered the chills, nausea, injection site swelling, diaphoresis, low blood pressure, fever and leg cramps to be related to BEXSERO. Additional details were received as follows: The patient's physician asked the patient in general to have breakfast before coming in to the office to get BEXSERO vaccination. In morning at 11:30 o'clock, the patient came to receive her shot of BEXSERO in left thigh. The patient sit for 20 minutes after vaccination with BEXSERO for observation. The patient went home after vaccination, had lunch and at about 2:30 pm came back to the office. The patient had shaking chills, a spike in temperature fever of 103 degree F and the patient was feeling nauseated. The patient also had cramping on the left leg where she received the vaccine, and was diaphoretic. The patient had a bit of a low blood pressure. The patient had some swelling at the injection site. However, the patient had no wheezing, no hives, no respiratory distress. The patient was given food and ADVIL. The patient was also kept in the office. The patient then went home. The patient had a low grade fever that night. The patient was given popsicles with sugar. She took ADVIL again at home. The day after vaccination, the patient was fine and had recovered from all the symptoms. This case was linked with case US2018165454, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of throat swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was unknown. It was unknown if the reporter considered the throat swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had a delayed reaction after receipt of the 1st dose of SHINGRIX which was characterized by throat swelling. The information collected via chat, only got gender from the healthcare professional he would not provide anything else and his office did not administer the first dose of SHINGRIX so had no vaccine information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site macule, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site macule in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, no adverse reaction). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site macule, injection site rash, injection site hypersensitivity, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site macule, injection site rash, injection site hypersensitivity, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site macule, injection site rash, injection site hypersensitivity, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient said the side effects were started on the next day after vaccination. The area of the skin was about 6 inches at the injection site. The patient described blotchy skin as not being a rash but that was the only thing he could think of to describe the area. The area was warm to the touch as well as being sensitive. The patient had not spoken to a physician about this issue. No further follow up information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site macule in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, no adverse reaction). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site macule, injection site rash, injection site hypersensitivity, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site macule, injection site rash, injection site hypersensitivity, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site macule, injection site rash, injection site hypersensitivity, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient said the side effects were started on the next day after vaccination. The area of the skin was about 6 inches at the injection site. The patient described blotchy skin as not being a rash but that was the only thing he could think of to describe the area. The area was warm to the touch as well as being sensitive. The patient had not spoken to a physician about this issue. No further follow up information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 23rd March 2018, the patient received the 1st dose of SHINGRIX. On 23rd March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was recovered/resolved. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she experienced a big welt the size of a baseball at the injection site the same day she had the vaccine. It lasted at least 5 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Rash macular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythromacular rash in a 71-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 7 days after receiving SHINGRIX, the patient experienced erythromacular rash, pruritus and tingling sensation. On an unknown date, the outcome of the erythromacular rash, pruritus and tingling sensation were not recovered/not resolved. It was unknown if the reporter considered the erythromacular rash, pruritus and tingling sensation to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to the doctor. The case was reported by the certified medical assistant. The patient received SHINGRIX on the left arm. One week after receiving SHINGRIX, the patient experienced red spots on her forearm, she felt like needles pricking her and itching. The same events then spread to the abdomen on 22nd June 2018. The events resolved, and then returned after an unspecified time. The events then resolved again. At the time of reporting, the events were not present. The timeframe was not communicated by the patient, only that the event was periodic.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Hypoaesthesia oral, Oral discomfort
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning oral sensation in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced burning oral sensation, numbness oral and inadvertent exposure to vaccine. On an unknown date, the outcome of the burning oral sensation, numbness oral and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the burning oral sensation and numbness oral to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that she was giving an injection to the patient and she thought she might have got some vaccine in her mouth. The reporter thought she must have had some of the vaccine on my fingers from the bottle. She experienced burning sensation and numbness in her mouth. She could not have ingested much but she still had a funny sensation in her mouth/throat. She flushed her mouth with water, lots and lots of water.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced pain, fatigue, myalgia and fever. On an unknown date, the outcome of the pain, fatigue, myalgia and fever were unknown. The reporter considered the pain, fatigue, myalgia and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient experienced pain, fatigue, myalgia and fever. The reporter considered the symptoms were related. For tolerance to 2nd dose refer linked case US2018GSK171806, for the same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Lethargy, Myalgia, Oral herpes
Clinical narrative: This case was reported by a consumer and described the occurrence of cough in a 62-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 14 days after receiving SHINGRIX, the patient experienced cough, fever, general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation. On an unknown date, the outcome of the cough and fever were recovered/resolved and the outcome of the general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation were recovering/resolving. The reporter considered the cough, fever, general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation to be related to SHINGRIX. Additional details were provided as follows: The patient experienced severe cough and fever for 5 days, body aches, muscle pain, headache, lethargy, cold sore under lip skin and heart palpitation. This case has been linked with US2018GSK173028 (2nd dose of SHINGRIX), reported by same reporter for same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of cough in a 62-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 14 days after receiving SHINGRIX, the patient experienced cough, fever, general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation. On an unknown date, the outcome of the cough and fever were recovered/resolved and the outcome of the general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation were recovering/resolving. The reporter considered the cough, fever, general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation to be related to SHINGRIX. Additional details were provided as follows: The patient experienced severe cough and fever for 5 days, body aches, muscle pain, headache, lethargy, cold sore under lip skin and heart palpitation. This case has been linked with US2018GSK173028 (2nd dose of SHINGRIX), reported by same reporter for same patient.
Age: 90.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of atrial fibrillation in a 90-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HD for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 1st dose of FLUZONE HD. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was recovered/resolved. It was unknown if the reporter considered the atrial fibrillation to be related to SHINGRIX. Additional details were reported as follows: The patient was approximately 90 years old and received SHINGRIX in unknown arm. Before the reporting date, past weekend the reporter had a patient that experienced atrial fibrillation. The patient had received FLUZONE HD in an unknown arm. According to the reporter, the patient was then thrown into atrial fibrillation. They were able to correct this and the patient was now stable.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on 3rd May 2018 and experienced fatigue, myalgia, and fever, refer linked case US2018GSK167608). On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced pain, fatigue, myalgia and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain, fatigue, myalgia and fever were unknown. The reporter considered the pain, fatigue, myalgia and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient experienced pain, fatigue, myalgia, and fever. The reporter considered the symptoms were related.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 55 years old male patient who received a 0.5 mL dose of FLUZONE HIGH DOSE lot UJ004AA, expiry date: 30-Mar-2019, via intramuscular route in the left arm on 14-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. The patient did not experience any adverse event following the vaccination (no reported symptoms). 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 the sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial unsolicited report received from pharmacist on 14-Sep-2018. This case involves a [73 years old] male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UI993AB, expiration date: 31-Mar-2019, route: intramuscular and site of administration: left arm on an unknown date where little amount leaked out where the needle attaches to the syringe. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine under dose. This is also a case of product complaint due to syringe leak. 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.
Sex: U
Vaccine: RAB
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and gender patient who received vaccine IMOVAX RABIES lot N1B051M, expiry date 26 Feb 2019 via unknown route in unknown administration site on unknown date. The patient's past medical history, concomitant medication 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 vaccine under dose, exposure via skin contact, syringe issue. It was reported that IMOVAX dripped on the patients arm during administration. The patient got only 3/4's of the dose. It was leaking from where the needle attaches. Unknown if it was cracked because it had already been discarded. 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: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves five patients (age and gender not reported) who experienced a knot at injection site, redness at injection site, itching at injection site and burning at injection site, while he/she received vaccine FLUZONE QUADRIVALENT. 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 QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious a knot at injection site (vaccination site nodule), redness at injection site (vaccination site erythema), itching at injection site (vaccination site pruritus) and burning at injection site (vaccination site pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, she has photos of some of these site reactions and thought it was unusual that several patients reported this; she wondered if the formula or strain was "more acidic" this year. No information about relevant test reported. Final diagnosis was burning, itching, redness and a knot at injection site. The patient was treated with HYDROCORTISONE (HYDROCORTISONE) and LORATADINE (CLARITINE) for Injection site reaction. The patient recovered for all events within a few days of injection on an unknown date. List of documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from a Nurse on 14-Sep-2018. This case is linked to case 2018SA262249 (same reporter). This case involves a five months old male patient who was vaccinated with a 0.5 mL dose of IPOL (Batch number: N1A461M, expiration date: 30-Sep-2020) intramuscularly in left thigh on 06-Sep-2018. The patients past vaccination(s) included IPOL. The patient's past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that the first excursion was at 47.5F for 36 minutes. The IPOL had been used before the excursion and was used after the excursion. It was an invalid dose. The second excursion was with the same vaccine, at 55.6 F for 5 hours and 12 minutes. It was unknown whether the 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: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA262537 (same reporter). This case involves a 11 years old female patient who received 0.5ml vaccine MENACTRA lot U595AA, expiry date 27 Aug 2019 and FLUZONE QUADRIVALENT MDV lot UI982AC, expiry date 30 June 2019 via intramuscular route in the left deltoid on 17-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage as it was reported that patient received MENACTRA and FLUZONE QUAD after temp excursion and vaccine unacceptable for use. Temperature: -1.64 Celsius for 24 hours. It was unknown whether patient experienced any adverse reaction. 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: 0.75
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA262531 for patient age 11 yrs. same reporter. This case involves a 9 months old patient (gender unknown) who received vaccine FLUZONE 0.5ml dose, lot UT6259KA, expiry date 30-Jun-2019 via intramuscular route in the left thigh. The patients past medical history, concomitant medication and family history were not provided. No other vaccines given at the time. It was an actual medication error due to incorrect product storage. It was reported that patient received FLUZONE after temp excursion and vaccine unacceptable for use. Temp- 1.64 C for 24 hours. 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 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: FLU4
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64 years old male patient who experienced shivering pain, fever at 102 and pain at the injection site, while he 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 standard dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB via unknown route in the left arm. On an unknown date, the patient developed a non-serious shivering pain (chills), fever at 102 (pyrexia) and pain at the injection site (vaccination site pain) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the symptoms were started about 0300 and lasted through the night for about 24 hours. (Other relevant tests included No lab data.) Final diagnosis was pain at the injection site, fever at 102 and shivering pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for shivering pain, pain at the injection site and fever at 102. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a two- months old patient who was vaccinated with a dose of BOOSTRIX instead of DTaP (lot number, expiry date, dose, dose in series, route and site of administration was not reported on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. The Doctor in the ER ordered DTap and the nurse gave BOOSTRIX. It was reported that patient already received Hib and polio portion. It was not reported whether the patient experienced any adverse reactions following the vaccination. 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: 0.42
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff). This case involves five months old patient who received expired dose of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine 13V for Immunization; and Rotavirus Vaccine for Immunization. On 13-Sep-2018, the patient received 0.5 ml expired dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5)/HIB(PRP/T) Vaccine, lot C5419AA, via intramuscular route in the right thigh. It was a case actual medication error due to Expired vaccine used. It was not reported that any adverse event occurred 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: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient (gender unknown) who received injection of ACT-HIB lot UI799AA, expiry date 08 Jul 2018 via unknown route in unknown administration site on an unknown date. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that the nurse gave a vaccine to a 12-month old that expired on July 8. The vaccine was administered yesterday. 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: U
Vaccine: TTOX
Symptoms: Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist via other company (Merck). This case involves patient (age and gender unknown) who experienced localized injection site reaction with large hard while received vaccine TETANUS TOXOID ADSORBED. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID ADSORBED produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, more than a year ago, the patient developed a non-serious localized injection site reaction with large hard bump and (vaccination site reaction) with unknown latency following the administration of TETANUS TOXOID ADSORBED. Lab data was not provided. Final diagnosis was localized injection site reaction with large hard bump. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for localized injection site reaction with large hard bump that lasted about a year. List of documents held by sender - none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a five-years old male patient who received a 0.5 mL first dose of QUADRACEL (one dose) lot C5325BA, expiry date: 14-Nov-2019 in right leg on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that QUADRACEL that had a temperature excursion and the vaccine should not be used. The vaccine was set aside, but someone took out a dose and gave it to a patient. It was not reported if the patient experienced 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 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: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA264048 (same reporter). This case involves a 09 years old female patient who received 0.5 mL dose of vaccine FLUBLOK QIV, lot QFAA1805, expiry date- 02-06-2019 via unknown route in the right deltoid (Frequency-once) on 18 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had no Concomitant medications. It was an actual medication error due to Inappropriate age at vaccine administration. 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: M
Vaccine: FLUR4, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA264036 (same reporter). This case involves a 11 years old male patient who received 0.5 mL dose of vaccine FLUBLOK QIV lot QFAA1805, expiry date- 02-06-2019 via unknown route in the left deltoid (Frequency-once) on 18 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 for Immunisation. It was an actual medication error due to Inappropriate age at vaccine administration. 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.