chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site 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: 720609), concerns a 46-year-old, adult female patient. The patient's history included obesity and non-insulin-dependent diabetes mellitus (NIDDM). The patient had no current illness and allergies. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.65 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506, expiry date: not reported). Immediately after the injection, the patient developed golf ball sized red lump under skin at injection site along with excessive pain (value on pain scale: 7/10). The pain scale showed value of 5/10, after 6 days. The patient decided not to seek any consultation but took ALEVE as treatment. At the time of this report the patient had not recovered from the events injection site lump and pain. The reporter assessed the case as non-serious.
Sex: U
Vaccine: FLU4
Symptoms: Dysgeusia, Flushing, Immediate post-injection reaction, Injection site erythema, Injection site pain
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: 720614) concerns a 26-year-old, adult, female patient. The patient's historical drug included influenza vaccine (unspecified date) and did not experience any events (without incident). The patient's medical history was not reported. The patient had no known drug and other allergy. The patient's concomitant medication included unspecified birth control pill. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: left arm, batch number: XF30506 and expiry date: not reported). On the same day, at the time of vaccination, the patient felt metallic taste. Immediately after administration of vaccine, the patient's injection site became red, swollen and warm. Also the patient's injection site was painful (7/10 in min after in after injection).It was reported that site continued to be painful (5/10), 2 hours later, with throbbing pain. The patient was treated with BENADRYL and MOTRIN which gave some relief. At the time of report, the outcome of the events was not recovered. The reporter assessed the case as non-serious.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Pain, Swelling face
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: 720614) concerns a 26-year-old, adult, female patient. The patient's historical drug included influenza vaccine (unspecified date) and did not experience any events (without incident). The patient's medical history was not reported. The patient had no known drug and other allergy. The patient's concomitant medication included unspecified birth control pill. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: left arm, batch number: XF30506 and expiry date: not reported). On the same day, at the time of vaccination, the patient felt metallic taste. Immediately after administration of vaccine, the patient's injection site became red, swollen and warm. Also the patient's injection site was painful (7/10 in min after in after injection).It was reported that site continued to be painful (5/10), 2 hours later, with throbbing pain. The patient was treated with BENADRYL and MOTRIN which gave some relief. At the time of report, the outcome of the events was not recovered. The reporter assessed the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Influenza
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: 720633), concerns a 40-year-old, adult female patient. On an unspecified date in 2010, at an age of 33 the patient was administered with influenza vaccine and the patient developed influenza after receiving the vaccine. The patient did not have any current illness. The patient was allergic to LEVAQUIN. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: XF33808 and expiry date: not reported). On the same day, after 1.5 hrs of vaccination patient had paresthesia of left arm to left hand. It was reported that, the patient did not receive any treatment medications. No lab tests done for the patient. After 2 days, the patient was recovered from the event. The reporter considered this case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: 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: 720633), concerns a 40-year-old, adult female patient. On an unspecified date in 2010, at an age of 33 the patient was administered with influenza vaccine and the patient developed influenza after receiving the vaccine. The patient did not have any current illness. The patient was allergic to LEVAQUIN. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: XF33808 and expiry date: not reported). On the same day, after 1.5 hrs of vaccination patient had paresthesia of left arm to left hand. It was reported that, the patient did not receive any treatment medications. No lab tests done for the patient. After 2 days, the patient was recovered from the event. The reporter considered this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720681), concerns a 48-year-old, adult, female patient. The patient's historical conditions included asthma and arthritis (unspecified date). The patient had been allergic to sulpha drugs, seafood and coconut. The patient had no current illness. The patient's concomitant medications included Multivitamin, Triamcinolone cream, clotrimazole cream, methotrexate injection, ZANAFLEX, Leucovorin, folic acid, TRINTELLIX, SEROQUEL, TOPAMAX, VISTARIL, MINIPRESS, VENTOLIN, KLONOPIN, QVAR and Baby aspirin. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: 00844621A, anatomical location: right arm and expiry date: not reported). On the same day, after the vaccination, the patient experienced soreness, swelling and red puffiness which were 2 inches in diameter. The patient was treated with TYLENOL, CLARITIN and would use ice for the events. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Headache, Tremor
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: 720757), concerns a 28-year-old, adult female patient. The patient had no known allergies and was ruled out for Lupus by PMD (as reported). The patient had no current illness and concomitant medications. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33408, expiry date: not reported). On 14-Oct-2017, the next day of vaccination, patient had dizziness, unsteady gait, tremors and headache. At the time of this report, the patient had recovered from the events (dizziness, unsteady gait, tremors and headache). The reporter assessed the case as non-serious.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: 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: 720778), concerns a 63-year-old adult male patient. It was reported that, the patient had no current illness. The patient's concomitant medications included amlodipine besylate, losartan, HCTZ, Citrate, ranitidine, aspirin, B 12 and Krill oil. On 22-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 23-Sep-2017, 1 day after the administration of vaccine, the patient experienced tingling of arm (ring finger) and extreme pain in arm, back of forearm, front and back of lower arm, and elbow. It was reported that, the patient's family physician prescribed prednisone (10mg for 8 days- with decreasing dosage). At the time of this report, the patient had not recovered from all the events. The reporter assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
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: 720808), concerning a 57-year-old, adult female patient. The patient's historical condition included: heat disease. Historical procedure included: stent placement. Historical drug included: sulfa drugs. Concomitant medication included: unspecified blood pressure and thyroid medication. On 05-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XF32908, expiry date: not reported). On the same day, the patient was also administered with non-company suspect drug PNEUMOVAX (dose, route of administration: intramuscular, anatomical location: right arm (left deltoid), batch number: N013541, expiry date: not reported). On the same day, the patient's arm was sore. So, she iced it and took ibuprofen for pain. On the following day, the patient's upper right arm was more swollen. Hence, she continued with ice and ibuprofen. On 07-Oct-2017, the patient could not move her arm. In addition, the whole circumference of upper right arm, below injection site was very red, swollen and sore. On 07-Oct-2017, the patient went to the urgent care where she was advised to use topical hydrocortisone cream and unspecified allergy tablets. She was also given unspecified antibiotics. On 11-Oct-2017, the patient's swelling and soreness was gone. The patient had recovered from all the events. The reporter assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, 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: 720826), concerns a 44-year-old, adult, female patient. The patient's historical condition included asthma (unspecified date). The patient had seasonal allergies, gluten and lactose intolerance. The patient's current condition and concomitant medications were not reported. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch number: XF33208, route of administration and expiry date: not reported). On the same day, after the vaccination, the patient was not able to raise her left arm above shoulder height and it was improving by the day. After 4 days (as reported), the patient's arm was still painful to raise above shoulder height. 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: Asthenia, Dizziness, Fall, Headache, Loss of consciousness
Clinical narrative: This spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720844), concerns a 10-year-old, female child. The patient's had no history or current conditions, allergies and concomitant medications. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 011446118 (as reported), expiry date: not reported). On the same day, the patient had headache, felt very dizzy and weak. She could not see well. It was reported that, the patient had to sit down for some time, when she started walking. The patient passed out/fainted while walking and felt sick. At the time of this report, the patient had recovered from all the events, headache, dizzy, weak, abnormal vision, fall, faint and sick. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Syncope, Visual impairment
Clinical narrative: This spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720844), concerns a 10-year-old, female child. The patient's had no history or current conditions, allergies and concomitant medications. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 011446118 (as reported), expiry date: not reported). On the same day, the patient had headache, felt very dizzy and weak. She could not see well. It was reported that, the patient had to sit down for some time, when she started walking. The patient passed out/fainted while walking and felt sick. At the time of this report, the patient had recovered from all the events, headache, dizzy, weak, abnormal vision, fall, faint and sick. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Injection site reaction, Pain in extremity
Clinical narrative: This is spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 724854), concerns a 51-year-old, adult female patient. The patient's current condition included penicillin allergy and historical condition included GERD (gastroesophageal reflux disease). The patient's concomitant medication included: PREVACID, multi vitamin, Vitamin D, biotin, lutein. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), batch number: 00544611A, anatomical location: right arm, route of administration: intramuscular). On the same day, after administration of vaccine, the patient had bleeding at injection site followed by muscle for two days. On 17-Oct-2017 (Tuesday, in morning), the patient had severe pain and inability to move right arm in an upward motion with muscle failure. The patient has limited mobility in her right arm and constant pain. The patient visited a physician office for the events. The outcome of the events (injection site bleeding, injected limb mobility decreased, pain in extremity, injection site pain) had not yet recovered. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pyrexia, Retching
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: 720953), concerns a 75-year-old, elderly, female patient. The patient's historical condition included COPD (chronic obstructive pulmonary disease) and "post" (as reported). The patient's current condition included high blood pressure (since an unspecified date). The patient had no allergies. The patient's concomitant medications included COZAAR, NORVASC, BYSTOLIC, Oxybutynin, melatonin, Probiotics, bismuth subsalicylate and BEANO for an unknown indication. On 13-Sep-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 the vaccination, the patient experienced chills, fever of 102.2-degree F, nausea and dry heaves. No lab investigations were done. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, 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: 721004), concerns a 41-year-old adult female patient. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33108, expiry date: not reported). On the same day, after the administration of vaccine, her arm was swollen about the size of a golf ball. The patient was treated with ice and MOTRIN. On the following day, the patient reported that, her arm was less swollen. The patient also stated that she had redness across her arm (on an unknown date) and band of redness about 2-3 wide. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous case, initially received from other health professional via health authority (VAERS ID: 721020) on 05-Dec-2017, concerning a 68-year-old elderly male patient. On 28-Feb-2017, the patient was administered with AFLURIA QUADRIVALENT (anatomical location: left arm, batch number: WT58008, route of administration, dose and expiry date: not reported) and PREVNAR (anatomical location: left arm, batch number: N34935, route of administration, dose and expiry date: not reported). On the same day, after the administration of vaccine, the patient experienced rash. The patient was treated with loratadine (10 mg every day) and ranitidine 150 mg every day. At the time of this report, the outcome of the event not reported. The reporter assessed this case as non-serious.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema
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: 721131), concerns a 72-year-old, elderly, female patient. On 14-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 00844621A and expiry date: not reported). On the same day, after the vaccination, the patient experienced an area of redness which spanned from the injection site (left deltoid) down to below her elbow. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
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: 721144) concerning a 53-year-old, adult female patient. The patient had no medical history. On an unspecified date, approximately in 2011, the patient received Tdap and experienced malaise and low-grade fever. Concomitant medications included: fish oil pills everyday as OTC. On 10-Oct-2017, the patient received AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 12-Oct-2017, after 2 days of vaccination, the patient had severe left shoulder pain with severe limitation of range of motion (injection site pain and injected limb mobility decreased). Later, she had severe pain. Hence, she was unable to raise the left arm higher than 3 inches from the side. On 13-Oct-2017, the patient received Ibuprofen (dose: 400 mg, twice daily) but had no effect on pain. Hence, again she took ibuprofen (dose: 400 mg, thrice a day) which resulted decrease in pain and 50 percent of range of motion. Subsequently, the patient had no tenderness at injection site. No redness, no swelling and no fever. On 15-Oct-2017, the patient had recovered from all the events (injected limb mobility decreased, injection site pain and pain). The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: This spontaneous case, initially received on 17-Oct-2017, from other health professional (nurse), concerning a 31-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular and anatomical location: right deltoid [right arm], batch no: XF31507, expiry date: 30-Jun-2018). On the same day, after administration of vaccine, the patient experienced rash around the injection site. In addition, she developed large golf ball size lump, redness, itching and hives. The patient had recovered from all the events. The reporter assessed the events as non-serious and causality of the event injection site as related to the suspect vaccine. Non-significant follow up received on 19-Oct-2017: No new information was available. Follow-up received on 27-Oct-2017: Updated dose, route of administration and anatomical location of the suspected vaccine. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly. Follow up retrieved by Seqirus from VAERS (reported to health authority by other health professional) (VAERS ID: 721266) on 21-Feb-2018: Added age of the patient (31-year-old) in the patient tab. Added anatomical location as right arm in the product tab. Updated vaccine administration section in the product tab. The event was changed from "patient had [hives], lumps, [and rashes] around the injection site" to "large golf ball size lump", "patient had hives, [lumps, and rashes] around the injection site" was changed to "hives". Added new event as redness and itchiness in the event tab. Outcome of the events was changed from not reported to recovered. Added VAERS ID in the additional information tab. The narrative was amended accordingly.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from a nurse, concerning a 38-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch no: XF31507, expiry date: 30-Jun-2018). On the same day, after the administration of vaccine, the patient developed hives, lump (tennis ball size), redness, soreness, itchiness and rashes around the injection site. The outcome of the events reported as recovered. The reporter assessed the events as non-serious and causality as related to the vaccine. Follow-up received on 27-Oct-2017: Updated dose, route of administration and anatomical location of the suspected vaccine. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly. Follow up retrieved from VAERS (reported to VAERS by other health professional) on 21-Feb-2018: Health authority number (VAERS ID: 721269) was updated. Added new events (mass, redness, itchy and soreness). Onset date (12-Oct-2017) of the events was added. The anatomical location was changed from deltoid to left arm. The outcome of the events was changed from not reported to recovered. Narrative was amended accordingly.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from a nurse, concerning a 38-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch no: XF31507, expiry date: 30-Jun-2018). On the same day, after the administration of vaccine, the patient developed hives, lump (tennis ball size), redness, soreness, itchiness and rashes around the injection site. The outcome of the events reported as recovered. The reporter assessed the events as non-serious and causality as related to the vaccine. Follow-up received on 27-Oct-2017: Updated dose, route of administration and anatomical location of the suspected vaccine. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly. Follow up retrieved from VAERS (reported to VAERS by other health professional) on 21-Feb-2018: Health authority number (VAERS ID: 721269) was updated. Added new events (mass, redness, itchy and soreness). Onset date (12-Oct-2017) of the events was added. The anatomical location was changed from deltoid to left arm. The outcome of the events was changed from not reported to recovered. Narrative was amended accordingly.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous case, initially received from other-health professional (nurse) on 17-Oct-2017, concerns a 43-year-old, adult female patient. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch no: XF31507, expiry date: 30-Jun-2018). On the same day, after administration of vaccine between 30 minutes and one hour, the patient experienced hives, lumps/mass, pruritus, rash and pain around the injection site. The injection site appeared red. At the time of this report, the patient had recovered from the events. The reporter assessed this report as non-serious. Non-significant follow-up received on 19-Oct-2017 (no new information received). Follow-up report received on 27-Oct-2017: Dose, anatomical location, route of administration was added. The reporter stated that, it was unknown which patient still had lumps. Amended narrative accordingly. Non-significant follow-up received on 09-Nov-2017 with no new information available. Follow up retrieved from VAERS (reported to VAERS by other health professional) on 21-Feb-2018: Health authority number (VAERS ID: 721270) was updated. Added new events (pain, redness and itchiness at injection site). The outcome of the events was changed from not reported to recovered. Narrative was amended accordingly. Significant case correction received 21-Feb-2018: The listedness was corrected for the event redness. No changes were made in the narrative.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous case, initially received from other-health professional (nurse) on 17-Oct-2017, concerns a 43-year-old, adult female patient. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch no: XF31507, expiry date: 30-Jun-2018). On the same day, after administration of vaccine between 30 minutes and one hour, the patient experienced hives, lumps/mass, pruritus, rash and pain around the injection site. The injection site appeared red. At the time of this report, the patient had recovered from the events. The reporter assessed this report as non-serious. Non-significant follow-up received on 19-Oct-2017 (no new information received). Follow-up report received on 27-Oct-2017: Dose, anatomical location, route of administration was added. The reporter stated that, it was unknown which patient still had lumps. Amended narrative accordingly. Non-significant follow-up received on 09-Nov-2017 with no new information available. Follow up retrieved from VAERS (reported to VAERS by other health professional) on 21-Feb-2018: Health authority number (VAERS ID: 721270) was updated. Added new events (pain, redness and itchiness at injection site). The outcome of the events was changed from not reported to recovered. Narrative was amended accordingly. Significant case correction received 21-Feb-2018: The listedness was corrected for the event redness. No changes were made in the narrative.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: This spontaneous case, initially received on 17-Oct-2017 from a nurse, concerning a 58-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid (right arm), batch no: XF31507, expiry date: 30-Jun-2018). On the same day, between 30 minutes to 1 hour after administration of vaccine, the patient developed hives and rashes around the injection site. In addition, she experienced golf ball size lump, itchiness and redness. The patient had recovered from the events golf ball size lump, itchiness and redness. The outcome of other events injection site urticaria and injection site rash was not reported. The reporter assessed the events as non-serious. Follow-up received on 27-Oct-2017: Updated dose, route of administration, anatomical location and batch number was added in the screen. The reporter stated that it was unknown which patient still had lumps. The narrative was amended accordingly. Follow up retrieved by Seqirus from VAERS (VAERS ID: 721272) (reported to health authority by other health professional) on 21-Feb-2018: Updated anatomical location as right arm (in product tab). Updated vaccine information section in the product tab. The event "injection site lump" was changed to "mass". Added new event redness and itchiness in the event tab. Updated to VAERS ID in the additional information tab. The narrative was amended accordingly.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site rash, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from a nurse, concerning a 60-year-old female adult patient. The patient's historical drug included flu vaccine and experienced adverse event lump. The patient's concomitant medications were not reported. On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch no: XF31507 and expiry date: 30-Jun-2018). On the same day, instantly between 30 minutes to 01 hours after administration of vaccine, the patient developed hives, lumps, swelling, stiffness and rashes around the injection site. The patient also experienced shoulder pain. The patient recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 27-Oct-2017: Updated dose, route of administration and anatomical location of the suspected vaccine. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly. Follow up retrieved from VAERS (reported to VAERS by other health professional) on 21-Feb-2018: Health authority number (VAERS ID: 721274) was updated. Added new events (mass, shoulder pain, stiffness and swelling). The anatomical location was changed from deltoid to left arm. The outcome of the events was changed from not reported to recovered. The patient's medical history was added. Narrative was amended accordingly.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from a nurse, concerning a 60-year-old female adult patient. The patient's historical drug included flu vaccine and experienced adverse event lump. The patient's concomitant medications were not reported. On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch no: XF31507 and expiry date: 30-Jun-2018). On the same day, instantly between 30 minutes to 01 hours after administration of vaccine, the patient developed hives, lumps, swelling, stiffness and rashes around the injection site. The patient also experienced shoulder pain. The patient recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 27-Oct-2017: Updated dose, route of administration and anatomical location of the suspected vaccine. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly. Follow up retrieved from VAERS (reported to VAERS by other health professional) on 21-Feb-2018: Health authority number (VAERS ID: 721274) was updated. Added new events (mass, shoulder pain, stiffness and swelling). The anatomical location was changed from deltoid to left arm. The outcome of the events was changed from not reported to recovered. The patient's medical history was added. Narrative was amended accordingly.
Sex: M
Vaccine: FLU4
Symptoms: Headache, Neck pain, Swelling
Clinical narrative: This spontaneous case, reported by a other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 721378), concerning a 56-year-old, adult male patient. The patient's medical history, current illness and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33008, expiry date: not reported). 28-Sep-2017, after 1 day of vaccination, the patient left sided neck pain and swelling, and headache. The patient presented to urgent care center after neck pain persisted and was given a muscle relaxer. He took unspecified medications for 4 days for alleviated neck pain. Later, he felt ok and had no more pain, swelling and headache. The patient had recovered from all the events. The reporter assessed this case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Skin warm
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: 721385), concerns a 64-year-old, elderly female patient. The patient's current conditions included, high cholesterol and concomitant medications included pravastatin, VENTOLIN HFA inhaler, lorazepam for unknown indications. The patient was allergic to penicillin and erythromycin. On 14-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: XF31507, expiry date: not reported) and PNEUMOVAX (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: M041686, expiry date: not reported). Approximately half an hour after vaccination, the patient had swollen arm from her shoulder to elbow and was hot to touch, but not red. The patient applied ice and the swelling reduced. The patient took the AFLURIA vaccine on left arm and no events were reported. At the time of this report, the patient had recovered from the events, swollen arm and skin warm. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
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: 721396), concerns a 50-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. 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: XF32508 and expiry date: not reported). On the same day, after vaccination, the patient had severe constant pain in upper arm, shoulder and neck. At the time of report, the patient had not recovered from the events (shoulder pain, neck pain and pain in arm). The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Blood pressure abnormal, Injection site cellulitis, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 721431), concerns 86-year-old, elderly female patient. The patient's vaccination history included PREVNAR (at least 1 year ago). It was reported that, the patient was never vaccinated with PNEUMOVAX 23 and there was no history of any reaction to a vaccine. The patient was healthy with no other health conditions or allergies. The patient's current illnesses included abnormal blood pressure and glaucoma. The patient's concomitant medication included SYMBICORT, unspecified medications for blood pressure and eye drops for glaucoma. On 08-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, anatomical location: right arm, route of administration, batch number, expiry date: not reported) and PNEUMOVAX 23 (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: N19348 (as reported), expiry date: 08-Feb-2019). On 10-Oct-2017, after 2 days of vaccination, the patient developed cellulitis type reaction, with swelling and a wet, blistery, rash (described as awful looking) at the site of injection on the left deltoid down to the elbow. Upon visiting the pharmacy with the events, the pharmacist referred, the patient to consult a physician, as hospitalization might also be required. The reporter was unaware whether the patient was hospitalized and described the event as "horrifying event". At the time of this report, the patient had not recovered from the events (was experiencing really bad symptoms). The reporter assessed the case as serious (medically significant).
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
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: 721505), concerns a 54-year-old, adult, male patient. The patient current condition included, high blood pressure, cholesterol, allergy to penicillin, and allergies from time to time (from an unspecified date). It was also reported that, sickness or strong odours triggers the asthmatic condition (since on an unspecified date). The concomitant medications included Losartan for cholesterol and Amlodipine for blood pressure on an unspecified date. On 05-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: injection, anatomical location: left arm, batch number and expiry date: not reported). On 08-Oct-2017, after 3 days of vaccination, the patient had a pain at injection site, which continues to gain the intensity. On day 14, the moved from injection site to down to elbow with an intensity as pulled muscle. The patient also had pain, upon movement of head and neck. It was reported that, her arm was consistently hurting during sleep and at rest. Two weeks after, the patient didn't get better from the events. At the time of the report, the patient had not recovered from the events (injection site pain, pain upon movement and pain in arm). The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling abnormal, Hypoaesthesia, Injection site erythema, Injection site induration
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: 721675), concerns a 51-year-old, adult, female patient. The patient's historical condition included cellulitis of ankle (unspecified date). The patient's allergy, current condition and concomitant medication were not reported. On 19-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33208 and expiry date: not reported). On the same day, soon after the vaccination, the patient had a tingling, numbing sensation and heaviness to her arm, which was red, indurated and warm. It was reported that, it might be the fluid given in the tissue and not to the muscle. As day progressed, she did not feel good. On the same day, the patient observed left deltoid area with erythema, induration and warmth with size 5.5 cm x 6.5 cm in diameter. The patient did not experience fever or other signs and symptoms of malaise. It was reported that, patient felt better than last night (as reported). She was advised to take ibuprofen for pain, discomfort and cold compresses as needed and to report to office on Monday (as reported) for follow-up. At the time of this report, the patient was recovering from the events. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 21-Feb-2018: Case comment was corrected.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Limb discomfort, Paraesthesia, Skin warm
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: 721675), concerns a 51-year-old, adult, female patient. The patient's historical condition included cellulitis of ankle (unspecified date). The patient's allergy, current condition and concomitant medication were not reported. On 19-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33208 and expiry date: not reported). On the same day, soon after the vaccination, the patient had a tingling, numbing sensation and heaviness to her arm, which was red, indurated and warm. It was reported that, it might be the fluid given in the tissue and not to the muscle. As day progressed, she did not feel good. On the same day, the patient observed left deltoid area with erythema, induration and warmth with size 5.5 cm x 6.5 cm in diameter. The patient did not experience fever or other signs and symptoms of malaise. It was reported that, patient felt better than last night (as reported). She was advised to take ibuprofen for pain, discomfort and cold compresses as needed and to report to office on Monday (as reported) for follow-up. At the time of this report, the patient was recovering from the events. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 21-Feb-2018: Case comment was corrected.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pityriasis rosea
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: 721762), concerns a 61-year-old, adult, male patient. The patient had no known allergies. The concomitant medications included lisinopril, metformin, JANUVIA and atorvastatin (on an unspecified date). On 01-Oct-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: XF33008 and expiry date: not reported). On the same day, after vaccination, the patient had pitryriasis rosea. At the time of the report the patient had not recovered from the event (pitryriasis rosea). The patient's lab data was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Impaired driving ability, Injected limb mobility decreased, Injection site joint pain
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: 721772), concerns a 29-year-old, adult female patient. It was reported that, the patient was allergic to ULTRAM. On 13-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), batch number: XT59606, anatomical location: right arm, route of administration: intramuscular). On the same day, after vaccine administration, the patient had soreness from 7:00pm to 12:00am. Then the patient had numbness in her right wrist/thumb, elbow pain, aching and tingling in right wrist and thumb. Ice was applied from 12:00-2:00 for 20mins on and 20 mins off. The patient was unable to lift her arm horizontal to body, aching in shoulder joint continued. At 3:20 am, while attempting to sleep she can only lay on back or left side. It was reported that, the patient had right arm tingling and aching through right thumb, outer thumb/wrist. The patient was unable to move wrist/hand without intense pain. She took two ibuprofen. The patient was called out from work. She was a nurse and cannot work if one of her arms doesn't work). Over course of day, the patient was able to move thumb a little more, but still with pain. On 15-Oct-2017, soreness with movement of right arm was noted. On 16-Oct-2017, arm felt fine but right thumb was still in pain with movement. The patient had recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain, Pain in extremity, Paraesthesia
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: 721772), concerns a 29-year-old, adult female patient. It was reported that, the patient was allergic to ULTRAM. On 13-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), batch number: XT59606, anatomical location: right arm, route of administration: intramuscular). On the same day, after vaccine administration, the patient had soreness from 7:00pm to 12:00am. Then the patient had numbness in her right wrist/thumb, elbow pain, aching and tingling in right wrist and thumb. Ice was applied from 12:00-2:00 for 20mins on and 20 mins off. The patient was unable to lift her arm horizontal to body, aching in shoulder joint continued. At 3:20 am, while attempting to sleep she can only lay on back or left side. It was reported that, the patient had right arm tingling and aching through right thumb, outer thumb/wrist. The patient was unable to move wrist/hand without intense pain. She took two ibuprofen. The patient was called out from work. She was a nurse and cannot work if one of her arms doesn't work). Over course of day, the patient was able to move thumb a little more, but still with pain. On 15-Oct-2017, soreness with movement of right arm was noted. On 16-Oct-2017, arm felt fine but right thumb was still in pain with movement. The patient had recovered from the events. The reporter assessed the case as non-serious.