chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache, Joint stiffness, Musculoskeletal stiffness, Peripheral swelling, Throat tightness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of stiff neck in a 48-year-old male patient who received TWINRIX adult (batch number Z75Y2, expiry date unknown) for prophylaxis. Previously administered products included TWINRIX (1st dose) and TWINRIX with an associated reaction of injection site pain (after receiving 2nd dose on 9th January 2018, see case US2018GSK110239). On 14th June 2018, the patient received the 3rd dose of TWINRIX adult. On 15th June 2018, 1 days after receiving TWINRIX adult, the patient experienced stiff neck (serious criteria disability), throat tightness (serious criteria disability), swelling arm (serious criteria disability), joint tightness (serious criteria disability) and headache (serious criteria disability). The patient was treated with TYLENOL. On an unknown date, the outcome of the stiff neck, throat tightness, swelling arm, joint tightness and headache were not recovered/not resolved. The reporter considered the stiff neck, throat tightness, swelling arm, joint tightness and headache to be related to TWINRIX adult. Additional details were provided as follows: The patient received the 3rd dose on 14th June 2018 at 1:00 PM and the next day experienced a headache, throat tightness, arm swelling that started on the left and has now moved to both arms, joint tightening in both arms and legs and stiffness in his neck. The registered nurse made note that this was a very muscular man. The patient took TYLENOL last Friday to treat his symptoms. The reporter did not have the expiry date of the lot number. The reported TWINRIX adult batch number (SKBZ75Y2) did not exist and was updated to Z75Y2 as per sales database. Both doses (2nd and 3rd) were from same lot number.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Constipation, Diarrhoea, Diarrhoea haemorrhagic, Lysinuric protein intolerance
Clinical narrative: Initial unsolicited report received from a physician on 10-May-2018. This case involves a female patient of unknown age who was vaccinated with 0.5 ml of PENTACEL, frequency once (Batch number, expiry date, dose in series, route and site of administration were not reported) on an unknown date at 3 pm. Patient's medical history and concomitant medications were not reported. It was reported that child is not allergic to milk and has not seen the allergist at this time. On an unknown date, following the vaccination, patient experienced constipation related to a case amino acids sensitivity, few hours following the vaccination (reported as that night during the night) patient experienced 6 bouts of diarrhea with mucus and blood. It was also reported that child had primary constipation issue and is on ALLIMENTUM. Patient's mother became aware case amino acids are used in the Dtap portion of the PENTACEL. Physician will likely send this child to an allergist for further evaluation before giving vaccines. Lab data and corrective treatment were not reported. On an unknown date, (reported as by the next AM) patient recovered from the event diarrhoea and outcome of the event constipation was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Initial unsolicited report received from a healthcare professional in the on 11-May-2018. This case involves a female patient, who was vaccinated once with 0.5 ml FLUZONE QUADRIVALENT via intramuscular route (batch number, expiry date not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had Bell's Palsy. Lab test and corrective treatment was not reported. On an unknown date, patient recovered from the event. Upon internal review the case was considered as serious because of important medical event: Bell's Palsy. Documents held by sender: none. Sender's Comments: Patient developed Bell's palsy after vaccination with FLUZONE. Time to onset is unknown. The event is listed with the vaccine. Further information regarding vaccination details (vaccination date), time to onset, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the given information the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Eyelid ptosis, Facial paralysis, Facial paresis, Laboratory test normal
Clinical narrative: Initial solicited report received on 25 April 2018 from an investigator participating in study. This case involves a 91-year-old male subject who had Bell's palsy during the study participation. The subject's medical history and concomitant therapies were not reported. On 12 April 2018, 169 days after receiving a single 0.5 ml intramuscular dose of blinded therapy on 25 October 2017 for seasonal influenza prevention (site of administration and batch number not reported), the subject had Bell's palsy. The subject's weight was 67.2 kg and height 168.9 cm. Subject visited the ER after 6 days of left forehead weakness and several months of left ptosis. The working diagnosis was Myasthenia gravis vs. Bell's Palsy. Lab tests for Myasthenia were done. The subject was diagnosed with Bell's Palsy. The event was considered as non-serious by the investigator, however it was upgraded to serious by the company based on IME list. Lab tests for Myasthenia were negative. It was reported that the subject continued on home regiment of oral steroids. The subject was recovering from the event of Bell's palsy at the time of the report. According to the investigator, the event was possibly related to the study vaccine or trial procedures. Relationship to investigational product according to company: not associated. List of documents held by sender: none. Sender's Comments: A 91-year-old male subject had Bell's Palsy five months after receiving a dose of study vaccine. This is a listed event. Investigator considered the event as possibly related. Based on limited data available, the sponsor assesses this event as not related to study product or trial procedure.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient developed arm redness which became cellulitis and had to have treatment with an antibiotic.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports neuropathic pain in both ankles and both hands, as well as fatigue. She describes the pain as pins and needles. The pain began 06/24/18 in her legs and has progressed in intensity as well as to both hands. She has tried APAP with no relief. She has scheduled an appointment with her PCP 06/27/18.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Neuropathy peripheral
Clinical narrative: Patient reports neuropathic pain in both ankles and both hands, as well as fatigue. She describes the pain as pins and needles. The pain began 06/24/18 in her legs and has progressed in intensity as well as to both hands. She has tried APAP with no relief. She has scheduled an appointment with her PCP 06/27/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Hypoaesthesia, Rash, Rash vesicular
Clinical narrative: Pt describes a red rash that developed to bilateral forearms about 3 days after first SHINGRIX injection. Pt attributed her sx to gardening the day prior. After second SHINGRIX vaccine pt reported another rash to bilateral forearms, this time "much worse."  Pt describes the rash as looking like pimples, and PCP (who saw photos) described the rash as vesicular. Pt denied any pain or pruritis. About 9 days following vaccination (6/7) pt recalls Dr. inquiring about her droopy eyelid. Pt did not experience any numbness or tingling at that time, but presented to the ED 7 days later (6/14) with numbness to left arm and left cheek. Diagnosis possible TIA. Pt put on statin and aspirin therapy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, chills, extreme site soreness, site swelling, tiredness, fever, nausea, stomach upset.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Headache, chills, extreme site soreness, site swelling, tiredness, fever, nausea, stomach upset.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: Injection site has become inflamed and was red, and hot to the touch and caused a fever. The redness of the injection site lasted for approximately for 1 week.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Injection site has become inflamed and was red, and hot to the touch and caused a fever. The redness of the injection site lasted for approximately for 1 week.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: The patient developed raised redness and swelling approximately 1.5-2 inches in diameter after receiving the immunization.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness, swelling, pain at injection site; chills, body aches, nausea, high fever 101.6 - 101.8; headache, stuffy head, lethargy; most symptoms abated by 2nd day after injection, however headache and  fever remained and was even higher.  I am still on my 2nd day after injection and feeling absolutely horrible. I WILL NOT BE GETTING THE 2ND DOSE!!!
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Redness, swelling, pain at injection site; chills, body aches, nausea, high fever 101.6 - 101.8; headache, stuffy head, lethargy; most symptoms abated by 2nd day after injection, however headache and  fever remained and was even higher.  I am still on my 2nd day after injection and feeling absolutely horrible. I WILL NOT BE GETTING THE 2ND DOSE!!!
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: Redness, swelling, pain at injection site; chills, body aches, nausea, high fever 101.6 - 101.8; headache, stuffy head, lethargy; most symptoms abated by 2nd day after injection, however headache and  fever remained and was even higher.  I am still on my 2nd day after injection and feeling absolutely horrible. I WILL NOT BE GETTING THE 2ND DOSE!!!
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Rash vesicular
Clinical narrative: Small patch of shingles on my forehead, noticed pain/itch on 6/26/18 and woke up with blistery looking patch appears similar to shingles.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Acupuncture, Blood test, Chiropractic, Endoscopy, Heart rate increased
Clinical narrative: Patient has seen 15 doctors who were treating her for each condition. This had to stop and we had to get to the root of this problem. To cover just a snapshot of her treatment this last year, she has had an endoscopy and ultrasound and we started seeing a naturopathic doctor that did Electro- Dermal Scanning  and later saw another group of doctors at Medical Center that have put her on different supplements and year later, she is slowly improving BUT her high heart rate has gotten worse so we are seeing a cardiologist next week to make sure. She has done acupuncture, lymphatic massage, lymphatic dry brushing and lymphatic heat treatment, heat therapy, detox baths and saunas, chiropractic, SO MUCH BLOOD-WORK, homeopathic treatments, saliva panels, breath tests and urine tests.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound scan, Urine analysis
Clinical narrative: Patient has seen 15 doctors who were treating her for each condition. This had to stop and we had to get to the root of this problem. To cover just a snapshot of her treatment this last year, she has had an endoscopy and ultrasound and we started seeing a naturopathic doctor that did Electro- Dermal Scanning  and later saw another group of doctors at Medical Center that have put her on different supplements and year later, she is slowly improving BUT her high heart rate has gotten worse so we are seeing a cardiologist next week to make sure. She has done acupuncture, lymphatic massage, lymphatic dry brushing and lymphatic heat treatment, heat therapy, detox baths and saunas, chiropractic, SO MUCH BLOOD-WORK, homeopathic treatments, saliva panels, breath tests and urine tests.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: The first dose of SHINGRIX (3/20/18) patient experienced an intense adrenaline reaction where patient reports hairs standing up throughout body immediately. This reaction itched throughout whole body for 2-3 days. However, patient reports no hives/rash/difficultly breathing, only itching. Patients' itching was resolved on its own after 3 days.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given an expired vaccination, no adverse reactions noted. Expiration date on Vaccination dated 5/20/18 pt was given vaccine on 5/30/18. This was discovered on 6/25/18. No adverse reaction noted.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Palpitations
Clinical narrative: Patient had heart palpitations, dizziness, took BP, took baby aspirin.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary mass
Clinical narrative: lump in left armpit next morning
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breath holding, Loss of consciousness
Clinical narrative: Patient had a breathe holding episode for about 15 seconds. This was around 9:20 on 06/26/2018. Patient held her breath and then lost consciousness. No further action was needed. Patient was transported by EMS for observations for a few hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fatigue, chills, fever started day after injection. Fatigue continued for 3 days, chills and fever for 2 days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: 06/23/18 Had fever and chills throughout the day and part of night. 06/24/18 woke with rash on torso and under arms. 06/25/18 fever gone but still had rash. 06/26/18 all symptoms resolved and client says he feels fine. Client received no treatment for the reaction.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Tenderness
Clinical narrative: Redness and swollen of site of administration. Patient reported tenderness and pain also.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, Pruritus
Clinical narrative: PT HAS CELLULITIS WITH ITCHING TO LEFT ARM.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Disorientation, Dizziness, Fall, Head injury, Nausea
Clinical narrative: Patient became disoriented, light headed, fell backwards hitting head on wall, he complained of feeling sick to his stomach and dizzy when sitting up, wanted to lay down. Symptoms lasted about 20 minutes.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient's mother reports that redness and swelling on injection site began shortly after leaving the office 06/25/2018. Mother reports that it doubled in size the following day. Mother denies any fever, N/V, or diarrhea. Presented to the office on 06/27/2018 to have patient seen for the above symptoms. After assessment by CRNP, it was determined patient had a localized reaction at the injection site of the above stated vaccines. Patient was prescribed steroids and mother instructed to give BENADRYL PO PRN and OTC ibuprofen or acetaminophen per package instructions as needed for pain or fever. Mother educated concerning what symptoms should prompt them to present to the ER immediately. Mother instructed to return patient to clinic if problem not improving or worsening, despite treatment given.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Pain, Pyrexia
Clinical narrative: Mild fever and body aches.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 06-JUN-2018, the patient was inadvertently vaccinated with VAQTA dose and route of administration were not provided (lot # N030287 and expiration date 22-JAN-2019) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 60-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2014 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had an allergy to the vaccine both the pneumococcal vaccine and the influenza vaccine on an unspecified date. The patient became extremely ill and was hospitalized for almost a week after the pneumococcal vaccine in 2014. The outcome of the events was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 12-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient (age and gender were not reported) who experienced "one adult patient received DAPTACEL instead of ADACEL/ no ae reported", while he/she received vaccine DAPTACEL instead of ADACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) 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 an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. No adverse event was 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Sex: U
Vaccine: DTAPHEPBIP, IPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a nurse on 14-Jun-2018. This case involves a patient (age and gender was not reported) who was not vaccinated dose of IPOL but was vaccinated with PEDIARIX (batch number, expiry date, dose series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender not reported) who was vaccinated with DTaP/IPV portion only, not reconstituted with ACTHIB of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified 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. No adverse event 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Eye swelling, Rash
Clinical narrative: Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 12 years old female patient who experienced faint rash under both eyes and swollen eye, while she received vaccines HIB vaccine and MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a first dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine lot U5848AA in unknown administration site. On an unknown date, the patient received a dose of suspect HIB vaccine not produced by Sanofi Pasteur lot number not reported in unknown administration site. The patient developed a non-serious faint rash under both eyes (eyelid rash) Unknown latency following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine and Unknown latency following the administration of HIB vaccine. The patient developed a non-serious swollen eye (eye swelling) Unknown latency following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine and Unknown latency following the administration of HIB vaccine. (Other relevant tests included No lab test.) Final diagnosis was swollen eye and faint rash under both eyes. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for faint rash under both eyes and as Unknown for swollen eye. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial unsolicited report received from nurse on 31 May 2018. This case involves a 17 years 09 month old male patient who was vaccinated with 0.5 ml first dose of MENACTRA at 11 years (batch number: U5917AA, expiry date: 30 Jun 2018) on 15 MAR 2012 and second dose of MENACTRA instead of MENINGOCOCCAL VACCINE B (MenB) at 17 years (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that MenB injection but was given MENACTRA in error. This would be his 3rd dose and the second MENACTRA dose he received this year. 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 holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Child patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. 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 Expired vaccine used. No adverse event 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 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: No adverse event, Product preparation error
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (office person medical assistant). This case involves a child patient (age and gender not reported) who was vaccinated with dtap-ipv component without reconstituting the PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. 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 inappropriate reconstitution technique. No adverse event 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 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: No adverse event, Product preparation error
Clinical narrative: Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional (Office person med asst.). This case involves a child patient (gender and age not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified 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 as patient received only DTaP/IPV component of PENTACEL. No adverse event 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender was not reported), who was vaccinated with only Dtap/IPV portion of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history, family history and concomitant medication was not reported. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (LPN). This case is linked to case 2018SA166717. This case involves a patient (age and gender was not reported), who was vaccinated with only PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified 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 also reported that they do not know which one received only dtap/ipv and which one received full dose. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves three patients of unknown demographics who were vaccinated erroneously with a dose of FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the three children received FLUZONE HIGH DOSE this past season by mistake. It was reported that the patients did not experience any side effects. 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: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, Headache, fever, tired.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, FLUC4, HEP, MNQ, TDAP
Symptoms: Throat irritation
Clinical narrative: Itchy throat.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LD lower area is red and swollen. Patient states the area also hurts. No fever,dizziness or headache per patient. MD informed and he went in to talk to patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: I have a very sore arm, which I expected but I also seem to have a low grade fever and aches in my joints (hands, knees, neck).
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal pain, Peripheral swelling, Skin warm
Clinical narrative: Shoulder pain, difficulty moving the arm, heat, redness, swelling of upper arm.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hep B #2 (L) Deltoid 6/18/18 at 3pm administered. 11pm, Patient woke with low grade fever and total body hives, including ears/mouth. No respiratory distress.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: Arm soreness, nausea, chills, malaise, fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dyspnoea, Headache, Nasal disorder
Clinical narrative: Fever 102.5, aches, stomach upset, nasal, trouble breathing, headache, chills.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 102.5, aches, stomach upset, nasal, trouble breathing, headache, chills.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt was given vaccine, and told to wait 15 min. was left with sister (19) in the room. Approximately 5 min later I went to go check on patient and as I was walking to the room I can hear the sister yelling his name. I entered the room and patient was laying down on the bed. Sister had helped lay him down so he didn't fall. Patient woke up as soon as I entered room wondering what happened, we placed a cold pack under patient's neck and I fanned him until he gained color in his face. Then he was given cold water to sip on. Patient's vitals were taken and he was seen by provider before letting him leave with sister.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient reported increased swelling daily following her vaccination. Patient was referred to her doctor for evaluation.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Lot number N01982 is non valid for PROQUAD. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 08-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N019828 (previously reported as N019282) expiration date 09-JAN-2019; and VARIVAX on an unknown date. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA).; Sender's Comments: US-009507513-1806USA007938: US-009507513-1806USA007939: US-009507513-1801USA006139: US-009507513-1806USA007936: US-009507513-1806USA007937:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Herpes zoster, Hypoaesthesia, Neuralgia
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 was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy on 22-JUL-2016, for routine health maintenance and for the prevention of shingles. The zoster vaccine live did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient began to experience feelings of numbness, tingling and joint pain, accompanied by a burning sensation concentrated in her left shoulder and the midsection of her body. In response to these complaints, on 28-OCT-2016, the patient presented to her primary care physician and was diagnosed as suffering from neuropathic pain. The patient's complaints did not improve. Accordingly, the patient was referred to a neurologist who diagnosed her as suffering from small fiber neuropathy. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of live, physical impairment and injury. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster, joint pain, and neuropathic pain/small fiber neuropathy were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Small fibre neuropathy
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 was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy on 22-JUL-2016, for routine health maintenance and for the prevention of shingles. The zoster vaccine live did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient began to experience feelings of numbness, tingling and joint pain, accompanied by a burning sensation concentrated in her left shoulder and the midsection of her body. In response to these complaints, on 28-OCT-2016, the patient presented to her primary care physician and was diagnosed as suffering from neuropathic pain. The patient's complaints did not improve. Accordingly, the patient was referred to a neurologist who diagnosed her as suffering from small fiber neuropathy. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of live, physical impairment and injury. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster, joint pain, and neuropathic pain/small fiber neuropathy were considered to be disabling. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Redness and bruising around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of SQ injection (MMR-V) on date of administration (6/25). On 6/27, redness increased and spreading second rim of pinkness. Area of reaction outlined. Parents advised to start cephalexin if redness spreads out of marked areas and/or fever.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Inside of upper arm was swollen, red and warm to touch.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Dizziness, Dyspnoea, Flushing, Hypoaesthesia
Clinical narrative: Patient had reported not eating for the last few hours prior to administration. She was monitored for 15 minutes prior to exiting the OCC health clinic with no S/S of adverse reaction. She had reported feeling well just hungry. She was working in a factory in heated conditions at time the symptoms started 1 hour after administration. One hour after leaving the occupational health clinic patient started feeling anxious, all over numbness and tingling, SOB that resolved quickly, lightheaded, shaking, flushed, no hives, itching or other complaints. She was sent to the ER for further eval and treatment. Outcomes not available at this time.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Tremor
Clinical narrative: Patient had reported not eating for the last few hours prior to administration. She was monitored for 15 minutes prior to exiting the OCC health clinic with no S/S of adverse reaction. She had reported feeling well just hungry. She was working in a factory in heated conditions at time the symptoms started 1 hour after administration. One hour after leaving the occupational health clinic patient started feeling anxious, all over numbness and tingling, SOB that resolved quickly, lightheaded, shaking, flushed, no hives, itching or other complaints. She was sent to the ER for further eval and treatment. Outcomes not available at this time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Influenza like illness, Myalgia
Clinical narrative: 102 fever, chills, muscle ache, headache, flu like symptoms and slept for 18 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 102 fever, chills, muscle ache, headache, flu like symptoms and slept for 18 hours.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm is swollen from her shoulder to her elbow, inflamed, hard to the touch and itching x 24-48hrs.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Grip strength decreased, Pyrexia
Clinical narrative: Starting in the morning of 6/26: low grade fever, chills, sore joints (knees, legs and hands) severe that the patient had a hard time holding items in hands.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dry skin, Headache, Injection site pain, Pruritus
Clinical narrative: Headache, fever, joint pain, dry and itchy skin, pain in injection site. Did not happen with first dose. Symptoms started about 12 hours following injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, fever, joint pain, dry and itchy skin, pain in injection site. Did not happen with first dose. Symptoms started about 12 hours following injection.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Incorrect route of drug administration, No adverse event
Clinical narrative: MMRV vaccine may have been given IM instead of SQ not a true "IM" injection either with 5/8 inch needle. The correct needle size was used in the injection however the patient was fighting with nurse during the injection and the angle of the needle was more of a direct 90 degree angle than a 45 degree angle. Phone call follow up was made on 06/26/2018 and no problems were noted by the guardian.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Site of injection: swelling, red, sore. Movement painful for two days. That night through 35 hours, systemic reaction: full body shivers, painful muscle inflammation in legs, arms, hands, neck, headache, feeling sick, low appetite, exhaustion, slept most of the day, alternate between ibuprofen and acetaminophen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Myalgia, Myositis
Clinical narrative: Site of injection: swelling, red, sore. Movement painful for two days. That night through 35 hours, systemic reaction: full body shivers, painful muscle inflammation in legs, arms, hands, neck, headache, feeling sick, low appetite, exhaustion, slept most of the day, alternate between ibuprofen and acetaminophen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Site of injection: swelling, red, sore. Movement painful for two days. That night through 35 hours, systemic reaction: full body shivers, painful muscle inflammation in legs, arms, hands, neck, headache, feeling sick, low appetite, exhaustion, slept most of the day, alternate between ibuprofen and acetaminophen.
Age: 50.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Fatigue, Injection site pain
Clinical narrative: Started with neck pain/stiffness that progressed to transit joint pain, especially hips, knees, hand plus some myalgia & abdominal discomfort about 4-5 hours after injections; 2 ADVIL taken before bed that helped decrease symptoms. The next day, joint pain, especially neck, knees, shoulders and abdominal discomfort continued and then worsened significantly by 12:00 PM, at which time significant fatigue and myalgia was noted at which time I was unable to complete ADLs. About 2:00, chills set in and by 5:00 I was found to have a fever of 100.3 F. At this time, 4 ADVIL were taken and the symptoms decreased. Today is day 3 and I still have neck & hip pain (worst) and mild generalized joint discomfort. SHINGRIX injection site remains somewhat painful at use of left arm and is tender to touch. MMR site (R arm) is non-tender.