chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
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 female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2011, a physician at an office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2016, the patient was treated by a healthcare provider at a medical center for shingles. 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 the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2008, a healthcare provider at a department of health administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Pt taken to Hospital with diagnosis of simple febrile seizure.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Intense pain at the injection site followed by severe arm, shoulder pain. Decreased range of motion and ability to move without using other hand to list arm.
Age: 0.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect Tdap vaccine was given instead of intended newborn Hep B. Pharmacist, provider and nursing manager were alerted. No adverse reactions observed at this time. Error was discovered 19 hours after administration. Parents made aware. Given the option for delay of discharge. At this time unsure of decision.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Arm/ shoulder felt sore after shot, as normal for a few days. Never got better, and after a few weeks noticed even more painful to lift arm up - especially above head almost unbearable. All at home treatments, heat, whirlpool etc.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Pain, Pain in extremity
Clinical narrative: 3 hours later, severe pain upper left arm. During night onset of severe body aches, throbbing headache, sleeping most of next day. Symptoms continued for 48 hours, easing later in day two.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: She is complaining of shooting pains in her upper arm the day after receiving her flu shot. She said there was no issue when the shot was given, but at almost 1 month out she is still complaining of pains in her arm muscle.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in Left shoulder since the injection. ROM affected. Pain remains 9 weeks post injection.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received second dose of ANTHRAX to left deltoid on 1/5/2019, unknown time. On 1/6/2019, she reported noticing symptoms of redness and swelling at the site. Denies SOB, chest pain, fever, chills, nausea, vomiting. She presented to the facility around 0900 on 1/7/2019 noted for a left deltoid induration measuring 5cm that is warm and tender to touch. Erythematous but no surrounding rashes or lesions. Treatment: observation, warm packs to affected area. Vitals WNL. Return to facility tomorrow for recheck. Education regarding worsening signs/symptoms and educated to seek nearest care at ED for worsening condition.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site joint swelling, Injection site pain, Muscular weakness
Clinical narrative: Patient has had 'sore arm' since date of vaccination. Patient seen in followup for this issue 11/20/2018. 'CC: Patient presents presenting with pain in the left shoulder s/p flu vaccine injection related tenderness. Still able to move arm and shoulder up to 90 degrees abduction. Musculo: Admits to left shoulder joint and muscle pain, joint swelling but no redness of the joint. She stated it was worse with movement and abduction, with radiation of pain to the left hand and into the left shoulder muscle as well.' Provider Dr then contacted patient 1/6/2019 after she has left a message for return call. Patient states : she still has weakness in the arm and shoulder where she was given her flu vaccine. It has been painful, and since the day of the injection, it has been weak, with her having difficulty keeping her arm in front to use the computer, due to the pain and subsequent weakness.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient has had 'sore arm' since date of vaccination. Patient seen in followup for this issue 11/20/2018. 'CC: Patient presents presenting with pain in the left shoulder s/p flu vaccine injection related tenderness. Still able to move arm and shoulder up to 90 degrees abduction. Musculo: Admits to left shoulder joint and muscle pain, joint swelling but no redness of the joint. She stated it was worse with movement and abduction, with radiation of pain to the left hand and into the left shoulder muscle as well.' Provider Dr then contacted patient 1/6/2019 after she has left a message for return call. Patient states : she still has weakness in the arm and shoulder where she was given her flu vaccine. It has been painful, and since the day of the injection, it has been weak, with her having difficulty keeping her arm in front to use the computer, due to the pain and subsequent weakness.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Neuropathy peripheral, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient has had 'sore arm' since date of vaccination. Patient seen in followup for this issue 11/20/2018. 'CC: Patient presents presenting with pain in the left shoulder s/p flu vaccine injection related tenderness. Still able to move arm and shoulder up to 90 degrees abduction. Musculo: Admits to left shoulder joint and muscle pain, joint swelling but no redness of the joint. She stated it was worse with movement and abduction, with radiation of pain to the left hand and into the left shoulder muscle as well.' Provider Dr then contacted patient 1/6/2019 after she has left a message for return call. Patient states : she still has weakness in the arm and shoulder where she was given her flu vaccine. It has been painful, and since the day of the injection, it has been weak, with her having difficulty keeping her arm in front to use the computer, due to the pain and subsequent weakness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus
Clinical narrative: Pt reported that on evening of vaccination face started getting itchy. Felt fine the following morning. At 11A, started feeling itchiness of face again. Came to school nurse and was given 25mg BENADRYL PO.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-OCT-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 17-DEC-2012, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. In March 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster meningitis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-APR-2013, the patient was inoculated by a pharmacist with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 11-OCT-2012 (onset date of events is prior to date of inoculation), the patient was treated by a physician for herpes zoster meningitis. 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 the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, herpes zoster meningitis was determined significant medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 20-FEB-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13 (batch number unknown), via an unspecified route of administration in Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle pain in arm and continued to be present in 2018. The outcome of the event was not recovered. Information on the batch number has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Mononeuropathy
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a female patient of unknown age (reported as over 40 years old) who experienced unspecified mononeuropathy of right upper limb and pain and swelling at the injection site, while she received vaccine FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines. On 05-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the right deltoid. On an unknown date, the patient developed a non-serious unspecified mononeuropathy of right upper limb (mononeuropathy) and pain and swelling at the injection site (injection site inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that on an unknown date 2weeks post injection visited urgent care and on 05-Dec-2018 to an orthopedic who prescribed her a prednisone pack. Orthopedic notes: had limited abduction 90 degrees forward post injection. Limited rotation, rotator cuff is in intact. Deltoid atrophy, intact radial and ulnar pulses. Right shoulder pain, secondary axillary nerve irritation. Recommended gentle exercises to be done at home. Will hold off on physical therapy. Diagnosis is unspecified mononeuropathy of right upper limb. (Other relevant tests included No lab data.) Final diagnosis was pain and swelling at the injection site and unspecified mononeuropathy of right upper limb. The patient was treated with PREDNISONE (PREDNISONE). Reported as it helped her pain about 50% but once treatment was done the pain returned as it was before. The patient outcome is reported as Unknown for still experiencing pain and swelling at the injection site and as Unknown for diagnosis is unspecified mononeuropathy of right upper limb. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation error
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who only received ACTHIB portion of (mixed with reconstituted with sterile diluent) PENTACEL without the DTAP IPV portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapies included Rotavirus and PREVNAR 13. Vaccines taken on an unknown dates. On 29-Nov-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number C5529AA via unknown route in left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was not reported if 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.
Age: 0.25
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old patient who was accidentally injected an expired PENTACEL while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for Immunisation; and HEPATITIS B VACCINE for Immunisation. On 20-Dec-2018, the patient received a dose suspect PENTACEL lot C5456AA via intramuscular route in the right thigh. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for accidentally injected an expired PENTACEL. 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demography who experienced received only the Dtap-IPV portion from vaccine PENTACEL lot number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLUR4, MMR, TYP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse and additional information also received on 21-Dec-2018 from same reporter. This case involves a 57 years old male patient who received vaccine TYPHIM VI (batch number, expiry date, dose, dose in series and site of administration were not reported) via subcutaneously instead of Intramuscularly on 21-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUBLOK QUADRIVALENT; MMR; HEPATITIS B VACCINE and Inveo. It was a case of actual medication error due to Inappropriate route of vaccination. No adverse event was experienced. Reported as No ill effects have been 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, FLUR4, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This was linked to case 2018SA393726 (same reporter). This case involves 700 number of patients (age and gender not reported) who received vaccines FLUBLOK QIV, FLUZONE HIGH DOSE and ADACEL. The patients past medical history, concomitant medication and family history were not provided. Between 30-Oct to 02-Dec-2018, the patients received injection of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown administration site. Between 30-Oct to 02-Dec-2018, the patients received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. Between 30-Oct to 02-Dec-2018, the patients patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date not reported via unknown route in unknown administration site. It was a case of an actual medication error due to incorrect product storage as it was reporter by Nurse that according to their data logger, the refrigerator containing the vaccines (ADACEL, FLUZONE Ped/HD, and FLUBLOK QUADRIVALENT) reached 28F between 1800 on 30oct2018 - 0500 on 31oct2018. She believes that it is an erroneous temperature report because nothing was frozen and the probe was against a metal bar in the refrigerator. Approximately 700 people received vaccines that had been stored in that refrigerator  Some of the patients experienced events (link case: 2018SA393726 registered). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. Link case: 2018SA396614 (same reporter). This case involves two patients of unknown demographics who experienced received vaccine PENTACEL there was a temperature excursion (fridge went down to 29 Fahrenheit for 75 minutes). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patients received a dose of suspect PENTACEL lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown if 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 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.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 28-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient who received an expired dose of vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccine received. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who received a dose of ACT-HIB diluted with water without reconstituted with the DTaP-IPV portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included KINRIX for Immunisation; FLUBLOK for Immunisation; and PREVNAR for Immunisation. On 28-Dec-2018, the patient received a 0.5 ml single dose of suspect ACT-HIB lot U1905AA (expiry date: 17-Nov-2019) via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown if 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 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: M
Vaccine: TYP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient who was vaccinated with 0.5 ml TYPHIM VI on an unknown date (batch number, expiry date route and site of administration was unknown). It was reported that, patient had received Typhoid dose 6 month prior in JUL2018. 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 as again after giving the typhoid vaccine noted that he last had one in July of 2018 6 months before. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site rash, Pyrexia
Clinical narrative: Headache, fever, chills, rash below site of injection, fatigue. I thought I had the flu. These symptoms lasted for 3 days.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotavirus vaccine given past maximum age range as first dose in series. Provider called mother and discussed error as well as that we believe she will tolerate this fine but that there is no good data on it being given for the first dose in babies over 15 weeks of age. Discussed potential concern for intussusception.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Pain, Pyrexia
Clinical narrative: EXTREMELY SORE ARE. 10 DAYS INTERMITENT FEVER. 3 MONTHS PERSISTENT BRONCHITIS.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Patient with local reaction of swelling and erythema. Patient's mother instructed to keep an eye on it and use cool compresses.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Patient called the pharmacy on 1/7 to report that she noticed soreness and a nodule at the injection site from a PREVNAR 13 immunization that we gave the patient on 12/31. We advised the patient to continue taking anti-inflammatory medication and follow up with PCP if symptoms don't continue to improve.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: The associate's right arm turned light red along with tiny bumps. The associate reported feeling achy and stiff which felt like nerve aggravation. These symptoms cleared up within 36 hours. The patient did not seek medical attention and did not receive any medications to treat the symptoms.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Pain in arm which got worse over the next week and I was unable to lift a coffee cup with my left arm. After a month the pain gravitated to my shoulder and my neck and is 24/7 pain, excruciating pain. I have been unable to do many of my normal activities and chores.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Mother called in and reported to me after she took patient to the doctor. Stated next morning her son's arm was red, feverish and swollen to the touch. She took the son to the doctor's office today. He put the patient on Cephalexin 500mg 1 twice daily, he says maybe cellulitis, but he asked the mom to have us report this reaction.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Red rash over entire body with slight fever.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-DEC-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 18-FEB-2016, the patient was treated by a physician at a hospital 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 the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs 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. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-AUG-2012, a licensed practical nurse at a VA health care facility/medical center administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-APR-2017 and 19-JUL-2017, the patient was treated by a physician at a medical center for shingles and post-herpetic neuralgia. The patient was diagnosed with shingles, post-herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Computerised tomogram head, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram
Clinical narrative: 6-16-18 - vaccine, 6-19-18 - 6-25-18 - had a right side of skull tingling with pain on touch and even hurt to touch hair. Called Dr. on 6-25-18 and said 7 days of tingling pain on skull. The soonest I could get an appointment with neurologist was 12-11-18. At 7:30 p.m. on 6-27-18, I was walking outside and fell to the ground. I blacked out. After blacking out from standing position, I came to, just in time to realize my head hit asphalt. I had big goose egg on left forehead near left eye. I was able to get up and walk home. I went to the ER. I had a head CT 6-27-18. My eye was swollen shut for 2 days. CT scan head. Holter monitor 7-11-18. Eye exam 7-16-18 visual field test. Orthopedic exam 7-3-18. Dr. visit 7-6-18. EKG 7-6-18. X-ray of ribs 7-6-18. Dr. 7-30-18 to check thyroid. Dr. 7-18-18 carotid artery Doppler test. Neurologist 12-11-18. EEG - 12-18-18.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Head injury, Loss of consciousness, Ophthalmological examination, Orthopaedic examination
Clinical narrative: 6-16-18 - vaccine, 6-19-18 - 6-25-18 - had a right side of skull tingling with pain on touch and even hurt to touch hair. Called Dr. on 6-25-18 and said 7 days of tingling pain on skull. The soonest I could get an appointment with neurologist was 12-11-18. At 7:30 p.m. on 6-27-18, I was walking outside and fell to the ground. I blacked out. After blacking out from standing position, I came to, just in time to realize my head hit asphalt. I had big goose egg on left forehead near left eye. I was able to get up and walk home. I went to the ER. I had a head CT 6-27-18. My eye was swollen shut for 2 days. CT scan head. Holter monitor 7-11-18. Eye exam 7-16-18 visual field test. Orthopedic exam 7-3-18. Dr. visit 7-6-18. EKG 7-6-18. X-ray of ribs 7-6-18. Dr. 7-30-18 to check thyroid. Dr. 7-18-18 carotid artery Doppler test. Neurologist 12-11-18. EEG - 12-18-18.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Swelling face, Swelling of eyelid, Visual field tests
Clinical narrative: 6-16-18 - vaccine, 6-19-18 - 6-25-18 - had a right side of skull tingling with pain on touch and even hurt to touch hair. Called Dr. on 6-25-18 and said 7 days of tingling pain on skull. The soonest I could get an appointment with neurologist was 12-11-18. At 7:30 p.m. on 6-27-18, I was walking outside and fell to the ground. I blacked out. After blacking out from standing position, I came to, just in time to realize my head hit asphalt. I had big goose egg on left forehead near left eye. I was able to get up and walk home. I went to the ER. I had a head CT 6-27-18. My eye was swollen shut for 2 days. CT scan head. Holter monitor 7-11-18. Eye exam 7-16-18 visual field test. Orthopedic exam 7-3-18. Dr. visit 7-6-18. EKG 7-6-18. X-ray of ribs 7-6-18. Dr. 7-30-18 to check thyroid. Dr. 7-18-18 carotid artery Doppler test. Neurologist 12-11-18. EEG - 12-18-18.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: I'm patient have been getting numbness on my left arm; from shoulder all the way down to my fingers. It's been a month and still getting a feeling it every 10 to 15 minutes all day long. 24/7.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: 2nd vaccine (SHINGRIX 50 mg) caused pain, itchiness and red rash at injection site.....also feeling tired, weak, headache, shivering and muscle aches which lasted two days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Myalgia
Clinical narrative: 2nd vaccine (SHINGRIX 50 mg) caused pain, itchiness and red rash at injection site.....also feeling tired, weak, headache, shivering and muscle aches which lasted two days.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Bone pain, Immediate post-injection reaction, Joint noise, Pain
Clinical narrative: Immediate onset of pain - states injection placed near top proximal humerus. "Felt like it went into the bone'. Has complaints now of pain with ROM, weakness with lifting above shoulder level or holding items up, also popping. Has used ibuprofen intermittently when pain is worse.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blister, Erythema, Facial pain
Clinical narrative: Patient reported painful blistering and pink discoloration to the skin on the left side of the face. The reported onset was 7 days after administration and resolved after 2 weeks. No treatment was reported.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Pt came into clinic and stated her left arm had started swelling where she received the flu vaccine on 03 Jan.19 .She stated she has gotten flu vaccine in past with no previous reaction.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: I do not have access to the lot number etc. i spoke with the Dr on the phone, he verified Men B was given in left arm. MCV in right arm-- and his staff stated they did not know how to report in this system. I saw pt today at my site. His left arm had a raised, red, painful, and warm to touch spot that started on the lower end of the deltoid just in front of the injection site. The raised red area measured 10.5 cm tall by 6 cm wide. He declined benadryl due to the side effects. He accepted ice to site. No swelling of tongue, lips, throat, or respiratory distress. Right arm was not affected. Phoned Mom and Dr and informed them of findings. Marked edges of site affected with small black pen marks so pt and mom can assess if swelling or redness increases. Pt has an appt with Dr on 1/11. Informed mom and Dr if swelling worsens he should be seen earlier.
Age: 0.58
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Pt received TRUMENBA & was supposed to receive MENVEO.
Age: 61.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Client was 61yo when seen at Immunization Clinic on 10/19/18 and was given Influenza and PCV13 vaccines. Based on a review of the clients chronic health conditions and his age he did not qualify for a PCV13 vaccine, but rather should of been given a PPSV23 vaccine. The client did not have any side effects to being given this vaccine. The error was discovered when the clients insurance denied payment for the provided PCV13 vaccine. Client has been contacted, informed of the error and encouraged to have a PPSV23 vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient had the FLUZONE HD Shot on October 10th 2018 and he came to pharmacy on Jan. 4th, 2019 saying his arm where the shot was given still hurts. Patient think that the pharmacist might have given the shot at the bone. Patient was advised to rotate warm pack on and off the injection site and take pain reliever if required.
Age: 3.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Pt was given TRUMENBA and was supposed to get MENVEO.