chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Myalgia, Photophobia
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 722908), concerning a 20-year-old, adult, female patient. Historical drug included TDAP shot and Amoxicillin for an unknown indication. TDAP shot caused muscle pain and swelling at the injection site. The patient's historical condition included: PTSD (post-traumatic stress disorder) and major depressive disorder. Concomitant drugs included: LEXAPRO and JUNEL for an unknown indication. On 25-Oct-2017, the patient was administered with influenza vaccine (route of administration: injection (reported as SYR), anatomical location: right arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On 26-Oct-2017, after 1 day of vaccination, the patient had severe muscle aches in neck, back, arm and legs. In addition, she had severe headache due to light sensitivity. At the time of this report, the patient had not yet recovered from all the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Discomfort, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 722961), concerning a female patient of unknown age. In 1990, the patient was vaccinated (unspecified vaccine) for vaccine challenge to determine IgG levels (low IgG1). The patient was vaccinated (unspecified vaccine) second time (probably in 2000). The patient's historical conditions included chronic sinusitis, migraine, osteoarthritis, positive B test since 1954. The patient had latex allergy, sulfa allergy and wheat sensitivity. It was reported that, the patient had no current illnesses. The patient's concomitant medications included EXCEDRIN, VOLTAREN; acyclovir, omeprazole, LEVAQUIN, mirtazapine, Turmeric, cats claw, black seed oil and unspecified stool softener all for an unknown indication. On 03-Oct-2017, the patient was administered with influenza vaccine (route administration: injection (reported as SYR), dose: unk (as reported), anatomical location: left arm, batch number, expiry date, PNEUMOVAX (route of administration: intramuscular, dose: unk (as reported), anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day (03-Oct-2017), after administration of vaccines, the patient's body temperature was 103 (unit not reported) and white blood cell count (WBC) was found to be 27,500 (unit not reported). The patient also had discomfort the day after the shot. The patient's bodily joints hurt and had excruciating pain in right arm and elbow (in the arm that got shot). Her arm (left) was red, had pain and swelling. The patient visited emergency department due to the events. On an unknown date, after rechecking WBC was 10,500 (reported as normal). It was reported that, fever lasted for 48 hrs. The outcome of the events WBC count increased, and fever was reported as recovered and for other events outcome was not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 722961), concerning a female patient of unknown age. In 1990, the patient was vaccinated (unspecified vaccine) for vaccine challenge to determine IgG levels (low IgG1). The patient was vaccinated (unspecified vaccine) second time (probably in 2000). The patient's historical conditions included chronic sinusitis, migraine, osteoarthritis, positive B test since 1954. The patient had latex allergy, sulfa allergy and wheat sensitivity. It was reported that, the patient had no current illnesses. The patient's concomitant medications included EXCEDRIN, VOLTAREN; acyclovir, omeprazole, LEVAQUIN, mirtazapine, Turmeric, cats claw, black seed oil and unspecified stool softener all for an unknown indication. On 03-Oct-2017, the patient was administered with influenza vaccine (route administration: injection (reported as SYR), dose: unk (as reported), anatomical location: left arm, batch number, expiry date, PNEUMOVAX (route of administration: intramuscular, dose: unk (as reported), anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day (03-Oct-2017), after administration of vaccines, the patient's body temperature was 103 (unit not reported) and white blood cell count (WBC) was found to be 27,500 (unit not reported). The patient also had discomfort the day after the shot. The patient's bodily joints hurt and had excruciating pain in right arm and elbow (in the arm that got shot). Her arm (left) was red, had pain and swelling. The patient visited emergency department due to the events. On an unknown date, after rechecking WBC was 10,500 (reported as normal). It was reported that, fever lasted for 48 hrs. The outcome of the events WBC count increased, and fever was reported as recovered and for other events outcome was not reported.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Headache, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 722964), concerns a 60-year-old, adult male patient. The patient's current condition included high blood pressure (HBP) and pre-diabetic (since an unspecified date) and no history of allergies. The patient's concomitant medications included Vitamins D3 and melatonin for an unknown indication. It was reported that on the advice of the physician on an annual physical exam on an unspecified date in Sep-2017, went for shingles shot, since he turned 60. The patient was suggested to receive flu vaccine in one arm and shingle shot in another arm. On 16-Oct-2017, the patient was administered with ZOSTAVAX (dose: unknown, route of administration: injections, anatomical location: arm, manufacturer: unknown, trade name, batch number and expiry date: not reported). On 17-Oct-2017, after one day of vaccination, it was stated that, when patient awake in the morning, his arm found to be three times than normal size and painful. The patient stated that, the swollen region was red in colour and enlarged. Later changed to pink on the outer edges of the region until it spread to the elbows. Two days later, the patient had headache and he could not sleep at night. On an unspecified date, the patient received TYLENOL and compressed with ice, still symptoms did not dissipate after one week. The outcome of the events not reported. The reporter assessed this case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723226), concerning a 49-year-old, adult, female patient. The patient's historical condition included transverse myelitis (on an unspecified date). The patient was using codeine, opiate derivates and chlorhexidine gluconate in past. The patient had no any current illness. The patient's concomitant medications included AVONEX and MIRENA both for an unknown indication. On 20-Sep-2017, the patient was administered with influenza vaccine (dose: 1, route of administration: intramuscular, anatomical location: right arm, batch number, expiry date, trade name, and manufacturer). On the same day, after administration of vaccine, the patient's right arm had pain which was for 1 month. On 24-Oct-2017, CBC (complete blood count) was done for which result was not provided. The patient was treated with prednisone for the event pain in right arm. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site pruritus, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723246), concerns a 54-year-old, adult female patient. The patient's medical history included, asthma (childhood onset), neck and pain degenerative disc Syndrome, depression or anxiety, fibromyalgia, arthritis and vitamin D deficiency. The concomitant medications included VYVANSE, venlafaxine-ER; magnesium; MOTRIN, XANAX, trazadone for unknown indications. The patient was allergic to bees, hay fever, formaldehyde, cilantro, most grass, narcotics (codeine). The patient had no illness at the time of vaccination. The patient took spicy tea (coriander seeds, fennel seeds and cumin) at the time of vaccination. On 05-Oct-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade number, manufacturer: not reported). Immediately after vaccination, the patient developed itching at the injection site which progressively worsened with burning. The patient developed bruising at the injection site and later spread. She also had running nose (clear water) and took no medications. All the symptoms continued that day. After one week of injection, the patient visited a clinic and the nurse advised that the events could resolve or else contact the health facility (if events persisted). On 22-Oct-2017, the patient BENADRYL, but had no effect. The patient also tried topical cortisone cream, which did not help. Bruising improved and later reappears in different spot in the same area. The injection site was extremely tender to touch and had burning sensation inside. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Loss of consciousness, Posture abnormal
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723250), concerning a 15-year-old, adolescent female patient. The patient's concomitant medication included: VYVANSE for an unknown indication. On 19-OCT-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported. On the same day, approximately 30 minutes after injection, the patient was feeling dizzy or light-headed. She slumped, and appeared unconscious for a few seconds. Subsequently, a cold cloth was placed on her forehead and a blood pressure cuff was placed on her arm. Later, she appeared better within 5-10 minutes. It was reported that, the patient was scheduled appointment with the neurologist. The patient had recovered from the events.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Contusion, Myalgia
Clinical narrative: This spontaneous case, reported by non-healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723251), concerns a 73-year-old, elderly, male patient. The patient's historical drug included influenza vaccine (reported as 5 years ago) for unknown indication and the patient had no current conditions and concomitant medications. On 27-Sep-2017, the patient was administered with influenza vaccine, (anatomical location: left arm, dose, route of administration, manufacturer, trade name, batch number and expiry date: not reported). On 28-Sep-2017, after 1 day of vaccination, the patient had extreme bruising on his left arm and muscle pain, especially in legs (thigh). At the time of report, the patient had not recovered from the events (muscle pain and bruising of arm). The reporter assessed the events as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: This spontaneous case reported by other health professional to VAERS and initially retrieved on 03-Fbb-2018 by Seqirus from VAERS (VAERS:723328), concerns a 35-year-old, adult female patient. The patient's medical history and current illness no reported. The patient concomitant medications included Royal jelly, Probiotic and Multivitamin (NOS) for an unknown indication. On 15-Sep-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: arm, dose, route of administration, manufacturer, batch number, and expiry date: not reported). On the same day, after the vaccination, the patient stated that, she had arm pain for 6 weeks, and extreme pain with movement, which leads to limited mobility. The patient also stated that she was unable to carry or pick anything with the affected arm. The reporter assessed this case as non-serious.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723333), concerning a 60-year-old, adult, male patient. The patient's medical history and allergic conditions were not reported. Concomitant medications included ibuprofen, cephalexin (cephalexin, 7-day therapy which started on 19-Oct-2017). On 26-Oct-2017, the patient received influenza vaccine, (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On the same day, the patient received non-company suspect drug ZOSTAVAX (1 dose, route of administration: subcutaneous, anatomical location: right arm, batch number: N009167, expiry date: not reported). On 27-Oct-2017, after 1 day of vaccination, the patient developed severe swelling at the injection site. The injection site was swollen, and rash was visible. In addition, the injection site was warm to touch. However, the patient denied of any fever and stated that he did not feel well. The patient was advised to consult physician for evaluation of the reactions. Hence, on 28-Oct-2017, the patient presented to the pharmacy. The outcome of the events (severe swelling at the injection site, injection site rash, warmth at the site of injection and the patient did not feel well) was reported as unknown. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Chills, Myalgia, Nausea
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723388), concerning a 24-year-old, adult, male patient. The patient's historical condition included epilepsy and he had no known allergies. The patient was taking  levetiracetam for an unknown indication. On 27-Oct-2017, the patient was administered with influenza vaccine (dose: 1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 29-Oct-2017, 3 days after vaccine administration, the patient experienced myalgia, low back pain, weakness, nausea, chills, and mild pharyngitis. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Pharyngitis
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723388), concerning a 24-year-old, adult, male patient. The patient's historical condition included epilepsy and he had no known allergies. The patient was taking  levetiracetam for an unknown indication. On 27-Oct-2017, the patient was administered with influenza vaccine (dose: 1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 29-Oct-2017, 3 days after vaccine administration, the patient experienced myalgia, low back pain, weakness, nausea, chills, and mild pharyngitis. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723405), concerning a 62-year-old, adult, male patient. The patient's medical history was not reported. On 24-Oct-2017, the patient was administered with influenza vaccine, (dose: not reported, route of administration: unknown, anatomical location: not reported, batch number and expiry date: not reported). On the same, the patient was also administered with PNEUMOVAX (dose: as reported 1, route of administration: intramuscular, anatomical location: left arm, batch number: N022650 and expiry date: not reported). On 27-Oct-2017, 4 days after vaccine administration, the patient experienced redness and swelling of arm. It was reported that the patient was inflamed from upper arm to lower arm which was warm to the touch. The patient was advised to take BENADRYL and use ice on the affected area. The patient also received cephalexin as treatment. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Adverse drug reaction, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous case, reported by other health professional (nurse) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723426), concerning a 90-year-old, adult, female patient. The patient's current condition included dementia (since an unspecified date). The patient's medical history and concomitant therapies were not reported. On an unknown date, the patient was influenza vaccine (dose: unk, route of administration, anatomical location, batch number and expiry date: not reported). On an unknown date, the patient was also vaccinated with a dose of PNEUMOVAX (strength, dose: unk, route, frequency, lot/batch number and expiration date were not reported). On an unknown date, after receiving the vaccines, the patient developed a reaction at the injection site. It was reported that the injection site was swelled up, became red, and looked puffy. The patient went to an unspecified emergency department and received BENADRYL. It was also reported that the patient had an unknown reaction to BENADRYL that they gave her at the emergency department, but the patent got better and recovered in about 1 week. The outcome of the events was reported as recovered/resolved. The reporter assessed the event as non-serious.
Age: 16.0
Sex: F
Vaccine: FLUX, MENB, MNQ
Symptoms: Discomfort, Paraesthesia
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723499), concerning a 16-year-old, adolescent female. The patient's medical history and concomitant medications were not reported. On 24-Oct-2017, the patient was administered with influenza vaccine (anatomical location: right arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported). On the same day, the patient received non-company suspect drug TRUMENBA, (anatomical location: left arm, single dose, route of administration, batch number, expiry date: not reported. On the same day, the patient was administered with non-company suspect drug MENACTRA (anatomical location: right arm, singe dose, route of administration, batch number, expiry date: not reported). On the same day, after vaccination, the patient experienced tingling in the arm that progressed to her face. Hence, she was very uncomfortable. The outcome of the event was unknown. The reporter assessed the event (tingling in the arm) as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This is a serious spontaneous case, initially received from FDA (VAERS ID: 723501) (reported to HA by other health professional) on 03-Feb-2018, concerning a 50-year-old adult female patient. The patient was allergic to penicillin. The patient had no medical history. The patient did not receive any concomitant medications. On 22-Sep-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: (RA) right arm, dose, batch number, expiry date, manufacturer and trade name: not reported). The patient had an extreme pain during injection and experienced loss of use of injected arm. Subsequently, she went to emergency room. The patient had MRI (magnetic resonance imaging) and X rays (results not reported). The patient received physical therapy for the events. It was reported that, the patient had multiple MD visits. At the time of this report, the patient had not yet recovered from the events.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723768), concerning a 37-year-old, adult, female patient. The patient historical conditions included endometriosis and anemia (dates not specified). The patient's current condition included anxiety since an unspecified date. The patient's concomitant medication included PROZAC for an unknown indication. The patient was also an unknown medication for anxiety. On 24-Oct-2017, the patient was vaccinated with INN Flu Vaccine Seasonal (dose: as reported 1, route of administration, anatomical location, batch number, trade name and expiry date: not reported). On the same day, after receiving the vaccine, the patient developed numbness in lips and finger and throbbing headache. It was reported that about 4 pm the symptoms were going on and off. The outcome of the events was reported as not recovered. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Hypersensitivity
Clinical narrative: This is spontaneous case, reported by healthcare professional (other non) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723786), concerning a 26-year-old, adult, female patient. The patient was administered with Tdap for pregnancy on an unspecified date in Jup-2015 and had the reaction, fibromyalgia. The patient had no current conditions and concomitant medications included prazosin, gabapentin and CELEXA. On 24-Oct-2017, the patient was administered with influenza vaccine (dose: 1 (as reported), route of administration: intramuscular, site: left arm, manufacturer, trade name, batch number and expiry date: not reported). On 25-Oct-2017, after 48 hrs of vaccination, the patient had chills, fatigue, stomach pain, diarrhea, generalized body pain, allergy and sinus related issues. It was reported that, after 6 days of vaccination, the patient was still sick, and she believed that it was viral. No lab tests done. The outcome of the events not recovered. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Sinus disorder
Clinical narrative: This is spontaneous case, reported by healthcare professional (other non) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723786), concerning a 26-year-old, adult, female patient. The patient was administered with Tdap for pregnancy on an unspecified date in Jup-2015 and had the reaction, fibromyalgia. The patient had no current conditions and concomitant medications included prazosin, gabapentin and CELEXA. On 24-Oct-2017, the patient was administered with influenza vaccine (dose: 1 (as reported), route of administration: intramuscular, site: left arm, manufacturer, trade name, batch number and expiry date: not reported). On 25-Oct-2017, after 48 hrs of vaccination, the patient had chills, fatigue, stomach pain, diarrhea, generalized body pain, allergy and sinus related issues. It was reported that, after 6 days of vaccination, the patient was still sick, and she believed that it was viral. No lab tests done. The outcome of the events not recovered. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Infection, Product administered at inappropriate site, Rash, Skin warm
Clinical narrative: This is a spontaneous case, reported by other non health professional to VAERS and initially retrieved on 03-Feb-2018 by Sequris from VAERS (regulatory reference number: 723873), concerning a 06-year-old, male patient. The patient's medical history was not reported. The patient was on the treatment of melatonin and on children's gummy multivitamin. On 01-Oct-2017, the patient was vaccinated with influenza vaccine (dose: not reported , route of administration: (Syr as reported) injection, anatomical location: left gluteus, batch number and expiry date: not reported). The day after receiving the vaccine, the patient's 3/4 of leg developed rash like symptoms and was extremely hot to the touch. The patient was allowed to sleep on that day after drawing a perimeter around the affected area. On the next day, the patient seemed to be normal, but the area of infection slightly grew past the perimeter around the affected area. On the next day, the patient seemed to be normal, but the area of infection slightly grew past the perimeter marked and was still hot to the touch. On an unknown date, the patient had detoxification bath and had essential oils topically. The patient was recommended cold compress and TYLENOL as a treatment. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 723924), concerning a 39-year-old, female patient. The patient's historical condition included Ehlers-Danlos Syndrome, fibromyalgia and was allergic to latex, kiwi, banana, erythromycin and ZITHROMAX. The patient did not have any current illness. The patient's concomitant medications included LYRICA, meloxicam, cyclobenzaprine, SYNTHROID, ZYRTEC, liothyronine all for an unknown indication. On 01-Oct-2017, the patient was vaccinated with INN Flu vaccine seasonal (dose: not reported, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, the patient also received Pneumococcal vaccine polyvalent (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 28-Oct-2017, 28 days after vaccination, the patient had severe left arm pain, redness, had fever of 102+ (102 F) for two days and severe ache and pain. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Significant case correction received with IRD 03-Feb-2018: The causality of the event 'erythema' was changed to not related from unassessable.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723953) concerns a 48-year-old, adult, female patient. The patient had no relevant medical history or current illness. The patient had no known allergies. The patient's concomitant medication included unspecified medication for birth control. On 03-Oct-2017, the patient was administered with influenza vaccine, (route of administration: intramuscular, anatomical location: right arm, dose: 1 (as reported), batch number, expiry date, trade name, manufacturer: not reported). On the same day (03-Oct-2017) after vaccination, the patient had intense pain in the shoulder which had passed down to the elbow. It was reported that, the pain had not decreased or reduced in severity with course of time. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. Significant case correction received with IRD 03-Feb-2018: The lower level term (LLT) of the event (intense pain in shoulder down to elbow) was changed from musculoskeletal pain to shoulder pain. No changes were made in the narrative.
Age: 64.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site inflammation, Injection site nodule
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724002), concerns a 64-year-old, adult, female patient. The patient's history included osteoarthritis, breast cancer, sinusitis, hypertension (unspecified dates). The patient was hospitalized for an unknown reason at 6 months of age and at 1 year of age for pneumonia. The patient had allergy to penicillin, codeine (NORCO, PERCOCET cause severe upper quadrant abdominal pain (RUQ) gastric pain] and sulfa drugs. The concomitant medications FEMARA, losartan, citalopram, meloxicam, CLARITIN, FLONASE, LIPITOR, CENTRUM SILVER. The patient had no illness at the time of vaccination. On 24-Oct-2017, the patient was administered with influenza vaccine (anatomical location: right arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported) and PREVNAR 13 (anatomical location: left arm, route of administration: intramuscular, dose, batch number, expiry date: not reported). On the same day, the patient developed 6 mm warm, inflamed round area with a nodule like area beneath the skin at the injection site. The patient was unable to sleep for 3 days, as injection site was painful. It was reported that, the patient received flu vaccine in the right arm without a reaction. The patient also had low-grade temperature of 100.3 to 100.6 for 3 days. The patient used unspecified topical ointments and cold compression, which were ineffective in decreasing the swelling and itching. After one week of vaccination, redness and erythema were resolved, but the site appeared to be red/purple. The nodule at the injection site could be palpated. On 30-Oct-2017, the patient had to visit the primary care physician (PCP) and was prescribed with 4 mg MEDROL DOSEPAK. At the time of this report, the patient had recovered from all the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site warmth, Insomnia, Pruritus, Swelling
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724002), concerns a 64-year-old, adult, female patient. The patient's history included osteoarthritis, breast cancer, sinusitis, hypertension (unspecified dates). The patient was hospitalized for an unknown reason at 6 months of age and at 1 year of age for pneumonia. The patient had allergy to penicillin, codeine (NORCO, PERCOCET cause severe upper quadrant abdominal pain (RUQ) gastric pain] and sulfa drugs. The concomitant medications FEMARA, losartan, citalopram, meloxicam, CLARITIN, FLONASE, LIPITOR, CENTRUM SILVER. The patient had no illness at the time of vaccination. On 24-Oct-2017, the patient was administered with influenza vaccine (anatomical location: right arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported) and PREVNAR 13 (anatomical location: left arm, route of administration: intramuscular, dose, batch number, expiry date: not reported). On the same day, the patient developed 6 mm warm, inflamed round area with a nodule like area beneath the skin at the injection site. The patient was unable to sleep for 3 days, as injection site was painful. It was reported that, the patient received flu vaccine in the right arm without a reaction. The patient also had low-grade temperature of 100.3 to 100.6 for 3 days. The patient used unspecified topical ointments and cold compression, which were ineffective in decreasing the swelling and itching. After one week of vaccination, redness and erythema were resolved, but the site appeared to be red/purple. The nodule at the injection site could be palpated. On 30-Oct-2017, the patient had to visit the primary care physician (PCP) and was prescribed with 4 mg MEDROL DOSEPAK. At the time of this report, the patient had recovered from all the events. The reporter assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 724057) concerns a 57-year-old, adult female patient. The patient's current condition included diabetes (since an unspecified date). The patient's concomitant medications included lisinopril, JANUVIA and metformin for unknown indication. On 01-Oct-2017, the patient was administered with influenza vaccine, (dose: unknown, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, after vaccination the patient experienced red, swollen, fluid accumulated under the skin from injection site to elbow and suspected cellulitis. The patient was treated with unspecified steroids. At the time of this report, the outcome of the events was recovering. The reporter assessed as this case as non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, reported by a pharmacist to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724063), concerns a 63-year-old, adult, female patient. The patient's relevant medical history or current illness and concomitant medications were not reported. On 24-Aug-2017, the patient was administered with influenza vaccine (dose: UNK (as reported), anatomical location, route of administration, batch number, expiry date, trade name, manufacturer: not reported) and the patient was administered with non-company suspect product, PNEUMOVAX 23 (dose: UNK (as reported), route of administration: subcutaneous, anatomical location, batch number, expiry date: not reported). On 24-Aug-2017 (reported as later that evening), the patient experienced pain, redness, and the injection site was hot to touch. The patient consulted a medical personnel and she was treated with BENARDYL and ice packs were applied to the injection site. On an unknown date in 2017, the patient had recovered from all the events. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Injection site pain, Pain in extremity, Tremor
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS (VAERS ID: 724177), concerns a 54-year-old, adult male patient. The patient's medical history included high cholesterol and environmental allergy. The patient's concurrent condition included high blood pressure. The patient's concomitant medications included WELLBUTRIN, PROZAC, Simvastatin, Terazosin, Loratadine, SUDAFED, Magnesium, Vitamin D and Omega-3 for an unknown indication. On 18-Oct-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On 19-Oct-2017, the patient had pain in left arm (entire arm), wrist fatigue, stabbing pain in left hand. On 30/Oct-2017, the patient had tremors in left hand. At the time of the report, the events were not resolved. The reporter assessed the case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Bed rest, Disturbance in attention, Dizziness, Nausea
Clinical narrative: This spontaneous case reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 724246), concerns a 51-year-old, adult female patient. The patient's current condition included pneumonia and reactive airways (unspecified date). Concomitant medications were reported. On 03-Oct-2017, the patient was administered with influenza vaccine (route of administration: injection, anatomical location: arm, dose, batch number and expiry date: not reported) and PNEUMOVAX 23 (route of administration: intramuscular, anatomical location: arm, dose: 25mcg/0.5ml, batch number and expiry date: not reported). On the same day, after 2 hours of vaccination, the patient experienced localized pain (reported as 3/10) in arm. At night the pain increased (reported as 7/10) and it was reported (10/10) on palp and patient experienced localized swelling on arm. After 12 hours of vaccination, the injection pain persisted (reported as 7/10). The patient also experienced nausea, dizziness, vertigo, mild fever and body ache and joint pain (reported as 4/10). The patient was unable to concentrate (reported as count to 10). It was reported that pain (3/10) and swelling subsided within 48 hours of injection. The patient was on bed rest for 53 hours after injection. No lab tests were done to the patient. The outcome of the events not reported. The reporter assessed this case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Vertigo
Clinical narrative: This spontaneous case reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 724246), concerns a 51-year-old, adult female patient. The patient's current condition included pneumonia and reactive airways (unspecified date). Concomitant medications were reported. On 03-Oct-2017, the patient was administered with influenza vaccine (route of administration: injection, anatomical location: arm, dose, batch number and expiry date: not reported) and PNEUMOVAX 23 (route of administration: intramuscular, anatomical location: arm, dose: 25mcg/0.5ml, batch number and expiry date: not reported). On the same day, after 2 hours of vaccination, the patient experienced localized pain (reported as 3/10) in arm. At night the pain increased (reported as 7/10) and it was reported (10/10) on palp and patient experienced localized swelling on arm. After 12 hours of vaccination, the injection pain persisted (reported as 7/10). The patient also experienced nausea, dizziness, vertigo, mild fever and body ache and joint pain (reported as 4/10). The patient was unable to concentrate (reported as count to 10). It was reported that pain (3/10) and swelling subsided within 48 hours of injection. The patient was on bed rest for 53 hours after injection. No lab tests were done to the patient. The outcome of the events not reported. The reporter assessed this case as non-serious.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724254), concerns a 67-year-old, adult female patient. The patient's concomitant medications included WELLBUTRIN and ALLER TEC. On 03-Oct-2017, the patient was administered with influenza vaccine, (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient had persistent and intense upper arm pain in the arm where the flu shot injection was given. Subsequently, the patient had upper left arm aches most of the time and had a sharp pain when she moved the arm in an upward motion. It was reported that, the patient usually had a sore arm for a day or two, but this time persisted for a month. At the time of this report, the events were persisting. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Middle insomnia
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724318), concerns a 60-year-old, adult male patient. The patient's concomitant medications included Vitamin d and aspirin for an unknown indication. On 30-Oct-2017, the patient was administered with influenza vaccine (anatomical location: left arm, route of administration: injection (reported as SYR), dose: unknown, batch number, expiry date, trade name and manufacture: not reported). On 31-Oct-2017, after 1 day of administration of vaccine, the patient was vaccine, the patient woke up in the middle of the night and his balance was completely off. It was lasted for a short period of time (minute or so). At the time of this report, the outcome of the events was recovered. The reporter assessed this case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724340), concerns a 63-year-old, adult, female patient. The patient underwent stent placement (2 stents) recently. The patient's historical drug included tetanus for unknown indication and had a reaction (unspecified). On an unspecified date, at the age of 59 years, the patient administered the tetanus toxoid vaccine and experienced fever and dizzy. On 19-Oct-2017, the patient was administered with influenza vaccine (route of administration: injection, anatomical location, dose, manufacturer, trade name, batch number and expiry date: not reported). On the same day, at 9 PM in the evening, after vaccination, the patient had extreme pain with the movement of left shoulder, due to lack of mobility and the patient was unable to lift and reach, hard to sleep. Later, the pain radiates down the arm to elbow and shoulder to neck. After a week, she felt slightly better but still felt painful with reduced the range of movement. At the time of report, the patient had not recovered from the events (mobility decreased, sleep problem, pain upon movement and pain in extremity). The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Injection site erythema, Pain in extremity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724355), concerns a 33-year-old, adult female patient. On 18-Oct-2017, the patient was administered with influenza vaccine (route of administration: injection, anatomical location: arm, dose, manufacturer, trade name, batch number and expiry date: not reported). On the same day, after vaccination, the patient's arm became very sore, then developed swelling, heat and redness below the vaccination site region, lasted for 3 days. It was reported that the swelling and redness was very large (reported as 3 in long and 3 in wide) and it is visible. The patient had bruise which persisted for 10 days. The outcome of the events had recovered. The reporter considered this case as non-serious.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Diarrhoea, Insomnia, Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724439), concerning a 20-year-old, adult male patient. The patient had no medical history or allergies. The patient's concomitant medication included VYVANSE for an unknown indication. On 30-Oct-2017, the patient received influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 31-Oct-2017, the day after vaccination, the patient couldn't sleep and was puking all over night. In the morning, the patient experienced diarrhoea. At 3 PM, the patient had fever (reported as over 100 degrees) and extremely bade backache. It was reported that event back pain was getting intensified. The patient recovered from the event fever but not yet recovered from the other events. The reporter assessed this case as non-serious.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Extra dose administered, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case, reported by physician to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724763), concerns a 67-year-old, elderly female patient. The patient had no family medical history. The patient's historical vaccines included varicella zoster vaccine (on an unspecified date in 2012) and had an unspecified reaction, pneumococcal 13 (on an unspecified date in Dec-2015), DPT and had allergic reaction (on an unspecified date in Apr-2016). The patient's historical procedure included lymph node excision (lymph nodes removed from her right arm area) (unspecified date). The patient's current conditions included breast cancer. The patient's concomitant medication included rosuvastatin for an unknown indication. On 29-Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). On the same day, at 12:00 hrs, the patient was also administered with PREVNAR 13 (dose: 1 DF (single), dose number: 2, anatomical location: right upper arm, route of administration, batch number, manufacturer, trade name and expiry date: not reported). It was reported that, the patient had already received PREVNAR 13 vaccine (on an unspecified date in Dec-2015) and then on 29-Oct-2017 was administered with second injection by mistake (explicitly coded as extra dose administered). On the same day (29-Oct-2017), after the vaccination, the patient's right arm was painful and weak. The patient also had a fever, chills, stiff neck and swollen hand. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.