chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Nerve injury, Pain
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 718089), concerns an 86-year-old, elderly, male patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as, 1st dose), route of administration: intramuscular, anatomical location: left arm, batch number: 179902P, expiry date: not reported). On the same day (immediately after the vaccination), the patient experienced pain and numbness. On an unspecified date, the patient consulted the physician. The physician stated that, nerve was hit during the vaccination. The patient was given steroid injection for the events. The patient felt better, on the next day. On an unspecified date in Oct-2017 (within 3 to 4 days), the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 718109), concerns a 67-year-old, elderly, female patient. The patient had no medical history and current illness. On 26-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1720701 and expiry date: not reported) and non-company suspect product PNEUMOVAX 23 (dose: reported as 1st dose, route of administration: intramuscular, anatomical location: left arm, batch number: N010105 and expiry date: not reported). On 27-Sep-2017, 1 day after vaccination, the patient developed redness and slight swelling from upper arm to elbow, which was warm to touch. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 718161), concerns a 63-year-old, adult, female patient. The patient's historical condition included herpes-simplex. On 28-Spep-2017, the patient was administered FLUVIRIN (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: unknown, batch number: 1720701, expiry date: not reported). On the same day, the patient also received non-company suspect PNEUMOVAX (dose: 1, route of administration: intramuscular, anatomical location: unknown, batch number: N020501, expiry date: not reported). On 29-Sep-2017, 24 hrs after immunization, the patient experienced rash under the injection site (size about 4 x 5 inches). It was red and raised. The patient had not yet recovered from the events (injection site rash, injection site swelling and injection site erythema). The reporter assessed this case as non-serious. Update on 22-Jul-2018: Non-significant case correction was performed with IRD 20-Jun-2018: The event verbatim of the event (injection site redness) was changed from 'injection site, [size about 4 x 5 inches. Started 24 hrs after immunization], red' to 'injection site, red' and for the event (injection site swelling) from injection site, size about 4 x 5 inches. [Started 24 hrs after immunization, red] and raised to injection site, raised in the event tab. Added co-suspect PNEUMOVAX in the case comment. Update 09-Aug-2018: Non-significant case correction was performed with IRD 20-Jun-2018: The verbatims of the adverse event, injection site swelling was changed from 'injection site raised' to 'injection site [red and] raised' and injection site erythema from 'injection site red' to 'Injection site red [and raised]'. The sentence in narrative was reframed as : 'On 29-Sep-2017, 24 hrs after immunization, the patient experienced rash under the injection site (size about 4 x 5 inches). It was red and raised'. Narrative was amended accordingly.
Age: 17.0
Sex: F
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: This is a spontaneous case, reported by pharmacist to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719455), concerns a 17-year-old, female adolescent patient. The patient's medical history, concomitant medications and allergies were not reported. On 29-Sep-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 1720701, expiry date: not reported). On the same day, the patient was also administered MMR II (dose: 1 dose, route of administration: subcutaneous, anatomical location: right arm, batch number: M037096, expiry date: not reported), BOOSTRIX (dose: unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 7ZZ32, expiry date: not reported), VARIVAX (dose, route of administration: subcutaneous, anatomical location: left arm, batch number: M033213, expiry date: not reported). The patient had no issues on the day of vaccination. On 10-Oct-2017, 11 days after vaccination, the patient developed rash on upper chest. The patient reported the pharmacy about the event. The patient was given diphenhydramine and topical hydrocortisone. The patient was recommended to consult MD (doctor of medicine), if the symptoms persisted. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious. Update 22-Jul-2018: Significant case correction was performed with IRD 20-Jun-2018: The company causality of the event 'rash' was changed from 'unassessable' to 'not related'. Case comment was amended. No changes were made in the narrative.
Sex: M
Vaccine: FLUX, FLUC4
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719556), concerns a male patient of an unknown age. On an unspecified date, the patient was administered influenza vaccine, anatomical location: left deltoid, route of administration: intramuscular, dose, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, the patient felt sore in the left deltoid. The outcome of the event was not reported. The reporter assessed the case as non-serious. This case was cross-linked to the case 201803471 due to same patient. Update 29-Aug-2018: Non-significant case correction was performed 16-Aug-2018: The sentence in case comment was changed from 'the causality is unassessable due to lack of information (onset latency)' to 'the causality was unassessable due to lack of information regarding onset latency of event'. No changes were made in the narrative.
Sex: M
Vaccine: FLUX, FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719556), concerns a male patient of an unknown age. On an unspecified date, the patient was administered influenza vaccine, anatomical location: left deltoid, route of administration: intramuscular, dose, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, the patient felt sore in the left deltoid. The outcome of the event was not reported. The reporter assessed the case as non-serious. This case was cross-linked to the case 201803471 due to same patient. Update 29-Aug-2018: Non-significant case correction was performed 16-Aug-2018: The sentence in case comment was changed from 'the causality is unassessable due to lack of information (onset latency)' to 'the causality was unassessable due to lack of information regarding onset latency of event'. No changes were made in the narrative.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719722), concerns a 11-year-old, male child patient. The patient had no medical history and did not received concomitant medication. On 10-Oct-2017, the patient received FLUVIRIN Thiomersal (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 1720701 and expiry date: not reported). On the same day, the patient also received non-company suspect vaccine BOOSTRIX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 9XJ5L and expiry date: not reported). On 11-Oct-2017, one day after vaccination, the patient developed hives on arms and hands. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious. Update 22-Jul-2018: Significant case correction was performed with IRD 20-Jun-2018: The sentence 'the patient had no medical history and received concomitant medications' was modified to 'the patient had no medical history and did not receive concomitant medication' in the narrative.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719836), concerns a 07-year-old child female patient. The patient's historical conditions, allergies and concomitant medications were not reported. The patient had no current illness. On 28-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5ml [reported as 1 DF], anatomical location: left arm, batch number: 1720701, route of administration and expiry date: not reported). On 29-Sep-2017, after one day of vaccination, the patient experienced redness and warm to touch. No pain or hurt was reported as per patient's grandmother. The patient's grandmother was suggested to give patient TYLENOL, MOTRIN for pain and BENADRYL for redness. On 30-Sep-2017 (reported as next day), the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Generalised erythema, Pyrexia, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719854), concerns a 65-year-old male patient. The patient's historical condition was unknown, and the patient had no recent illness and allergies. The concomitant medications were unknown but was reported as nothing new. On 10-Oct-2017, at around 09:30 am, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, frequency: reported as 1, route of administration: intramuscular, anatomical location, right arm, batch number: 1721201 and expiry date: not reported). On the same day (10-Oct-2017), after vaccination, the patient developed a fever of temperature 104 and his entire body turned to bright red and the patient became disoriented. On 11-Oct-2017 (by next morning as reported), the patient experienced hives on his chest and abdomen. The patient took BENADRYL for which hives resolved for a couple of hours, but it returned and covered his entire body. The patient continued with BENADRYL, which resolved the hives until the dose weared off and he had taken more. The patient was instructed to call the physician as soon as possible (ASAP as reported). At the time of this report, the patient had not recovered from the events (spiking temperature, disorientated, redness generalized and hives). The reporter assessed this case as non-serious. Update 27-Jul-2018: Non-signification case correction was performed 20-Jun-2018: The narrative statement was corrected from 'he has taken more' to 'he had taken more' and 'which resolves the hives until the dose wears off' to 'which resolved the hives until the dose weared off'. Narrative and case comment was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719862), concerns a 60-year-old, adult, male patient. The patient had no medical history and concomitant medications. The patient's current condition included injection site swelling. On 29-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 1720701 and expiry date: not reported). On the same day immediately after vaccination, the patient developed swelling after the needle removal. The patient was treated with BENADRYL (50 mg, 1 dose). The outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Rash, Rash erythematous, Rash pruritic, Skin exfoliation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719943), concerns a 56-year-old, adult female patient. The patient did not have any medical history, current illness and concomitant medications. On 28-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 179902P, anatomical location, expiry date: not reported). On the following day (29-Sep-2017), after administration of vaccine, the patient experienced face tingling, small red, painful, itchy dots around mouth and forehead. In addition, the patient also experienced peeling and flaky skin. Hence, the patient visited clinic and was prescribed with mupirocin ointment and topical cortisone cream. At the time of this report, the outcome of the events (oral mucosal eruption, paraesthesia, rash, rash erythematous, rash pruritic and skin exfoliation) was unknown. The reporter considered the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Haemorrhage, Immediate post-injection reaction, Nodule
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719947), concerns a 59-year-old, adult, female patient. On 07-Sep-2015, the patient received FLUVIRIN (dose: 0.5 ml (reported as first dose), route of administration: intramuscular, anatomical location: left arm, batch number: 1720701 and expiry date: not reported]. On the same day after vaccination, instant nodule developed, and the patient had small amount of blood loss, wiped with cotton. The area turned red and swollen. The area was still swollen after 15 minutes. The patient had soreness in arm. As per printed injection site reaction, ice and NSAID to be used (as reported). She had taken ADVIL and half dollar bruise was noted on the following Monday. At the time of this report, the patient had recovered from the events (contusion, erythema, haemorrhage, immediate post-injection reaction, nodule, pain in extremity and swelling). The reporter assessed this case as non-serious. Update 27-Jul-2018: Non-significant case correction performed with IRD 20-Jun-2018: In the narrative 'the patient had soreness in arm and printed injection site reaction. She was advised to use ice and NSAID' was changed to 'the patient had soreness in arm. As per printed injection site reaction, ice and NSAID to be used (as reported).' Amended narrative accordingly.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 719947), concerns a 59-year-old, adult, female patient. On 07-Sep-2015, the patient received FLUVIRIN (dose: 0.5 ml (reported as first dose), route of administration: intramuscular, anatomical location: left arm, batch number: 1720701 and expiry date: not reported]. On the same day after vaccination, instant nodule developed, and the patient had small amount of blood loss, wiped with cotton. The area turned red and swollen. The area was still swollen after 15 minutes. The patient had soreness in arm. As per printed injection site reaction, ice and NSAID to be used (as reported). She had taken ADVIL and half dollar bruise was noted on the following Monday. At the time of this report, the patient had recovered from the events (contusion, erythema, haemorrhage, immediate post-injection reaction, nodule, pain in extremity and swelling). The reporter assessed this case as non-serious. Update 27-Jul-2018: Non-significant case correction performed with IRD 20-Jun-2018: In the narrative 'the patient had soreness in arm and printed injection site reaction. She was advised to use ice and NSAID' was changed to 'the patient had soreness in arm. As per printed injection site reaction, ice and NSAID to be used (as reported).' Amended narrative accordingly.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injection site pain, Swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720150), concerns a 33-year-old, adult, female patient. On an unspecified date, the patient received anthrax vaccine for an unknown indication and experienced injection site pain. The patient had no medical history and the concomitant medications were not reported. At the time of vaccination, the patient had no other illness. On 04-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, anatomical location: left arm, batch number: 1720701, route of administration and expiry date: not reported). On the same day, after vaccination, the patient developed unusual redness, bruising and swelling. The patient developed localized pain at the injection site. The pain scale showed a score of 6 out of 10. The patient neither had pain nor numbness in the rest of the arm. The patient stated that, the injection caused more pain than the anthrax vaccine (as reported). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein, Full blood count, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720198), concerns a 30-year-old, adult, female patient. The patient's current illness included asthma and anxiety disorder (since an unspecified). The patient had been allergic to metals, which caused skin reaction. The patient's concomitant medications included ZOFRAN, LEXAPRO, LEVORA and QVAR. On 11-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179729P (as reported) and expiry date: not reported) and non-company suspect product PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: N022303, dose and expiry date: not reported). The reported batch number (179729P), did not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. However, the query regarding batch number had been raised. On 13-Oct-2017, 02 days after vaccination, the patient experienced intermittent nausea, fever, redness, pain and swelling at injection site, which was warm to touch. On the same day, the patient went to the physician office and complete blood count (CBC), C-reactive protein (CRP), white blood cell (WBC) count tests were performed to rule out other concerns (results not reported). The doctor prescribed KEFLEX and prednisone course of medication and ZOFRAN to manage symptoms of nausea. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update 11-Jul-2018: Significant case correction was performed 20-Jun-2018: The batch number: 179729P was deleted from the product tab. The narrative was amended accordingly.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, White blood cell count
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720198), concerns a 30-year-old, adult, female patient. The patient's current illness included asthma and anxiety disorder (since an unspecified). The patient had been allergic to metals, which caused skin reaction. The patient's concomitant medications included ZOFRAN, LEXAPRO, LEVORA and QVAR. On 11-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179729P (as reported) and expiry date: not reported) and non-company suspect product PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: N022303, dose and expiry date: not reported). The reported batch number (179729P), did not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. However, the query regarding batch number had been raised. On 13-Oct-2017, 02 days after vaccination, the patient experienced intermittent nausea, fever, redness, pain and swelling at injection site, which was warm to touch. On the same day, the patient went to the physician office and complete blood count (CBC), C-reactive protein (CRP), white blood cell (WBC) count tests were performed to rule out other concerns (results not reported). The doctor prescribed KEFLEX and prednisone course of medication and ZOFRAN to manage symptoms of nausea. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update 11-Jul-2018: Significant case correction was performed 20-Jun-2018: The batch number: 179729P was deleted from the product tab. The narrative was amended accordingly.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720264), concerns a 34-year-old, adult, female patient. The patient was allergic to sulfa drugs. The patient's current condition included recent child birth. On 12-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1721301 and expiry date: not reported). On 14-Oct-2017, 2 days after vaccination, the patient developed itchy rash on elbow and hand. The outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720269), concerns a 40-year-old, adult, female patient. The patient's current conditions included - IBSD (irritable bowel syndrome), high blood pressure, high cholesterol, depression, GERD (gastrooesophageal reflux disease) (reported as medical history) and allergy to monosodium glutamate (MSG) and eggs (reported as allergies). The concomitant medications included - VIBERZI, ranitidine, amlodipine, simvastatin, ZOLOFT and sulfamethoxazole with trimethoprim. The patient had urinary tract infection at the time of vaccination and had no lab investigations. On 06-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day after vaccination, the patient experienced vomiting, nausea and headache. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update 09-Aug-2018: Non-significant case correction was performed with 20-Jun-2018: The narrative was corrected as per the update.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720439), concerns a 60-year-old adult female patient. The patient had no medication history and allergies. On 10-Oct-2017, the patient received FLUVIRIN Thiomersal [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 1721501 and expiry date: not reported]. On 11-Oct-2017, after vaccination, the patient's upper arm about 4-5 inches below the injection site was red, hot and itchy. These symptoms remained for a day and began to resolve the following day, on 12-Oct-2017. On 13-Oct-2017, the patient stated that, she could barely see that area and area was not firm or warm, but it was tender, if she pushed on it. At the time of this report, the patient had recovered from the events (injection site erythema, injection site pain, injection site pruritus and injection site warmth). The reporter assessed this case as non-serious. Update 09-Aug-2018: Non-significant case correction was performed with IRD 20-Jun-2018: The verbatims of all the events were corrected. Added patient's age at vaccination (60-year-old) in relevant tab and missing information (I can barely see that area and if I push on it) in narrative. The narrative was corrected.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720447), concerns a 60-year-old, adult female patient. The patient's medical history, current illness and concomitant medications were unknown. The patient was allergic to sulfa and latex. On 01-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 179603A, expiry date: not reported). On the same day, after the vaccination, the patient experienced shoulder pain. Hence, the patient made a visit to the physician's office and was prescribed with pain medication. The patient was referred to the orthopedic. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720851), concerns a 55-year-old, adult, female patient. The patient's current condition included weight problems. The patient was allergic to Atropine, DEMEROL, KEFLEX, Oxycodone, metals, Sulfa drugs and DOVE deodorant. The patient's concomitant medication included Phentermine hydrochloride and metformin for an unknown indication. At the time of vaccination, the patient had no illness. On 16-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day after vaccination, the patient experienced itching and hives on face. Approximately at 1 PM, the patient took BENADRYL and about one and half hour later itching resolved. It was reported that, about 5 hours later, itching had started again for which the patient had taken two BENADRYLs. On 17-Oct-2017 (morning), the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721040), concerns a 63-year-old, adult, female patient. The patient's medical history was unknown and had no known allergies. The concomitant medications included levofloxacin, prednisone, lisinopril, famotidine, potassium, tramadol, gabapentin and alendronate for unknown indications. At the time of vaccination, the patient had no other illness. On 10-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml (reported as first dose), route of administration: intramuscular, anatomical location: right arm, batch number: 1720801 and expiry date: not reported). On 12-Oct-2017, 2 days after vaccination, the patient experienced right shoulder pain, which continued through 18-Oct-2017 (as reported). No lab tests were performed to the patient. At the time of this report, the patient had not recovered from the event (injection site pain). The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Dysstasia, Muscle spasms
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721050), concerns a 62-year-old, adult, female patient. The patient had no history any muscular activity to cause muscle spasms nor a history of previous back spasms. The patient was a non-smoker and drinker. The patient experienced rash from Penicillin and KEFLEX, anaphylaxis from ZOSYN, nausea, vomiting, aches and pains for 2 times from BIAXIN, flushing from ZITHROMAX, hives from MINOCIN and cashews, aphthous ulcers from FELDENE and MOBIC, severe diarrhea for 3 times from crab, migraines from mushrooms and olives. The patient's current conditions included allergic rhinitis, hypercholesterolemia, gestational diabetes for 2 times, rosacea (since an unspecified date). The patient was a caffeinated soda consumer. The patient did not use any illicit drug. The patient's concomitant medications included ZYRTEC, ZETIA, VITAFUSION multivitamins, VITAFUSION vitamin D3, Estradiol, FINACEA cream and ibuprofen for unknown indications. On 22-Sep-2017 (on Friday), at about 03:50 pm, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) and non-company suspect product ZOSTAVAX (route of administration: intramuscular, dose, anatomical location, batch number and expiry date: not reported). On 24-Sep-2017 (on Sunday), at 6:30 am, the patient woke up and felt fine and moved finely. At 7:30 am, after 02 days of vaccination, the patient sat down and was not able to stand due to severe 8/10 sharp pain in her lower back and two 50-cent-sized muscle knots were found over both sacroiliac joints. The patient received ibuprofen (600 mg, every 8 hours) and ice pack for 02 days but were unresponsive for spasms and pain. The patient went to the (primary care physician) PCP and received TORADOL and tizanidine for some relief. On an unspecified date, the patient had recovered from the events over one week. The reporter assessed the case as non-serious and considered the causality of the event nodule as related to the suspect vaccine. Update 22-Jul-2018: Significant case correction was performed with IRD 20-Jun-2018: The as determined causality of the events (nodule and low back pain) was corrected from related to no related. The case comment was amended accordingly. Update 23-Aug-2018: Significant case correction was performed with IRD 20-Jun-2018: Reporter causality for the event 'nodule' was changed from not reported to related in the event assessment tab and narrative.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721152), concerns a 55-year-old, adult female patient. On 08-Oct-2017, the patient was administered with FLUVIRIN (dose 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179901P and expiry date: not reported). On the same day, after vaccination, the patient developed red itchy rash. At the time of this report, the patient had recovered from the events (red itchy rash). The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Headache, Heart rate increased, Peripheral swelling
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721169), concerns a 65-year-old, elderly female patient. The patient was allergic to iodine, PNC (Penicillin), BENTYL, peanuts, gluten, wheat and lactose. The patient had no history of hypertension. The patient's concomitant medications included SYNTHROID, PROTONIX and lorazepam. On 13-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml [4th dose, as reported], route of administration: intramuscular, anatomical location: left arm, batch number; 1720801, expiry date: not reported). On 13-Oct-2017, 25 minutes after vaccination, the patient experienced dizziness, headache, rash, swelling in the arm, tachycardia (heart rate [HR] was 109 beats per minute), elevated high arterial pressure (158/88 mmHg). The outcome of all the events was not reported. Update on 13-Jul-2018: Case correction was performed with IRD 20-Jun-2018: The start date of all the events were corrected from on an unspecified date in Oct-2017 to 13-Oct-2017 (added in event tab). The events dizziness and headache were mapped symptoms of blood pressure increased. The narrative was amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tachycardia
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721169), concerns a 65-year-old, elderly female patient. The patient was allergic to iodine, PNC (Penicillin), BENTYL, peanuts, gluten, wheat and lactose. The patient had no history of hypertension. The patient's concomitant medications included SYNTHROID, PROTONIX and lorazepam. On 13-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml [4th dose, as reported], route of administration: intramuscular, anatomical location: left arm, batch number; 1720801, expiry date: not reported). On 13-Oct-2017, 25 minutes after vaccination, the patient experienced dizziness, headache, rash, swelling in the arm, tachycardia (heart rate [HR] was 109 beats per minute), elevated high arterial pressure (158/88 mmHg). The outcome of all the events was not reported. Update on 13-Jul-2018: Case correction was performed with IRD 20-Jun-2018: The start date of all the events were corrected from on an unspecified date in Oct-2017 to 13-Oct-2017 (added in event tab). The events dizziness and headache were mapped symptoms of blood pressure increased. The narrative was amended accordingly.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721249), concerns a 34-year-old, adult male patient. The patient's medical history, current illness, allergies and concomitant medications were not reported. On 16-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 18-Oct-2017, 2 days after vaccination, the patient developed fever of approximately 101 F. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721363), concerns a 75-year-old, adult, female patient. The patient's current condition included hypertension (since an unspecified date). The patient was allergic to CYMBALTA, sulfa drugs and VYTORIN. On 09-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 1720901, expiry date: not reported) was injected quickly by pinching the skin on right medial deltoid lateral side. On the same day, at night time, the patient began to experience pain at the injection site. The pain was so bad that, the patient could not use arm at all. The patient consulted a physician consulted a physician and found no signs of bacterial infection at the injection site. The patient took unspecified NSAIDs, heat compression, ice (at the injection site) and rubbed the site. The patient had no fever, erythema, discharge from the site, nausea, vomiting and respiratory issues. At the time of this report, the outcome of all the events was unknown. The reporter assessed this case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Mobility decreased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721747), concerns a 64-year-old, adult female patient. The patient's current condition included asthma, lichen sclerosus. The patient was allergic to aspirin, penicillin, erythromycin and sulfa drugs. The patient's concomitant medication included chlorhexidine. The patient reported that it was common to feel a little ill on the day of prior vaccinations and one immunization was administered in a forceful stabbed way in the past. On 01-Oct-2017, the patient was admnistered with FLUVIRIN (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). The vaccine was injected in a forceful stabbed way. The patient felt uncomfortable initially after vaccination. On the same day of vaccination (01-Oct-2017) in the night, the patient felt little feverish and arm was very sore. It was reported that, two and half weeks later, the patient woke up with acute pain in the muscle again and could not lift the arm with assistance from her right hand. The patient had not yet recovered from the events (discomfort, injected limb mobility decreased, myalgia, pain in extremity and pyrexia). The reporter assessed the case as non-serious. Updated on 20-Jun-2018: Case correction received with IRD 28-Jun-2018: Case was downgraded to non-serious. Case comment was updated. Amended narrative accordingly.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pharyngitis streptococcal, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721846), concerns a 20-year-old, adult female patient. The patient had no historical conditions, allergies and current illness. The patient did not receive any concomitant medications. On 21-Oct-2017, the patient was administered with FLUVRIN (dose: 0.5 ml, route of administration: injection [reported as SYR], anatomical location: left arm, batch number and expiry date: not reported). On 22-oct-2017, after vaccination, the patient experienced strep throat like sore throat (as reported) and runny nose. The patient consulted a physician. At the time of this report, the patient had not yet recovered from the events (oropharyngeal pain and rhinorrhoea). The reporter assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722172), concerns a 49-year-old, adult female patient. On 18-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 2nd dose], batch number: 179903P, anatomical site: left arm, route of administration: unknown and expiry date: not reported). On the same day, after vaccination, the patient complained of severe pain and stiffness. The patient was not able to use her arm. It was reported that, the patient applied ice but had no relief. At the time of this report, the patient had not yet recovered from the events (pain, musculoskeletal stiffness and musculoskeletal disorder). The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722184), concerns a 61-year-old, adult, female patient. The patient had no medical history and did not receive any concomitant medications. On 16-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 1721501 and expiry date: not reported) and PNEUMOVAX (dose: [reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: N020501 and expiry date: not reported). On the same day after vaccination, the patient experienced redness and swelling of the arm, which was warm to touch. The patient also experienced fever (reported as for 3 days), nausea and light-headedness. At the time of this report, the patient had not recovered from all the events. The reporter assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722184), concerns a 61-year-old, adult, female patient. The patient had no medical history and did not receive any concomitant medications. On 16-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 1721501 and expiry date: not reported) and PNEUMOVAX (dose: [reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: N020501 and expiry date: not reported). On the same day after vaccination, the patient experienced redness and swelling of the arm, which was warm to touch. The patient also experienced fever (reported as for 3 days), nausea and light-headedness. At the time of this report, the patient had not recovered from all the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722304), concerns a 62-year-old, adult, female patient. The patient's historical conditions and allergies were not reported. It was reported that the patient was not sick. The patient's current illness included occasional allergy (since an unspecified date). The patient's concomitant medications included Levothyroxine and allergy medications (unspecified). On 12-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical, location: left arm, batch number: 1720801 and expiry date: not reported). On 13-Sep-2017, one day after vaccination, the patient experienced prolonged muscle pain, which extended above and below the elbow, shooting pain down to thumb. The patient also had pain right above her elbow (reported as one day). The patient could not lift anything without pain. The patient made an appointment with the doctor but cancelled it. As of 19-Oct-2017, the patient had not yet re-scheduled her appointment with the doctor. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722333), concerns a 55-year-old, adult female patient. The patient had no current illness. On 27-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 1720701 and expiry date: not reported). On the same day, after vaccination, the patient experienced injection site muscle pain. As of 11-Oct-2017, the patient had not yet recovered the event. The reporter assessed the case as non-serious.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Rash papular, Rash pruritic
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722422), concerns a 23-year-old, adult, male patient. On 25-Aug-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 1st dose], route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 01-Oct-2017, 1 month and 6 days after vaccination, the patient developed itchy red bumps on hand, which spread to his chest. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 722597), concerns a 26-year-old, adult female patient. The patient had no historical conditions and current illness. On 12-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 1st dose], route of administration: intramuscular, anatomical location: left arm, batch number: 179801P, expiry date: not reported). On the same day, after vaccination, the shot or needle was removed, and the site started to bleed. Hence, it was compressed and bandaged. The patient had recovered from the event (injection site hemorrhage). The reporter assessed the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 723357), concerns a 35-year-old, adult, female patient. The patient's medical history and the concomitant medications were not reported. On 01-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 179703P, anatomical location and expiry date: not reported). On the same day (01-Oct-2017), after administration of vaccine, the patient remained in observation for 15 minutes in pharmacy. Afterwards the patient went to her car, and felt the need to use her albuterol inhaler. Later, the patient returned to the pharmacy to report her symptoms as she felt dizzy. The pharmacist called the emergency services (911 as reported) and they checked the vital signs which found to be stable. The emergency services still transported the patient to emergency room. At the time of this report, the outcome of the event (dizziness) was unknown. The reporter assessed the case as non-serious.