chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of viral meningitis in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and abdominal discomfort. On 26th December 2018, the patient experienced viral meningitis (serious criteria disability and GSK medically significant) and feeling unwell. In December 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the viral meningitis, feeling unwell and abdominal discomfort were not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the viral meningitis, injection site erythema, pain in arm, feeling unwell and abdominal discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site. Her arm was also sore for about 3 days. She said that she was expecting these type of side effects so she was not surprised about having them. However, the patient did not feel well and went to emergency room on 26th December 2018 and stayed about 4 to 5 hours at the emergency room and had in the Magnetic resonance imaging (MRI) machine for an hour. They did not know what she was having. The patient received a follow up from the neurologist and she was diagnosed with viral meningitis. The patient did not know if SHINGRIX caused the viral meningitis. However, she had a lot of belly activity and she was incapacitated for several days and she was at the time of reporting not back to herself and could not drive. The patient did not consent to follow-up. The patient did not have a primary care physician.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: IIIrd nerve paralysis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of iiird nerve palsy in a 86-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced iiird nerve palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the iiird nerve palsy was unknown. It was unknown if the reporter considered the iiird nerve palsy to be related to SHINGRIX. Additional details were provided as follows: The patient presented with partial third nerve palsy. The reporting physician stated that the third nerve palsy could also be related to the patient's hypertension. The reporting physician consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Meningitis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of meningitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the meningitis was unknown. It was unknown if the reporter considered the meningitis to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable for this report. The age group was not provided, but was selected adult as per the vaccine indication. The nurse reported that the person was refusing the 2nd dose of SHINGRIX because he has heard that patients were experiencing severe adverse effects such as meningitis and were ending up in the ICU (intensive care unit). The reported did not consent to follow up. The reporting nurse did not had knowledge of further information concerned the incidents that the patient referenced. The reporter declined to follow up for this reason.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained of severe pain in his left arm. Patient stated he had difficulty lifting his arm. Patient said he can't take ibuprofen because on blood thinner but agreed to take TYLENOL and ice down the arm.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a red swollen upper right arm that extended down arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Headache, fatigue, muscle and joint aches.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: That evening had a fever and fatigue that caused him to feel extremely ill. Continued until the next day.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Client spiked temp of 103 approximately 12 hours after getting immunizations, he was taken to local hospital and mom was told to treat the symptoms of the fever. At approximately 24 hours after immunizations, his temp spiked to 104.3. Parents took him to a different ER, they were told that it could be related to the vaccines. He had no other symptoms, no rash, nor were any of his siblings ill. Parents were told to avoid next booster of Dtap and next time get shots one at a time. At the 48 hour mark, he has temp of 100 and then was fine after that. No follow up with PCP.
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Patient states did not experience any symptoms until 2 weeks after receiving vaccine. States has been having stiff neck since and is ongoing. Denies, fever, headache, nausea, vomiting. States pain occurs when moving head side to side but not when bending neck forward. States pain level varies throughout the day. Has taken ADVIL, gotten a massage, used heating pad and icy hot while temporarily alleviate the pain but eventually returns. Patient was not concerned about it at first but states had other family members that experienced the same thing and realized it was after receiving Yellow Fever vaccine (STAMARIL). Informed Dr., advised to see PCP and to inquire about vaccine related viral meningitis. Since patient states neck stiffness has happened to two of her relatives, also patient's son and husband received vaccine 1 month after but deny symptoms at this time, Dr. suggest we report. Patient states she will keep us updated with any further treatment and outcome.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reports pain during injection. That evening/next day pt had a lot of pain in arm and swelling around injection site. Pt reporst swelling stayed for 1 week. Pt reportedly could not move arm due to pain. Also, developed redness/brown area around injection site which has been there since the injection (12 days).
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt reports pain during injection. That evening/next day pt had a lot of pain in arm and swelling around injection site. Pt reporst swelling stayed for 1 week. Pt reportedly could not move arm due to pain. Also, developed redness/brown area around injection site which has been there since the injection (12 days).
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Eye disorder, Oral mucosal blistering
Clinical narrative: Pt reports that 4 days after she received SHINGRIX a blister on her right eye and blisters in her mouth came out. Her joints are still achy until now and her right elbow is still hurting.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Swelling face, Swelling of eyelid, Throat irritation
Clinical narrative: Pt developed mild swelling around eyes, slightly swelled cheeks, headache and a slightly itchy throat 1 hr after receiving FLUMIST in clinic. No difficult breathing. Sx decreased overnight. Slightly puffy eyes still the next AM at office visit.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PT HUSBAND SAID HER LEFT ARM WAS RED AND SWOLLEN AFTER SHE GOT VACCINATED AND LASTED FOR 3 DAYS AND FROM 4TH DAY ONWARDS SWELLING GOT REDUCED AND NOW SHE IS DOING FINE AFTER TAKING IBUPROFEN.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Pt is reporting face swelling.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Injection site bruising, Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Flu Shot was given in Employee Health to the L shoulder. I looked away as it was given. Afterwards, 30 minutes afterwards my arm was feeling stiff with my range of motion decreased from stiffness. Also having pain when trying to use my range of motion. Shot was noted to be given in the front portion of the upper shoulder. I shared with my employee my worries as it appears to be there anterior portion, I shared with my employees my concerns. I was told to wait and see if this continues as some soreness is known. Soreness and pain with stiffness continue for next 2 days and by 4th day stiffness began wearing off slowly, but soreness kept lingering with a feeling as if the shoulder is weaker and is mild pain with range of motion with intermittent pain. Pain still present week afterwards with range of motion pain as well. Week afterwards = soreness with mild pain present upon pressure to insertion site with bruised area. Employee health notified and told to fill out Employee incident report.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Flu Shot was given in Employee Health to the L shoulder. I looked away as it was given. Afterwards, 30 minutes afterwards my arm was feeling stiff with my range of motion decreased from stiffness. Also having pain when trying to use my range of motion. Shot was noted to be given in the front portion of the upper shoulder. I shared with my employee my worries as it appears to be there anterior portion, I shared with my employees my concerns. I was told to wait and see if this continues as some soreness is known. Soreness and pain with stiffness continue for next 2 days and by 4th day stiffness began wearing off slowly, but soreness kept lingering with a feeling as if the shoulder is weaker and is mild pain with range of motion with intermittent pain. Pain still present week afterwards with range of motion pain as well. Week afterwards = soreness with mild pain present upon pressure to insertion site with bruised area. Employee health notified and told to fill out Employee incident report.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: The patient called at 8:55pm on 1/15/19 and says that her arm is very sore and that she feels tingling in her fingers. I told her to try taking some ibuprofen and ice the sore area and to call her doctor in the morning. I called the patient at about 6 PM to see how she was. She said that she didn't want to call her doctor. She also said that it hurt to put on her coat. She says that the numbness/tingling in her hands is gone but the arm still hurts when she moves it. Once again I told her to try ice and ibuprofen and to call her doctor.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Full blood count, Impaired work ability, Metabolic function test
Clinical narrative: Burning skin, itching with no rash, extreme fatigue, no appetite, thirst, called Pharmacy in Sept to see if known factor, said it could be related to injection being in nerve areas, wait and see, however in Oct sysmptoms still continue so called medical Dr and had blood work done in series to detect anything going on with symptoms of ongoing, diagnosed low white blood cell count and referred to Hematologist, I lost work time in Dec due to fatigue and not being able to do by job as Dental Hygiene, wanted to go to bed and sleep so fatigued, no appetite etc.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin burning sensation, Thirst, White blood cell count decreased
Clinical narrative: Burning skin, itching with no rash, extreme fatigue, no appetite, thirst, called Pharmacy in Sept to see if known factor, said it could be related to injection being in nerve areas, wait and see, however in Oct sysmptoms still continue so called medical Dr and had blood work done in series to detect anything going on with symptoms of ongoing, diagnosed low white blood cell count and referred to Hematologist, I lost work time in Dec due to fatigue and not being able to do by job as Dental Hygiene, wanted to go to bed and sleep so fatigued, no appetite etc.
Age: 75.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Asthenia, Chronic fatigue syndrome, Cough, Diarrhoea, Gastrointestinal disorder
Clinical narrative: Flu, severe allergies, nerve damage, sore arm, general weakness, chronic fatigue syndrome, intestinal trouble, diarrhea, cough, wound taking four months to heal.
Age: 75.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Hypersensitivity, Impaired healing, Influenza, Nerve injury, Pain in extremity
Clinical narrative: Flu, severe allergies, nerve damage, sore arm, general weakness, chronic fatigue syndrome, intestinal trouble, diarrhea, cough, wound taking four months to heal.
Age: 75.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Flu, severe allergies, nerve damage, sore arm, general weakness, chronic fatigue syndrome, intestinal trouble, diarrhea, cough, wound taking four months to heal.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: High fever, chills, aches and pains, severe tiredness, arm pain, redness and swelling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: High fever, chills, aches and pains, severe tiredness, arm pain, redness and swelling.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient experienced severe pain in her arm a few days after receiving the flu vaccine (she think 4 days to 1 week after receiving the vaccine). It moved to shoulder and back of her neck. She could not lift up her arm or move her neck. Symptoms did not improve and patient did look for medical help. She contacted the pharmacy 5 months later and stated that she still experienced pain which keep her up at least every other night.
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Blood pressure increased, Chest pain, Discomfort, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Right after the immunizations were administered, patient complained of whole body stiffness and discomfort with chest pain. She said she was not able to move. Patient was sweating, skin felt warm and appeared red. She mentioned she had difficulty breathing. 911 was called immediately and patient appeared better after the parameters came.
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Hyperhidrosis, Mobility decreased, Musculoskeletal stiffness, Skin warm
Clinical narrative: Right after the immunizations were administered, patient complained of whole body stiffness and discomfort with chest pain. She said she was not able to move. Patient was sweating, skin felt warm and appeared red. She mentioned she had difficulty breathing. 911 was called immediately and patient appeared better after the parameters came.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Injection site pain
Clinical narrative: Chills, Fever of 100.5 po, lightheadedness, loss of appetite, fatigue and pain at the site of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, Fever of 100.5 po, lightheadedness, loss of appetite, fatigue and pain at the site of injection.
Age: 1.75
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: Pt tolerated procedure well, but unfortunately was not due for MENACTRA. MMR was intended to have been given instead of MENACTRA. This was also given via SC injection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Syncope
Clinical narrative: Patient reported within 24 hours of receiving vaccine a fainting episode, estimated to last approximately one minute. It occurred when she got up from a sitting position to a standing one. After the event she got up on her own. She also experienced chills in the middle of the night. Additionally, she felt dizzy and fatigued. These symptoms resolved within 24 hours. She did not report this to her health care providers at the time.
Age: 48.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Feeling hot, Hypoaesthesia, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Patient said arm starting hurting the evening after vaccination. She said it was really sore to the touch. Has not improved. Has noticed tingling, and some numbness in thumb. Sometimes gets hot. Went to chiropractor 5 times since vaccination thinking she might have hurt her arm, no improvement. She has tried ice and NSAIDS with no improvement.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Dizziness, Electroencephalogram normal, Nausea, Seizure like phenomena
Clinical narrative: Seizure-like activity lasting approximately 15 seconds. No memory of event upon awakening. No further signs of seizure activity once taken to hospital. Awoke with lightheadedness and nausea.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Aphasia, Asthenia, Blood lactic acid, Cardiac monitoring, Computerised tomogram head
Clinical narrative: Seizure-like activity lasting approximately 15 seconds. No memory of event upon awakening. No further signs of seizure activity once taken to hospital. Awoke with lightheadedness and nausea.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Confusional state, Differential white blood cell count, Drug screen, Electrocardiogram, Full blood count
Clinical narrative: Seizure-like activity lasting approximately 15 seconds. No memory of event upon awakening. No further signs of seizure activity once taken to hospital. Awoke with lightheadedness and nausea.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Heart rate decreased, Hyperhidrosis, Hypoacusis, Loss of consciousness, Metabolic function test
Clinical narrative: Seizure-like activity lasting approximately 15 seconds. No memory of event upon awakening. No further signs of seizure activity once taken to hospital. Awoke with lightheadedness and nausea.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Seizure like phenomena, Skin discolouration, Syncope, Urine alcohol test, Urine analysis
Clinical narrative: Seizure-like activity lasting approximately 15 seconds. No memory of event upon awakening. No further signs of seizure activity once taken to hospital. Awoke with lightheadedness and nausea.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: 9 x 7cm rash and swelling at the DTaP injection area, one day after the injection. Advised cool compress and Bendryl 4ml every 6-8 hours as needed.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Cellulitis starting about an inch below the injection site to the crease of inner elbow. Dermatologist gave injection of ROCEPHIN and script for BACTRIM DS bid for 7 days area is hot to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: (L) deltoid redness, swelling, soreness, with some "streaking" as described by patient.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test positive, Arthralgia, Feeling hot, Influenza, Loss of personal independence in daily activities
Clinical narrative: 1/9/19-5 days after HPV #3 hives to face and chest. Mom reported that this occurred after HPV #2. 01/14/2019 A 16 year old female with "severe ST" - "hurts to swallow." Nausea. "Burning up" today at school. Temp not taken. No antipyretic taken. Sx started five days ago with hives. Mother called to report hives on face and chest and she shows me pictures today. She also told our nurse when she called that patient had fever and flu sx. ALLEGRA 180 mg every day since then and the hives have not returned per patient. Vomited 3 and 4 days ago, once each day, and not since then. The first vomiting was after chicken soup. No diarrhea. Knees and bottom of feet were hurting "so bad" 3 and 4 days ago, but this sx has resolved. Body aches four days ago. No balance issues. ST started severely 3 days ago per patient. No headache. No neck swelling. No cough, except to clear throat patient says. No rhinorrhea. No dysuria. Missed school 3 and 4 days ago, but went to school today. Drinking and eating per MOC. CEPACOL throat lozenge helpful, uses before bed. Ibuprofen 400 mg sometimes daytime and before bed which helped a little. No one at home is sick. Allergy testing 9/2018: "very large positive results" to tree, grass, weed, mold, cat. Borderline to soy and avoidance was recommended. Mom asks if the hives and ST and aches are related to the HPV vaccine given 1/4/19.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Odynophagia, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: 1/9/19-5 days after HPV #3 hives to face and chest. Mom reported that this occurred after HPV #2. 01/14/2019 A 16 year old female with "severe ST" - "hurts to swallow." Nausea. "Burning up" today at school. Temp not taken. No antipyretic taken. Sx started five days ago with hives. Mother called to report hives on face and chest and she shows me pictures today. She also told our nurse when she called that patient had fever and flu sx. ALLEGRA 180 mg every day since then and the hives have not returned per patient. Vomited 3 and 4 days ago, once each day, and not since then. The first vomiting was after chicken soup. No diarrhea. Knees and bottom of feet were hurting "so bad" 3 and 4 days ago, but this sx has resolved. Body aches four days ago. No balance issues. ST started severely 3 days ago per patient. No headache. No neck swelling. No cough, except to clear throat patient says. No rhinorrhea. No dysuria. Missed school 3 and 4 days ago, but went to school today. Drinking and eating per MOC. CEPACOL throat lozenge helpful, uses before bed. Ibuprofen 400 mg sometimes daytime and before bed which helped a little. No one at home is sick. Allergy testing 9/2018: "very large positive results" to tree, grass, weed, mold, cat. Borderline to soy and avoidance was recommended. Mom asks if the hives and ST and aches are related to the HPV vaccine given 1/4/19.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcus test negative, Urticaria, Vomiting
Clinical narrative: 1/9/19-5 days after HPV #3 hives to face and chest. Mom reported that this occurred after HPV #2. 01/14/2019 A 16 year old female with "severe ST" - "hurts to swallow." Nausea. "Burning up" today at school. Temp not taken. No antipyretic taken. Sx started five days ago with hives. Mother called to report hives on face and chest and she shows me pictures today. She also told our nurse when she called that patient had fever and flu sx. ALLEGRA 180 mg every day since then and the hives have not returned per patient. Vomited 3 and 4 days ago, once each day, and not since then. The first vomiting was after chicken soup. No diarrhea. Knees and bottom of feet were hurting "so bad" 3 and 4 days ago, but this sx has resolved. Body aches four days ago. No balance issues. ST started severely 3 days ago per patient. No headache. No neck swelling. No cough, except to clear throat patient says. No rhinorrhea. No dysuria. Missed school 3 and 4 days ago, but went to school today. Drinking and eating per MOC. CEPACOL throat lozenge helpful, uses before bed. Ibuprofen 400 mg sometimes daytime and before bed which helped a little. No one at home is sick. Allergy testing 9/2018: "very large positive results" to tree, grass, weed, mold, cat. Borderline to soy and avoidance was recommended. Mom asks if the hives and ST and aches are related to the HPV vaccine given 1/4/19.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: This spontaneous case, initially received on 06-Nov-2017, from a pharmacist, concerning a 21-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 05-Nov-2017, the patient was administered FLUVIRIN (dose: dose less than 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 179940P, expiry date: 31-May-2018). It was reported that, during administration with needle to the patient's arm some of the vaccine leaked down on to the patient's arm and was not exactly sure if the vaccine came out around the injection site of the skin (explicitly coded as incomplete dose administered). Reportedly, there was no way to determine the leakage, but it was between the syringe and needle. The pharmacist could not confirm if it was an incorrect technique or if there was a leakage issue of the syringe (explicitly coded as syringe issue). This case was associated with PTC reference number: 1025997. The complainant was unable to provide information or a sample to support this case, however, complainant information does suggest the issue could be user-related. This was the only complaint received so far for FLUVIRIN batch 179904P and according to trend analysis, there was no indication of a trend for the manufacturing campaign for leaking syringes. Based on the information available, a product defect could not be identified or attributed, therefore, the complaint was not justified. The reporter considered this report as non-serious. Non-significant follow up received 14-Nov-2017: The PTC (product technical complaint) reference number 1025997 was updated. Follow up received 14-Dec-2017 and 02-Jan-2018 (combinedly processed): The event syringe issue was added. The pharmacist could not confirm if it was an incorrect technique or if there was a leakage issue of the syringe. The complainant was unable to provide information or a sample to support this case, however, complainant information does suggest the issue could be user-related. This was the only complaint received so far for FLUVIRIN batch 179904P and according to trend analysis, there was no indication of a trend for the manufacturing campaign for leaking syringes. Based on the information available, a product defect could not be identified or attributed, therefore, the complaint was not justified. Narrative was amended accordingly. Update received on 11-Nov-2018: Non-significant case correction (14-Nov-2017): The term "QA reference number' was changed to 'PTC Reference Number' in the notes section of the additional information tab.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 02-Nov-2017, was reported by other health professional and concerns a 29-year-old adult female patient. On 01-Nov-2017, it was reported that, the vaccine was stored at 39 degrees and later the temperature was found to be in between 32 to 34 degrees from 9:00 am to 5:00 PM. The temperature was adjusted but, again it went up to 36 degrees (explicitly considered as incorrect product storage). The vaccine was not frozen. On the same day, the patient was administered with FLUVIRIN Thiomersal (batch number: 1721001, expiry date: 31-May-2018, dose, route of administration, anatomical location: not reported) which underwent temperature excursion (explicitly considered as drug administration error). It was reported that the patient had no adverse event. Follow-up received on 04-Dec-2017: Added patient demographics (date of birth, age: 29, gender: female) and date of vaccination was corrected from 02-Nov-2017 to 01-Nov-2017.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Barium swallow abnormal, Blood creatine phosphokinase increased, Chest X-ray abnormal, Cough
Clinical narrative: This spontaneous case, initially received from a physician on 17-Nov-2017, concerning a 60-year-old, adult, male patient. The patient's historical vaccine included flu vaccine (in the past with no issues as reported). The patient's current condition was diabetes. On 03-Oct-2017, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, batch number: 1720701, expiry date: 30-Apr-2018). On 17-Oct-2017, 15 days after administration of FLUVIRIN, the patient experienced dysphagia, cough, and severe muscle weakness in legs (could not get up out of chair) and edema about 2 weeks after receiving FLUVIRIN. Barium swallow showed esophageal dysmotility, chest x-ray showed lower lobe interstitial lung disease, CPK (creatine phosphokinase) elevated, ANA (antinuclear antibody panel) negative, RA (rheumatoid factors) highly positive. The patient received LEVAQUIN and omeprazole. Then he received Prednisone taper (as reported) which had shown dramatic improvement. At the time of this report, the events were resolving. The reporter assessed the case as non-serious. Follow-up received on 12-Jan-2018: Non-significant follow-up received with no additional information. The reporter confirmed the batch number and expiry date. Narrative was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Interstitial lung disease, Muscular weakness, Oedema, Oesophageal motility disorder
Clinical narrative: This spontaneous case, initially received from a physician on 17-Nov-2017, concerning a 60-year-old, adult, male patient. The patient's historical vaccine included flu vaccine (in the past with no issues as reported). The patient's current condition was diabetes. On 03-Oct-2017, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, batch number: 1720701, expiry date: 30-Apr-2018). On 17-Oct-2017, 15 days after administration of FLUVIRIN, the patient experienced dysphagia, cough, and severe muscle weakness in legs (could not get up out of chair) and edema about 2 weeks after receiving FLUVIRIN. Barium swallow showed esophageal dysmotility, chest x-ray showed lower lobe interstitial lung disease, CPK (creatine phosphokinase) elevated, ANA (antinuclear antibody panel) negative, RA (rheumatoid factors) highly positive. The patient received LEVAQUIN and omeprazole. Then he received Prednisone taper (as reported) which had shown dramatic improvement. At the time of this report, the events were resolving. The reporter assessed the case as non-serious. Follow-up received on 12-Jan-2018: Non-significant follow-up received with no additional information. The reporter confirmed the batch number and expiry date. Narrative was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Rheumatoid factor increased
Clinical narrative: This spontaneous case, initially received from a physician on 17-Nov-2017, concerning a 60-year-old, adult, male patient. The patient's historical vaccine included flu vaccine (in the past with no issues as reported). The patient's current condition was diabetes. On 03-Oct-2017, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, batch number: 1720701, expiry date: 30-Apr-2018). On 17-Oct-2017, 15 days after administration of FLUVIRIN, the patient experienced dysphagia, cough, and severe muscle weakness in legs (could not get up out of chair) and edema about 2 weeks after receiving FLUVIRIN. Barium swallow showed esophageal dysmotility, chest x-ray showed lower lobe interstitial lung disease, CPK (creatine phosphokinase) elevated, ANA (antinuclear antibody panel) negative, RA (rheumatoid factors) highly positive. The patient received LEVAQUIN and omeprazole. Then he received Prednisone taper (as reported) which had shown dramatic improvement. At the time of this report, the events were resolving. The reporter assessed the case as non-serious. Follow-up received on 12-Jan-2018: Non-significant follow-up received with no additional information. The reporter confirmed the batch number and expiry date. Narrative was amended accordingly.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 27-Nov-2017 from a pharmacist, concerning a 64-year-old, female adult patient. The patient had no medical history and was not under any concomitant medications. On 27-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179804P, expiry date: not reported), that was stored at a maximum temperature of 53 F, about 10 hours. It was reported that, no adverse event was occurred after the vaccination. Follow up received on 03-Jan-2018: Indication (influenza vaccination) of the suspect product was updated.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 21-Nov-2017, concerning a 36-year-old, adult, female patient. The patient was allergic to latex. On 30-NOV-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 158901 (as reported), expiry date: May-2017). It was reported that the patient with latex allergy received FLUVIRIN PFS (explicitly coded as contraindicated product administered) but no adverse event was reported. The reporter assessed the event as non-serious.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle injury, Pain in extremity, Product administered at inappropriate site, Skin indentation
Clinical narrative: This is a spontaneous case, initially received on 29-Nov-2017, from a consumer, concerning a 31-year-old, adult, female patient. The patient was allergic to penicillin. It was reported that, the patient never had flu reaction in the past. On 22-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: reported as 1720701 or 179601P (reporter didn't know which one pertained to the vaccine that she received), expiry date: 30-Apr-2018). On 24-Nov-2017, after 3 days of vaccination, the patient had severe pain in the arm, hole in her arm and deterioration of a piece of muscle tissue. The patient believed that the reaction occurred as the injection was given at wrong location. The patient used ice packs on the affected area of her arm. It was reported that, the patient received TYLENOL. The patient had scheduled an appointment with the physician. At the time of the report, the patient had completely recovered from the events and reported that the patient did not felt pain anymore and everything was fine to her. The reporter assessed the events as non-serious. Non-significant follow-up received from other non-health professional on 02-Jan-2018: Added lot number (1720701 or 179601P, reporter didn't know which one pertained to the vaccine that she received). The reporter confirmed that the patient received TYLENOL. The narrative was amended accordingly. Follow-up from other non-health professional received on 24-Jan-2018: The other non-health professional confirmed that patient had recovered from the events. Narrative amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysstasia, Mobility decreased, Pain, Pyrexia
Clinical narrative: This initial spontaneous case, was received on 16-Nov-2017 from Other Non-Health Professional, concerns a 43-year-old adult female patient. On an unspecified date, the patient was administered with FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On unspecified date, (reported as) several days after vaccination, the patient had fever and body aches. It was reported that, the patient could not move head or neck and she was too weak to stand in shower. On unspecified date, the patient got resolved from events. The reporter assessed this case as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional on 29-Nov-2017, concerning a patient of an unspecified age and gender. On an unspecified date, the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number and expiry date: not reported). It was reported that, the patient received the vaccine, which underwent temperature excursion (explicitly coded as incorrect product storage and drug administration error). Follow-up received on 08-Feb-2018: This case was considered as lost to follow-up since the reporter could not be contacted for further information after 2 attempts in 30 days.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event
Clinical narrative: This spontaneous case, initially received on 30-Nov-2017, reported by a pharmacist and concerns a 29-year-old, adult, female patient. Patient's medical history and concomitant medications were not reported. On 15-Nov-2017, the patient received FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 170104P, expiry date: 31-May-2018). However, not all of it went in, but tiny bit of vaccine leaked out of administration site and onto patient's arm during administration. It was reported that, no adverse effect was noted in the patient. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 30-Nov-2017: The expiry date of the suspect product was corrected from May-2018 to 31-May-2018. The narrative was amended accordingly. Case correction received with IRD 30-Nov-2017: Added new event as "exposure via skin contact" in the event tab. The narrative was amended accordingly.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: This spontaneous case, initially received on 30-Nov-2017, reported by a Pharmacist and concerns a 20-year-old female patient. Patient's medical history and concomitant medications were not reported. On 21-Nov-2017, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported, batch number: 170104P, expiry date: May-2018). It was reported that, while administering the vaccine the most of it leaked onto the patient's arm. It was reported that, the patient was revaccinated, no leakage with second vaccination occurred. The patient had no adverse effects after administration of the vaccine. The reporter assessed the case as non-serious. Significant case correction received with IRD: 30-Nov-2017: The product expiry date changed from May-2018 to 31-May-2018. The event 'product leak' was changed to 'skin contact'.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from a nurse on 18-Jan-2018, concerning a 45-month-old child female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 12-Jan-2018, 03-year-old child (under 4 years of age) patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1721201 and expiry date: 30-Jun-2018) (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient did not experienced any adverse effects after the vaccination. The reporter assessed the event as non-serious. Follow up report received on 16-Feb-2018: The reporter confirmed that, the patient did not experienced any adverse effects after the vaccination.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 04-Dec-2017, reported by other health professional and concerns a 28-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 01-Nov-2017, the patient received FLUVIRIN Thiomersal (batch number: 1721001, expiry date: 31-May-2018, dose, route of administration, anatomical location: not reported). It was reported that, temperature was checked, and it was 39 degrees. Between 9:00 am to 5:00 pm, the temperature was 32-34 degrees. Upon adjustment the temperature went to 36 degrees (explicitly coded as incorrect product storage). It was stated that, one vial was administered after the excursion (explicitly drug administration error). It was confirmed that, MDV (unopened) reached down to 32F for 8 hours, it was the first-time excursion, six doses were administered, and the vaccine was not frozen. It was reported that, the patient did not experience any adverse events after the vaccination. Non-significant case correction received 04-Dec-2017: The expiry date of the suspect product was corrected from May-2018 to 31-May-2018. The narrative was amended accordingly.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 04-Dec-2017, was reported by other health professional and concerns a 21-year-old adult female patient. On 01-Nov-2017, the patient was administered with FLUVIRIN Thiomersal (batch number: 1721001, expiry date: 31-May-2018, dose, route of administration, anatomical location: not reported) which underwent temperature excursion down to 32 F for 8 hours and 6 doses were administered. It was reported that, the vaccine was stored at 39 degrees and later the temperature was found to be in between 32 and 34 degrees from 9:00 am to 5:00 PM. The temperature was adjusted but, again it went up to 36 degrees. The vaccine was not frozen. It was reported that the patient had no adverse event.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 from a pharmacist, concerning a 29-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2017, the refrigerator in which vaccine was stored, reached a maximum temperature of 56 F and reporter was not sure of the time span of temperature excursion (reported as 17 hours). On 05-Dec-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179602P expiry date: 30-Apr-2018), which had undergone temperature excursion above 46 Fahrenheit. It was unknown, whether patient had any adverse event after the vaccination. The reporter assessed the case as non-serious. Non-significant follow up received on 05-Jan-2018: No new information received.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case, was initially received from pharmacist on 11-Dec-2017 and concerns a 59-year-old, adult, female patient. The patient's medical history included hypertension, affective psychosis and vaginitis since an unspecified date. The patient's concomitant medications included simvastatin, losartan with hydrochlorothiazide, escitalopram and TRINTELLIX for an unknown indication. On 03-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179903P and expiry date: 31-May-2018). On the same day after vaccination, the patient had severe muscle soreness in the left arm, where the vaccine was administered. It was reported that the patient had little stiffness in the shoulder, little residual soreness in left arm and unable to rotate her arm. The patient did not receive any treatment for the events. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Follow-up received from pharmacist on 25-Jan-2018: The pharmacist confirmed that patient had recovered from the event. Narrative amended accordingly. Follow-up received from pharmacist on 14-Mar-2018: The events (shoulder stiffness and mobility decreased) were added. It was reported that, the patient still had a little stiffness in the shoulder, little residual soreness in left arm and unable to rotate her arm. The outcome of the event (injection site pain) was changed from recovered to not recovered. The reporter also confirmed that, the patient had not received any treatment for the event. Narrative amended accordingly. Follow-up information received from the pharmacist on 20-Apr-2018: It was confirmed that the patient had not been administered with any treatment medication(s). The outcome of the events was updated to recovered from not recovered/ not resolved and narrative was amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 17-Jan-2018, concerning a 50-year-old, adult, female patient. The patient's current condition: wears braces. It was reported that the patient was healthy. On 17-Jan-2018, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1720901 and expiry date: 31-May-2018). On the same day, immediately after receiving the vaccine, the patient experienced metallic taste. On 18-Jan-2018, the patient completely recovered from the event metallic taste. The reporter considered the event metallic taste as non-serious. Follow up received from other health professional (Nurse) on 09-Feb-2018: The reporter confirmed that, the patient had recovered completely from the event (metallic taste) on 18-Jan-2018. Narrative amended accordingly.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Patient stated that he had severe pain in his left arm for over a month after receiving his flu shot. He was diagnosed with a frozen shoulder and given a cortisone shot.