chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Discomfort, Immediate post-injection reaction, Injection site pain, Limb discomfort
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739555), concerning a 62-year-old, adult, female patient. The patient's historical condition included some osteoarthritis. The patient had no allergies diagnosed. The patient did not receive any concomitant medication on the day of vaccination. On 23-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical site: right arm, batch number and expiry date: not reported]. Immediately after the vaccination, the patient felt discomfort shooting down to the top of the right hand. The patient's hand was hurting for several days and the injection site was sore. The patient thought it would resolve in a day or two, but the injection site remained sore. Even though, pain was intermittent the patient had unspecified discomfort every day. The patient's arm was sore and felt a mild burning discomfort. The patient could not comfortably lie on her side or on her right arm to sleep. Sometimes the patient did not notice the pain as it comes and goes. It was reported that, every day it was hurting a little to a more moderate degree. The patient felt uncomfortable for several hours upon typing this report. The patient was active and used her arms and hands a lot. It was reported that, those activity had not reduced the pain. The patient stated that, she would contact her regular physician later (reported as next week). No lab investigations were performed. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (25-Sep-2018): The sentence in the case comment was corrected from 'the company assessed the causality of the event sleep disorder as not related to the suspect vaccine and the other events as related to the suspect vaccine due to plausible temporal relationship' to 'the company assessed the causality of the event sleep disturbance as not related to the suspect vaccine, as the event can be explained by pain and discomfort.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739555), concerning a 62-year-old, adult, female patient. The patient's historical condition included some osteoarthritis. The patient had no allergies diagnosed. The patient did not receive any concomitant medication on the day of vaccination. On 23-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical site: right arm, batch number and expiry date: not reported]. Immediately after the vaccination, the patient felt discomfort shooting down to the top of the right hand. The patient's hand was hurting for several days and the injection site was sore. The patient thought it would resolve in a day or two, but the injection site remained sore. Even though, pain was intermittent the patient had unspecified discomfort every day. The patient's arm was sore and felt a mild burning discomfort. The patient could not comfortably lie on her side or on her right arm to sleep. Sometimes the patient did not notice the pain as it comes and goes. It was reported that, every day it was hurting a little to a more moderate degree. The patient felt uncomfortable for several hours upon typing this report. The patient was active and used her arms and hands a lot. It was reported that, those activity had not reduced the pain. The patient stated that, she would contact her regular physician later (reported as next week). No lab investigations were performed. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (25-Sep-2018): The sentence in the case comment was corrected from 'the company assessed the causality of the event sleep disorder as not related to the suspect vaccine and the other events as related to the suspect vaccine due to plausible temporal relationship' to 'the company assessed the causality of the event sleep disturbance as not related to the suspect vaccine, as the event can be explained by pain and discomfort.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry skin, Pruritus generalised
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739603), concerns a 46-year-old, adult female patient. The patient's historical condition included eczema. The patient had no current condition and allergies. The patient did not receive any concomitant medications. On 28-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: right arm, batch number: 195247 and expiry date: not reported). On the same day, 1 hour and 30 minutes after vaccination, the patient experienced itching all over the body. As of 4 days, the patient had itching, and her skin was drying out on hand and feet. The patient went to seek medical assistant as her co-worker said to seek assistance from occupational health. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEP, MNQ, TDAP
Symptoms: Dysphagia, Throat irritation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739668), concerns an 18-year-old, adult male patient. The patient's family member had history of penicillin allergy, but patient had no penicillin allergy. The patient had no relevant medical history and allergies. The patient did not have any current illnesses. The patient did not receive any concomitant medications. On 02-Mar-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported) and non-company product ENGERIX B (route of administration: intramuscular, anatomical location: right arm, dose, batch number and expiry date: not reported) in same arm. On the same day, the patient was also administered other non-company suspect products Adenovirus type 4 and type 7 vaccine, live, oral [route of administration: oral (PO), anatomical location: mouth (reported as MO), dose, batch number and expiry date: not reported], MENACTRA (route of administration: intramuscular, anatomical location: left arm, dose, batch number and expiry date: not reported) and BOOSTRIX (route of administration: intramuscular, anatomical location: left arm, dose, batch number and expiry date: not reported). On an unspecified date, the patient received Penicillin injection (dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication. On 02-Mar-2018, after vaccinations and Penicillin injection, the patient complained of difficulty in swallowing in throat and felt like something grabbing at throat. The patient was treated with BENADRYL (dose: 50 mg, route of administration: intramuscular). The patient did not undergo any laboratory investigations. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Palpitations
Clinical narrative: This spontaneous case reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739965), concerns a 55-year-old, adult male patient. The patient's had history of flu vaccines. On 23-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, batch number: 195249, anatomical site: right arm and expiry date: not reported). The patient was also administered a non-company co-suspect vaccine varicella zoster vaccine (reported as SHINGRIX) (route of administration: intramuscular, batch number: P3777, frequency reported as 1, anatomical site: left arm, dose and expiry date: not reported). On the same day, around 7 pm after vaccine administration, the patient experienced palpations while playing video games. The patient called 911 and was seen in emergency room (ER). The patient had card and was without rash, shortness of breath (SOB), lips swelling and choking. The patient's heart rate was around 130 (unit and normal range not reported). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professionals to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 740042), concerns a 63-year-old, adult, female patient. The patient's historical condition included: high cholesterol/triglycerides. The patient had no reported cases of allergies. The patient had no medication at the time of vaccinations (reported as nothing picked up from pharmacy in the months before the vaccination). On 27-Sep-2017, the patent was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195222, expiry date: not reported). On the same day, after vaccination, the patient experienced pain at the injection site. In addition, the patient had weakness in her right arm as well. The aforementioned information was reported by the patient after months. It was reported that, the patient had temporary relief with the creams given by her dermatologist. However, it was still lingering. At the time of the report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 740251), concerns a 42-year-old, adult, female patient. The patient's historical condition included degenerative cervical spine. The patient's current condition included vitamin D deficiency. The patient was allergic to sulfa drugs and morphine. The concomitant medications included vitamin D and Multi vitamins. On 03-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195232 and expiry date: not reported]. On the same day, immediately after vaccination, the patient experienced pain and tingling down the left arm. The patient also experienced weakness and pain in left deltoid. The patient had made a physician office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 740866), concerns 57-year-old, adult male patient. On 01-Feb-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), batch number: 195243, anatomical location: unknown and expiry date: not reported]. On 13-Mar-2018, 1 month and 12 days after vaccination the patient experienced tingling and numbness at injection site. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 6.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, VARCEL
Symptoms: Erythema, Papule, Pyrexia, Rash, Rash pustular
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 741341), concerns a 06-year-old, child, female patient. The patient did not have any medical history. At the age of 4, the patient was given amoxicillin for an inflamed throat and experienced rash consisting of small red macules. The patient did not have any other known allergies. It was reported that the patient did not have any current illness. The patient's younger sister had similar rash 2 weeks prior to eruption of patient's rash (resolved). On 08-Mar-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195235 and expiry date: not reported]. The co-suspect vaccines included HAVRIX [dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 77D5K and expiry date: not reported], ENGERIX-B [route of administration: intramuscular, anatomical location: left arm, dose: frequency reported as 1, batch number: G9H24 and expiry date: not reported] and VARIVAX (route of administration: subcutaneous, anatomical location: left arm, dose: frequency reported as 1, batch number: N022986 and expiry date: not reported). On 17-Mar-2018, the patient developed fever and rash. On 19-Mar-2018, the patent was examined by physician (MD). The aural temperature was 99.8 (unit unspecified). The patient had lesions consistent with chicken pox. The lesions were in various stages (some scabbed, some red papules, some pustules on red base) on trunk, and a few on face and extremities. Rash had begun on back. The patient made an office visit. The patient did not undergo any laboratory tests. At the time of this report, the patient had not recovered from the event- varicella post vaccine. The reporter assessed the case as non-serious.
Age: 6.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, VARCEL
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 741341), concerns a 06-year-old, child, female patient. The patient did not have any medical history. At the age of 4, the patient was given amoxicillin for an inflamed throat and experienced rash consisting of small red macules. The patient did not have any other known allergies. It was reported that the patient did not have any current illness. The patient's younger sister had similar rash 2 weeks prior to eruption of patient's rash (resolved). On 08-Mar-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195235 and expiry date: not reported]. The co-suspect vaccines included HAVRIX [dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 77D5K and expiry date: not reported], ENGERIX-B [route of administration: intramuscular, anatomical location: left arm, dose: frequency reported as 1, batch number: G9H24 and expiry date: not reported] and VARIVAX (route of administration: subcutaneous, anatomical location: left arm, dose: frequency reported as 1, batch number: N022986 and expiry date: not reported). On 17-Mar-2018, the patient developed fever and rash. On 19-Mar-2018, the patent was examined by physician (MD). The aural temperature was 99.8 (unit unspecified). The patient had lesions consistent with chicken pox. The lesions were in various stages (some scabbed, some red papules, some pustules on red base) on trunk, and a few on face and extremities. Rash had begun on back. The patient made an office visit. The patient did not undergo any laboratory tests. At the time of this report, the patient had not recovered from the event- varicella post vaccine. The reporter assessed the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Bone pain, Neck pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 742633), concerns a 41-year-old, adult, female patient. On 13-Jan-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: 195243 (reported as 195423) and expiry date not reported]. On 14-Jan-2018, one day after vaccination, the patient experienced pain from neck/collarbone to elbow and hand. The patient sometimes experienced shooting pain which was worse at night when trying to sleep. The patient made an emergency room and office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Anorectal disorder, Immediate post-injection reaction, Limb discomfort, Neuralgia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially received on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 743350), concerns 61-year-old, adult, female patient. On unspecified dates, the patient had dystonia (reported on 29-Mar-2018) and fibromyalgia (VAR as reported). The patient did not use any medications at the time of vaccination. On 04-Dec-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: not reported]. On the same day, right after the flu shot, the patient experienced a nerve type of pain which started in her neck and went into her head and then down to her back and then to her rectum and felt like it was pulling her down. In addition, the patient's legs became very heavy. No lab investigations were done. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 12-Oct-2018: Non-significant case correction (25-Sep-2018): Added the verbatim 'pain' in the event 'neuralgia'. No changes were made in the narrative.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain, X-ray
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 743550), concerns 64-year-old, adult female patient. On 18-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency: 1, route of administration: injection (reported as SYR), anatomical location: right arm, batch number: 195223 and expiry date: not reported]. On 20-Jan-2018, two days after vaccination, the patient could not move her right shoulder and upper arm which was persisting even after 3 months. The patient experienced pain which was getting better at the time of this report but still she did not have full mobility. On unspecified dates, the patient underwent physical therapy and X-rays were performed for which results were not reported. At the time of this report, the patient had not recovered from the events injected limb mobility decreased and was recovering from the pain. The reporter assessed the case as non-serious.
Age: 16.0
Sex: M
Vaccine: FLUC4, MENB, MNQ
Symptoms: Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially received on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 743854), concerns 16-year-old, male adolescent patient. The patient's historical condition and current illness were not reported. The patient's allergies and concomitant medications were unknown. On 09-Apr-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195235 and expiry date: not reported) and non-company suspect product BEXSERO (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 16B101 and expiry date: not reported). Both the vaccines (FLUCELVAX QIVc and BEXSERO) were given in the same arm (left arm). Also, the patient was administered another non-company suspect product MENACTRA (dose: frequency reported as 2, route of administration: intramuscular, anatomical location: right arm, batch number: U5835AA and expiry date: not reported). On the same day, after vaccination, the patient experienced onset of pain, which increased to '8' on 1 to 10 scale throughout the evening, overnight and up to the next morning. The patient did not undergo any laboratory investigations. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Significant case correction (25-Sep-2018): The event 'drug administration error' was added in the event tab. The narrative and case comment were amended accordingly. Update received on 25-Oct-2018: Non-significant case correction (25-Sep-2018): The medication error check box was checked in product tab. No changes were made in the narrative.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 743921), concerns a 58-year-old, adult male patient. The patient's historical condition included diabetes (on an unspecified date). On 10-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On 17-Jan-2018, 7 days after vaccination, the patient developed arm pain and shoulder pain. It was reported that the pain was radiating which woke him up at night. On an unspecified date, the patient made an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dysstasia, Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 744855), concerns a 53-year-old, adult female patient. The patient's historical condition included multiple sclerosis. The patient's current illness included sinusitis. The patient was allergic to iodine and shellfish. The patient's concomitant medications included estradiol and progesterone for unknown indications. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195243 and expiry date: not reported]. On the same day, after vaccination, the patient experienced dizziness and could not stand. The patient was also throwing up. The patient did not undergo any laboratory investigations. On 27-Oct-2017, the patient had recovered from the events (reported as lasted 3 days). The reporter assessed this case as non-serious. Update received on 12-Oct-2018: Non-significant case correction (25-Sep-2018): The case comment was amended by adding estradiol and progesterone as confounding drugs.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Decreased immune responsiveness, Headache, Impaired work ability
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 744857), concerning a 54-year-old, adult, male patient. The patient's medical history included: Complex regional pain syndrome (CRPS), pancreatitis, chronic arthralgia, myalgia, asthma, chronic obstructive pulmonary disease (COPD), radiculopathy, neuropathy, Gastroesophageal reflux disease (GERD), cytomegalovirus hepatitis (CMV hepatitis), low back pain (LBP), cervicalgia, herpes zoster, Hyperlipidaemia (HLD), Obstructive sleep apnoea syndrome (OSA) and plantar fasciitis. The patient's historical drug included: PERCOCET which induced adverse event: delirium. The patient had reported that he experienced the same adverse effects (arthralgia, chills, headache, impaired work ability, malaise, myalgia, nausea, pyrexia and rhinorrhea) whenever he received influenza seasonal vaccine (IIV). It was reported that, the patient experienced the events arthralgia, fever, chills, malaise, arthralgia and myalgia for 5-7 duration (units unspecified). The patient's current condition included: anxiety, depression, post-traumatic stress disorder (PTSD), allergic rhinitis, benign prostatic hyperplasia (BPH), migraine, insomnia and panic disorder (reported as medical history). The patient's concomitant medications included: alfuzosin, sertraline, bupropion, ADDERALL, Clonidine, alprazolam, topiramate, temazepam and vitamins for unknown indications; and it was reported that ibuprofen (800 mg) was continued for 2-3 days (unspecified) to decrease immune response symptoms. On 27-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195247, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported). It was reported that the Proof of Concept (POC) was to trial FLUCELVAX, which was a different manufacturing process. On 01-Mar-2018, 2 days after the vaccination, the reporter telephoned the patient while the patient reported headache, malaises, nausea, rhinorrhea and impaired work ability. On an unspecified date in 2018, the patient also developed decreased immune responsiveness, fever, chills, arthralgia, and myalgia. No lab investigations were performed. On an unspecified date (reported as today) the reporter telephoned to review POC. On an unspecified date the patient had recovered from the events. The reporter assessed the case as non-serious and considered the events as related to the suspect vaccine. Update received on 30-Oct-2018: Non-significant case correction (IRD: 25-Sep-2018): The verbatim of the current condition was changed from panic to panic disorder in the patient tab. The narrative was amended accordingly.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 744857), concerning a 54-year-old, adult, male patient. The patient's medical history included: Complex regional pain syndrome (CRPS), pancreatitis, chronic arthralgia, myalgia, asthma, chronic obstructive pulmonary disease (COPD), radiculopathy, neuropathy, Gastroesophageal reflux disease (GERD), cytomegalovirus hepatitis (CMV hepatitis), low back pain (LBP), cervicalgia, herpes zoster, Hyperlipidaemia (HLD), Obstructive sleep apnoea syndrome (OSA) and plantar fasciitis. The patient's historical drug included: PERCOCET which induced adverse event: delirium. The patient had reported that he experienced the same adverse effects (arthralgia, chills, headache, impaired work ability, malaise, myalgia, nausea, pyrexia and rhinorrhea) whenever he received influenza seasonal vaccine (IIV). It was reported that, the patient experienced the events arthralgia, fever, chills, malaise, arthralgia and myalgia for 5-7 duration (units unspecified). The patient's current condition included: anxiety, depression, post-traumatic stress disorder (PTSD), allergic rhinitis, benign prostatic hyperplasia (BPH), migraine, insomnia and panic disorder (reported as medical history). The patient's concomitant medications included: alfuzosin, sertraline, bupropion, ADDERALL, Clonidine, alprazolam, topiramate, temazepam and vitamins for unknown indications; and it was reported that ibuprofen (800 mg) was continued for 2-3 days (unspecified) to decrease immune response symptoms. On 27-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195247, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported). It was reported that the Proof of Concept (POC) was to trial FLUCELVAX, which was a different manufacturing process. On 01-Mar-2018, 2 days after the vaccination, the reporter telephoned the patient while the patient reported headache, malaises, nausea, rhinorrhea and impaired work ability. On an unspecified date in 2018, the patient also developed decreased immune responsiveness, fever, chills, arthralgia, and myalgia. No lab investigations were performed. On an unspecified date (reported as today) the reporter telephoned to review POC. On an unspecified date the patient had recovered from the events. The reporter assessed the case as non-serious and considered the events as related to the suspect vaccine. Update received on 30-Oct-2018: Non-significant case correction (IRD: 25-Sep-2018): The verbatim of the current condition was changed from panic to panic disorder in the patient tab. The narrative was amended accordingly.
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling hot, Neuropathy peripheral, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 745516), concerns a 66-year-old, elderly, male patient. The patient did not have any known allergies. On 22-Jan-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: 195221 and expiry date not reported]. On an unspecified date in Jan-2018, within seven days after vaccination, the patient started to experience adverse effects as neuropathy in his feet, his feet sometimes felt warm and hot and he experienced a pins and needles feeling in his feet. The patient believed that the adverse effects were from flu shot. The patient made an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 745749), concerns a 20-year-old, adult, male patient. The patient had no medical history, current illness and no known drug allergy (NKDA). The patient did not receive any concomitant medications. On 25-Apr-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195247 and expiry date: not reported] and non-company product BOOSTRIX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: TF422 and expiry date: not reported). On the same day, the patient was also administered Adenovirus type 4 and type 7 vaccine, live, oral [dose: frequency reported as 1, route of administration: oral, anatomical location: mouth (MO as reported), batch number: 34600338 and expiry date: not reported) and MENACTRA (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: U5836BA and expiry date not reported). The same day (25-Apr-2018), after administration of vaccines, the patient experienced an unevaluable event. On an unspecified date, the patient had made a physician office visit. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 22.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEPAB, MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 745755), concerning a 22-year-old, adult male patient. The patient had no medical history, allergies and current illness. The patient did not receive any concomitant medications. On 25-Apr-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 195247 and expiry date: not reported) and non-company products VARIVAX (dose: frequency reported as 1, route of administration: subcutaneous, anatomical location: right arm, batch number: N026075 and expiry date: not reported and expiry date: not reported) and BOOSTRIX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location, right arm, batch number: TF422 and expiry date: not reported) on the same arm. On the same day, the patient was also administered Adenovirus type 4 and 7 vaccine, live oral (dose: frequency reported as 1, route of administration: oral, anatomical location: mouth [reported as MO], batch number: 34600338 and expiry date: not reported), TWINRIX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: Z75Y2 and expiry date: not reported) and MENACTRA (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: U5836BA and expiry date: not reported). The same day (25-Apr-2018), after administration of vaccines, the patient experienced an unevaluable event. On an unspecified date, the patient had made a physician office visit. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Neck pain, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 747923), concerns 52-year-old, adult male patient. The patient's current condition included diabetes. On 11-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: 2, route of administration: intramuscular, anatomical location: left arm, batch number: 195238 and expiry date: not reported). On the same day after vaccination, the patient experienced pain in shoulder which radiated to the neck. The patient had multiple doctors visits for pain. On an unspecified date, the patient had office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, FLUC4, HEP, MNQ, TDAP
Symptoms: Throat irritation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 755954), concerns an 18-year-old, adult, female patient. The patient had no relevant medical history, current illness and concomitant medications at the time of vaccination. The patient was allergic to cheese. On 27-Jun-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195247, expiry date: not reported] and non-company suspect vaccine BOOSTRIX [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 9PD92, expiry date: not reported]. The patient was administered non-suspect vaccines MENACTRA [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: Y5866BC, expiry date: not reported], Adenovirus types 4 and 7 [dose, frequency reported as 1, route of administration: oral, anatomical location: mouth, batch number: 34600378, expiry date: not reported] and ENGERIX-B [dose: reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 5DL22, expiry date: not reported]. On the same day of vaccination, the patient developed itchy throat. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768024), concerns a 49-year-old, adult female patient. The patient's historical condition included migraine. The patient was allergic to sulpha drug. The concomitant medications included tramadol, naproxen and Multivitamins. On 27-Aug-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252380 and expiry date: not reported). On the same night after the vaccination, the patient experienced headache. On the next day (reported as following morning), the patient experienced migraine. At the time of the report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Axillary pain, Erythema, Injection site pain, Injection site reaction, Injection site streaking
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768614), concerns a 58-year-old, adult female patient. The patient's historical condition included asthma. The patient had no current conditions and allergies. The patient's concomitant medication included Ginseng and coconut oil. On 29-Aug-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 252380 and expiry date: not reported] and non-company suspect vaccine PNEUMOVAX [frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: N034525 and expiry date: not reported]. On the same day after vaccination, the patient experienced pain in addition to the injection site which radiated to her armpit. The patient also had pain and stiffness in her right shoulder. The patient also experienced extreme pain when tried to raise her arm above her shoulder. There were also 2 red streaks that started about 3 inches from the injection site, towards to and going into the armpit. The streaks started a couple of inches down and towards the abdomen from the injection site. The pain started that evening and stated that redness had gone away but was still present. The lesions were still red and raised. It was reported that as of that time, the patient had not sought medical attention but was going to schedule a doctor appointment. On an unspecified date in 2018, the patient was recovering from the event redness and had not recovered from other events. The reporter assessed this case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 768614), concerns a 58-year-old, adult female patient. The patient's historical condition included asthma. The patient had no current conditions and allergies. The patient's concomitant medication included Ginseng and coconut oil. On 29-Aug-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 252380 and expiry date: not reported] and non-company suspect vaccine PNEUMOVAX [frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: N034525 and expiry date: not reported]. On the same day after vaccination, the patient experienced pain in addition to the injection site which radiated to her armpit. The patient also had pain and stiffness in her right shoulder. The patient also experienced extreme pain when tried to raise her arm above her shoulder. There were also 2 red streaks that started about 3 inches from the injection site, towards to and going into the armpit. The streaks started a couple of inches down and towards the abdomen from the injection site. The pain started that evening and stated that redness had gone away but was still present. The lesions were still red and raised. It was reported that as of that time, the patient had not sought medical attention but was going to schedule a doctor appointment. On an unspecified date in 2018, the patient was recovering from the event redness and had not recovered from other events. The reporter assessed this case as non-serious.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness of upper extremities in a 83-year-old male patient who received SHINGRIX for prophylaxis.  On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 4th October 2018, 2 days after receiving SHINGRIX, the patient experienced numbness of upper extremities and activities of daily living impaired. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the numbness of upper extremities and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 82 or 83 years of age. The patient reported feeling numbness in both arms. The patient cannot tie shoe laces or button his shirts.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness of upper extremities in a 83-year-old male patient who received SHINGRIX for prophylaxis.  On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 4th October 2018, 2 days after receiving SHINGRIX, the patient experienced numbness of upper extremities and activities of daily living impaired. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the numbness of upper extremities and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 82 or 83 years of age. The patient reported feeling numbness in both arms. The patient cannot tie shoe laces or button his shirts.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Decreased appetite, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Received shot at 11am. By 12:30am that night (1/3/19) he was running 102 fever. MOTRIN would lower it by about 1 degree. Thursday was active but could tell wasnt feeling well. On 1/4/19 he still had fever that didnt drop much, but this day he wouldnt do anything but lay around and got up very minimal times, no appetite and his thigh from hip to knee where shot was given was all swelled up. Around 9:30pm, his fever finally broke but leg stayed swollen for about 2-3 more days.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's medical history and concurrent conditions were not provided. Concomitant therapy included sterile diluent (lot # M015992 and expiration date 26-NOV-2018). On 17-OCT-2018, the patient was received unspecified doses of improperly stored varicella VARIVAX (lot # R002509 and expiration date 25-JAN-2020), subcutaneously for prophylaxis (product use issue and product storage error). The vaccine was exposed to temperature of 28F for less than one hour and the data logger was involved. No previous excursions were reported. The reporter did not report sterile diluent was improperly stored. No adverse effects reported. This is one of three reports received from the same reporter (Linked case # 1901USA001564 and 1901USA001175). Sender's Comments: US-009507513-1901USA001564: US-009507513-1901USA001175:.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication, and drug reactions/allergies was not provided. From 12-DEC-2018 to 08-JAN-2019, the patients were administered improperly stored doses of ROTATEQ (lot #: R021055, expiration date: 01-APR-2020, temperature: 32 fahrenheit up to 35 fahrenheit (33.9 fahrenheit), time frame: 7 hours; strength, dose, and frequency were not reported) orally, for prophylaxis. No adverse effects reported. There was no previous temperature excursion. The data logger was included.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 29-NOV-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot # R019470, expiration date: 10-APR-2021, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA009289: US-009507513-1901USA009290: US-009507513-1901USA009291: US-009507513-1901USA009292: US-009507513-1901USA009293: US-009507513-1901USA009294: US-009507513-1901USA009295: US-009507513-1901USA009296: US-009507513-1901USA009297: US-009507513-1901USA009298: US-009507513-1901USA009299: US-009507513-1901USA009300: US-009507513-1901USA009301: US-009507513-1901USA009302: US-009507513-1901USA009303: US-009507513-1901USA009304: US-009507513-1901USA009305: US-009507513-1901USA009306: US-009507513-1901USA009307: US-009507513-1901USA009308: US-009507513-1901USA009309: US-009507513-1901USA009310: US-009507513-1901USA009311: US-009507513-1901USA009312: US-009507513-1901USA009313.
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report, was received from a physician, via a company representative, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 15-JAN-2019, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On the same date, following the administration of PNEUMOVAX 23 the patient experienced headache. It was also reported that on 17-JAN-2019, the patient experienced soreness in the arm where the injection occurred. The patient sought medical attention and contacted the physician. At the time of reporting, the outcome of headache and soreness in the arm where the injection occurred was unknown. The causal relationship between the vaccination with NEUMOVAX 23 and the events was not provided by the reporting physician.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a Licensed practitioner nurse concerning to an adult patient (gender not reported) who was also a physician. The patient's medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA (route, lot number and expiration date not reported) for prophylaxis. No adverse event was reported.