chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Ocular hyperaemia, Oculorespiratory syndrome, Swelling face
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved or 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726212, concerns a 58-year-old-adult, female patient. The patient's historical conditions included cough and cold (ended in 1-Oct-2017) and the patient was allergic to penicillin. On 11-Sep-207, the patient was administered with AFLURIA (dose:0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: XF33408, expiry date: not reported). On the same day, approximately 3 hrs of vaccination, the patient had burning sensation in her eyes (felt like they had sandpaper) and felt like swollen. Approximately after 4 hrs of vaccination, the patient did not had breathing distress, but she felt like she had upper respiratory cold, felt that her chest was tight and burning sensation. On the next day, approximately after 19 hrs of vaccination, the patient's eyes were bright red and was swollen. The patient's face was swollen and felt like her lungs were compromised. It was reported that symptoms described about oculo-respiratory syndrome. Approximately after 29 hrs of vaccination, the patient's eyes were red, but not swollen, her chest feel normal and oedema on her face was decreasing. The outcome of the events was not recovered. The reporter considered this case as non-serious.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13, VARCEL
Symptoms: Blister, Pyrexia, Rash pustular, Scab, Varicella post vaccine
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726220), concerns a 1-year-old male (child) patient (0.92 as reported). The patient had no medical history. The patient's current conditions included upper respiratory cold and runny nose was primary symptom. On 01-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (unknown as reported), anatomical location: left gluteus, route of administration, batch number was not reported). On the same day, the patient was also administered with co-suspect PROQUAD (dose: unknown, route of administration: intramuscular, anatomical location and batch number was not reported), PREVNAR 13 (dose: 4 (as reported), route of administration: intramuscular, anatomical location: left gluteus, batch number was not reported), and VARIVAX (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left gluteus, batch number was not reported). On 07-Nov-2017, 37 days after vaccination, the patient had a full-blown chicken pox with fever for more than 3 days. Chicken pox was spreading everywhere in the extremity, face, lips, inside mouth and trunk. The patient had a normal course of virus so far and the pox development was on day 04. It was stated that, day by day pox and its distribution had increased. As the patient's old pox developed blister and scab, the newer pox popped out. Based on the description in the call to the clinic, it was confirmed as chicken pox and refused to admit the child as it was a contagious virus. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726345), concerns a 55-year-old adult female patient. The patient's current conditions included penicillin allergy and sulfa (as reported) allergy. The patient's concomitant medications included aspirin and atenolol. In past, the patient did not receive flu vaccine. On 11-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF30907, anatomical location: left arm, route of administration: intramuscular). On 12-Oct-2017, 2 days after vaccine administration, the patient had shoulder pain and mobility decreased. It was reported that, the patient had no pain while receiving the vaccine and location of the vaccine administered was in the appropriated deltoid region of the arm. The patient was still experiencing the pain and decreased mobility in shoulder while trying to move arm in certain directions. It was stated that, the patient had slowly gained part of the lost mobility in shoulder while trying to move arm in certain directions. It was stated that, the patient had slowly gained part of the lost mobility (some of the lost mobility: as reported) while trying to take NSAIDS. The patient was advised to have heat therapy and to consult MD for a possibility of starting physical therapy/further care. It was reported that, flu vaccine night be causing an immune/allergic response which lead to cause the bursitis. The outcome of the events (bursitis, mobility decreased and musculoskeletal pain) was unknown. The reporter assessed the case as non-serious.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726419), concerning a 54-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. On 31-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 01-Nov-2017, after 1 day of vaccination, the patient had serious shoulder pain. He also had difficulty with range of motion while "putting on deodorant or a pull over shirt was painful and difficult". At the time of this report, the patient had not yet recovered from the all the events. The reporter assessed the case as non-serious.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Lethargy, Malaise, Pyrexia
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726446), concerns a male patient of 5-year-old child. On an unknown date in past, the patient had digestive issues and reflux after his 1 month, 2 months and 4 month vaccines administration. The patient's current condition was allergic to blue berries. On 15-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: injection (SYR as reported), anatomical location: arm, batch number: not reported). On the same day, the patient was also administered with KINRIX (dose: 5 as reported, route of administration: SYR as reported, anatomical location: arm, batch number: not reported). On the same day (15-Sep-2017), after administration of vaccines, the patient felt sick, was lethargic and had fever for 3 days. The outcome of the event was recovered. The reporter assessed the case as non-serious. Significant case correction received 21-Feb-2018: Causality was changed from unassessable to related. Case comment was corrected.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Muscle twitching, Pain, Pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726469), concerning a 44-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. On 26-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 01044621A, expiry date: not reported). On the same day after vaccination, the patient had symptoms of itching, twitching of left arm, headache and body aches. The patient took BENADRYL. The patient informed reported that he had EPIPEN but it was unknown if the patient was administered with it or not. The patient was asked to consult the physician if the condition worsens. On 26-Oct-2017, at 04:15 pm, the patient had recovered from the events itching, twitching of left arm, headache and body aches. The reporter assessed this case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: EPIPEN was deleted in the product tab. Added the information 'the patient informed reporter that, he had EPIPEN but it was unknown whether the patient was administered with it or not'. The narrative was amended accordingly.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site oedema, Injection site rash
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726488), concerns a 58-year-old, adult, female patient. The patient's historical conditions included cough, tinea corporis, hyperlipidaemia, hypothyroid, allergy to rhinitis, Latex, ALLEGRA, diclofenac, PREVACID, Sulfa drugs and environment (from an unspecified date). The concomitant medications included SINGULAIR, Metrocream, PROAIR, atorvastatin, levothyroxine, ranitidine, FLONASE and ZYRTEC (on an unspecified date). On 30-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30707 and expiry date: not reported). On the same day, after vaccination, the patient had bruising, rash and edema at injection site. It was reported that, the patient had a physician's visit for the events. At the time of report, the patient had recovered from the events (Injection site rash, edema and bruising). The reporter assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726687), concerns a 56-year-old adult female patient. On 31-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm). It was reported that, the injection was administered at very high. On the same day, after the administration of vaccine, the patient experienced pain. It was reported that, for 14 days the patient had very limited range of motion (ROM) and severe pain in left deltoid shoulder especially while abducting her arm away from her body. At the time of this report, the outcome of the events was not recovered. The reporter assessed the case as non-serious. Significant case correction received with IRD 21-FEB-2018: The causality of the event vaccine administered at inappropriate site was changed from related to not related. Case comment was amended accordingly.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injection site pain, Limb discomfort, Musculoskeletal pain
Clinical narrative: This is spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 726933) concerns a 28-year-old adult female patient. The patient's current condition included asthma and had no known allergies. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: injection (SYR as reported), anatomical site: right arm). On the same day, after administration of the vaccine the patient had pain at injection site in the right shoulder. It was reported that, the patient experienced discomfort while raising and rotating the right arm. The pain of the patient had not subsided or reduced. The patient took naproxen (OTC) to alleviated some of the inflammation, however, it has not helped. The outcome of the events (injection site pain and pain) was not recovered. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Fev-2018: The verbatim (discomfort when raising or rotating right arm) was added for the event (pain). No charges were done in narrative. Non-significant case correction received with 21-Feb-2018: Case comment was changed.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727015), concerns a 54-year-old, adult, female patient. The patient's current condition included asthma and seasonal allergies (from an unspecified date). The concomitant medications included SINGULAIR, valsartan and FLONASE all for unknown indications (on an unspecified date). On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 06-Oct-2017, after 1 days of vaccination, the patient had horrible pain in right shoulder blade which radiated to her forearm. On the same day, the patient was treated with ibuprofen 800 mg at every 6 hours, for pain. On an unspecified date, X-ray was performed, results were not reported. At the time of this report, the patient had not recovered from the events (shoulder blade pain and pain in arm). The reporter assessed the events as non-serious. Non-significant case correction received with the IRD 21-Feb-2018: The formulation of the treatment drug ibuprofen was changed from injection to tablet. Non-significant case correction received with the IRD 21-Feb-2018: Case comment was changed ('R' to 'right'). Amended narrative accordingly.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site pain, Joint range of motion decreased, Limb discomfort
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727084), concerns a 41-year-old, adult, female patient. On an unspecified date, it was reported that, the patient had flu-like symptoms after flu shots. The patient's current condition included difficulty to tolerate of AUGMENTIN (from an unspecified date). The concomitant medications included LOESTRIN, Levothyroxine, Vitamin C, Calcium + vit D, Echinacea, Acetyl L Carnitine; Iron and women's multivitamin (on an unspecified date). On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: XF33508 and expiry date: not reported). On the same day, after vaccination, the patient had discomfort and pain in left arm for weeks since injection, including limited range of motion. No lab tests were done to the patient. At the time of the report, the patient had recovered form the events (arm discomfort, pain in arm and injected limb mobility decreased). The reporter assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727102), concerns a 61-year-old, adult, female patient. On 03-Nov-2017, the patient was administered with AFLURIA QUADIRVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: XF32608, anatomical location and expiry date: not reported). On the same day, after the vaccination, the patient had pain in arm, especially with raising the arm. Her upper arm and shoulder area was warm to touch. The patient went to the physician office and received ibuprofen. The patient was advised to continue ibuprofen and use of ice on the affected area with alteration of 15 minutes. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Oropharyngeal pain, Pain, Sneezing
Clinical narrative: This is serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727194), concerns a 37-year-old, adult female patient. It was reported that, every year the patient received unspecified flu shot and had chills, oropharyngeal pain, pain and sneezing. On 08-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml batch number: XF34809, anatomical location: left arm, route of administration: intramuscular). On 09-Nov-2017, 1 day after vaccine administration, the patient had the symptoms of sneezing, sore throat, body aches and chills. The temperature of the patient was 98.4F so she was instructed to take TYLENOL and follow up with PCP. The patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4, HEPA, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727363), concerns a 01-year-old, female infant patient. The patient had no medical history and concomitant medications. On 01-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, the patient was administered with non-company suspect product HAVRIX (dose, route of administration, anatomical location, batch number and expiry date: not reported) and MMR II (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 17-Nov-2017, after 16 days of vaccination, the patient experienced severe vomiting and fever. At the time of the report, the patient had not recovered from the events (vomiting and fever). The reporter assessed the case as non-serious. Significant case correction received with IRD 21-Feb-2018: The as determined listedness for the event vomiting was corrected from unlisted to listed Flu Vaccine Egg Split CSL.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pruritus, Headache, Injection site erythema, Myalgia, Nausea
Clinical narrative: This is a spontaneous case, reported by healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727371), concerns a 64-year-old, adult male patient. The patient's medical history was not reported. The patient had no known allergy. On 16-Nov-2017, the patient was vaccinated with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: XF304309 and expiry date: not reported). On the same day (16-Nov-2017), after vaccination, the patient experienced itchy eyes, headache, muscle pain, nausea and body aches. Reportedly, the patient's vision was not normal and he needed to blink few times to reset the eye to read and point of needle entry was slightly red. At the time of this report, the patient had not recovered from the events. The reporter considered this report as non-serious.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Visual impairment
Clinical narrative: This is a spontaneous case, reported by healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727371), concerns a 64-year-old, adult male patient. The patient's medical history was not reported. The patient had no known allergy. On 16-Nov-2017, the patient was vaccinated with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: XF304309 and expiry date: not reported). On the same day (16-Nov-2017), after vaccination, the patient experienced itchy eyes, headache, muscle pain, nausea and body aches. Reportedly, the patient's vision was not normal and he needed to blink few times to reset the eye to read and point of needle entry was slightly red. At the time of this report, the patient had not recovered from the events. The reporter considered this report as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Insomnia, Joint range of motion decreased, Myalgia, Pain
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727381), concerns a 30-year-old, adult, female patient. The patient's current condition included ear infection and sinus infection (from an unspecified date). The concomitant medication included TRINTELLIX (on an unspecified date). On 26-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: injection, anatomical location: left arm, batch number and expiry date: not reported). On the same day, immediately after vaccination, the patient had consistent soreness. It was reported that, after 3 weeks, the patient still had persistently sore and muscular soreness, but range of motion was limited. Due to pain, the patient was unable to sleep on left side. At the time of report, the patient had not recovered from the events (immediate post-injection reaction, pain in arm, mobility decreased and sleep disorder). The reporter assessed the events as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727395), concerns a 51-year-old, adult female patient. On 25-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 00944611A and expiry date: not reported). On the same day, after vaccination, the patient had the pain at the injection site. It was stated that, the patient had an extreme sore arm. The patient had pain radiating down the entire left arm and slightly towards the back. The patient was unable to move her arm and not able to take off her shirt when changing. The patient had tingled sensation through the neck and it was dissipated later. The outcome of the events was not recovered. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727395), concerns a 51-year-old, adult female patient. On 25-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 00944611A and expiry date: not reported). On the same day, after vaccination, the patient had the pain at the injection site. It was stated that, the patient had an extreme sore arm. The patient had pain radiating down the entire left arm and slightly towards the back. The patient was unable to move her arm and not able to take off her shirt when changing. The patient had tingled sensation through the neck and it was dissipated later. The outcome of the events was not recovered. The reporter assessed the case as non-serious.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Pyrexia, Rash
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727410), concerns a 02-year-old, child, female patient. The patient had no historical condition and allergy. The patient's current conditions included cough, cold and runny nose (since an unspecified date). The patient did not receive any concomitant medication. On 16-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right leg, batch number and expiry date: not reported). On 17-Nov-2017, after 2 days of vaccination, the patient experienced fever, rash, ankle and knee swelling. The patient was taken to the physician office. It was reported that, these (fever, rash, ankle and knee swelling) might be the symptoms of serum syndrome. No lab investigation was done. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727559), concerns a 61-year-old, adult, female patient. The patient's medical history was not reported. On 18-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: XF32808 and expiry date: not reported) and PNEUMOVAX (dose, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 19-Nov-2017, after 1 day of vaccination, the patient had low grade fever of 100 degrees. The patient had redness and swelling at the vaccination site. The patient received the unspecified NSAID (non-steroidal anti-inflammatory drugs) for body aches and fever. On 20-Nov-2017, the fever was recovered and the injection site became normal, but the redness and swelling spread down from the arm to the bicep. It was reported that, it was sore and not warm to touch. The redness and swelling encompasses an area of 3 inches by 4 inches on the skin. The patient was continuing the NSAID as directed. At the time of the report, the events redness, swelling, and body aches were not recovered. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Sequirus from VAERS (VAERS ID: 727628), concerns a 35-year-old adult female patient. The patient had a history of fainting after procedures involving needles (adverse event after prior vaccinations). No known allergies to the patient. The patient had same event in the past after administration of unknown vaccine. On 16-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF32908, route of administration: intramuscular, anatomical location: left arm). On the same day, after administration of vaccine, the patient experienced dizzy for about 30 minutes. The patient laid down in the pharmacy, but did not lose consciousness, it was reported that, the patient did not want to seek further medical treatment and left the pharmacy as soon as dizziness recovered. The outcome of the event was recovered. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: The sentence 'the patient was laid down' was corrected to 'the patient laid down' in the narrative.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Malaise
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727848), concerning a 51-year-old, adult female patient. The patient's historical condition included: depression. The patient was allergic to penicillin. The patient did not have any current illness. Concomitant medications included: CYMBALTA for an unknown indication. On 19-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XD22008 (as reported), expiry date: not reported). On the same day, after administration of vaccine, the patient felt extremely painful when nurse was giving the shot. The nurse stated that it was difficult to push in the serum. The patient's arm at the site of injection was sore and had pain in the right shoulder joint. In addition, she had fever the day after her shot. It was reported that, the patient felt sick the day after fever and chills. She complained of loss of range of motion in the right arm and pain caused her waking up at night. No relevant tests or examination was done by the physician. Seqirus Quality Assurance have confirmed that the batch number reported (XD22008) is not a Seqirus batch number, however because the reporter named Seqirus product 'AFLURIA QUADRIVALENT' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. The patient had not yet recovered from all the events. The reporter assessed the events as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727848), concerning a 51-year-old, adult female patient. The patient's historical condition included: depression. The patient was allergic to penicillin. The patient did not have any current illness. Concomitant medications included: CYMBALTA for an unknown indication. On 19-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XD22008 (as reported), expiry date: not reported). On the same day, after administration of vaccine, the patient felt extremely painful when nurse was giving the shot. The nurse stated that it was difficult to push in the serum. The patient's arm at the site of injection was sore and had pain in the right shoulder joint. In addition, she had fever the day after her shot. It was reported that, the patient felt sick the day after fever and chills. She complained of loss of range of motion in the right arm and pain caused her waking up at night. No relevant tests or examination was done by the physician. Seqirus Quality Assurance have confirmed that the batch number reported (XD22008) is not a Seqirus batch number, however because the reporter named Seqirus product 'AFLURIA QUADRIVALENT' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. The patient had not yet recovered from all the events. The reporter assessed the events as non-serious.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727897), concerns a 49-year-old, adult, male patient. The patient's historical condition included acid reflux (unspecified date). The patient had no current condition or allergy. The patient did not received any concomitant medication. On 10-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On 11-Oct-2017, after 2 days of vaccination, the patient had long lasting arm pain, which was at back of arm and above elbow. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 727971), concerns a 41-year-old, adult, male patient. The patient's current condition included hypertension (since an unspecified date). The patient had no known allergy (NKDA). The patient's concomitant medications included Lisinopril-HCTZ and simvastatin for an unknown indication. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF31107A, and expiry date: not reported). On 13-Oct-2017 (approximately after 48 hours of vaccination), the patient started to have dull pain at injection site, which spread elbow. The patient was referred to PCP (primary care physician). At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Vomiting
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728052), concerns a 19-year-old, adult, male patient. The patient historical condition included dizziness (reported as a month ago at the gym while working out). On 18-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number XF32808 and expiry date: not reported). On the same day, after vaccination, it was reported that, the patient seemed like having syncope. The patient had fainted and sweating of forehead, after a few minutes the patient had regained consciousness and provided some water to drink. The patient reported that, he did not eat anything in the morning that might be the cause of dizziness. The patient was provided to eat, he drank more water but threw up. The emergency medical technician (EMT) arrived at the spot, checked the vital signs of the patient. It was reported that, the patient was found to be normal. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: The verbatim (threw up) was added for the event (vomiting). The verbatim information (threw up) for event vomiting was included in event description in narrative.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 729053), concerns a 49-year-old, adult, female patient. It was reported that, the patient had a procedure mechanical mitral valve due to rheumatic fever in childhood. The concomitant medications included Diltiazem and Warfarin for an unknown indication (on an unspecified date). On 21-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, after vaccination, the patient felt dizziness. On 22-Nov-2017, the patient woke up with severe dizziness, nausea and was unable to eat or drink. On the next day, the patient still felt dizzy and threw up everything, she ate or drank (vomiting). It was reported that, the patient never had such dizziness as her heart rate and blood pressure were normal. No lab tests were done to the patient. At the time of the report, the patient had not recovered from the events (dizzy, nausea and vomiting). The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: The information regarding event (vomiting) was captured in narrative.
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728201), concerning a 51-year-old, adult female patient. The patient had no medical history, current illness and allergies. The patient did not receive any concomitant medications. On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: XF33608 (reported as XF335008) and expiry date: not reported). On the same day, after vaccination, the patient's arm was painful which was unusually weak and also painful while doing things like "removing a shirt or lifting anything with that arm". The patient visited her physician as her arm was hurting for a month. The physician confirmed that, it was rotator cuff syndrome. Hence, she required some physical therapy and time to get better. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728202), concerns a 40-year-old, adult, female patient. The patient had no known drug allergy (NKDA) and no known food allergy (NKFA). The patient's medical history and concomitant medications were not reported. On 11-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF32908 and expiry date: not reported). On 12-Nov-2017, after 1 day of vaccination (reported as Sunday evening), the patient started to have puffy hands on both sides, which worsened on Monday morning. The patient also developed hives and itching all over. She called her doctor who prescribed her low dose of prednisone for 5 days and recommended OTC (over the counter) ALLEGRA/BENADRYL as needed. As of 24-Nov-2014, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728241), concerns a 48-year-old, adult, female patient. The patient historical condition included anemia (on an unspecified date) and current condition included asthma and thyroid disorder (from an unspecified date). It was reported that, the patient had no known allergies. The concomitant medications included Levothyroxine, Vitamin D, Hydrocodone/APAP, Buspirone, VENTOLIN, Ropinirole, Phentermine, LOVAZA, MOVANTIK, DEXILANT, Magnesium oxide and Senna (on an unspecified date). On 13-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 01044611A and expiry date: not reported). On 15-Nov-2017, after 2 days of vaccination, the patient had muscle ache in arm, which was swollen. During first few days, she felt her arm was stiff. Later, it seems to be swollen and ached. She also had numbness and tingling, which migrates from down the arm to hand. The patient was treated with TYLENOL (on an unspecified date). No lab tests details were available. At the time of the report, the patient had not recovered from the events (numbness of upper extremities, musculoskeletal stiffness, muscle swelling, muscle ache and tingling of extremity). The reporter assessed the case as non-serious. Significant case correction received 21-Feb-2018: The LLT of the event, hypoaesthesia was corrected from numbness in hand to numbness of upper extremities.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728241), concerns a 48-year-old, adult, female patient. The patient historical condition included anemia (on an unspecified date) and current condition included asthma and thyroid disorder (from an unspecified date). It was reported that, the patient had no known allergies. The concomitant medications included Levothyroxine, Vitamin D, Hydrocodone/APAP, Buspirone, VENTOLIN, Ropinirole, Phentermine, LOVAZA, MOVANTIK, DEXILANT, Magnesium oxide and Senna (on an unspecified date). On 13-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 01044611A and expiry date: not reported). On 15-Nov-2017, after 2 days of vaccination, the patient had muscle ache in arm, which was swollen. During first few days, she felt her arm was stiff. Later, it seems to be swollen and ached. She also had numbness and tingling, which migrates from down the arm to hand. The patient was treated with TYLENOL (on an unspecified date). No lab tests details were available. At the time of the report, the patient had not recovered from the events (numbness of upper extremities, musculoskeletal stiffness, muscle swelling, muscle ache and tingling of extremity). The reporter assessed the case as non-serious. Significant case correction received 21-Feb-2018: The LLT of the event, hypoaesthesia was corrected from numbness in hand to numbness of upper extremities.
Age: 31.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Fear of injection, Syncope
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728318), concerns a 31-year-old, adult female patient. The patient had no medical history and no concomitant medications were used. The patient had no allergies. On 22-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), batch number: XT59505, anatomical location: unknown, route of administration: intramuscular) and ENGERIX-B (dose: 1 as reported, batch number: 531039, anatomical location: unknown, route of administration: intramuscular). It was reported that, the patient requested for Hepatitis B vaccine and flu vaccine at the same visit. After administration of the vaccines, within few minutes the patient fainted. RPH (registered pharmacist) and the store manager helped her, but she refused to go for ER (emergency room) visit. Blood pressure and heart rate were examined, results not reported. Later, upon contact, the patient said that, she was fine but scared of needle. The patient had recovered from the event. The reporter assessed the case as non-serious. Significant case correction received 21-Feb-2018: The causality of the events was corrected. Case comment was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Pain, Skeletal injury, Syringe issue
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728427), concerns a 50-year-old, adult, female patient. The patient's concomitant medications included PERCOCET, VALIUM, tramadol and cyclobenzaprine for unknown indications. On 28-Oct-2017, during the administration of AFLURIA QUADRIVALENT (dose:0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30607, expiry date: not reported) the plunger did not depress and gave a new injection during which hit the bone. On 29-Oct-2017, the patient had pain while raising the arm above her shoulder. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAI reference number was PR492979. The outcome of the events was unknown. The reporter assessed the case as non-serious. Non-significant assessed the case as non-serious. Non-significant follow-up received from quality assurance department on 01-Mar-2018: Added QAIR number in additional information tab. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728462), concerns a 53-year-old, adult, female patient. The patient's medical history, allergy and concomitant medications were not reported. On 14-Nov-2017, the patient was administered with AFLURIA QUADRIVLANET (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number XF34309, expiry date: not reported). On 18-Nov-2017, after 5 days of vaccination, the patient had shoulder pain and she was unable to lift her arm above head. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728691), concerns a 44-year-old, adult, female patient. The patient's current condition included acid reflex (since an unspecified date). The patient had been allergic to codeine. The patient's concomitant medication included omeprazole for an unknown indication. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506 and expiry date: not reported). On the same day, after 20 minutes of vaccination, the patient experienced numbness in entire left arm. The patient also had redness, swelling, heat and pain at the injection site. No lab investigation was done. It was reported that numbness subsided 24 hours later and redness, swelling (bump the size of a golf ball) lasted after 3 weeks of vaccination. The patient recovered from the events. The reporter assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728691), concerns a 44-year-old, adult, female patient. The patient's current condition included acid reflex (since an unspecified date). The patient had been allergic to codeine. The patient's concomitant medication included omeprazole for an unknown indication. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506 and expiry date: not reported). On the same day, after 20 minutes of vaccination, the patient experienced numbness in entire left arm. The patient also had redness, swelling, heat and pain at the injection site. No lab investigation was done. It was reported that numbness subsided 24 hours later and redness, swelling (bump the size of a golf ball) lasted after 3 weeks of vaccination. The patient recovered from the events. The reporter assessed the events as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 728698), concerns a 55-year-old, adult, female patient. The patient had no medical history and no allergies. The patient's concomitant medication included Vitamins for an unknown indication (on an unspecified date). On 10-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: injection, anatomical location: left arm, batch number and expiry date: not reported). On the same day, the patient received flu shot on extremely high on the arm, almost on the shoulder, which lead to severe shoulder pain and treated with Prednisone for 5 days (on an unspecified date). At night, the patient had high fever, aches and chills. On the same day, the patient still had a lot of pain and went to physician and received ZITHROMAX Z-PACK 6 days for an unknown indication. It was reported that, after 2.5 weeks, the patient still had severe pain. On unspecified date, 2.5 weeks ago, X-ray was performed, which showed no injury and result reported as normal. At the time of the report, the patient had not recovered from the events (chills, shoulder pain, ache and fever). The reporter assessed the case as non-serious.