chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: In 2018, about 6 months before the reporting date, the patient had sore arm after the dose of SHINGRIX she had no other symptoms. The patient provided details of the physician. For tolerance after 2nd dose refer case US2018189458.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unknown date, see case US2018GSK19311). Concurrent medical conditions included shingles. Concomitant products included VALTREX. In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX injection previous month when he had an active case of shingles and was receiving VALTREX. The patient wanted to know would this hurt him in any way. The patient did not want to provide date of birth or physician's contact information or other adverse event information. The patient had denied permission to contact their physician. The patient had provided limited information.
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 2-month-old female patient received PREVNAR 13, (solution for injection in pre-filled syringe, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization and PEDIARIX, via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. The patient developed a rash on an unspecified date. The outcome of the event was unknown.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dysphonia, Dyspnoea, Tremor, Wheezing
Clinical narrative: Flu shot was done at a flu clinic. Patient experienced shaking, difficulty in breathing, hoarseness of voice, wheezing, uneasy. One of the doctors in the clinic gave her oral Benadryl and administered Epipen. 911 was called.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: sanofi-pasteur manufacturer Pt came into pharmacy complaining that her right thigh has been itching since she got the flu vaccine, she has applied some neosporin and bactroban on site and has also taken at least 1 dose of benadryl. I counseled to continue benadryl and apply hydrocortisone to site. She has a dermatologist appointment in 3 weeks.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reported still having soreness at the injection site 2 weeks after receiving the injection.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Pain of skin, Paraesthesia, Swelling
Clinical narrative: Pt reports receiving first dose of SHINGRIX at pharmacy and approximately 10 minutes later she began to have tingling and pain to skin from mid-back wrapping around to front of abdomen in a line. She was seen in PCP office and noted to have raised, red, blistered areas along where she complained of pain. Covering MD and infectious disease MD both examined patient and concur that affected areas are zoster. Pt is being treated with antiviral medication.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Irritability, Malaise
Clinical narrative: Pt reports receiving first dose of SHINGRIX at pharmacy and approximately 10 minutes later she began to have tingling and pain to skin from mid-back wrapping around to front of abdomen in a line. She was seen in PCP office and noted to have raised, red, blistered areas along where she complained of pain. Covering MD and infectious disease MD both examined patient and concur that affected areas are zoster. Pt is being treated with antiviral medication.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash erythematous
Clinical narrative: Pt reports receiving first dose of SHINGRIX at pharmacy and approximately 10 minutes later she began to have tingling and pain to skin from mid-back wrapping around to front of abdomen in a line. She was seen in PCP office and noted to have raised, red, blistered areas along where she complained of pain. Covering MD and infectious disease MD both examined patient and concur that affected areas are zoster. Pt is being treated with antiviral medication.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Headache, Pain in extremity, Presyncope
Clinical narrative: Presyncopal next morning followed by shaking for hours. Arm increasingly sore with fever to 102.9.  Abdominal pain and headache. Syncopal each am for 4 days, fever continued for 4 days in 100 to 101 range after first day. arm pain for 6 days. Shaking lasted 2 days as did abd. pain and headache. Was in bed first 2 days and weak next 2 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope, Tremor
Clinical narrative: Presyncopal next morning followed by shaking for hours. Arm increasingly sore with fever to 102.9.  Abdominal pain and headache. Syncopal each am for 4 days, fever continued for 4 days in 100 to 101 range after first day. arm pain for 6 days. Shaking lasted 2 days as did abd. pain and headache. Was in bed first 2 days and weak next 2 days.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RVX
Symptoms: Wrong product administered
Clinical narrative: 5mo 4day old Pt at clinic for immunization update. Pt needed Dtap, IPV, Rotavirus, Hib, and PCV13. Rotavirus, HB, and PCV13 administered correctly. Administered Dtap-IPV KINRIX on RT IM. KINRIX not recommended for this age. Separate Dtap and IPV should have been given. Recorded immunizations in IR, but was unable to select KINRIX. Called former coworker to advise on how to document. Former coworker said the KINRIX could not be selected due to Pt age. I then called Dr. to notify her of med error. Med lot number and expiration noted. Dr. contacted manufacturer for recommended action. GSK reports dosage of the vaccine components are the same as that in individual vaccines and are age appropriate. Though not FDA approved, some studies have been completed in the age range of this child and the only adverse effects noted were redness at the injection site, irritability, and rarely fever (same as for the individual vaccine components). CDC recommendations for inadvertently administered dosage is to count these doses. Notified mother by phone of incident. Unable to reach, but left voicemail regarding manufacturer recommendations to count vaccine as valid. Left office number for parent to call if there are any other questions or concerns. Will follow up with IR tomorrow for recommendations and complete any other GSK requirements. Received phone call from grandmother with concern for med error. I apologized and restated the manufacturer guidelines and that I had reported the error to our doctor. Received call from Pt peds office. They stated the mother would like another phone call as she has questions. I reached mother by phone and again explained the error and the manufacturer recommendations. Mother stated she understood, and I told her to call me again if she has any other questions or concerns.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Extra dose administered
Clinical narrative: Pt had first flu shot on 10/13/18. Second flu shot was given to pt on 10/18/18.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Erythema, Hallucination, Pain in extremity, Pyrexia
Clinical narrative: Patient started to develop a fever the day after the immunization, arm is red, warm and painful to touch. Redness is moving down the arm. Patient states she was hallucinating and had no appetite.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site swelling, Pyrexia
Clinical narrative: Patient called on 10/29/18 and said that she woke up on 10/26/18 with aches especially in her knees and a fever of 100 degrees F and also that the injection site had swelled to the size of a baseball.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: 9/7 - extremely sore arm at injection site, muscle pain. 9/8 - w/muscle pain fever - 101 degree, shivering normal activity impossible slept all day - extreme exhaustion, headache upset stomach - nausea, vomiting diarrhea. 9/9 - still exhausted, headache. Note: reaction to 1st dose limited to sore muscle at vaccination site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia, Nausea, Pyrexia
Clinical narrative: 9/7 - extremely sore arm at injection site, muscle pain. 9/8 - w/muscle pain fever - 101 degree, shivering normal activity impossible slept all day - extreme exhaustion, headache upset stomach - nausea, vomiting diarrhea. 9/9 - still exhausted, headache. Note: reaction to 1st dose limited to sore muscle at vaccination site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: 9/7 - extremely sore arm at injection site, muscle pain. 9/8 - w/muscle pain fever - 101 degree, shivering normal activity impossible slept all day - extreme exhaustion, headache upset stomach - nausea, vomiting diarrhea. 9/9 - still exhausted, headache. Note: reaction to 1st dose limited to sore muscle at vaccination site.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Fatigue
Clinical narrative: Having continued fatigue.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Oedema peripheral
Clinical narrative: Edema and induration from Deltoid to the proximal forearm. No evidence of cellulitis, vesicles or pustules.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Dizziness, Dyspnoea, Rash, Thinking abnormal
Clinical narrative: Rash neck, scalp, upper back, chest pain, short of breath, head dizzy, "foggy" thinking. Assoc. with steroid shot wk before. Took 4 day to clear with rest, no activity, TV, comptr other medic: INDOCIN, steroid shot wk before.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 18-APR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 4 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 11-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 6 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 69 years old male patient who experienced possible skin reaction at same area of his flu vaccine along with raised, scaly and discolored area on his left deltoid, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included mole of skin which was scaly, and is darker brown in color. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018, the patient received 0.5 ml dose of suspect FLUZONE HIGH DOSE lot UJ000AA, expiry date: 28 Mar 2019 via intramuscular route in the left deltoid. On 22 Oct 2018, the patient developed a non-serious possible skin reaction at same area of his flu vaccine/raised/scaly/discolored area on his left deltoid (vaccination site reaction) 17 days following the administration of FLUZONE HIGH DOSE. Patient was encouraged to follow-up at the ER there or his regular HCP. Other relevant tests included no lab test. Final diagnosis was possible skin reaction at same area of his flu vaccine/raised/scaly/discolored area on his left deltoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for possible skin reaction at same area of his flu vaccine/raised/scaly/discolored area on his left deltoid. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV, RVX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 44 months old male patient who was vaccinated with 0.5 ml second dose of PENTACEL (lot number: C5316AA and expiry date: 13-Feb-2018) via intramuscular route in the left thigh at 05-May-2017 (16 months) and 0.5 ml first dose of ACT-HIB (Batch number: UI366AA and expiry date: 14-Apr-2017) via intramuscular route in the right thigh on 05-Mar-2016 (9 weeks). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown if any adverse event occurred or not 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.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 78 years old female patient who experienced chronic pain at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the deltoid. On an unknown date, the patient developed a non-serious chronic pain at the injection site (vaccination site pain) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data). Final diagnosis was chronic pain at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for chronic pain at the injection site. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves an adult patient (age and gender was not reported) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (lot UJ005AF; expiry date: UJ005AF) that was left the vials out of fridge on 22 Oct 2018. The patient had no other concomitant medications reported. It was a case of actual medication error due to incorrect product storage. It was reported that the vials were left out of fridge. No specific adverse events reported. The patient didn't visit to doctor. 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 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: FLU3
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves seven Elderly patient of Unknown demographics who experienced big red baseball size swollen area on arms and hot to touch and soreness, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Mediation was not reported. On an unknown date, the patients received a 0.5 ml dose of suspect FLUZONE HIGH DOSE lot UJ039AA expiry date: 15-May-2018 via intramuscular route. On an unknown date, the patients developed a non-serious big red baseball size swollen area on arms (inflammation) following the administration of FLUZONE HIGH DOSE. (Other relevant tests included No lab data.)Final diagnosis was hot to touch and soreness and big red baseball size swollen area on arms. It was not reported if the patients received a corrective treatment. The patient outcome is reported as Unknown for big red baseball size swollen area on arms, hot to touch and soreness. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 63-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, 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 inappropriate age at vaccine administration and overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an eight-year-old patient who was vaccinated with FLUBLOK QIV (batch number, expiration date, dose, route and site of administration was not reported) on an 20-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. (it was reported that vaccine was for 18 years of age and older patients and that was given to an 8 year old patient). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA294618 (Same reporter). This case involves a 64 years old male patient who received a 0.5 mL dose of FLUZONE HIGH DOSE (lot UJ042AA) in error, via intramuscular route on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that he did not have any bad reactions or 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 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: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Exposure during pregnancy, Fatigue, Feeling hot, Headache
Clinical narrative: Initial pregnancy information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 43 years old female patient who received vaccine FLUBLOK QIV while she was pregnant. It was a case of vaccine exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was 15-Feb-2018, the estimated due date is 18-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient felt more tired, had a headache, felt really hot and sweaty without fever, and was not feeling energetic following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab tests). Final diagnosis was not feeling energetic, sweaty without fever, felt really hot, felt more tired and headache. No corrective treatment was received. The patient outcome is reported as Unknown for headache, as Unknown for feels more tired, as Unknown for feels really hot, as Unknown for sweaty but has no fever, as Unknown for not feeling energetic and as Not Applicable for vaccine exposure during pregnancy. Pregnancy outcome was unknown at the time of report. List of document held: none.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Hyperhidrosis
Clinical narrative: Initial pregnancy information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 43 years old female patient who received vaccine FLUBLOK QIV while she was pregnant. It was a case of vaccine exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was 15-Feb-2018, the estimated due date is 18-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient felt more tired, had a headache, felt really hot and sweaty without fever, and was not feeling energetic following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab tests). Final diagnosis was not feeling energetic, sweaty without fever, felt really hot, felt more tired and headache. No corrective treatment was received. The patient outcome is reported as Unknown for headache, as Unknown for feels more tired, as Unknown for feels really hot, as Unknown for sweaty but has no fever, as Unknown for not feeling energetic and as Not Applicable for vaccine exposure during pregnancy. Pregnancy outcome was unknown at the time of report. List of document held: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA294589 (same reporter). This case involves a 60 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE in error (lot UJ042AA and Exp. Date not reported) via intramuscular route in the left deltoid on 22-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that patient did not have any bad reaction and have not had treatment. 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, PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 79 years old female patient who experienced left arm swollen and hot to the touch, it felt like a heat pad, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history included Hypersensitivity (allergic to penicillins, myacins and sulfur). The patients past vaccination(s) included influenza vaccination (Flu shot) from 20-22 years. Concomitant medications included PREVNAR 13 for Immunization. On an unknown date in Sep 2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6290NA and Exp. Date 30 Jun 2019) via unknown route in the left arm. On an unknown date, her left arm swollen and hot to the touch, 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that it felt like a heat pad. Details of lab data not provided. Final diagnosis was left arm swollen and hot to the touch, It felt like a heat pad. No information about corrective treatment reported. On an unknown date the patient was recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA295187, same reporter. This case involves a 63 years old female patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 63-year-old Female who was injected with the FLUZONE HIGH-DOSE. 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.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case 2018SA295174. This case involves a 60 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose (60 year of age female patient received FLUZONE High-Dose). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves six-year-old patient (gender not reported) who was vaccinated with a dose of ADACEL instead of DAPTACEL on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if 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 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. Follow-up report was received from a consumer/non-healthcare professional (office staff) on 23-Oct-2018. No new information was updated. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with 2018SA295453 and 2018SA295455 (same reporter). This case involves a female patient of unknown age who received a 0.5 mL dose of FLUZONE QUADRIVALENT (lot UT6301LA and expiration date 30-Jun-2019) via unknown route in the left deltoid on 18-Oct-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 the vaccine was reached -2 degrees C while administered. It was not reported 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 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: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case  received from a Nurse. This case involves a five-years old male patient who received a dose of vaccine FLUZONE QUADRIVALENT on 15 Oct 2018 and another dose of the same vaccine at the school on 19 Oct 2018, (lot number not reported) via unknown route in unknown administration site for both. Patients past medical history, medications, vaccinations, concomitant therapies were not reported. It was a case of actual medication error due to extra dose administered. It was not reported 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 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: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 30 months old male patient who was inadvertently vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6301MA) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. It was unknown if any adverse event occurred or not following the administration of 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.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old who received 0.5 ml dose of vaccine FLUZONE QIV (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), concomitant medication(s) and family history were not provided. 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.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (pediatric- of an unknown age) who received 0.5 mL dose of vaccine FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was actual medication error due to overdose as adult dose given to pediatric age patient. 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 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: 19.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old male patient who received 0.5 mL dose of vaccine IMOVAX RABIES lot M13911M, expiry date: 24-Jul-2018 via intramuscular route in the right deltoid on 23-Oct-2018. It was actual medication error due to Expired vaccine used. It was reported that administering expired Imovax to patient. No reaction 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: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 79 years old female patient who was vaccinated with two dose FLUZONE HIGH DOSE, lot UJ024AC via unknown route in the left deltoid on 01-Oct-2018 and 22-Oct-2018 instead of PNEUMOCOCCAL VACCINE. The patients past medical history, medical treatments, vaccinations and family history were not provided. It is an actual medication error case due to extra dose administered and wrong vaccine administered. It was reported that the patient had two doses within 3 weeks of interval instead of PNEUMOCOCCAL VACCINE for the second dose of FLUZONE HD. It was reported that no adverse reactions were found. 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: Injection site rash, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 62 years old patient of unknown gender who experienced faint rash about the size of a quarter at the injection site, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 20-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. On an unknown date, the patient developed a non-serious developed faint rash about the size of a quarter at the injection site (vaccination site rash) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported No itching or burning. It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose. (Other relevant tests included no lab data.) Final diagnosis was 62 year old developed faint rash about the size of a quarter at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for developed faint rash about the size of a quarter at the injection site. 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 2 months old female patient for whom gave only the liquid of the PENTACEL was reported, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 22-Oct-2018, the patient received a 0.5 ml dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in unknown administration site. It was reported that nurse gave only the liquid portion of the PENTACEL to the patient. Final diagnosis was gave only the liquid of the PENTACEL. This case is actual medication error due to Inappropriate reconstitution technique. Outcome of the event was not applicable. 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.