chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received on 13-Sep-2017 from a pharmacist, concerning a 3-year-old female child. The patient's medical history and concomitant medications were not reported. On 06-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A (as reported), expiry date: MAR-2018, route of administration, anatomical location: not reported). FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older explicitly coded as inappropriate age at vaccine administration. It was reported that, no adverse effects were noted. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 13-Sep-2017 from a pharmacist and concerns a 48-year-old adult male patient. The patient's concomitant medications included unspecified anti-inflammatory and muscle relaxer. It was reported that the patient had no chronic condition during vaccine administration. On an unspecified date in 2017, the vaccine stored beyond the recommended range for 12 hr reaching 50 F maximum. On 13-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195213 (as reported), expiry date: Mar-2018, route of administration, anatomical location: not reported). The outcome of the events was not reported. The reporter assessed the report as non-serious.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via eye contact, Exposure via skin contact, Eye irrigation, Syringe issue
Clinical narrative: This spontaneous case, initially received on 31-Oct-2017, reported by other health professional and concerns a 23-year-old female patient. Patient's medical history and concomitant medications was not reported. On 31-Oct-2017, while administering FLUCELVAX QIV (dose: not sure of the quantity (as reported), route of administration, batch number: 195233, expiry date: 31-May-2018), the vaccine squirted out of the syringe, syringe malfunctioned and vaccine squirted into another student's and nurse eyes and mouth. The patient washed her eyes after the incident. As per the PTC report, the damage occurred when one of the student was about to prepare for administering. It was reported that, the vaccine was not administered. It was reported that, there was no signs of damage, the syringe tray received sealed, rest of the syringes have been inspected, product stored in its original carton after receipt. The PTC number was reported 1025703 and the QA investigation conducted that FLUCELVAX Batch 195233 was manufactured in compliance with the approved internal procedures and in accordance with quality requirements. No internal root cause was identified in the manufacturing process, and no trends were identified for the batch for leaking syringes. The most likely root cause can be attributed to Supplier/Material/Defective. On 31-Oct-2017, while administering the vaccine. The reporter assessed the case as non-serious. Follow-up received from the QA (quality assurance) department on 13-Dec-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195233 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, and no trends were identified for the batch for leaking syringes. The most likely root cause can be attributed to Supplier/Material/Defective.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Limb discomfort, Pain in extremity, Urticaria
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 06-Sep-2017, concerning a 53-year-old adult male patient. The patient's medical history included work injury (years ago) but was not sure of the extent of it. The patient's current conditions included sleep and prostate related disorder (since an unspecified date). The patient concomitant medications included trazodone (sleep) and tamsulosin (for prostate). On 27-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, lot number: 195214, expiry date: Apr-2018, route of administration, anatomical location: not reported). On the same day, after vaccine administration, the patient's arm was quite sore from the shot. He felt his arms heavy and sore. On 28-Aug-2017(the day after the shot), he got hives all over his body. It was reported that the hives were kind of sporadic, randomly present all over and they had not gone yet. Hives got better once but moved to a different place. The patient's sore arm persisted for 10 days from the administration of vaccine. The patient was treated with prednisone 10 mg dose packs for 6 days. The patient was not hospitalized for the events. At the time of this report, the patient was not yet recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 19-Oct-2017: The patient's concomitant and treatment medications were updated. Narrative amended accordingly.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Mom called on 1/16/18 at 10am and states pt right thigh where the injection was given there was a 2in in diameter red swollen and hot to touch knot. Advised mom to refer to the MMRV VIS and call back with any new or continued symptoms. Mom came back into the clinic on 1/22/18 and states pt right thigh knot and redness did go away quickly that day, but then came back today and was now 1.5 in red, warm to touch and swollen. Pt had no fever in clinic and no other symptoms. Mom called back on 1/23/18 and states pt right thigh is red with a purplish center, hot and hard to touch. Mom was advised to go to urgent care and mom did not and was seen in office on 1/24/18 and was advised by Dr and Dr that this looked more like a local reaction at the vaccine site or possible fat necrosis and to call back for any streaking or induration noted. Mom understands and will do phone follow up on 1/26/18.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient called one day after vaccine administration and described the injection site as being red, hot, quarter sized, and painful. She called again three days after vaccination and described the injection site as being red, hot, and softball size. She states that the pain at the injection site had decreased from our previous conversation.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Patient complains of having a "blue line" (vein) on her biceps on both arms.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Lymphadenopathy
Clinical narrative: Member presented to the immunization clinic with swollen lymph nodes and chest tightness/pain. Patient didn't seem to be in any distress. We looked at the site which was normal and immediately brought him to our urgent care center.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The arm where the flu shot was administered has limited range of motion and extreme pain. I cannot lift arm up to my head or to the side.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: I was completing our monthly medication review form today, 1/25/18, to be submitted to the pharmacy. Our clinic has had two doses of stock PENTACEL available since November, possibly even before, no additional stock PENTACEL has been ordered after November. Both doses of PENTACEL shared the same lot number and expiration dates. I found one complete dose of the two components, and one dose of only the DTaP-IPV. It appeared the Hib portion had been used. I found one patient within the appropriate time frame from December's medication review form until today's medication review form. I followed-up with the manufacturer. The manufacturer stated the dose received on 1/2/18 was not to be considered valid, and the patient is to repeat the dose.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 05-Sep-2017 from pharmacist, concerning a 57-year-old, adult, male patient. The patient's current condition included smoker (since an unspecified date). The patient's concomitant medications included diazepam and methylphenidate. On an unspecified date, it was reported that, FLUCELVAX QIV was stored at 55 F (Fahrenheit) overnight from 9 PM to 10 AM next day (first excursion), which was considered as incorrect product storage. On 05-Sep-2017, the patient was administered with FLUCELVAX QIV (batch number: 195210A, expiry date: Mar-2018, dose, route of administration, anatomical location: not reported). The patient was administered with vaccine which was stored at 55 F, approximately 11 hours, instead of storing at 36-46 F. It was reported that patient did not experience any adverse event following administration of the vaccine. The outcome of the events was not reported. Follow-up received on 01-Nov-2017: It was reported that patient did not experience any adverse event following administration of the vaccine. Narrative amended accordingly.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This initial non-serious spontaneous case, received from other health professional on 06-Sep-2017, concerning a 68-year-old female patient. Patient's medical history and concomitant medications were not reported. On 06-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, batch number: 195226, expiry date: Apr-2018, route of administration and anatomical location was not reported). It was reported that FLUCELVAX QIV is to be stored protected from light and refrigerated between 36 degrees F and 46 F (2 degrees C and 8 degrees C) as stated in the approved product label and must not be freeze. HCP staff states that FLUCELVAX had a temperature excursion between 6:00 PM one day to 7:00 AM the next day (13h) reaching 26.1F maximum. Not frozen. It was reported that, this was the first time for the excursion. Characterized as incorrect product storage. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Pleurisy
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Sep-2017 from a pharmacist and concern a 60-year-old adult female patient. The patient had not received any relevant concomitant medication. On 12-Sep-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195214, expiry date: Apr-2018, route of administration and anatomical location: not reported). On the same day, after an hour of vaccination (flu shot), the patient had difficult in breathing and was admitted to the emergency room. She was diagnosed with pleurisy and left the emergency room on the same day. At the time of this report, the outcome of the event was recovering (reported as 'patient was ok after leaving from the hospital'). Follow-up received from the reporter on 22-Sep-2017: As per the follow-up the case was downgraded from serious to non-serious, as the patient was admitted to emergency room, but not hospitalized due to event. The outcome of the event was updated from unknown to recovering. It was reported that, patient had not received any relevant concomitant medication. Narrative amended accordingly. Non-significant follow-up report received on 06-Oct-2017: The patient was recovering and reported no further problems. Amended narrative accordingly. Non-significant case correction received 14-Sep-2017: Batch no. (195214) was captured in the case from and narrative was amended accordingly.
Age: 91.0
Sex: F
Vaccine: FLUC4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous case, was received from other-non health professional on 20-Oct-2017, concerns a 91-year-old, elderly female patient. The patient's current condition included hypertension, hypothyroidism, high cholesterol, and unspecified kidney disease since an unspecified date. Subject had a history of uterine cancer (dates not reported). On an unspecified date, the subject underwent hysterectomy and tripe bypass (dates not reported). Concomitant medication included NORVASC, LEXAPRO, levothyroxine, simvastatin and metformin for an unknown indication. On 07-Sep-2017, the patient was administered with first dose and on 18-Oct-2017, the patient was administered with second dose of FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no. 195237 and expiry date: May-2018). The patient was vaccinated with 2 doses in the same season (explicitly coded as inappropriate schedule of vaccine administered). It was reported that, no adverse event noted (explicitly coded as no adverse event). The reporter considered the case as non-serious.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were not provided.  On an unknown date, the patient was vaccinated with PNEUMOVAX 23 0.5ml, intramuscularly, lot # N022303 for prophylaxis. The reporting pharmacist stated that she attempted to remove the air from the syringe, prior to administered the injection, but the syringe leaked from the needle connection site.  Due to the pharmacy did not have another PNEUMOVAX 23 prefilled syringe to use for this patient, he did not receive their PNEUMOVAX 23 injection. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 11-year-old, female child. On 11-Apr-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as 185586, 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). It was reported, that multiple temperature excursions occurred on 02-Mar-2017, as the vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017 at 47F for 16h (2nd excursion), 04-Mar-2017 at 47F for 19.75h (3rd excursion), 07-Apr-2017 at 35F for 14.5h which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F it was considered as drug administration error. The outcome of the events was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 07-year-old child, female patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was ninth of 10 reports. On 04-Aug-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586, 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion), 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) and On 07-April-2017, vaccine was stored at 35F for 14.5h (4th excursion) which was considered as incorrect product storage. As the patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. Non-significant case correction received with IRD: 14-Aug-2017: Batch number (186686) was captured in the case form and narrative was amended accordingly.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received from a physician on 14-Aug-2017, concerns a 06-year-old male child patient. Physician reported 10 patients who were vaccinated after multiple temperature excursions. This report was 7th of 10 reports. On 03-Apr-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported ass 185586, 186686), expiry date: 31-May-2017, dose, route of administration and anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), on 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and on 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. Non-significant case correction received with IRD: 14-Aug-2017. Batch number (186686) was captured in the case form and narrative was amended accordingly.
Age: 17.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 17-year-old, adolescent, female patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was eight of 10 reports. On 05-Apr-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as 185586 and 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as Incorrect product storage. As the patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the events was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received from a physician on 14-Aug-2017, concerning a 04-year-old male patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was sixth of 10 reports. On 24-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as: 185586), expiry date: 31-May-2017, dose, route of administration and anatomical location: not reported). On 24-Mar-2017, the patient was vaccinated after multiple temperature excursions. First excursion occurred on 02-Mar-2017 (47-degree F, 14.7h), second on 03-Mar-2017 (47-degree F, 16 h) and third on 04-Mar-2017 (47-degree F, 19.75 h) which was characterized by incorrect storage of drug and drug administration error. The outcome of the events was not reported. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 06-year-old, female child. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was fifth of 10 reports. On 22-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586 and 186686), expiry date: (reported as 31-May-2017), dose, route of administration, anatomical location: not reported). It was reported that multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017 at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. As the patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F was considered as drug administration error. Non-significant case correction received: 14-Aug-2017. Batch no. (186686) was captured in the case form and narrative was amended accordingly.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 08-year-old, child, female patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was third of 10 reports. On 16-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586), expiry date: (reported as 31-May-2017), dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the events was not reported. Non-significant case correction received with IRD: 14-Aug-2017 Batch number (186686) was captured in the case form and narrative was amended accordingly.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 04-year-old child, male patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was fourth of 10 reports. On 22-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as 185586 and lot number reported as 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the event was not reported. Non-Significant case correction received on 05-Sep-2017: Description as reported for the event drug administration error was changed from vaccine was administered to vaccine was administered after the excursion occurred. Non-significant case correction received with IRD: 14-Aug-2017 Batch number (185686) was captured in the case form and narrative was amended accordingly.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received from a physician on 14-Aug-2017, concerning a 12-year-old female patient. Physician reported 10 patients who were vaccinated after multiple temperature excursions. This report was 2nd of 10 reports. On 09-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reporter as 185586 and 186686), expiry date: 31-May-2017, dose, route of administration and anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), on 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and on 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the events was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Aug-2017, concerns a 05-year-old male child patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was 1st of 10 reports. On 08-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). On 08-Mar-2017, the patient was vaccinated after multiple temperature excursions. First excursion occurred on 02-Mar-2017 (47-degree F, 14.7h), second on 03-Mar-2017 (47-degree F, 16h) and third on 04-Mar-2017 (47-degree F, 19.75 h) which was characterized by drug administration error. The outcome of the events was not reported.  Non-significant case correction received 14-Aug-2017: Batch number (186686) was captured in the case form and narrative was amended accordingly.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Migraine, Vision blurred
Clinical narrative: This initial non-serious spontaneous case, was received on 08-Aug-2017 from other non-health professional and concerns a 22-year-old female patient. The medical history of the patient was not reported. The concomitant medications included EXCEDRIN MIGRAINE, ZYRTEC and medications for birth control. On 05-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). A couple of hours after receiving the vaccine, the patient experienced blurred vision of left eye and lightheadedness. On 06-Aug-2016, the patient woke up with migraine. The treatment medication included EXCEDRIN MIGRAINE. On 07-Aug-2017, the patient again experienced blurred vision of left eye. It was reported that the events resolved on 07-Aug-2017. Significant case correction received on 05-Sep-2017: As determined causality of the event migraine was changed from unassessable to not related and case comment was updated accordingly.
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Ultrasound scan normal, Vaccination site pain
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017 was reported by an other non health professional and concerns a male patient of unknown age. Administration of Company suspect drug (s): On an unspecified date, the patient received FLUCELVAX QIV (batch number: KWK21APR17: dosage, expiration date, route of administration: not reported). Adverse reactions/events and outcomes: On an unknown date after receiving the flu shot (FLUCELVAX QIV), from pharmacy, the patient experienced pain in arm, also vaccination site pain which was almost for 5 months at the time of reporting. The patient stated that it had been hurting every time he wore a suit jacket and he could hardly lift any weight at all when he extended his arm in a particular direction due to pain. He consulted a physician who suspected a cyst caused by vaccination which turned to be nothing on ultrasound and wondered about a shoulder joint issue. The condition had been worsened for last 1 month. Action taken with FLUCELVAX QIV was not reported. The event was not recovered. Reporter's Assessment: The other non health professional assessed the events as non-serious and the causality for the events were related. This case was non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Underdose
Clinical narrative: This spontaneous case, was initially received on 11-Aug-2017 from other health professional, concerning a 21-year-old, adult female patient. The patient's medical history and concomitant medication was not reported. On 09-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: (reported as less than 0.5 ml). batch number: 195214, route of administration, anatomical location, expiry date: not reported). Partial dose of vaccine was administered as the patient could not tolerate the pain. The outcome of the event pain during injection was resolved. The reporter assessed this case as non-serious. Non-significant case correction received 11-Aug-2017: Batch no. (195214) was captured in the case form and narrative was amended accordingly.
Age: 2.17
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Blindness
Clinical narrative: Blindness, autism.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Non-painful Rash x 3 days since date of occurrence on 1/21/17.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain
Clinical narrative: Swelling of site below injection site, redness, pain. It got so bad I went to ER the following day. My entire upper arm was swollen, hard and warm to the touch. The redness became a purplish color. I was clearly having an allergic reaction.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling of site below injection site, redness, pain. It got so bad I went to ER the following day. My entire upper arm was swollen, hard and warm to the touch. The redness became a purplish color. I was clearly having an allergic reaction.
Sex: M
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: This initial non-serious spontaneous case, was received on 20-Oct-2017, reported by other health professional and concerns a male patient of unspecified age. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). On unspecified date after administration of vaccine, the patient experienced aches and pains all over his body, particularly in his legs. The pains were bad enough to cause him to miss his work after the day of vaccination. It was reported that, no known fever and no treatment was given other than self-administration. The outcome of the events was not reported. Non-significant follow-up received on 07-Nov-2017: It was reported that nothing had changed from the initial for the patient.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Band neutrophil percentage, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood bilirubin normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity increased
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chills
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphocyte percentage decreased, Monocyte percentage, Nausea, Neutrophil percentage increased, Protein total normal
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Red blood cells urine positive, Urine analysis, Vomiting, White blood cell count normal
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: White blood cells urine negative
Clinical narrative: Chills ,fever, generalized headache, dizziness, nausea and emesis went to Emergency room 12 hours after vaccine given. Got labs, IV fluids, ZOFRAN and sent home. VS P106 BP 103/59,T100.6 RR18.
Age: 46.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on lower legs, hands and arms.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous case, was received from other health professional (nurse) on 18-Oct-2017, concerns a 37-year-old, adult, male patient. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (as reported), batch number: 195230, expiry date: 31-May-2018, route of administration; intramuscular: anatomical location: left deltoid muscle). The patient received partial dose of the vaccine (explicitly considered as under dose). It was reported that, needle was not secured to the syringe and some of the dose leaked out as it was administered to the patient (explicitly considered as syringe issue). The patient had not experienced any adverse effects after receiving the vaccine. The outcome of the event was not reported. The reporter assessed the events as non-serious. Follow-up received on 26-Oct-2017: The additional event (no adverse effect) was added. It was reported that, the patient had not experienced any adverse effects after receiving the vaccine. The narrative was amended accordingly. Significant case correction received 18-OCT-2017: The LLT of the event 'the needle was not secured to the syringe and some of the dose leaked out as it was administered' was changed and listedness was corrected.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia
Clinical narrative: Patient called 1/25/18 to report that she was having nerve pain since receiving the flu shot on 1/10/18. said nerve pain on arm, neck, shoulder, back and chest.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PAIN IN THE ARM FOR 2 WEEKS AFTER THE VACCINATION.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was given the shot and developed shingle symptoms a little over 24 hours later on the left leg.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Mobility decreased, Motor dysfunction, Pain in extremity, Rash
Clinical narrative: Right hand "froze up." Was painful. Could move tips of fingers a bit but very difficult to grasp. Right wrist became swollen and had a rash.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pruritus
Clinical narrative: Patient experienced pain and redness at injection site the afternoon after shot was administered. Later in the evening there was pain on movement. Swelling and redness (about a 4 inch blotch) moved down the arm a little from injection site over the next day or two. Patient took ibuprofen for the pain and diphenhydramine for the slight itch that also developed. As off 1/25/18 around 6 PM patient states that rash is fading and pain is gone but still itches a little.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient experienced pain and redness at injection site the afternoon after shot was administered. Later in the evening there was pain on movement. Swelling and redness (about a 4 inch blotch) moved down the arm a little from injection site over the next day or two. Patient took ibuprofen for the pain and diphenhydramine for the slight itch that also developed. As off 1/25/18 around 6 PM patient states that rash is fading and pain is gone but still itches a little.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: Pain starting at injection site that worsen and developed to include the arm and left side of her torso making sleeping difficult. Per patient, no redness or rash.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: ZOSTAVAX diluent mixed with SHINGRIX drug.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Donor came into center on 1/25/18 with a hot, itchy, reddened area 4 in. by 4 in. on right upper arm at the immunization site for tetanus vaccine. Donor was immunized 1/22/18. Donor states she was "using the right arm a lot that night and was crocheting."
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated she had pain in left arm since Monday night, continuing through Thursday when she cam into pharmacy. She stated she had swelling and redness. She had a red band around the arm, below the injection site but above the elbow. She stated she didn't use any treatment (no ice, no ibuprofen, etc).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccine.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Contusion, Erythema, Fall, Headache
Clinical narrative: Patient received vaccine dose, pharmacist applied Band-Aid to arm but Band-Aid not sticking well, so pharmacist went to get another Band-Aid and by the time the pharmacist returned, patient had fallen down on the floor and lost consciousness. Patient woke up in just 1 to 2 minutes, we called 911 emergency, made patient comfortable until paramedics arrived within 5-minutes of our 911 call. Patient skin red in color, skin clammy, felt nausea. The paramedics examined her, asked her some questions and patient was complaining of nausea, head pain, and was taken to the hospital by the paramedics.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient received vaccine dose, pharmacist applied Band-Aid to arm but Band-Aid not sticking well, so pharmacist went to get another Band-Aid and by the time the pharmacist returned, patient had fallen down on the floor and lost consciousness. Patient woke up in just 1 to 2 minutes, we called 911 emergency, made patient comfortable until paramedics arrived within 5-minutes of our 911 call. Patient skin red in color, skin clammy, felt nausea. The paramedics examined her, asked her some questions and patient was complaining of nausea, head pain, and was taken to the hospital by the paramedics.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Muscle strain, Myalgia, Pain in extremity
Clinical narrative: The patient remained in her chair for 5 minutes after the vaccine was administered. When she left the pharmacy she spoke to the pharmacist and was feeling fine. She went home and had a normal evening. The next morning (approximately 12 hours later) she began to have pain in her armpit and the underside of the vaccinated arm. She lifts moderately heavy objects at work so she left early to rest her arm. After 24 hours she visited with a physician about the pain and was diagnosed with a strained deltoid muscle. She was provided a prescription for naproxen and told to rest the arm for several days. At no time did she have a fever, experience shortness of breath or have any other symptoms other than the arm pain.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Rash
Clinical narrative: Lump, pain, and bruising at the injection site. Slight rash developing on the face but not sure if that was related. Patient took diphenhydramine and TYLENOL. No further updates at this time.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cold urticaria, Cough, Pyrexia, Urticaria
Clinical narrative: Hives on hands and feet triggered when she went outside in cold 24 hours later. Continued on and off for several days, not severe but noticeable for a child who hadn't been sick for 3 years straight. Would go away on own. Into third week and she developed a cough and got hives again and also fevers.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Chills, Cough, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Patient received both FLUZONE HD and PNEUMOVAX 1/23, and began experiencing symptoms 1/24. Symptoms included swelling and redness at injection site ("large hard knot"), pain so severe that patient "could not lift her arm", fever/chills, dry cough and pain in the chest. Most symptoms were resolved by 1/25, except for the swelling and redness at injection site.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient received both FLUZONE HD and PNEUMOVAX 1/23, and began experiencing symptoms 1/24. Symptoms included swelling and redness at injection site ("large hard knot"), pain so severe that patient "could not lift her arm", fever/chills, dry cough and pain in the chest. Most symptoms were resolved by 1/25, except for the swelling and redness at injection site.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient reported increasing pain and rash spreading and getting worse at injection site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Malaise, Pyrexia, Skin warm
Clinical narrative: WITHIN 8 HOURS PATIENT BEGAN FEELING ILL, DEVELOPED A FEVER OF 100.5, LEFT ARM BECAME RED/ WARM TO TOUCH AND "FIRM" 2 DAYS LATER SEEN AT URGENT CARE GIVEN LIDOCAINE AND CEFTRIAXONE INJECTION. CONTINUED WITH KEFLEX 500MG SITE IMPROVED AND RESOLVED WITHIN 5 DAYS.
Age: 11.0
Sex: M
Vaccine: FLUC4, HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Vaccines were given to patient. Patient walked out of the room with no problem after a few min. Pt. C/O of feeling dizzy. Per Dr. possible vasovagal. Patient was taken back to the exam room and we had him lay down. Vital signs were checked. Patient was observed and left the clinic feeling well.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: On the left vastus lateral pt thigh was very red and swollen on the right vastus lateral thigh was swollen pt had a rash resolved in day 2.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 28-Sep-2017, concerning a 62-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered last year's expired FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286 (as reported), expiry date: Apr-2017, route of administration, anatomical location: not reported). The reporter assessed the report as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 54-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered last year's expired FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported) The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerns a 56-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Loss of personal independence in daily activities, Mobility decreased, Tendonitis
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 20-Sep-2017, concerning an adult female patient. The patient's concomitant medications included: Ibuprofen (high dose) for unknown indication. On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). One week after receiving the flu vaccination, patient developed bursitis, tendinitis and the patient had difficulty in raising arms that affected the task as difficulty in dressing themselves. The patient was treated with ice packs, Ibuprofen and steroids. The outcome of the event was not recovered (ongoing). The reporter assessed the events as non-serious.