chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Headache, Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 26-DEC-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient began to suffer headaches, fatigue, feeling of his nerve endings shooting off' throughout his whole body, burning in his arm, and a rash which started on his right hip and traveled all over his body. As a result, the patient was diagnosed with shingles on or about 15-MAY-2017. As a direct and proximate result of the ZOSTAVAX, the patients symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. As a result of the ZOSTAVAX, 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 life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Shingles was considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 26-DEC-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient began to suffer headaches, fatigue, feeling of his nerve endings shooting off' throughout his whole body, burning in his arm, and a rash which started on his right hip and traveled all over his body. As a result, the patient was diagnosed with shingles on or about 15-MAY-2017. As a direct and proximate result of the ZOSTAVAX, the patients symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. As a result of the ZOSTAVAX, 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 life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Shingles was considered disabling. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 19-Sep-2018, concerning a 27-year-old, adult female patient. On 19-Sep-2018, the patient (under age of 65 years) was inadvertently administered FLUAD (TIV), [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783 and expiry date: 30-Apr-2019]. No adverse reactions were experienced by the patient after the vaccine administration. The reporter assessed the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 20-Sep-2018, concerns 40-year-old, adult female patient. The patient's historical condition included breast feeding. The patient had no concomitant medications. On 19-Sep-2018, the patient (underage of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, batch number: 250785, expiry date: 30-Apr-2019 and route of administration: not reported] (explicitly coded as inappropriate age at vaccine administration). It was reported that the patient was given a wrong flu vaccine as the patient was supposed to be given a flu vaccine that was appropriate for a 40-year-old (explicitly coded as wrong vaccine administered). The patient did not experience any adverse event. The reporter assessed the case as non-serious. Follow-up received on 09-Oct-2018 from other health professional: It was reported that the patient had no known post-partum complications or disorder, therefore post-partum disorder was deleted from other relevant history. The patient did not experience any adverse event. The narrative was amended accordingly. Non-significant follow-up on 30-Oct-2018 from other health professional: It was clarified that 'gave wrong flu vaccine' meant that the patient was supposed to be given a flu vaccine that was appropriated for a 40-year-old, but instead gave the FLUAD. Narrative was amended accordingly.
Age: 91.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 20-Sep-2018, from a pharmacist, concerns a 91-year-old, elderly male patient. The patient's historical conditions included dysphagia, left-sided weakness, foot pain, depression, tobacco use, hypomagnesaemia, shoulder pain, weight loss, high risk for falls, hyponatremia, major abdominal surgery, asbestos induced pleural plaques, moderate chronic obstructive pulmonary disease (COPD), chronic pancreatitis, peripheral vascular disease, coronary heart disease, multiple renal cysts, pecan lesion, sleep apnoea, cognitive impairment, congestive heart failure, transient ischemic attack (TIA), degeneration of lumbar intervertabral disc, stable aneurism of abdominal aorta, total replacement of bilateral hip joints, sensorineural hearing loss, bilateral cataract extraction, type 2 diabetes and gastric ulcer. The patient's current conditions included vitamin B12 deficiency, vitamin D deficiency, dementia, essential hypertension and benign prostatic hyperplasia (BPH) without outflow obstruction. The patient's concomitant medications included vitamin D, Vitamin B12, losartan, oxybutynin, tropaeolum, FLOMAX, TYLENOL, and calcium, all for unknown indications. It was reported that the vaccine underwent first time temperature excursion reaching 34 F (Fahrenheit) for 15-20 minutes. On 19-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: 250796 and expiry date: 31-May-2019] that underwent temperature excursion. The patient had not experienced any adverse effects after administration. The reporter assessed this case as non-serious. This case 201803915 was cross-linked with the case 201803916 reported by the same reporter. Non-significant follow up received on 12-Oct-2018: The date of vaccination previously reported as 19-Sep-2019 was confirmed to be 19-Sep-2018. No new information was received. No changes were made in the narrative.
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 27-Sep-2018, concerning a female patient of an unspecified age (reported as younger than 65 year). On an unspecified date, the patient was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number, expiry date: mot reported] (explicitly coded as inappropriate at vaccination). No adverse event was reported.
Age: 40.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional on 13-Sep-2018, concerns a 40-year-old, adult patient of an unspecified gender. On 13-Sep-2018, the patient under age of 65 years was administered FLUAD (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration). No adverse reactions had occurred since administration. The reporter assessed the case as non-serious. This case was considered as lost to follow-up since the reported had not given consent to provide further information.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed redness, pain and swelling at injection site approx. 48 hrs after receiving VARIVAX. Seen by NP in ED - Red. Abx x 10d.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous case, initially received from a pharmacist on 26-Sep-2018, concerns a 72-year-old, elderly, female patient. The patient was allergic to formaldehyde. On 25-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250792 and expiry date: 30-Apr-2019), who was allergic to formaldehyde (explicitly coded as contraindicated product administered). No adverse event was reported following vaccination. The reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Impaired work ability, Lymph node pain
Clinical narrative: This spontaneous case, initially received from other health professional on 03-Oct-2018, concerns a 30-year-old, adult female patient. The patient had no relevant medical history. The patient had not received any concomitant medications. On 29-Sep-2018, the patient was administered influenza vaccine, (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date, trade name and manufacturer: not reported). On 01-Oct-2018, 2 days after vaccination (reported as Monday), the patient felt tenderness on lymph node, underneath her right arm. On 02-Oct-2018 (reported as yesterday), the tenderness had increased when she got back from work and patient was uncomfortable. It was reported that, the patient also developed tenderness of lymph node on her neck. On 03-Oct-2018 (reported as today) the patient could not go to work. At the time of this report, the patient had not recovered from the events (reported as ongoing). The reporter assessed this case as non-serious.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Feeling abnormal, Hypoaesthesia, Pain in extremity
Clinical narrative: Patient got home and started feeling funny so she took a shower and was no better, was having pain and numbness in the right arm and right back pain. Husband brought her back to office. There was no redness or warm to touch but the patient stated she could move arm so per FNP-BC patient was directed to ER.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: After the administration of SHINGRIX on 12/18/18 pt felt fatigued and wiped out but was aware this was a potential adverse event. On the morning of 12/25/18 pt awoke with soreness and swelling in lower back/upper legs at site of previous shingles outbreak. She came in concerned that the vaccine might be responsible since she had shingles in that site previously and had previously received ZOSTAVAX. I told her that the vaccine was new enough that I would file a report on her behalf. Patient also had surgery in this area in 2009 and 2013, but had not engaged in any strenuous activity that could otherwise have led to her reported symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PPV, RV5
Symptoms: Abnormal behaviour, Diet refusal, Emotional distress, Pain, Vomiting
Clinical narrative: Infant fell asleep after appointment for about an hour and upon waking up she proceeded to violently and painfully vomit for the next 7 hours (on and off about every 30 minutes). She refused to nurse until about 8 or 9pm that evening, about 7 hours after vomiting started. This behavior was very uncharacteristic for her; she could not be calmed and it was very distressing for me and her.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: Visual disturbance, mild headache, and dizziness on ambulation.
Age: 57.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 04-Sep-2018 concerns a 57-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medication. On 04-Sep-2018, the patient under age of 65 years was accidently administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 250783 (reported as 2507863), expiry date: 30-Apr-2019]. The Seqirus confirmed that, batch number (250783) was a valid FLUAD batch number. No adverse event or adverse reaction was reported. It was reported that, the patient had a follow up with her primary care physician (PCP). This case was linked to case number: 201803732 reported by the same reporter. Update on 07-Sep-2018: Significant case correction (IRD: 04-Sep-2018): The Seqirus confirmed that, batch number (250783) was a valid FLUAD batch number. Hence, the batch number (250783) of the suspect product was added in the product tab and the narrative was amended accordingly. Non-significant follow up received by reporter on 12-Sep-2018: The patient did not report any adverse event or adverse reaction. The patient had a follow up with her primary care physician (PCP). The narrative was amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain in extremity
Clinical narrative: This non-serious spontaneous case, initially received on 17-Sep-2018, reported by other non-health professional and concerns a female elderly patient of unspecified age. It was reported that in the past (3-4 years), the patient administered influenza vaccine and developed soreness and redness in the arm. The patient's historical condition included asthma (on an unspecified date). On an unspecified date, the patient administered INN Flu vaccine seasonal (dose, route of administration, anatomical location, manufacturer, batch number and expiry date: not reported). On unspecified date, after vaccination, the patient experienced soreness and redness in the arm. At the time of this report, the outcome of the events was not reported. Follow up report received on 25-Sep-2018: The patient's date of birth was added in the tab. Non-significant follow-up received from other non-health professional on 14-Nov-2018: No new information was received. Hence, no changed were made to the case.
Age: 50.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received on 17-Sep-2018, reported by other health professional (nurse), concerns a 50-year-old, adult female patient. On 17-Sep-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: 250791 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse effects were noted after administration.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning an 80-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F. On 12-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804092 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Product quality issue, Syringe issue
Clinical narrative: This spontaneous case, initially received from other health professional on 26-Sep-2018 and follow-up received from other health professional on 26-Sep-2018 and follow-up received on 27-Sep-2018 (combinedly processed), concerning a 70-year-old, elderly, female patient. On 26-Sep-2018, the patient was not administered complete dose of FLUAD (TIV) (dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 251354 and expiry date: 30-Apr-2019). It was reported that, the patient was injected with the vaccine PFS and as the syringe was pulled out of patient's arm, the hub detached from the syringe and the needle and hub were attached to patient's arm. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1033688. On an unspecified date in 2018, after the vaccination, the patient experienced injection site pain. At the time of the report, the outcome of the event injection site pain was not reported. The reporter assessed the case as non-serious. Update received on 11-Nov-2018: Non-significant case correction (27-Sep-2018): The term was changed from 'QA reference number' to 'PTC reference number' in notes section of additional information tab.
Sex: M
Vaccine: FLUA3
Symptoms: Wrong product administered
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional (consumer) on 02-Oct-2018, concerns an elderly male patient of unspecified age (over 65 years old as reported). On an unspecified date, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, dose, batch number and expiry date: not reported] instead of high dose FLUZONE (explicitly coded as wrong vaccine administered). At the time of this report, no adverse event was not reported. Follow-up report received from reporter on 22-Oct-2018: The reporter confirmed that the patient was over 65 years old. The narrative was amended accordingly. Follow-up report received from reporter on 20-Nov-2018: The reporter doesn't have batch number and expiry date and confirmed that the patient received single dose of vaccine intramuscularly in the deltoid. The route of administration and anatomical location were added. The narrative was amended accordingly.
Age: 21.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion, Erythema
Clinical narrative: This spontaneous case, initially received on 03-Oct-2018 from a other non-health professional, concerning a 21-year-old, adult, female patient. The patient had no medical history and the concomitant medications were not reported. The patient believed he was not allergic to latex. The patient also did not have any coagulation issues (for which he was tested). On an unspecified date in 2017 (last year as reported), the patient was administered with FLUAD (TIV) [dose: 0.5ml, batch number: 178323, route of administration, anatomical location, and expiry date: not reported]. On an unspecified date, after vaccination, the patient developed bruising from shoulder to elbow and a red circular spot. It took 6 months for bruise to resolve and the patient talked to doctor to make sure it wasn't an allergic reaction. The patient told that it could have been some allergy and the patient was not sure that he was allergic to latex. The patient believed that was not an adverse event from the vaccine but probably the person who administered hit a vein or something and as an elderly patient he had more susceptibility to get bruises. At the time of this report, the patient had recovered from the event (bruising of arm) and the outcome of the events (redness and allergic reaction) was not reported. The reporter assessed the case as non-serious.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Ocular hyperaemia
Clinical narrative: This spontaneous case from, initially received from a pharmacist on 23-Aug-2018, concerning a 29-year-old, adult, male patient. On an unspecified date in 2017 (reported as last year), the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date in 2017, one day after vaccination, the patient experienced redness in the eye. The patient reported that, he had no complains of pain, no discharge and no treatment was needed. After one day, the redness of the eye disappeared (recovered). The reporter assessed this case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 23-Aug-2018): As determined causality of the event 'red eye' was corrected from not related to related. The case comment was amended accordingly.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: Patient given influenza vaccine at place of work by outside group. Since a few days after injection patient has had redness, swelling, pain and nodule under skin at site of injection. Pain got worse so pt was put into contact with group whom gave injection by his place of employment. Was given Doxycycline 150mg bid x 4 weeks and Prednisone 10mg pack from outside group. Pt employer later posted a statement from Department for Public Health for numerous reactions like patient had. He was instructed by HR to contact his own PCP for follow up exam and testing. Pt seen in office 12/26/18 and given lab orders and referred to General Surgery. Was seen today and sent to ER for possible I&D.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Biopsy, Incisional drainage, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient given influenza vaccine at place of work by outside group. Since a few days after injection patient has had redness, swelling, pain and nodule under skin at site of injection. Pain got worse so pt was put into contact with group whom gave injection by his place of employment. Was given Doxycycline 150mg bid x 4 weeks and Prednisone 10mg pack from outside group. Pt employer later posted a statement from Department for Public Health for numerous reactions like patient had. He was instructed by HR to contact his own PCP for follow up exam and testing. Pt seen in office 12/26/18 and given lab orders and referred to General Surgery. Was seen today and sent to ER for possible I&D.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Skin lesion
Clinical narrative: Patient given influenza vaccine at place of work by outside group. Since a few days after injection patient has had redness, swelling, pain and nodule under skin at site of injection. Pain got worse so pt was put into contact with group whom gave injection by his place of employment. Was given Doxycycline 150mg bid x 4 weeks and Prednisone 10mg pack from outside group. Pt employer later posted a statement from Department for Public Health for numerous reactions like patient had. He was instructed by HR to contact his own PCP for follow up exam and testing. Pt seen in office 12/26/18 and given lab orders and referred to General Surgery. Was seen today and sent to ER for possible I&D.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: 10/24/18 Patient called, states bruise "the size of an orange" at the injection site. No pain, getting better.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse administered High Dose in error (patient is 60 years old).
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Eye pruritus, Fatigue, Headache, Injection site erythema
Clinical narrative: Itching skin and severe eye itching that lasted 7 days. Headache, chills, fatigue - duration 3 days. Very swollen, hot and red at injection site - 7 days.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Itching skin and severe eye itching that lasted 7 days. Headache, chills, fatigue - duration 3 days. Very swollen, hot and red at injection site - 7 days.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning an elderly patient, older than 65 years old, of an unknown race. The patient's medical history, concurrent conditions, concomitant medications, drug reactions/allergies or historical drugs were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 dose #1, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, less than a year after the first dose, the patient received 1 injection of PNEUMOVAX 23 the second dose, for prophylaxis (strength, formulation, route of administration, anatomical location, lot # and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 06-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1812USA010605: US-009507513-1812USA008007: US-009507513-1812USA010606: US-009507513-1812USA010603:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 07-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1812USA008007: US-009507513-1812USA010604: US-009507513-1812USA010606: US-009507513-1812USA010603:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional information received as follows: Till the reporting time, the patient's shoulder was hurting. The patient asked about the 2nd shot of SHINGRIX if that would be as bad on the other arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative, Arthralgia, Chills, Feeling abnormal, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included influenza (experienced in 1992). On 26th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced fever, shivering, joint pain, injection site pain and feeling bad. The patient was treated with ibuprofen (Motrin). In November 2018, the outcome of the fever, shivering, joint pain and injection site pain were recovered/resolved. On an unknown date, the outcome of the feeling bad was unknown.  It was unknown if the reporter considered the fever, shivering, joint pain, injection site pain and feeling bad to be related to SHINGRIX. Additional details were received as follows: The patient never had chicken pox in the past. The patient reported that received a shot of SHINGRIX, the day before reporting. The patient had the worst night with fever and shivering as it was common. The patient don't want to receive the 2nd dose of SHINGRIX. The paperwork shows that SHINGRIX vaccine did not protect against chickenpox. The representative provided the information on SHINGRIX vaccine to the patient that the SHINGRIX vaccine is not contagious. However, the virus can be spread from a person to person with a shingles to someone who has never had chickenpox. The virus spread through direct contact with fluid from the blister. If the patient had chickenpox, that the they were 99 percent of people who already had the shingles virus inside. SHINGRIX was not a live vaccine. Once the shingles blister had developed crusts, they were no longer contagious. The patient said that she hadn't felt this bad as she had Flu in 1992. The patient never had blood titer that didn't pick up antibody.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included influenza (experienced in 1992). On 26th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced fever, shivering, joint pain, injection site pain and feeling bad. The patient was treated with ibuprofen (Motrin). In November 2018, the outcome of the fever, shivering, joint pain and injection site pain were recovered/resolved. On an unknown date, the outcome of the feeling bad was unknown.  It was unknown if the reporter considered the fever, shivering, joint pain, injection site pain and feeling bad to be related to SHINGRIX. Additional details were received as follows: The patient never had chicken pox in the past. The patient reported that received a shot of SHINGRIX, the day before reporting. The patient had the worst night with fever and shivering as it was common. The patient don't want to receive the 2nd dose of SHINGRIX. The paperwork shows that SHINGRIX vaccine did not protect against chickenpox. The representative provided the information on SHINGRIX vaccine to the patient that the SHINGRIX vaccine is not contagious. However, the virus can be spread from a person to person with a shingles to someone who has never had chickenpox. The virus spread through direct contact with fluid from the blister. If the patient had chickenpox, that the they were 99 percent of people who already had the shingles virus inside. SHINGRIX was not a live vaccine. Once the shingles blister had developed crusts, they were no longer contagious. The patient said that she hadn't felt this bad as she had Flu in 1992. The patient never had blood titer that didn't pick up antibody.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Feeling hot, Gait disturbance, Injection site pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching were unknown.  It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient presented with similar symptoms after vaccination with SHINGRIX. This case was linked with case US2018GSK216506 and US2018GSK216507, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching were unknown.  It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient presented with similar symptoms after vaccination with SHINGRIX. This case was linked with case US2018GSK216506 and US2018GSK216507, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Feeling hot, Gait disturbance, Injection site pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching were unknown. It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient presented with similar symptoms after vaccination with SHINGRIX. This case was linked with case US2018GSK216507 and US2018GSK216504, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching were unknown. It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient presented with similar symptoms after vaccination with SHINGRIX. This case was linked with case US2018GSK216507 and US2018GSK216504, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea were unknown. It was unknown if the reporter considered the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. At late afternoon, the patient had the second shingle vaccine. The patient had bad body aches, headache, loss of appetite, chills, the patient's arm was awaken and painful in the area. The patient had neck pain too and she had taken 2-225 mg Aleve. The patient was running out of fuel, feeling really really bad like she had the flu. The patient's throat was hurting, her glands were swollen. She had a temperature of 100 degrees F. She had swelling and pain at the injection site. The patient said she took Aleve 225 mg but it had not helped her headache. She also mentioned she was experiencing nausea and loss of appetite.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea were unknown. It was unknown if the reporter considered the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. At late afternoon, the patient had the second shingle vaccine. The patient had bad body aches, headache, loss of appetite, chills, the patient's arm was awaken and painful in the area. The patient had neck pain too and she had taken 2-225 mg Aleve. The patient was running out of fuel, feeling really really bad like she had the flu. The patient's throat was hurting, her glands were swollen. She had a temperature of 100 degrees F. She had swelling and pain at the injection site. The patient said she took Aleve 225 mg but it had not helped her headache. She also mentioned she was experiencing nausea and loss of appetite.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea were unknown. It was unknown if the reporter considered the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. At late afternoon, the patient had the second shingle vaccine. The patient had bad body aches, headache, loss of appetite, chills, the patient's arm was awaken and painful in the area. The patient had neck pain too and she had taken 2-225 mg Aleve. The patient was running out of fuel, feeling really really bad like she had the flu. The patient's throat was hurting, her glands were swollen. She had a temperature of 100 degrees F. She had swelling and pain at the injection site. The patient said she took Aleve 225 mg but it had not helped her headache. She also mentioned she was experiencing nausea and loss of appetite.
Sex: U
Vaccine: FLU4
Symptoms: Joint range of motion decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of joint range of motion decreased in a patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number Y279A, expiry date 30th June 2019) and (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was unknown. It was unknown if the reporter considered the joint range of motion decreased to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The physician reported that they had 8 patients who experienced limited range of motion in their arm after receiving the FLUARIX vaccine. The could not identify the patients who received the FLUARIX. They stated that 8 patients out of 1400 patients developed limited range of motion after receiving the FLUARIX vaccine. The reporter did not have specific patient information. The reporter stated that the patients required follow up treatment. The healthcare professional (HCP) did not give specifics on what that treatment involved. The reporter consented to follow up. This is 1 of 8 cases reported by the same reporter. There are 2 batch numbers provided for FLUARIX QUADRIVALENT 2018-2019 season, but it is not sure which is the correct batch number.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In November 2017, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of SHINGRIX dose and did not find availability for the 2nd dose of SHINGRIX with no hope in sight from any location, which led to product supply issue. In November 2018, the patient had the original vaccine and she then got Shingles last year after receiving the 1st part of the SHINGRIX then she had another but in November. The patient received first shot November of last year and then got shingles. The patient stated, she had tried everything, her doctor and pharmacies but they did not have any more information than she did. The patient asked If the company begins to dispatch the shipment on the reporting date, then how long could the shipment for and asked if the ship the needed amount. Especially for the 2nd dose which only had 6 months after the 1st dose of SHINGRIX.