chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258:US-009507513-1811USA009260: US-009507513-1811USA009261: US-009507513-1811USA009142.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009261: US-009507513-1811USA009142.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009260: US-009507513-1811USA009142
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered in wrong device, Erythema, Hypersensitivity, Incorrect route of product administration, Injection site erythema
Clinical narrative: This case was reported by a nurse via patient support programs and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (a dose received in 2012). On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever, pain, allergic reaction, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient was registered nurse working in a travel vaccine clinic. The age at vaccination was not reported. The patient went to received SHINGRIX vaccination because she could use her health insurance to help cover the cost. The registered pharmacist who gave her the shot used a TB syringe, which led to vaccine administered in wrong device. The patient did not see the size of the needle. The SHINGRIX was given well below the deltoid area, so the patient was sure that it was administered subcutaneously instead of intramuscularly, which led to incorrect route of administration. The patient stated that it was very painful the first night and she thought she had a fever during the night. The patient had been taking Tylenol for 2 days to reduce the discomfort. Less than a year after vaccination, the patient experienced allergic reaction, a site reaction that was really red and swollen for approximately one week. The patient was asking if this was truly SHINGRIX that she was given subcutaneously; the dose would be considered a valid dose or not. The patient also stated that her manager wondered if the patient was given ZOSTAVAX, but the paperwork the patient received said SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via patient support programs and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (a dose received in 2012). On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever, pain, allergic reaction, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient was registered nurse working in a travel vaccine clinic. The age at vaccination was not reported. The patient went to received SHINGRIX vaccination because she could use her health insurance to help cover the cost. The registered pharmacist who gave her the shot used a TB syringe, which led to vaccine administered in wrong device. The patient did not see the size of the needle. The SHINGRIX was given well below the deltoid area, so the patient was sure that it was administered subcutaneously instead of intramuscularly, which led to incorrect route of administration. The patient stated that it was very painful the first night and she thought she had a fever during the night. The patient had been taking Tylenol for 2 days to reduce the discomfort. Less than a year after vaccination, the patient experienced allergic reaction, a site reaction that was really red and swollen for approximately one week. The patient was asking if this was truly SHINGRIX that she was given subcutaneously; the dose would be considered a valid dose or not. The patient also stated that her manager wondered if the patient was given ZOSTAVAX, but the paperwork the patient received said SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia
Clinical narrative: This case was reported by a nurse via patient support programs and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (a dose received in 2012). On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever, pain, allergic reaction, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient was registered nurse working in a travel vaccine clinic. The age at vaccination was not reported. The patient went to received SHINGRIX vaccination because she could use her health insurance to help cover the cost. The registered pharmacist who gave her the shot used a TB syringe, which led to vaccine administered in wrong device. The patient did not see the size of the needle. The SHINGRIX was given well below the deltoid area, so the patient was sure that it was administered subcutaneously instead of intramuscularly, which led to incorrect route of administration. The patient stated that it was very painful the first night and she thought she had a fever during the night. The patient had been taking Tylenol for 2 days to reduce the discomfort. Less than a year after vaccination, the patient experienced allergic reaction, a site reaction that was really red and swollen for approximately one week. The patient was asking if this was truly SHINGRIX that she was given subcutaneously; the dose would be considered a valid dose or not. The patient also stated that her manager wondered if the patient was given ZOSTAVAX, but the paperwork the patient received said SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in upper extremities in a female patient who received SHINGRIX for prophylaxis. On 7th November 2018, the patient received SHINGRIX. On 7th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in upper extremities. On 8th November 2018, the patient experienced low back pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in upper extremities was recovering/resolving and the outcome of the low back pain was unknown. It was unknown if the reporter considered the pain in upper extremities and low back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced sever pain that radiated down to her hand. The patient took Advil which helped a bit. On the day of reporting the patient was somewhat better but had low back pain on the injection side.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 7 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, tremor, headache, nausea and malaise. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, tremor, headache, nausea and malaise were recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms, chills, tremor, headache, nausea and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine, about 7 hours after the shot, the patient received strong flu like symptoms: chills, shaking, headache, nausea and malaise. The patient took Tylenol and wrapped her self in an electric blanket. The patient was better after about 15 hours and felt normal the following day. The patient wanted to have the 2nd shot on the day of reporting but the patient's physician said since she had such a bad reaction, it could be worse to receive a 2nd dose. The patient was very good health and she did not want to end up in the hospital from another dose. The patient asked about what have found regarding people who took the first vaccine, suffered flu-like symptoms and then took the second shot and asked about if it was safe or not.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 7 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, tremor, headache, nausea and malaise. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, tremor, headache, nausea and malaise were recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms, chills, tremor, headache, nausea and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine, about 7 hours after the shot, the patient received strong flu like symptoms: chills, shaking, headache, nausea and malaise. The patient took Tylenol and wrapped her self in an electric blanket. The patient was better after about 15 hours and felt normal the following day. The patient wanted to have the 2nd shot on the day of reporting but the patient's physician said since she had such a bad reaction, it could be worse to receive a 2nd dose. The patient was very good health and she did not want to end up in the hospital from another dose. The patient asked about what have found regarding people who took the first vaccine, suffered flu-like symptoms and then took the second shot and asked about if it was safe or not.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 50-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the pain in arm, influenza-like symptoms and pruritus were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by medical assistant. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced a sore arm and significant flu like symptoms throughout the day. That evening he also reported itching from head to toe, no rash, and the itching responded to a dose of BENADRYL. The patient reported not taking any other medications or unusual activity that could be related to the itching. The reporter agreed to contact for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown. It was unknown if the reporter considered the pruritus to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had severe itching. The reporter did not feel comfortable administering the 2nd dose of SHINGRIX. The reporter agreed to be follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Immobile, Morbid thoughts
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of immobile in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced immobile (serious criteria GSK medically significant) and morbid thoughts. On an unknown date, the outcome of the immobile and morbid thoughts were unknown. It was unknown if the reporter considered the immobile and morbid thoughts to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that the patient could not move and thought he was about to die after vaccination with the second dose of SHINGRIX. The reporter agreed to be contacted for follow up.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 40-year-old female patient who received Fluarix Quadrivalent 2017-2018 season for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2017-2018 season, the patient experienced rash and injection site itching. The patient was treated with Medrol. On an unknown date, the outcome of the rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the rash and injection site itching to be related to Fluarix Quadrivalent 2017-2018 season. Additional information received as follows: The patient experienced itching at the injection site and rash. She had to took Medrol the year bofore reporting date for the reaction she had, and it took 8 weeks for it to completely resolve. No further details were provided. The reporter gave consent to follow up. This has been linked to the case US2018204728, reported for the same patient.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Incomplete course of vaccination, Joint swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of joint pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced joint pain and swelling of knees. On an unknown date, the patient experienced circumstance or information capable of leading to medication error and incomplete course of vaccination. On an unknown date, the outcome of the joint pain and swelling of knees were recovered/resolved and the outcome of the circumstance or information capable of leading to medication error and incomplete course of vaccination were unknown. It was unknown if the reporter considered the joint pain and swelling of knees to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX, the patient developed arthritis type pain in the joints and knee swelling that was lasted for 7 to 8 days. The patient would probably not come back for the second dose of the series, which led to circumstance or information capable of leading to medication error and incomplete course of vaccination. Consent to follow up was provided. The medical assistant did not have the vaccine details because the SHINGRIX was administered by another health care provider.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX (batch number G2ZF2, expiry date 22nd March 2021) for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and pain. On an unknown date, the outcome of the injection site erythema and pain were recovering/resolving. It was unknown if the reporter considered the injection site erythema and pain to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced redness at the injection site, which was 2.5 inches in diameter. The pain and redness were not worsened and it had gone down slightly this past weekend. The reporter had given consent for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 11th November 2018, the patient received SHINGRIX (intramuscular). On 12th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in right deltoid and had a 4 inch red area around the injection site. This call was transferred to medical information (MI) for further assistance.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, immediately after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional information received as follows: The age at vaccination was not reported. The patient received a flu vaccine several weeks before the reporting time. She described that she experienced burning and pain during the injection of the medication. Her arm was sore for approximately 3 to 4 days. The patient discontinued the call before further details could be obtained.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 68-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient received SHINGRIX. The healthcare professional (HCP) stated that the patient had an unknown reaction to a dose of SHINGRIX. The HCP stated that they were not entirely sure of the details of the reaction. The reporter gave consent to follow up. No further details were provided.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an adult female patient who was exposed to vaccine FLUZONE QUADRIVALENT in context of drug exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported drug exposure during pregnancy occurred at unknown gestation period and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 14 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE. The date of last menstrual period was reported as 07-Jul-2018. The estimated due date is 13-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. On 05-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported in the left arm. Relevant prenatal testing after exposure during. No lab data reported. Final diagnosis was drug exposure during pregnancy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as not applicable for drug exposure during pregnancy. Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Swelling
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited non-valid non-serious case received from a consumer/non-health care professional with live follow-up. This case involves Adult female patient (age was not reported) who had swelling and redness, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced swelling and redness. (Other relevant tests included no lab data.) Final diagnosis was swelling and redness. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health professional (office staff). This case involves a female patient of unknown age who received vaccine FLUZONE QUADRIVALENT (batch number, expiry date, dose, dose in series and route  were not reported) via subcutaneous route as hematologist had ordered that a patient of their get her flu injection subcutaneous to avoid undue bleeding 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 a case of actual medication error due to incorrect route of administration. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 34 months old patient who was inadvertently administered with a 0.5ml single dose of FLUZONE QUADRIVALENT lot UT6375MA via intramuscular route in the right deltoid on 15-Nov-2018 (reported as last night also). 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 overdose. It was not reported whether the patient experienced 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 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: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 36-month-old female patient who vaccinated with FLUZONE QUADRIVALENT (Batch number: UT6375NA, expiration date: 30-JUN-2019,0.5 ml dose, unknown route and left deltoid site of administration was reported) on 03-NOV-2018. It was also reported that, the patient received same suspect vaccine 0.5 ml in right deltoid on 16 Nov 2018. The patient's past medical history, medical treatment(s), and family history were not provided. It was reported that, the patient did not have any concomitant medication. It is an actual medication case error due to extra dose administered. It was unknown if patient had 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: 13.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a medical assistant referring to an approximately 14 year old male patient. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included diphtheria toxoid, pertussis acellular vaccine, tetanus toxoid (reported as "TDAP")  and a meningococcal vaccination. On an unspecified date in 2016, the patient was vaccinated with the first dose 0.5 milliliter GARDASIL 9 (frequency, route, lot # and expiration date were not reported) for prophylaxis at the age of 13 years old. The patient then came back to the office again and got his second dose 0.5 milliliter GARDASIL 9 (frequency, route, lot # and expiration date were not reported) for prophylaxis on an unspecified date in 2016. The patient subsequently finished the series by getting his third dose 0.5 milliliter GARDASIL 9 (frequency, route, lot # and expiration date were not reported) for prophylaxis on an unspecified date in 2017. Sometime in 2017, the patient started complaining of joint pain. Information about lab diagnostics/studies and medical attention was unknown by the reporter. The outcome of the event was unknown. The causality between GARDASIL 9) and the event was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: This spontaneous prospective pregnancy report was received from the office manager, referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 05-NOV-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, lot # and expiration date were not reported) intramuscularly, for prophylaxis. It was stated that patient inadvertently received GARDASIL 9, instead of PNEUMOVAX23. No treatment was provided for this event. The reporter stated the patient was currently pregnant at this time, and the last menstrual period (LMP) and estimated date of delivery (EDD) were not known. No adverse events. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an administrator refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 16-OCT-2018, the patient was administered a dose of PROQUAD (lot # R006216, expiry date: 28-AUG-2019) following a temperature excursion for prophylaxis. Dosing details and route of administration were unknown for the vaccine. The sterile diluent used for reconstitution did not have a temperature excursion. No adverse effect reported. The temperature excursion occurred at 68 degrees Fahrenheit (F) for a time frame of 43 hours. No previous temperature excursions occurred. There was a data logger involved. No product quality complaint was involved. Sender's Comments: US-009507513-1810USA012914: US-009507513-1810USA013008.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 48 year old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 08-OCT-2018, the patient was vaccinated with PROQUAD (route, dose, frequency, and anatomical location were unknown) with lot # N028446 for prophylaxis. The patient was vaccinated outside the recommended age according to the prescribing information. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2017. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2014, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and on 24-MAY-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX as permanent prevention and protection against shingles and zoster-related injuries (prophylaxis). (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) due to a health care professional recommendation. On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 03-JAN-2017, the patient was treated by it's health care provider for shingles. It was also reported that the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2012, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in approximately October 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 14-NOV-2016, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On unknown date, the patient experienced shingles and in approximately November 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2009, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in approximately 13-DEC-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforem entioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.