chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 08 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Depressed level of consciousness, Mental status changes
Clinical narrative: This initial spontaneous case, was received on 19-Oct-2017, from other non-health professional, concerning a 53-year-old female adult patient. The patient had no relevant medical history and concomitant medications were not reported. On 17-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59806, expiry dateL 05-JUN-2018). On the same day, the patient experienced decreased level of consciousness (altered mental status at work and reported possible seizure). The patient was taken to emergency room and CT (computed tomography) scan was performed which was negative. It was reported that the seizure was not confirmed and not witnessed by the medical personnel. It was not certain whether altered mental status at work was a part of decreased level of consciousness. The patient recovered from the event on the same day. The reporter assessed the event as non-serious. Follow-up received on 09-Nov-2017: The CT scan was negative. It was reported that the seizure was not confirmed and not witnessed by the medical personnel. It was not certain whether altered mental status at work was a part of decreased level of consciousness (hence coded as 2 separate events). Narrative amended accordingly. Non-significant case correction received with code 19-OCT-2017: Case opened in error.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional on 13-Oct-2017, concerns a patient of unspecified gender and age. On an unspecified date, the patient was administered with AFLURIA (dose: 2 ml, route of administration, anatomical location, batch no: 15149221A and expiry date: 30-Jun-2018) (explicitly coded as overdose). It was reported that, no events were noted after the overdose of the vaccine (reported as none at all). The reporter assessed the events as non-serious. Follow-up received on 03-Nov-2017: The product details were updated (batch number: 15149221A and expiry date: 30-Jun-2018). It was reported that, no events were noted after the overdose of the vaccine (reported as none at all). Narrative amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: This initial spontaneous case, was received on 16-Oct-2017, from Pharmacist, concerning a female patient of an unspecified age. On 16-Oct-2017, the patient was administered with AFLURIA (dose: (reported as less than 0.5 ml), route of administration: intramuscular, anatomical location, batch number: XT34208, expiry date: Jun-2018). It was reported that, the nurse who had administered the vaccine to the patient had not kept the needle correctly when she went for administration and therefore, some of the vaccine ran down on the arm of the nurse. As a result, complete dose was not administered to the patient which was characterized to partial dose was administered. The patient did not experience any adverse event. The outcome of the events was not reported. The reporter assessed the case as non-serious. Follow up received from pharmacist on 25-Oct-2017: Added patient details (gender), suspect vaccine details (start date, route, batch number and expiry date), event (no adverse event). Narrative amended accordingly.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: This non-serious initial spontaneous case, was received on 22-Sep-2017, concerning a 29-year-old, adult pregnant female patient. The patient did not use contraceptives. The patient's last menstrual period date was on 22-Jan-2017, foetus status was not reported. The patient had no pregnancy in the past. The infant gestational age was 34.5 weeks and there was no evidence of defect or adverse findings from prenatal test. Concomitant medication included: Prenatal vitamins. On 21-Sep-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, batch number: WT54607, expiry date: 30-Jun-2017 (expired dose), route of administration and anatomical location: not reported). It was reported that the pregnant patient received the expired vaccine. The patient experienced adverse event, but no adverse reaction was experienced in the foetus. The estimated date of delivery was on 29-Oct-2017. It was stated that, the mother and the baby was good with no problem. No other information was provided. The outcome of the event was not reported. Follow-up report received from the reporter on 17-APr-2018: The reporter confirmed that the estimated date of delivery was 29-Oct-2017 and the patient was not enrolled in the registry. It was stated that, the mother and the baby was good with no problem. No other information was provided. Amended narrative accordingly.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 11 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 26 of 84 patients. It was reported that, the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C) and was administered to the patient. The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow-up report received on 09-Nov-2017: It was reported that, the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Amended narrative accordingly.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram normal, Musculoskeletal stiffness
Clinical narrative: Mother called and said about 4 hours after the shots she was changing and patient suddenly stiffened and then both arms and legs started to move around wildly (not tonic-clonic movements) and then (see enclosed note).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 06-Nov-2017 from a pharmacist, concerning 63-year-old, adult, female patient. On 05-NOV-2017, the patient was administered with AFLURIA (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that the AFLURIA was at a temperature of 57 F for a few hours (lasted for 4 hours). Hence, vaccine was outside the recommended range which was administered to the patient (explicitly coded as Incorrect product storage and drug administration error). The reporter assessed the events as non-serious.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Rash started on Sunday on face and spread everywhere. Pink maculopapular rash almost confluent on face, scattered pink papules on trunk and extremities, few spots on palm: no vesicles or petechiae.
Age: 17.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Syncope
Clinical narrative: Patient had 20-30 sec. fainting spell after receiving Hepatitis A and typhoid, episode post Hepatitis A.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, nausea, fever, vomiting.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pain in jaw
Clinical narrative: This is pt's second vaccine. Headache, chills, shaking (Tremors) jaw pain and nausea. Also arm sore. Pt went to PCP, got a steroid shot and MD wrote fax for NSAIDs and BENADRYL. First dose SHINGRIX 2 months ago arm sore for 2 weeks.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This is pt's second vaccine. Headache, chills, shaking (Tremors) jaw pain and nausea. Also arm sore. Pt went to PCP, got a steroid shot and MD wrote fax for NSAIDs and BENADRYL. First dose SHINGRIX 2 months ago arm sore for 2 weeks.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Rash
Clinical narrative: Felt like he could not breathe, rash broke out across face.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Exactly 12 hours after shot I had pain, swelling, redness on arm and nausea. See picture 1. By morning the redness and swelling had grown. By night time it had spread all the way to my elbow. This lasted for four days before it began to subside. I am only concerned about what will happen if I get the 2nd shot in the series. Is this a normal reaction or should I not take the chance with the 2nd shot?
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rt deltoid area warm, firm and swollen with redness that is now spreading. 14 x 12 cm on 06/16/2018.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received a child dose hep A vaccine .5 instead of adult hep A which is 1 ml.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Seizure, Syncope
Clinical narrative: Vasovagal syncope and seizure (less than 30 seconds). No treatment needed. Initial BP 115/72; BP after event 94/52, HR 93, Blood sugar 111.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Lethargy, Pain
Clinical narrative: Pt. woke up the morning after immunization (approx. 16 hours later) feeling sore "from the top of my head to the tip of my toes". Extremely lethargic, no appetite. No fever.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bursitis, Injection site reaction, Injection site swelling
Clinical narrative: Localized swelling of the left upper arm with subacromial bursitis.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling of the left upper arm with subacromial bursitis.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Localized swelling of the left upper arm with subacromial bursitis.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site discolouration, Injection site erythema, Injection site nodule, Limb mass, Vaccination site swelling
Clinical narrative: 05/18/18 6:09pm. Per patient lump on left arm about 2 inches in size, a little redness, no red streaking. Per nurse advised take Ibuprofen, use cool compresses for 20 min at a time. No improvement or new symptom to call next day. 06/18/18 Pt. came to office for 2nd dose. Per Pt. to nurse had long lasting reaction to vaccine site red, swollen, warm to touch. Advised to come following day. 06/19/18 Pt seen today. Site warm, dry approx. 3/4 inch hyper pigmented patch, smaller sq pea sized firm knot.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vaccination site warmth
Clinical narrative: 05/18/18 6:09pm. Per patient lump on left arm about 2 inches in size, a little redness, no red streaking. Per nurse advised take Ibuprofen, use cool compresses for 20 min at a time. No improvement or new symptom to call next day. 06/18/18 Pt. came to office for 2nd dose. Per Pt. to nurse had long lasting reaction to vaccine site red, swollen, warm to touch. Advised to come following day. 06/19/18 Pt seen today. Site warm, dry approx. 3/4 inch hyper pigmented patch, smaller sq pea sized firm knot.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received on 29-MAR-2017 was reported by a Pharmacist and concerns a 62-years-old adult female patient. The pharmacist reported that, on an unspecified date, the vaccine was subjected for temperature excursion, which was further described as pre-filled syringe (PFS) went out of range for 4 hours and reached 52 degrees Fahrenheit. On 29-Mar-2017, the patient received intramuscular AFLURIA (0.5 ml, batch number: WT57008, Expiration date 30-Jun-2017). On 29-Mar-2017, the patient had administered the incorrectly stored drug. Action taken with AFLURIA was not reported. The outcome of events was not reported. Reporter's Assessment: The reporter did not provide the causality and company causality between events (incorrect storage of drug and drug administration error) and AFLURIA quad was assessed as not related. This report was not serious.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, hot to touch, golf ball size area on left thigh. Instructed to give BENADRYL and cold compress. Phone call to the office.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Had TRU shot in (R) deltoid; started with rash, redness, swelling and pain to area by same afternoon; also had a difficulty lifting up (R) arm; states legs swollen and painful today. No fever, no wheezing or SOB.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Had TRU shot in (R) deltoid; started with rash, redness, swelling and pain to area by same afternoon; also had a difficulty lifting up (R) arm; states legs swollen and painful today. No fever, no wheezing or SOB.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report, initially received on 04-Apr-2017, was reported by an other health professional (nurse) and concerns a patient of unspecified age and gender. The nurse reported that, the vaccine refrigerator door was left open at one of their sites from an unspecified date. The nurse said that, on 31-Mar-2017 at 5 pm, the refrigerator temperature was in range at 6 degree Celsius but on 03-Apr-2017 at 5 pm, the refrigerator temperature was found to be 10 degree Celsius and 9 doses of pre-filled syringes were affected (incorrect storage of drug). After follow up nurse reported that, the vaccine refrigerator door was closed when she got the vaccine. At 04:52 p.m., the temperature alarm triggers. At 05:00 p.m., the refrigerator door was found open. The manual temperature reading on 3 Apr 17 at 05:00 p.m. was 10 degree Celsius and data logger reading was 15 degree Celsius. The data logger also has the total time above the normal range as one hour and 58 minutes, with maximum temperature 16 degree Celsius. The data logger and manual temperature reading do not match exactly, but my information shows the excursion was less than 24 hours, an AE has not really occurred. Administration of Company suspect drug: On 03-Apr-2017, the patient had administered incorrectly stored AFLURIA [(drug administration error), influenza vaccine 0.5 ml, intramuscular, batch number: WT54607, Exp: 30-Jun-2017]. Action taken with AFLURIA was not reported. Outcome of incorrect storage of drug and drug administration error was not reported. Reporter's Assessment: The reporter did not provide the causality and company causality between AFLURIA and events (incorrect storage of drug and drug administration error) was assessed as not related. This case was not serious. Follow up received on 18 Apr 2017: The following information as updated, the nurse reported that, the vaccine refrigerator door was closed when she got the vaccine. At 04:52 p.m., the temperature alarm triggers. At 05:00 p.m., the refrigerator door was found open. The manual temperature reading on 3 Apr 17 at 05:00 p.m. was 10 degree Celsius and data logger reading was 15 degree Celsius. The data logger also has the total time above the normal range as one hour and 58 minutes, with maximum temperature 16 degree Celsius. The data logger and manual temperature reading do not match exactly, but my information shows the excursion was less than 24 hours, an AE has not really occurred.
Age: 50.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood glucose decreased, Eye swelling, Feeling hot, Headache, Injection site swelling
Clinical narrative: Pt. experienced swelling at the site of injection, eyes, and lips. Blood glucose levels dropped. Feeling hot and experienced headaches.
Age: 50.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Lip swelling
Clinical narrative: Pt. experienced swelling at the site of injection, eyes, and lips. Blood glucose levels dropped. Feeling hot and experienced headaches.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain described pain w/injection at site following day came to pharmacy-2 small bumps n inch in length and swelling, redness w/rash 5 days later. Pt saw M.D who treated who w/cephalexin and BENADRYL.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: This initial non-serious spontaneous case, was received on 11-Sep-2017, from a pharmacy and concerns a 58-year-old adult female patient. The current condition of the patient was high cholesterol. The concomitant medications included atorvastatin for high cholesterol and MOTRIN. On 08-Sep-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, expiry date: Jun-2018, route of administration, anatomical location, batch number: not reported). On 09-Sep-2017, the patient woke up with a stiff neck, but had no pain or swelling at the injection site. The patient notified about it to the pharmacist on 10-Sep-2017. The pharmacist spoke with the patient and suggested to consult a physician. As instructed by the physician, the patient took MOTRIN. At the time of this report, the patient recovered from the event. The causality between the event and the flu vaccine was not reported. Follow-up report received on 14-Sep-2017: Concomitant medications were updated. Outcome of the event was updated from not recovered to recovered.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 60th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician. Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site nodule, Injection site warmth, Pain
Clinical narrative: First, the day after the injection, a knot rose up at the injection site. Then "stinging bees" on left side of arm and neck. Achy joints. Redness around injection site, and has spread down arm. The affected area of arm is warm to the touch today, 6/19/18. Patient is planning to start taking BENADRYL tonight after work. She has been using ice packs sporadically for a few days.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Injection site discomfort, Injection site pain, Pain in extremity
Clinical narrative: This initial non-serious spontaneous case, was received on 20-Sep-2017, from a pharmacist concerning a 92-year-old female adult elderly patient. The concomitant medication included metoprolol extended release (ER) for an unknown indication. On 06-Dec-2016, the patient received AFLURIA (TIV) (anatomical location: left deltoid, dose, route of administration, batch number, expiry date). On 06-Dec-2016, the patient received non-company product PREVNAR 13 (anatomical location: left deltoid, dose, route of administration, batch number, expiry date). On the same day, within a day receiving the vaccine the patient developed some pain and discomfort in the same shoulder. The pain and discomfort persisted and got worse. The pain was at down her arm and even across her back. She was worried whether her arm may get worse. No treatment was taken. At the time of the report, the outcome of the events was not reported. Significant case correction received on 13-Oct-2017: The onset date was correct to 06-Dec-2016 for the events injection site pain and discomfort. The outcome of the events was corrected from not recovered to not reported. Narrative amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 04 to 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported. It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous case, was received from other-health professional (pharmacist) on 22-Sep-2017, concerning a 19-year-old, adult, male patient. On 22-Sep-2017, the patient was administered with AFLURIA (TIV) (dose: less than 0.5 ml, batch number: XT32208, expiry date: 30-Jun-2018, route of administration and anatomical location: not reported). It was reported that, the patient received dose of the vaccine less than the recommended dose (0.5 ml) due to syringe leakage. This report was associated with PTC reference Number: 431545. It was reported that by the information of PTC case reported on case SEQ17-2569, concluded that the leakage was between the syringe and needle. The reporter assessed the report as non-serious. Follow-up received on 25-Oct-2017: Patient's gender was updated to male and narrative was amended accordingly. Non-significant follow-up received on 27-Oct-2017: The PTC number (431545) was added. Follow-up received on 31-OCT-2017: It was reported that by the information of PTC case reported on case SEQ17-2569, concluded that the leakage was between the syringe and needle. The narrative was amended accordingly.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 25th out of 84 patients. The vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). It was reported that, the patient was administered with AFLURIA (TIV) Thiomersal that underwent temperature excursion (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow-up report received on 09-Nov-2017: It was reported that the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Amended narrative accordingly. Case correction received with IRD 09-NOV-2017: Deleted "no adverse event" from the product tab. Added "special case with no AE" in general tab". Narrative was corrected from initial to initially in lead sentence.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: This non-serious initial spontaneous case was received on 29-Sep-2017, reported by other non-health professional, concerning a 40-year-old adult female pregnant patient. This historical drug included albuterol for asthma. The patient's current condition included asthma. The patient's concomitant medications included prenatal vitamins, TYLENOL. No maternal and paternal medical history was reported. The patient had a pregnancy in the past (present one is the second pregnancy of 17 weeks), last menstrual period was 11-May-2017. No contraceptives were used by the patient. No miscarriages, congenital anomaly occurred in the past. No spontaneous abortion was reported. No adverse findings were reported in the prenatal test. It was reported that, there were no adverse reactions experienced by foetus. On 08-Sep-2017, at 17 weeks of the gestation age (second trimester) the patient received AFLURIA (explicitly coded as vaccine exposure during pregnancy) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date was not reported). On 08-Sep-2017, the patient had sore in the arm since she received injection, sore to touch, not able to lift the arm because it was painful. The patient was not able to sleep on her left side because of the sore in the arm. The estimated date of delivery was reported as 12-Feb-2018. It was reported that, the patient strongly believed the events as definitely related to the suspect vaccine. The outcome of the events had not yet recovered. Case correction received on 29-Sep-2017: Corrected the report type as spontaneous in the narrative and as determined causality of the event vaccine exposure during pregnancy was changed from related to not related.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: This non-serious initial spontaneous case was received on 29-Sep-2017, reported by other non-health professional, concerning a 40-year-old adult female pregnant patient. This historical drug included albuterol for asthma. The patient's current condition included asthma. The patient's concomitant medications included prenatal vitamins, TYLENOL. No maternal and paternal medical history was reported. The patient had a pregnancy in the past (present one is the second pregnancy of 17 weeks), last menstrual period was 11-May-2017. No contraceptives were used by the patient. No miscarriages, congenital anomaly occurred in the past. No spontaneous abortion was reported. No adverse findings were reported in the prenatal test. It was reported that, there were no adverse reactions experienced by foetus. On 08-Sep-2017, at 17 weeks of the gestation age (second trimester) the patient received AFLURIA (explicitly coded as vaccine exposure during pregnancy) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date was not reported). On 08-Sep-2017, the patient had sore in the arm since she received injection, sore to touch, not able to lift the arm because it was painful. The patient was not able to sleep on her left side because of the sore in the arm. The estimated date of delivery was reported as 12-Feb-2018. It was reported that, the patient strongly believed the events as definitely related to the suspect vaccine. The outcome of the events had not yet recovered. Case correction received on 29-Sep-2017: Corrected the report type as spontaneous in the narrative and as determined causality of the event vaccine exposure during pregnancy was changed from related to not related.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 21 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 03 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 13 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 15 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 16 to 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F an 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 18 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 19 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-dgree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (not adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly).
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult female patient of unspecified age. This case refers to 20th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 22 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient. This refers 23rd out of 84 patients. It was reported that, the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C) and was administered to the patient. The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow up received on 09-Nov-2017: It was reported that, the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 84 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination (not adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly. Non-significant follow up received on 27-Nov-2017 from a physician: Date of birth of the patient was updated.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from other health professional, concerning a 04-year-old male child. The patient had no medical history or concomitant medications. On 17-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XT33908, expiry date: 30-Jun-2018), instead of FLUZONE. The error was noticed later when the lot number did not match in the patient chart. It was reported that, no adverse event occurred after the administration of the vaccine. The reporter assessed the event as non-serious. Follow up received on 24-Oct-2017: It was reported that, no adverse event occurred after the administration of the vaccine. Non-significant case correction received on 24-Oct-2017: The case comment was corrected. Significant case correction was received with IRD 17-Oct-2017: The events 'wrong vaccine administered' and 'no adverse event' were deleted. Significant case correction was received with IRD 24-Oct-2017: The suspect product was changed from AFLURIA QUADRIVALENT to AFLURIA (TIV) based on the batch number. Narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers 01 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 02 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.