chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Rash pustular
Clinical narrative: Patient developed a red, itchy rash around lips that progressed until treatment 30 days post vaccine. The rash continues in patches throughout the body, with pustules. Patient had irritation in the mouth region for months prior to vaccination. Present to pharmacy stating dermatologist believes the cause was the vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: Patient reports next morning woke up with painful skin on leg with large oblong rash 5-6 inches long and 3-4 inches wide that lasted for 2 days.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Dizziness, Feeling cold, Myalgia, Nausea
Clinical narrative: The morning following vaccine patient felt nausea and then syncope (5 minutes unconscious). Mother reported she was cold, clammy, and felt feverish although she did not record fever with a thermometer. Following syncope patient experienced myalgia and nausea for several hours. Patient reports several more occurrences of feeling like she was about to faint, but never actually fainted after the initial syncope. This was 2nd and final dose of TRUMENBA given approximately 6 months after first dose. Patient reported no side effects from first dose of TRUMENBA other than a sore arm from injection.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Syncope
Clinical narrative: The morning following vaccine patient felt nausea and then syncope (5 minutes unconscious). Mother reported she was cold, clammy, and felt feverish although she did not record fever with a thermometer. Following syncope patient experienced myalgia and nausea for several hours. Patient reports several more occurrences of feeling like she was about to faint, but never actually fainted after the initial syncope. This was 2nd and final dose of TRUMENBA given approximately 6 months after first dose. Patient reported no side effects from first dose of TRUMENBA other than a sore arm from injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, aches, nausea.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Aura, Blood pressure increased, Computerised tomogram
Clinical narrative: Patient stated that two hours after vaccine blood pressure shot up and was seeing a visual aura. Sought treatment at ER was not sure if adverse event or a migraine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash according to patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: Had a fever 100.6, headache, malaise, body aches, flu-like symptoms, nausea, very tired, lasted until end of the day. TYLENOL did not help though later in the day ALEVE did help.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Had a fever 100.6, headache, malaise, body aches, flu-like symptoms, nausea, very tired, lasted until end of the day. TYLENOL did not help though later in the day ALEVE did help.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Patient called the pharmacy today and informed me that the muscles in her arm are very painful and have been getting worse ever since she got the shot on 12-11-18. She is concerned that it is from the flu shot. Not red or swollen, just muscles are painful. She said the shot was given low in the deltoid, not sure if that is why it hurts so much. I recommended she call her doctor tomorrow and find out what is wrong and let us know. Also we would follow up.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness of the upper right deltoid with some pain. Patient went to clinic and received some prescription steriod. She was also advised to take some BENADRYL and TYLENOL. Patient came to the pharmacy the next day and said the swelling was much better.
Age: 56.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Herpes virus infection, Injection site bruising, Limb discomfort, Pain
Clinical narrative: Bruising near inj. site still. Heavy arm, pain, up-tick in herpes virus outbreaks & spreading to what were unaffected areas.
Sex: M
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case, initially received on 24-Jul-2018 was reported by other health professional and concerns a male patient of unspecified age. The patient's current condition included mesothelioma (since an unspecified date). The patient's concomitant medications included KETRYDA for mesothelioma, ZOFRAN, COMPAZINE, oxycodone for unknown indications. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination the patient developed allergy to influenza vaccine. No further information was available. The outcome of the events was not reported. The reporter assessed this case as non-serious. Update 24-Aug-2018 (CRD): Significant case correction was performed with IRD 24-Jul-2018: As reported causality was corrected from not related to unassessable for the event Influenza vaccine/Allergy in the event tab. Also, the event of mesothelioma was removed from the case.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 11-Oct-2018, concerns a 67-year-old, elderly male patient. The patient's historical condition included a significant fall and was under surgery on his knee and elbow. On 09-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 250798 and expiry date: 31-May-2019]. On 10-Oct-2018, 1 day after vaccination, the patient woke up and noticed a rash on his chest on the side, where he received the flu shot. On an unspecified date in Oct-2018, the patient went to the dermatologist, who gave him a fluocinonide topical cream. Eventually, the patient applied the fluocinonide cream on the rash and reported that cream had worked. On 11-Oct-2018, the patient had recovered from the event. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 19-Sep-2018, concerns a female patient of an unspecified age. On an unspecified date, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient experienced swelling in the arm. At the time of this report, the outcome of the event was not reported. Non-significant follow-up report received from pharmacist on 08-Oct-2018: The pharmacist stated that the patient was not a regular patient. The patient only told that, the year before she had arm swelling after the vaccination. No new information was received.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This non-serious spontaneous case, initially received on 17-Sep-2018 reported by other non-health professional and concerns a female pregnant patient of unspecified age. On an unspecified date, the pregnant patient received influenza vaccine, (dose, batch number, route of administration, anatomical location, manufacturer, trade name was not reported).
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received on 29-Oct-2018 (combinedly processed with follow-up received on 02-Nov-2018), reported by other non-healthcare professional (consumer), concerns a 41-year-old adult pregnant patient. On an unspecified date, the pregnant patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). At the time of this report, no adverse event was reported.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Arthralgia and hand swelling.
Age: 87.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 87-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805481 was cross linked to original cases 201804863 due to same reporter.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 19-Nov-2018, concerning a 69-year-old, female patient. On 16-Nov-2018, the patient subcutaneously administered FLUAD (TIV) [egg-derived, MF59, dose: 0.5 ml, route of administration: subcutaneous, batch number: 250783, expiry date: 30-Apr-2019 and anatomical location: not reported] with a needle size of 5/8 (explicitly coded as inappropriate route of vaccination). No adverse events were reported after vaccination. The reporter assessed the case as non-serious. This case was considered as lost to follow up as the reporter did not give consent for follow up.
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received from a pharmacist on 20-Oct-2018, concerns a female patient of an unspecified age. The patient received unknown flu vaccine and experienced arm swelling. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient experienced swelling in the arm. On an unspecified date, 2 days after onset of the event (2 days after start as reported), the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 65.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F. On 11-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804093 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Med info number (SEQ18-04086) was updated in the additional information tab. No changes were made in the narrative.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: This spontaneous case, initially received from a pharmacist on 09-Nov-2018, concerns an 85-year-old, elderly female patient. On an unspecified date in the past, the patient had received FLUCELVAX vaccine for an unknown indication and had no adverse events. On 25-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250794 and expiry date: 30-Apr-2019]. On 05-Nov-2018, 11 days after vaccination, the patient developed hives on the lower part of left arm which extended to her hand. The patient did not receive any treatment for the events. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Adverse drug reaction, Eye disorder
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional on 21-Nov-2018, concerning a female patient of unspecified age. On an unspecified date (30 years ago as reported), the patient was administered influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. On an unspecified date, after vaccination, the patient developed unspecified eye condition which was reported as a reaction to thiomersal. The Ophthalmologist confirmed that the reaction was due to thiomersal. The outcome of the event was not reported. The reporter assessed the causality of the event as related to suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional (consumer) (Novartis reference number: PHEH2018US034681) on 24-Aug-2018, concerns a 43-year-old, adult, female patient. On an unspecified date, the patient received influenza vaccine [dose, route of administration, anatomical location, batch number, trade name, manufacturer: not reported]. On an unspecified date, after vaccination, the patient developed an allergy. At the time of this report, the outcome of the event was not reported.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Nausea, Pyrexia
Clinical narrative: This non-serious spontaneous case, initially received from other health professional via pharmaceutical manufacturer Novartis on 22-Sep-2018 and concerns a 75-year-old, elderly patient of an unspecified gender. On an unspecified date, the patient was administered FLUAD (TIV) [route of administration, anatomical location, dose, batch number and expiry date: not reported]. On an unspecified date, the patient experienced fever of 100 degrees and nausea (reported as: in the evening). It was reported that the patient felt better by late morning (date unspecified). At the time of this report, the patient was recovering from the events. This case was considered as lost to follow-up since the reporter has not given consent to provide further information.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 05-Oct-2018 reported by pharmacist and concerns a 70-year-old, elderly male patient. The patient did not have any medical history and did not take any medications at the time of vaccination. On 05-Oct-2018, the patient was administered expired FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 179303 and expiry date: 30-Jun-2018). At the time of this report, the patient did not experience any adverse events. The reporter assessed this case as non-serious. Follow-up received from the pharmacist on 30-Oct-2018: The route of administration was confirmed to be intramuscular. Narrative was amended accordingly.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case, initially received from other non-health professional via pharmaceutical manufacturer (Novartis) on 03-Aug-2018, concerning a 76-year-old, elderly, female patient of weight 126 kgs (280 pounds) and height 175.3 cm (69 inches). On an unspecified date, the patient was administered influenza vaccine, [dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported]. On an unspecified date, after vaccination, the patient developed allergy to flu shot. At the time of the report, the outcome of the event was not reported. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction was performed with IRD 03-Aug-2018: The co-suspect (COSENTYX) and the event (pink eye) was removed. The narrative and case comment amended accordingly.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dyspnoea, Heart rate increased, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated arm was sore same afternoon, but next day was painful and unable to move. 2 days after injection arm had doubled in size and had hives. Her arm was tight as a football. She had faster then normal heart rate, shortness of breath.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin tightness, Urticaria
Clinical narrative: Patient stated arm was sore same afternoon, but next day was painful and unable to move. 2 days after injection arm had doubled in size and had hives. Her arm was tight as a football. She had faster then normal heart rate, shortness of breath.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pruritus, Respiratory disorder
Clinical narrative: Seconds within administration patient complained of itching at the injection site. Examined by physician told to give BENADRYL. To ER if any respiratory issues developed.
Age: 47.0
Sex: M
Vaccine: FLUA3
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 19-Nov-2018, concerning a 47-year-old, adult male patient. The patient had no medical history and concomitant medications. On 19-Nov-2018, the pharmacist administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019) to the patient. Reporter stated that, before administering the vaccine he expelled the air bubble from the prefilled syringe and thought that at that moment a very small amount of the vaccine's fluid may have run down the syringe (a small drop), then he administered the vaccine to the patient. It was reported that, when pharmacist covered the vaccine with the tip cap to prevent stings with the needle, he felt something in the eye and thought that a small amount of vaccine might have splashed into his eye/or eyelashes. The event happened between 9-10 AM, then he washed the eye with water and was fine with no effects. Later, around 1 PM-1:30 PM, pharmacist felt some eye irritation and washed with water again. Pharmacist stated that, he had no redness. The outcome of the event eye irritation was not reported. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 21-Nov-2018, concerning a 64-year-old (reported as 64 and a half), adult female patient. The patient had no relevant medical history or concomitant medications. On 20-Nov-2018, the patient (under 65 years) was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793 and expiry date: 30-Apr-2019). The patient did not experienced any adverse events. The reporter assessed the case as non-serious.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 12-Nov-2018, concerning a 74-year-old, elderly, female patient. The patient had no relevant medical history and concomitant medications. On 09-Nov-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250805 and expiry date: 30-Jun-2019]. On 10-Nov-2018, 1 day after vaccination, the patient developed a red, itchy rash around the injection site. It was reported that the patient experienced the rash till date (as reported). No treatment measures were taken for the events. The outcome of the events was not recovered. The reporter assessed the case as non-serious.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Per self report: The day after receiving hep B dose #1, reported itching, red, swollen area at the injection site that was larger then a localized reaction. Symptoms lasted about 1 week. Took BENADRYL with hep B #2, no difficulties.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Rhinorrhoea
Clinical narrative: This is a non-serious spontaneous case, initially received from the other non-health professional on 14-Nov-2018, concerning a 29-year-old, adult female patient. The patient's current condition included multiple sclerosis (MS as reported) (since an unspecified date). On an unspecified date, the patient was administered non-company suspect product GILENYA (dose: 0.5 mg, frequency: once daily and route of administration: oral) for multiple sclerosis. It was reported that since the treatment with GILENYA, the patient's spasticity was not as bad in her legs/feet. The patient's shaking and balance had improved. On an unspecified date, the patient was administered influenza vaccine, [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. It was reported that, right after the vaccination, the patient experienced cough and runny nose for a couple of days later. The outcome of the events was not reported.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itching, redness and swelling on right arm below elbow 3rd day after vaccination. He tried OTC BENADRYL for itching but it did not help. At 5th day, he experienced the same symptoms on left arm. He has seen the doctor and get medication (prednisone-oral). As per patient information, he become symptoms free in 48 hours after starting therapy. He has done couple of test at doctor office. All results are normal per patient information over the phone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient called to report redness and pain after receiving the vaccination in his left arm Friday. He stated that the redness had grown to approximately an area of 6x6. He denies swelling below his elbow or up into his neck or face. He denies new or worsening dyspnea. 11/26/18 Primary Care MD note assesses condition, but does not indicate any treatment required.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This is a spontaneous case initially received from other health professional on 16-Nov-2018, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered partial dose of FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, dose, batch number and expiry date: not reported]. It was reported that when the needle was pulled out after vaccination, a little drop came back out, which they wonder to be a drop of the vaccine. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 89.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 20-Sep-2018, from a pharmacist, concerning an 89-year-old, elderly, male patient. The patient's historical conditions included syncope, constipation, ingrown toe nail, foot pain, corneal mild neovascularization, skin lesion, onychomycosis of toe nail, shoulder pain, peripheral oedema, low back pain, neck pain, obsessive-compulsive disorder (OCD), mood disorder dysthymia, hearing loss, polyp of colon, diverticulosis, sleep apnoea, atherosclerosis and visual impairment (on an unspecified date). The patient's current conditions included acquired blindness in one eye, atrophy of optic disc, epiretinal membrane, multiple environmental allergies, osteoporosis, degeneration of intervertebral disc, hyperlipidaemia, hypertension and chronic obstructive pulmonary disease (COPD) (reported as medical history). The patient's concomitant medications included FLONASE, hydrochlorothiazide, tramadol, calcium, PROAIR, TYLENOL, MICROLAX, vitamin D, Albuterol, Spiolto combo inhaler with tiotropium, Alendronate for unknown indications. It was reported that the vaccine underwent first time temperature excursion reaching 34 F (Fahrenheit) for 15-20 minutes (explicitly coded as incorrect product storage). On 19-Sep-2018, the patient was administered FLUAD TIV [egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: 250796 and expiry date: 31-May-2019] that underwent temperature excursion. The patient had not experienced any adverse effects after administration. The reporter assessed this case as non-serious. This case 201803916 was cross-linked with the case 201803915 reported by the same reporter. Follow-up received from reporter (combinedly processed with follow-up received on 23-Oct-2018) on 12-Oct-2018: The reporter confirmed the start date of vaccination as 19-Sep-2018. The historical condition previously reported as dejou impairment was confirmed to be visual impairment. The narrative was amended accordingly.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 72-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 15-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805522 was crossed linked to original cases 201804863 due to same reporter.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 25-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805543 was crossed linked to original cases 201804863 due to same reporter.
Age: 63.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case initially received from a pharmacist on 15-Nov-2018, concerning a 63-year-old, adult female patient. On 14-Oct-2018, the adult patient was administered FLUAD (TIV) [batch number: 250789, expiry date: 31-May-2019]. At the time of this report, no adverse event was reported. This case is linked to (201805586) due to same reporter. The reporter assessed the case as non-serious.
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is spontaneous case, initially received form a pharmacist on 15-Nov-2018, concerning a 62-year-old, adult male patient. On 14-Nov-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250789 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). The patient did not experience any adverse events after vaccination. The reporter assessed the case as non-serious. Follow-up report received from a pharmacist on 26-Nov-2018: The dose (0.5 ml), route of administration (intramuscular) and anatomical location (deltoid) of the suspect vaccine were added in product tab. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative was amended accordingly.
Age: 74.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 29-Oct-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805548 was crossed linked to original case 201804863 due to same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Induration, Nodule
Clinical narrative: This spontaneous case, initially received from a pharmacist on 12-Nov-2018, concerns a female patient of an unspecified age. The patient was allergic to egg. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient developed a hard knot under her arm. At the time of this report, the outcome of the event was not reported. The reporter assessed this case as non-serious.
Age: 71.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of unspecified gender. it was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 02-Nov-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805547 was crossed linked to original case 201804863 due to same reporter.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 25-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805546 was crossed linked to original cases 201804863 due to same reporter.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 25-Oct-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805545 was crossed linked to original cases 201804863 due to same reporter.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received form other no-health professional on 13-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 29-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805544 was crossed linked to original case 201804863 due to same reporter.
Age: 88.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 88-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 07-Nov-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805542 was crossed linked to original case 201804863 due to same reporter.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 16-Oct-2018, the patient was administered FLUAD (TIV) [ batch number: 250796, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805540 was crossed linked to original case 201804863 due to same reporter.
Age: 88.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 88-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 05-Nov-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805541 was crossed linked to original case 201804863 due to same reporter.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV), [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805539 was crossed linked to original cases 201804863 due to same reporter.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-healthcare professional on 13-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 Celsius. On 18-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805538 was crossed linked to original case 201804863 due to same reporter.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805537 was crossed linked to original cases 201804863 due to same reporter.
Age: 82.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 82-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, route of administration, anatomical location, expiry date and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805536 was crossed linked to original case 201804863 due to same reporter.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Blood culture negative, Headache, Influenza virus test negative, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, headache, sore throat began the day after dose 2. Persistent fevers x 5 days with negative strep, influenza, or blood culture results. Low-grade fever after first dose.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Streptococcus test negative
Clinical narrative: Fever, headache, sore throat began the day after dose 2. Persistent fevers x 5 days with negative strep, influenza, or blood culture results. Low-grade fever after first dose.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 15-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805523 was crossed linked to original cases 201804863 due to same reporter.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 67-year-old, elderly patient of unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [batch number 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805524 was crossed linked to original cases 201804863 due to same reporter.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805525 was crossed linked to original cases 201804863 due to same reporter.
Age: 87.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 87-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 30-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, route of administration, anatomical location, expiry date and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805528 was crossed linked to original case 201804863 due to same reporter.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 29-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805530 was cross linked to original cases 201804863 due to same reporter.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 84-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 30-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805531 was crossed linked to original 201804863 due to same reporter.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 79-year-old, elderly patient of unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 02-Nov-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805532 was crossed linked to original case 201804863 due to same reporter.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805526 was crossed linked to original case 201804863 due to same reporter.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 30-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805527 was crossed linked to original case 201804863 due to same reporter.
Age: 76.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 29-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805529 was crossed linked to original case 201804863 due to same reporter.