chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Epistaxis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of epistaxis in a 28-year-old male patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 16th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 16th November 2018, 6 hrs after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced epistaxis. On an unknown date, the outcome of the epistaxis was unknown. It was unknown if the reporter considered the epistaxis to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient got flu vaccine and 6 hrs after the injection got a nosebleed and had 26 major nose bleeds since then. The patient never had issues with nosebleeds until after receiving the flu vaccine. No further details were reported regarding the event. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Skin fissures
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 15th November 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 16th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced chapped skin. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of the chapped skin was unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and chapped skin to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced redness and heat at the injection site that started the next day after receiving the vaccine. These symptoms have resolved but now there was a chapped ring around the injection site where the redness and heat were previously. The reporter provided the lot number and expiration date she had on file but she did not know if this was for the first dose or the second dose. She only had lot number and expiry date information for one dose.
Age: 66.0
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 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without adverse event). On 1st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were received as follows: The patient received 2 doses of SHINGRIX, approximately 6 months apart. The patient received SHINGRIX on the left arm. On the next day of vaccination, the patient experienced arm soreness. At the time of reporting, the arm soreness had become more intermittent which came and went. It does not hurt when pressed. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling hot, Rash pruritic, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced vascular injury and itchy rash. On an unknown date, the patient experienced erythema of extremities, feeling hot and burning sensation. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the erythema of extremities, vascular injury, itchy rash, feeling hot and burning sensation were unknown. It was unknown if the reporter considered the erythema of extremities, vascular injury, itchy rash, feeling hot and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient had reaction to left upper extremity (LUE) that was massive (3.5 by 4) in size. Less than a year after receiving SHINGRIX, the patient's area of LUE became hot, red and burning that led her to follow-up with primary care provider who instructed her to place cool compresses on site. The area broke out into a rash that was aggravated, itchy and blood vessels broke out all around it. The patient was instructed to wait until 2nd January 2018, to get 2nd dose of SHINGRIX.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vascular injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced vascular injury and itchy rash. On an unknown date, the patient experienced erythema of extremities, feeling hot and burning sensation. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the erythema of extremities, vascular injury, itchy rash, feeling hot and burning sensation were unknown. It was unknown if the reporter considered the erythema of extremities, vascular injury, itchy rash, feeling hot and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient had reaction to left upper extremity (LUE) that was massive (3.5 by 4) in size. Less than a year after receiving SHINGRIX, the patient's area of LUE became hot, red and burning that led her to follow-up with primary care provider who instructed her to place cool compresses on site. The area broke out into a rash that was aggravated, itchy and blood vessels broke out all around it. The patient was instructed to wait until 2nd January 2018, to get 2nd dose of SHINGRIX.
Sex: M
Vaccine: FLUX
Symptoms: Epistaxis, Lower respiratory tract infection, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest infection in a adult male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced chest infection (serious criteria GSK medically significant), epistaxis and cold. On an unknown date, the outcome of the chest infection, epistaxis and cold were unknown. It was unknown if the reporter considered the chest infection and cold to be related to Flu vaccine. The reporter considered the epistaxis to be related to Flu vaccine. Additional details were provided as follows: This case was reported by the patient's grandparent. The age at vaccination was not reported. The patient received an unknown flu vaccine. The reporter indicated that, the pharmacy said that the patient received a GlaxoSmithKline product. Six hours after receiving Flu vaccine, the patient developed a bloody nose. The reporter indicated that since then, the patient had 26 nose bleeds and felt the bleeding has been profuse. The patient never had nose bleeds prior to this. The patient went to his physician recently because he had a bad cold and chest infection. He told the physician about the nose bleeds for the first time and the physician told him that it was related to climate changes. The reporter felt that the nose bleeds were related to the flu vaccine the patient received. The reporter indicated that the patient was a truck driver. The reporter would have his grandson call back to provide the lot number for the product. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Gait inability, Herpes zoster, Neoplasm, Non-Hodgkin's lymphoma
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), non-Hodgkin's lymphoma (serious criteria GSK medically significant), shingles, neoplasm, unable to walk and shingles. The patient was treated with chemotherapy, NOS. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the non-Hodgkin's lymphoma, neoplasm and unable to walk were not recovered/not resolved and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, non-Hodgkin's lymphoma, shingles, neoplasm and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the friend of the patient. The age at the vaccination was not reported, however patient could be either 63 or 64 years old. The reporter reported that the patient developed shingles after getting the 1st dose of SHINGRIX. The patient developed second case of shingles after getting the 2nd dose of SHINGRIX. The reporter stated that sometime after receiving the 2nd dose of SHINGRIX, the patient could not walk and went to see a physician and the physician found a tumor wrapped around his spine. The patient was diagnosed with non-Hodgkin's lymphoma. The emergency room visit was required. The patient was currently undergoing chemotherapy to shrink the tumor and the reporter stated that the prognosis did not look good for the patient. The reporter stated that the patient had been in a rehab facility and was receiving physical therapy. The reporter did not have any additional details regarding this event. This case was considered as suspected vaccination failure as a primary vaccination schedule, TTO (time to onset) of event and laboratory confirmation test were not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), non-Hodgkin's lymphoma (serious criteria GSK medically significant), shingles, neoplasm, unable to walk and shingles. The patient was treated with chemotherapy, NOS. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the non-Hodgkin's lymphoma, neoplasm and unable to walk were not recovered/not resolved and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, non-Hodgkin's lymphoma, shingles, neoplasm and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the friend of the patient. The age at the vaccination was not reported, however patient could be either 63 or 64 years old. The reporter reported that the patient developed shingles after getting the 1st dose of SHINGRIX. The patient developed second case of shingles after getting the 2nd dose of SHINGRIX. The reporter stated that sometime after receiving the 2nd dose of SHINGRIX, the patient could not walk and went to see a physician and the physician found a tumor wrapped around his spine. The patient was diagnosed with non-Hodgkin's lymphoma. The emergency room visit was required. The patient was currently undergoing chemotherapy to shrink the tumor and the reporter stated that the prognosis did not look good for the patient. The reporter stated that the patient had been in a rehab facility and was receiving physical therapy. The reporter did not have any additional details regarding this event. This case was considered as suspected vaccination failure as a primary vaccination schedule, TTO (time to onset) of event and laboratory confirmation test were not reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy breast abnormal, Breast cancer female, Breast prosthesis implantation, Diagnostic aspiration, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (in 2000, left breast and in 2001, right breast). On 8th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 12th June 2018, 35 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. The patient was treated with non-drug therapy (Mastectomy). On 18th July 2018, the outcome of the breast cancer was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the breast cancer to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on an unknown arm. The patient's breast cancer returned and she found out because on 12th June 2018, she had a bilateral nuclear magnetic resonance imaging (MRI), sonogram and core biopsy performed. On 18th July 2018, the patient had a bilateral mastectomy and on 31st October 2018, she had another surgery to get permanent breast implants. The patient was on the waiting list with her pharmacy to get the 2nd dose of SHINGRIX so the patient did not receive the 2nd dose of SHINGRIX till the reporting time. The patient required emergency room visit.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mastectomy, Nuclear magnetic resonance imaging breast abnormal, Product supply issue, Ultrasound breast abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (in 2000, left breast and in 2001, right breast). On 8th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 12th June 2018, 35 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. The patient was treated with non-drug therapy (Mastectomy). On 18th July 2018, the outcome of the breast cancer was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the breast cancer to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on an unknown arm. The patient's breast cancer returned and she found out because on 12th June 2018, she had a bilateral nuclear magnetic resonance imaging (MRI), sonogram and core biopsy performed. On 18th July 2018, the patient had a bilateral mastectomy and on 31st October 2018, she had another surgery to get permanent breast implants. The patient was on the waiting list with her pharmacy to get the 2nd dose of SHINGRIX so the patient did not receive the 2nd dose of SHINGRIX till the reporting time. The patient required emergency room visit.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff). This case involves a 60 years old patient of unknown gender who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number was not reported), on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information received on 07-Dec-2018 an unsolicited valid non-serious case received from non-healthcare professional (office staff). Information regarding no adverse event was updated. List of documents held by sender: none.
Age: 1.17
Sex: U
Vaccine: FLU4, HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient (gender unknown) who received vaccine ACT-HIB. The patients past medical history and family history were not provided. Concomitant medications included 0.25ml of injection of FLUZONE QUAD on 28-Nov-2018. On 28-Nov-2018, the patient received a fourth dose 0.5ml of suspect HIB (PRP/T) VACCINE lot UI943AAA, expiry date 24-Nov-2019 via intramuscular route in the right thigh. It was an actual medication error due to wrong solution used in drug reconstitution. It was reported that Nurse used sterile diluent with ACTHIB instead of the diluent provided with the vaccine. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Sex: F
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient who received partial dose of TYPHIM VI (lot number N1K811M and Expiry date 19-Oct-2019) as leakage occurred from where the needle attaches to the LUER LOK of the prefilled syringe and leakage occurred during administration of the, via unknown route in unknown administration site on 06-Dec-2018. The patients past medical history,medical treatments, vaccinations and family history were not provided. It was actual medication case error due to Vaccine under dose. It was also a case of Syringe leak. Reporter said they will need a replacement for this issue. They had reported the AE/PTC on 07Dec2018 and are now requesting a replacement. It was unknown if any adverse event occurred. 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. Follow up report received from a Pharmacist on 11-Dec-2018. Narrative updated with non-significant information. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number-UJ052AA and expiry date- 09-Jun-2019) on an unknown date at Oct-2018. It was reported that the patient was also vaccinated with a 0.5 ml dose of the same vaccine (lot number and expiry date was not reported) in the right deltoid via intramuscular route on 05-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given the same visit. It was a case of actual medication error due to extra dose administered. At the time of reporting, the patient had no adverse events. 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: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is link to case 2018SA340798 same reporter. This case involves a 17 years old patient who experienced flu strain A, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious flu strain A(influenza) following the administration of FLUZONE QUADRIVALENT. This event was assessed as medically significant. It was reported that several kids that were properly vaccinated this year have the flu and it's documented strain A. Physician states she has seen 1 patient in her office and there were 3 patients who went to the urgent care in the last 3-4 weeks that had been immunized for the flu come down with the flu. (Other relevant tests included no lab data.) Final diagnosis was flu strain A. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by sender: none. Sender's Comments: A 17 years old patient presented with Influenza type A after and despite receiving FLUZONE QUADRIVALENT vaccine. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other presdisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine and a case of vaccination failure cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity, Periarthritis
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 61 years old female patient who experienced frozen arm and arm pain an stiffness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Sep-2010, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UI982AB via intramuscular route. The patient developed a non-serious frozen arm (Periarthritis) following the administration of FLUZONE QUADRIVALENT. The patient developed a non-serious arm pain an stiffness (musculoskeletal stiffness) following the administration of FLUZONE QUADRIVALENT. (Other relevant tests included No lab test.) Final diagnosis was arm pain an stiffness and frozen arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for frozen arm and as Unknown for arm pain an stiffness.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 30 months old patient who received 0.5 ml dose instead of 0.25 ml dose of FLUZONE (Suspension for injection) as the first out of the two initial vaccinations. Reported that an adult dose of flu vaccine was given to a pediatric patient. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was received. On 05-Nov-2018, the patient received first single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC  (expiry date: 30-Jun-2019) via unknown route in unknown administration site. It was a case of actual medication error due to overdose NOS. It was unknown whether any adverse event occurred. 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: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Dark circles under eyes, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 18 months old male patient who received ADACEL in place of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE by mistake (lot number, expiry date, dose, dose in series, route and site of administration were not reported) on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date in Oct-2018, the patient developed a non-serious dark circles under his eyes following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date in Oct-2018, the patient developed a non-serious running around like crazy following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine used. No lab data was reported. Final diagnosis was running around like crazy, dark circles under his eyes. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for dark circles under his eyes and as Unknown for running around like crazy. Reporter did not think that it has anything to do with the ADACEL. 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: 35.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 35 years old male patient was vaccinated with an expired 0.5 ml dose of MENACTRA (lot UI828AA and Exp. Date 08-Apr-2018) on 10-Dec-2018 in the left deltoid. The patient's past medical history, vaccination(s) and family history and concomitant medications were not provided. It was a case of actual medication error due to expired vaccine used. The nurse gave the patient an expired MENACTRA vaccine. It was unknown whether the patient had any adverse reactions. 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: 14.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an 18-years-old patient (age at the time of first vaccination was 13 years), (gender was not specified) who was vaccinated with a first dose and second doses of vaccine MENACTRA (lot number and expiry date was not reported) on 20-Aug-2014 and then again 30-Jun-2015 respectively. 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 extra dose administered. It was not reported if the patient experience any adverse events. 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: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site mass, Insomnia, Pain, Pain in extremity
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 71 years old female patient who experienced lump at injection site, unable to sleep, pain rating a nine of scale of zero-ten lasting all day but worse overnight and it was radiating through her upper arm and cellulitis, while she received vaccines ADACEL and PREVNAR 13. The patients past medical history, medical treatments, vaccinations and family history were not provided. On 10-Aug-2018, the patient received a dose of suspect ADACEL lot number U5850AA (Expiry date 10-Aug-2019) via intramuscular route in the left deltoid. On 10-Aug-2018, the patient received a dose of suspect PREVNAR 13 (lot number and Expiry date unknown) via unknown route in the right arm. On an unknown date, the patient developed a non-serious a lump at injection site (vaccination site mass), sleep (sleep disorder), pain rating a nine of scale of zero-ten lasting all day but worse overnight and it was radiating through her upper arm (Pain) and serious cellulitis following the administration of ADACEL and PREVNAR 13. The event of cellulitis was assessed as medically significant. It is also a case of actual medication error due to inappropriate age at vaccine administration. (Other relevant tests included No lab data.) Final diagnosis was cellulitis, radiating pain, unable to sleep and lump at injection site. The patient was treated with IBUPROFEN, AUGMENTIN (875mg/125mg) 1 tablet BID for 10 days for a total of 20 tablets) and topical BENGAY type product. The event outcome was unknown for all events. 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. Sender's Comments: This case involves a 71 years old female patient who experienced cellulitis, lump at injection site, unable to sleep, pain radiating through her upper arm post vaccination with ADACEL and PREVNAR 13. Time to onset is unknown. There is, however, no information regarding patient's medical condition at time of vaccination, site of cellulitis, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccines cannot be individually assessed.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 71 years old female patient who experienced lump at injection site, unable to sleep, pain rating a nine of scale of zero-ten lasting all day but worse overnight and it was radiating through her upper arm and cellulitis, while she received vaccines ADACEL and PREVNAR 13. The patients past medical history, medical treatments, vaccinations and family history were not provided. On 10-Aug-2018, the patient received a dose of suspect ADACEL lot number U5850AA (Expiry date 10-Aug-2019) via intramuscular route in the left deltoid. On 10-Aug-2018, the patient received a dose of suspect PREVNAR 13 (lot number and Expiry date unknown) via unknown route in the right arm. On an unknown date, the patient developed a non-serious a lump at injection site (vaccination site mass), sleep (sleep disorder), pain rating a nine of scale of zero-ten lasting all day but worse overnight and it was radiating through her upper arm (Pain) and serious cellulitis following the administration of ADACEL and PREVNAR 13. The event of cellulitis was assessed as medically significant. It is also a case of actual medication error due to inappropriate age at vaccine administration. (Other relevant tests included No lab data.) Final diagnosis was cellulitis, radiating pain, unable to sleep and lump at injection site. The patient was treated with IBUPROFEN, AUGMENTIN (875mg/125mg) 1 tablet BID for 10 days for a total of 20 tablets) and topical BENGAY type product. The event outcome was unknown for all events. 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. Sender's Comments: This case involves a 71 years old female patient who experienced cellulitis, lump at injection site, unable to sleep, pain radiating through her upper arm post vaccination with ADACEL and PREVNAR 13. Time to onset is unknown. There is, however, no information regarding patient's medical condition at time of vaccination, site of cellulitis, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccines cannot be individually assessed.
Age: 0.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 days old male patient who was inadvertently received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot number: UT6315RA, expiry date: 30-JUN-2019) via intramuscular route in left arm on 11-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history was not reported. Concomitant medications were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. No symptoms were 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 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. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old male patient who received a single dose of vaccine FLUZONE QUADRIVALENT (lot number not reported) via unknown route in unknown administration site on 10-Dec-2018. It was reported that the Visiting Specialist Pediatric Clinic drew up the vaccine from the single dose vial on 03dec2018 and put it back into the fridge until administration. 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. It was not reported 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. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five years old male patient who was vaccinated with a dose of vaccine PENTACEL lot number, Exp. date, route and administration site not reported on 16-Mar-2018. The patient's medical history and concomitant medications were not reported.It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the 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 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: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old female patient and reported that she had a temperature of 102.9 plus vomiting, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and ROTATEQ. On 05-Dec-2018, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UI953AA and expiry date: Jun-2020) (dose in series and route was not reported) in the right thigh. On an unknown date, following the vaccination the patient experienced vomiting and body temperature. Relevant laboratory test results included: Body temperature - On an unknown date: 102.9. (Other relevant tests included no lab data). Final diagnosis was vomiting and body temperature. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who received first dose of  vaccine PENTACEL lot number not reported via intramuscular route in the left thigh on 11-Dec-2018. This case involves vaccine MENACTRA, IPOL, DAPTACEL, ADACEL, ACT-HIB, FLUZONE QUADRIVALENT and while treated with TUBERSOL and HAVRIX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; HEPATITIS B VACCINE for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to Incorrect product storage. It was reported that their frig went out and they have products: PENTACEL, FLUZONE QUAD 0.25 ml and 0.5 ml and FLUZONE High-Dose, ACTHIB, ENGERIX, ADACEL, DAPTACEL, IPOL(unopened), TUBERSOL (unopened), MENACTRA, HAVRIX out of range but not sure of how long the time was yesterday the reading was 12 degrees C and the frig was not checked on Saturday or Sunday and this AM it was reading above 15 degrees C but not sure how much above 15 degrees C. States they are concerned because a 2 month old received a vaccine today and it felt warm. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA344122 (same reporter). This case involves a 46 years old female patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (Suspension for injection) lot UJ040AA and Exp. Date not reported via unknown route in the right deltoid on 03-Dec-2018. The patient's past medical history included Endometrial disorder with Hysterectomy. No concomitant vaccines given. It was reported that, vaccine storage was potentially out of range for 7 days and exposed to freezing temperature, range was between 32 F and 47 F for 1 week. It was an actual medication error case due to incorrect product storage and vaccine was administered to a patient. It was unknown whether the 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. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Nausea
Clinical narrative: Headache, nausea.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Incomplete course of vaccination, Rash pustular
Clinical narrative: About 11/15/2018 until today I experience an outbreak of shingles on my face, neck and upper chest (of all places!). Each day new spots appear blisters, red, swollen, some with puss at center, leaves scar. I had no prior history of shingles, herpes or any skin disorder. I did not/will not have 2nd dose. The expense of this overpriced drug, notwithstanding, I am claiming that I have been infected with shingles as a result of vaccine and results in dermatology expense and stress to cope. Nowhere and from no one have I been able to determine if these warnings have been made known to public. Had I known the risk, I would not have gotten the vaccine. I think the public should be told of this possibility!