chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 723902), concerns a 73-year-old elderly male patient. The patient's medical history was not reported. On 21-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: Unknown, anatomical location: left arm, batch number: 179101). On 25-Oct-2017, 4 days after vaccination, the patient experienced fever, chills and headache. The outcome of the events was recovered. The reporter assessed the case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 723918), concerns a 66-year-old, elderly female patient. The patient's medical history was not reported, however the patient's concomitant medications included Estradiol Valerate w/Norethisterone, Trazodone and Clonazepam for an unknown indication. On 19-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 178802, expiry date: not reported) and non-company suspect drug PNEUMOVAX (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: N004564). On 21-Sep-2017, two days after vaccination, the patient experienced flu like symptoms associated with body ache, fever, chills. Subsequently, 3 to 4 days later, the patient felt better. On 30-Sep-2017, the patient had cold that got relieved, but symptoms of fever, extreme fatigue, naggy cough and lack of appetite were noted. The patient still felt sick and lot of cough, however cough was getting better. It was reported that, the patient made a visit to the physician's office for the events. The patient had not yet recovered from the event (flu like symptoms). The reporter assessed the case as non-serious. Case correction received with IRD 20-Mar-2018: Added co-suspect as PNEUMOVAX in the case comment. Upon internal review, it was realized that the onset date of event flu like symptoms was missed to capture. Hence, onset date of flu like symptom (21-Sep-2017) was captured on the screen of event tab and made a significant correction.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Malaise, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 723918), concerns a 66-year-old, elderly female patient. The patient's medical history was not reported, however the patient's concomitant medications included Estradiol Valerate w/Norethisterone, Trazodone and Clonazepam for an unknown indication. On 19-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 178802, expiry date: not reported) and non-company suspect drug PNEUMOVAX (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: N004564). On 21-Sep-2017, two days after vaccination, the patient experienced flu like symptoms associated with body ache, fever, chills. Subsequently, 3 to 4 days later, the patient felt better. On 30-Sep-2017, the patient had cold that got relieved, but symptoms of fever, extreme fatigue, naggy cough and lack of appetite were noted. The patient still felt sick and lot of cough, however cough was getting better. It was reported that, the patient made a visit to the physician's office for the events. The patient had not yet recovered from the event (flu like symptoms). The reporter assessed the case as non-serious. Case correction received with IRD 20-Mar-2018: Added co-suspect as PNEUMOVAX in the case comment. Upon internal review, it was realized that the onset date of event flu like symptoms was missed to capture. Hence, onset date of flu like symptom (21-Sep-2017) was captured on the screen of event tab and made a significant correction.
Age: 67.0
Sex: M
Vaccine: FLUA3, HEPAB
Symptoms: Pruritus generalised, Throat tightness, Urticaria, Vaccination complication
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 723920), concerns a 67-year-old, elderly, male patient. The patient's medical history, allergies and the concomitant medications were not reported. On 19-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 179103, route of administration, anatomical location, and expiry date: not reported). On the same day, the patient was administered with non-company suspect product, TWINRIX (batch number: Z7542, dose, route of administration, anatomical location, and expiry date: not reported). On 20-Oct-2017, after 24 hours of vaccination, the patient experienced a severe reaction (hives, itchiness all over the body and throat closing), went to physician who prescribed the steroid shots to stop the reaction. It was reported that, the reaction started, as the shot did not last for long period. On 30-Oct-2017, upon recommendation of the physician, the patient received Prednisone 20 mg, to stop the reaction. It was reported that, at the time of consultation, no hives or swollen spots were noticed. At the time of the report, the patient had recovered from the events (itching all over, throat tightness and hives). The reporter assessed the case as non-serious. Significant case correction received with IRD 20-Mar-2018: As determined causality for the events was corrected from unassessable to related and case comment was amended.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 724212), concerns a 73-year-old elderly female patient. The patient's medical history and concomitant medications was not reported. On 30-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 178901). On 04-Oct-2017, 5 days (reported as 4 to 5 days) after vaccination, the patient experienced pain in arm which persisted. Subsequently, the pain got mitigated by acetaminophen and ibuprofen, however the pain was worst upon movement. No laboratory tests were performed. The patient had not yet recovered from the event. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 30-Mar-2018: The event pain in arm was added in case comment. No changes were made in the narrative.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 724213), concerns a 77-year-old elderly female patient. The patient's historical conditions were unknown. The patient had no current illness. The patient had been allergic to sulfa drugs, tetracycline and hydrocodone. the patient's concomitant medications included raloxifene, Metoprolol, amlodipine and Levothyroxine for an unknown indication. On 20-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179401 and expiry date: not reported). On 21-Oct-2017, after 1 day of vaccination, the patient developed severe body aches, fever of 102.1 and diarrhea which lasted about 2 days. No lab investigations were performed for the events. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 70.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Mobility decreased, Pain, Periarthritis
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 724352), concerns a 70-year-old, elderly male patient. On 16-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 178502, expiry date: not reported) and PREVNAR 13 (dose: 1 (as reported), route of administration, anatomical location: left arm, batch number: S31257 (as reported), expiry date: not reported). On the same day of vaccination, the patient experienced frozen shoulder, sore/aching pain and could not move arm freely for 2 months. The patient was treated with ALEVE for pain and underwent physical therapy. On 25-Oct-2017, the patient reported the pharmacy about the events. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 724442), concerns a 57-year-old, adult, male patient. The patient's medical history and the concomitant medications were not reported. On 01-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179601 and expiry date: not reported) which was recommended to age above 65 years of age. No adverse effects were occurred after vaccination. The reporter assessed the case as non-serious.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Dry skin, Rash generalised, Skin exfoliation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-May-2018 by Seqirus from VAERS (VAERS ID: 726380), concerns a 75-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. On 15-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml reported as 1, route of administration: injection (SYR as reported), anatomical location: right arm, batch number: 179303). On 22-Oct-2017, the patient developed rash all over the body which resulted in dry and peeling skin. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Eye pruritus, Generalised erythema, Ocular hyperaemia, Oral pruritus, Pruritus generalised
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726415), concerns a 68-year-old, elderly female patient. The patient experienced numbness, throwing up, and difficulty breathing, when codeine, morphine and oxycontin were taken. The patient's current conditions included, difficulty in sleeping, high blood pressure, high blood sugar, however current illness was reported as none. The concomitant medications included trazodone, metoprolol tartrate, lisinopril, glipizide, fenofibrate, gabapentin for unknown indications. On 08-Nov-2017 (around noon on Wednesday), the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: right arm: 179603, batch number, expiry date: not reported). On 11-Nov-2017 (on Saturday), after 3 days of vaccination, the patient developed itching everywhere especially on hands and face. The patient developed redness also everywhere especially in eyes. The patient was treated with BENADRYL that partially helped in relief from the events. As of Monday, the patient had rash on face, itchy eyes, forehead, and mouth. The patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726415), concerns a 68-year-old, elderly female patient. The patient experienced numbness, throwing up, and difficulty breathing, when codeine, morphine and oxycontin were taken. The patient's current conditions included, difficulty in sleeping, high blood pressure, high blood sugar, however current illness was reported as none. The concomitant medications included trazodone, metoprolol tartrate, lisinopril, glipizide, fenofibrate, gabapentin for unknown indications. On 08-Nov-2017 (around noon on Wednesday), the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: right arm: 179603, batch number, expiry date: not reported). On 11-Nov-2017 (on Saturday), after 3 days of vaccination, the patient developed itching everywhere especially on hands and face. The patient developed redness also everywhere especially in eyes. The patient was treated with BENADRYL that partially helped in relief from the events. As of Monday, the patient had rash on face, itchy eyes, forehead, and mouth. The patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 82.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Dizziness, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726467), concerns an 82-year-old elderly female patient. The patient's historical condition and concomitant medications were not reported. The patient had no current illness. The patient had been allergic to iodine and penicillin. On 11-Oct-2017, approximately at 09:00 am, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, anatomical location: right arm, batch number: 179601, route of administration: unknown and expiry date; not reported) and non-company suspect product PNEUMOVAX (anatomical location: left arm, batch number: N019983, route of administration: unknown, dose and expiry date: not reported). On the same day, approximately at 6:00 pm, the patient experienced chills and at 11:30 pm, she woke up with fever of 101.8. Subsequently, the patient also experienced runny nose, headache over eyes, little dizziness, some facial swelling and her skin was hot to touch. On an unspecified date, the patient was recovered from the events. The reporter assessed the events as non-serious.
Age: 82.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin warm, Swelling face
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726467), concerns an 82-year-old elderly female patient. The patient's historical condition and concomitant medications were not reported. The patient had no current illness. The patient had been allergic to iodine and penicillin. On 11-Oct-2017, approximately at 09:00 am, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, anatomical location: right arm, batch number: 179601, route of administration: unknown and expiry date; not reported) and non-company suspect product PNEUMOVAX (anatomical location: left arm, batch number: N019983, route of administration: unknown, dose and expiry date: not reported). On the same day, approximately at 6:00 pm, the patient experienced chills and at 11:30 pm, she woke up with fever of 101.8. Subsequently, the patient also experienced runny nose, headache over eyes, little dizziness, some facial swelling and her skin was hot to touch. On an unspecified date, the patient was recovered from the events. The reporter assessed the events as non-serious.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: This spontaneous case, initially retrieved on 30-Mar-2018 reported by other health professional and concerns a 75-year-old elderly female patient. The patient's historical condition included heart disease. The patient's current condition included allergy to baker's yeast. On 10-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (N/A as reported), Batch number: 179301, route of administration: intramuscular, anatomical location: left arm). On the same day, after vaccination, the patient experienced pain which lasted for 48 hours. The patient was examined at administered site which showed, the vaccine was given possibly too high on the arm and close to the acromion. The patient was advised to consult PCP (primary care provider) if the symptoms did not resolve in 5-7 days. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the case as non-serious.
Age: 75.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726555), concerns a 75-year-old, elderly, female patient. The patient's historical condition included anaphylactic reaction (on an unspecified date in 1993 or 1994) and the patient had family history of thiomersal allergy. The patient was allergic to insect bite, sulfonamide (since 1980) specifically BACRTRIM, thiomersal (from 13 years) reported that her allergy was broader than thiomersal. The patient had a Bausch and Lomb eye wash and she used something (not thiomersal) into that which makes her eyes gloopy. The patient was a contact lens wearer (since 1970). The patient had allergy to wasp stings which developed very slow over 10 years, the first time she had swelling like a bee sting. The patient's concomitant medication included glucosamine chondroitin, Vitamin D3, ADVIL and multivitamin for an unknown indication (since an unspecified date). It was reported that, the patient had no history of previous immunization with pneumococcal 13 valent conjugated vaccine. On 21-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, material number: 70461-0002-01), batch number and expiry date: not reported) and on the same day, at 15:00, the patient administered with non-company suspect product, PREVNAR 13 (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported) single. On 22-Oct-2017, after 1 day of vaccination, the patient right arm became sore for 2-3 days but not red or anything. At the time of report, the patient had recovered from painful right arm. The reporter assessed the case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728868), concerns a 73-year-old, elderly, female patient. The patient's historical condition included depression. The patient's current conditions included mania episode and bipolar type-I (since an unspecified date). The patient had no known drug allergy (NKDA). The patient's concomitant medications included APAP, COMBIVENT, Aspirin, SYMBICORT, cefdinir, Levothyroxine, lisinopril, risperidone, lorazepam and Trazodone for an unknown indication. On 29-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left deltoid, batch number: 179501 and expiry date: not reported). On 30-Nov-2017, after 1 day of vaccination, the patient experienced swelling of left deltoid area, tenderness to palpation and restriction of movement. It was reported that, there were no involvement of airway or any other signs and symptoms of IgE (immunoglobulin E) mediated reaction. No lab investigations were performed. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Peripheral swelling, Product administered at inappropriate site, X-ray
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 30-MAR-2018 by Seqirus from VAERS (VAERS ID: 728911), concerns an 83-year-old, elderly, female patient. The patient had no historical conditions, allergies and current illness. However, patient's concomitant medications included atenolol for an unknown indication. On 27-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported). It was reported that, vaccine was given high in shoulder and into the joint. On the same day, after vaccination, the patient experienced unbearable pain and her arm, hand and fingers started to swell. The patient went to the emergency room, where X-ray performed, and patient was checked by the doctor. It was reported that, pain was excruciated, and patient was given an unspecified pain medication. The patient used sling. At the time of this report, the patient had not recovered from the events. The reporter assessed the events as non-serious. Non-significant case correction received with the IRD 30-Mar-2018: The sentence was corrected from 'vaccine was given to the high in shoulder' to 'vaccine was given high in shoulder', 'the patient was not recovered from the events' to "the patient had not recovered from the events" and X ray to X-ray in the narrative.
Age: 92.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site induration, Injection site mass, Mobility decreased, Pain
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728933), concerns a 92-year-old, elderly, female patient. The patient's current conditions included borderline high cholesterol and high blood pressure (since an unspecified date). The patient had no known allergies. The concomitant medications included amlodipine, atenolol, losartan, atorvastatin and metoprolol for an unknown indication (since an unspecified date). On 20-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179403 and expiry date: not reported). On 21-Oct-2017, after 1 day of vaccination, the patient had to prop her arm up at night and unable to lift her arm up during the day. The patient's injection site was hard for 1 week and there was still a lump in the area. After 5 weeks of vaccination, the patient was still experiencing soreness. The patient's appointment with primary care prescriber was scheduled for the events. At the time of this report, the outcome of events (mobility decreased, injection site induration) was unknown and the patient had not recovered from the events (injection site lump and painful L arm). The reporter assessed this case as non-serious.
Age: 72.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Eye swelling, Headache, Photophobia
Clinical narrative: Patient had 1st dose of Hep A. Patient had experienced with severe headache, deep sleep, sensitivity to sun light, drowsiness, stiff neck, could not function for 11 days.
Age: 72.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test, Dental examination, Headache, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: Patient had 1st dose of Hep A. Patient had experienced with severe headache, deep sleep, sensitivity to sun light, drowsiness, stiff neck, could not function for 11 days.
Age: 72.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Photophobia, Sleep disorder, Somnolence
Clinical narrative: Patient had 1st dose of Hep A. Patient had experienced with severe headache, deep sleep, sensitivity to sun light, drowsiness, stiff neck, could not function for 11 days.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, C-reactive protein increased, Eye inflammation, Vision blurred
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eye inflammation in a 59-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (for tolerance to the 1st dose received on 25th January 2018, refer case US2018GSK111391). On 30th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms. On 24th April 2018, the patient experienced eye inflammation. On an unknown date, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the eye inflammation was not recovered/not resolved and the outcome of the flu like symptoms was recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the eye inflammation, flu like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Twenty five days after receiving vaccination, the patient experienced inflammation right eye. Less than a year after receiving vaccination, the patient experienced injection site pain.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye inflammation, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eye inflammation in a 59-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (for tolerance to the 1st dose received on 25th January 2018, refer case US2018GSK111391). On 30th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms. On 24th April 2018, the patient experienced eye inflammation. On an unknown date, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the eye inflammation was not recovered/not resolved and the outcome of the flu like symptoms was recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the eye inflammation, flu like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Twenty five days after receiving vaccination, the patient experienced inflammation right eye. Less than a year after receiving vaccination, the patient experienced injection site pain.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injected limb mobility decreased, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, sertraline, Pravastatin and clozapine. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On 20th May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the patient experienced sleeplessness and emotional distress. The patient was treated with cyclobenzaprine. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved and the outcome of the sleeplessness and emotional distress were unknown. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, sleeplessness and emotional distress to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient reported pain in the arm where the injection was administered. The pain presented a few hours following the injection and has progressed to the point where she cannot even raise her arm. The patient stated that the pain was intense and went up to her shoulder and into her hand and sometimes to her elbow. The patient's right arm was completely disabled. The patient had lost the ability to move her arm or losing use of arm. The patient was in pain all the time and it was getting worse every day. The physician suggested heat which made it worse. Less than a month after vaccination, the patient experienced sleeplessness and upset. The patient was very upset. The patient was then prescribed Cyclobenzaprine by her physician. The patient wanted someone to call her back with regard to this.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, sertraline, Pravastatin and clozapine. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On 20th May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the patient experienced sleeplessness and emotional distress. The patient was treated with cyclobenzaprine. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved and the outcome of the sleeplessness and emotional distress were unknown. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, sleeplessness and emotional distress to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient reported pain in the arm where the injection was administered. The pain presented a few hours following the injection and has progressed to the point where she cannot even raise her arm. The patient stated that the pain was intense and went up to her shoulder and into her hand and sometimes to her elbow. The patient's right arm was completely disabled. The patient had lost the ability to move her arm or losing use of arm. The patient was in pain all the time and it was getting worse every day. The physician suggested heat which made it worse. Less than a month after vaccination, the patient experienced sleeplessness and upset. The patient was very upset. The patient was then prescribed Cyclobenzaprine by her physician. The patient wanted someone to call her back with regard to this.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, sertraline, Pravastatin and clozapine. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On 20th May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the patient experienced sleeplessness and emotional distress. The patient was treated with cyclobenzaprine. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved and the outcome of the sleeplessness and emotional distress were unknown. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, sleeplessness and emotional distress to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient reported pain in the arm where the injection was administered. The pain presented a few hours following the injection and has progressed to the point where she cannot even raise her arm. The patient stated that the pain was intense and went up to her shoulder and into her hand and sometimes to her elbow. The patient's right arm was completely disabled. The patient had lost the ability to move her arm or losing use of arm. The patient was in pain all the time and it was getting worse every day. The physician suggested heat which made it worse. Less than a month after vaccination, the patient experienced sleeplessness and upset. The patient was very upset. The patient was then prescribed Cyclobenzaprine by her physician. The patient wanted someone to call her back with regard to this.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 68-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 21st February 2021) for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 16th June 2018, 2 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), erythematous rash (serious criteria other: as per reporter) and papular rash (serious criteria other: as per reporter). The patient was treated with cephalexin. On an unknown date, the outcome of the cellulitis, erythematous rash and papular rash were recovering/resolving. It was unknown if the reporter considered the cellulitis, erythematous rash and papular rash to be related to SHINGRIX. Additional information was received as follows: The patient experienced a rash, described as red and bumpy, under her arm. The patient referred to and seen by urgent care at which point the rash was diagnosed as cellulitis. As treatment, the patient was prescribed and used 500 mg Cephalexin, and the symptoms improved. The reporting healthcare professional stated that the patient's primary physician believed that the rash was due to SHINGRIX, which was not cellulitis.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Rash erythematous, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 68-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 21st February 2021) for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 16th June 2018, 2 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), erythematous rash (serious criteria other: as per reporter) and papular rash (serious criteria other: as per reporter). The patient was treated with cephalexin. On an unknown date, the outcome of the cellulitis, erythematous rash and papular rash were recovering/resolving. It was unknown if the reporter considered the cellulitis, erythematous rash and papular rash to be related to SHINGRIX. Additional information was received as follows: The patient experienced a rash, described as red and bumpy, under her arm. The patient referred to and seen by urgent care at which point the rash was diagnosed as cellulitis. As treatment, the patient was prescribed and used 500 mg Cephalexin, and the symptoms improved. The reporting healthcare professional stated that the patient's primary physician believed that the rash was due to SHINGRIX, which was not cellulitis.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Broke out in shingles rash after taking first dose of SHINGRIX vaccine, back was itchy a few days before I broke out in rash on right side above and below collar bone and arm. Also rash on back. But after shot had pain in neck and shoulder and itchy. Went to ER and diagnosed with shingles and given medication Acyclovir 400 mg 3 x day. Two day later followed up with my own Doctor who changed medicine to Famciclovir 500 mg 3 x day, TYLENOL and Triamcinolone cream. Week later Doctor prescribed additional week of Famciclovir and also recommend after speaking to CDC that I take second dose of vaccine in 2-6 months much better but not fully recovered. Please let me know if other people broke out in shingles after taking SHINGRIX vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Neck pain, Pruritus, Rash
Clinical narrative: Broke out in shingles rash after taking first dose of SHINGRIX vaccine, back was itchy a few days before I broke out in rash on right side above and below collar bone and arm. Also rash on back. But after shot had pain in neck and shoulder and itchy. Went to ER and diagnosed with shingles and given medication Acyclovir 400 mg 3 x day. Two day later followed up with my own Doctor who changed medicine to Famciclovir 500 mg 3 x day, TYLENOL and Triamcinolone cream. Week later Doctor prescribed additional week of Famciclovir and also recommend after speaking to CDC that I take second dose of vaccine in 2-6 months much better but not fully recovered. Please let me know if other people broke out in shingles after taking SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received SHINGRIX. On 13th June 2018, 9 days after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site warmth and injection site itching. In June 2018, the patient experienced pain in arm. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site warmth was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema, injection site warmth, injection site itching and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. In 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm for 4 days then fine. The patient stated that, she started with a red rash and very hot around were the shot was given to me. Next morning rash still there but not as red still it was itching.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received SHINGRIX. On 13th June 2018, 9 days after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site warmth and injection site itching. In June 2018, the patient experienced pain in arm. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site warmth was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema, injection site warmth, injection site itching and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. In 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm for 4 days then fine. The patient stated that, she started with a red rash and very hot around were the shot was given to me. Next morning rash still there but not as red still it was itching.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received SHINGRIX. On 13th June 2018, 9 days after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site warmth and injection site itching. In June 2018, the patient experienced pain in arm. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site warmth was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema, injection site warmth, injection site itching and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. In 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm for 4 days then fine. The patient stated that, she started with a red rash and very hot around were the shot was given to me. Next morning rash still there but not as red still it was itching.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of unknown ages and gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The reporter informed that on an unspecified date, the patients were vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis and with improperly stored PROQUAD, lot #N019248 and expiration date 20-DEC-2018, for prophylaxis (strength, dose, frequency and route of administration were not reported). No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes. There was no previous temperature of excursion reported. There was a digital data logger involved. This is a non-valid case due to lack of patients' identifiers. Follow up information was received on 14-JUN-2018 from the medical assistant and it was determined that the case is valid because the patient identifier was provided. The patient was a child (greater than 12 month old) and gender was not reported. The patient received only VARIVAX on an unknown date in January 2018. The temperature of excursion was occurred on 02-JAN-2018. This is one among the several cases reported by the medical assistant. Sender's Comments: US-009507513-1806USA010174: US-009507513-1806USA010177: US-009507513-1806USA010176: US-009507513-1806USA010175: US-009507513-1806USA010173: US-009507513-1806USA010171: US-009507513-1806USA010180: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010181.
Age: 11.0
Sex: F
Vaccine: MMRV, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong patient received medication
Clinical narrative: This spontaneous report was received from a physician, referring to an 11 year old female patient. The patient's medical history included vaccination with VARIVAX and M-M-R II. Her concurrent conditions and drug reactions/allergies were not reported. On approximately 03-MAY-2018 (reported as 3 weeks ago), the patient was vaccinated with PROQUAD for prophylaxis (dose, frequency, route, lot #, and expiration date were not reported), which was intended to be administered to her sibling. On the same date, the patient also received ADACEL (dose, frequency, route, lot #, expiration date, and indication were not reported) and MENACTRA (dose, frequency, route, lot #, expiration date, and indication were not reported). No adverse effects were reported. The PROQUAD vaccination was then considered as an "extra dose" as she previously completed VARIVAX and M-M-R II series. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1805USA012316.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR
Symptoms: Culture negative, Gram stain negative, Incisional drainage, Injection site abscess sterile, Injection site induration
Clinical narrative: This literature marketed report has been received from authors of the published article, referring to a 21 month old male patient with aluminum allergy. He received standard 2 - and 4-month immunizations without any reactions. At 6 months of age, he received a PENTACEL and ENGERIX injection in the left leg. Several days later, a golf ball-sized, firm lesion appeared in the left thigh. The lesion became fluctuant and was subsequently incised, producing a culture which was sterile with a negative Gram stain. Seven days later, a small lesion reappeared in the same area that eventually self-drained purulent fluid. His next series of immunizations were administered at 1 year of age, on 19-OCT-2015, including the first dose of VAQTA (dose, lot# and expiration date unknown) in the right thigh for prophylaxis. Concomitant therapies included FLUZONE and M-M-R II. Following the immunizations he developed a similar lesion on his right thigh at the site of a VAQTA immunization. An incision and drainage procedure was performed, from which purulence was obtained but a culture was sterile and a Gram stain was negative. A third golf ball-sized lesion developed on the right thigh after receiving his next PENTACEL immunization 5 months later (on 01-APR-2016), and a fourth abscess appeared on 16-MAY-2017 in the left leg after another dose of VAQTA (also reported as "13 months later following a ENGERIX immunization"). He remained afebrile during all episodes, with no erythema or significant discomfort. He did not receive any antimicrobial therapy for the lesions. The outcome of the events was reported as recovered. The reporter considered the events to be related to aluminum-adjuvant based vaccine VAQTA.