chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: Case number PHHY2017US030061 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 664716) website on 21 Feb 2017. This report refers to 58 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618621) intramuscular on 07 Oct 2016. On 08 Oct 2016, patient went running her vision became blurry. The patient had to go to doctor/emergency visit (MD) office, MD did Magnetic resonance imaging (MRI, results and date were not reported) and physical exam; everything came back normal. MD advised might be flu shot. The outcome of the event was complete recovery on an unknown date; seriousness of the event was non serious and causality of the event was not reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Nausea
Clinical narrative: Case number PHHY2017US030511, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 665301) website on 21 Feb 2017. This report refers to a 44 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619801) into left arm, intramuscularly on 13 Oct 2016. On the same day after vaccination, the patient experienced nauseated and blood pressure increased 147/96 (unit unspecified) and stated eggs cause her to be nauseated. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2017US036786 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 665443) website on 21 Feb 2017. This report refers to 74 year old female patient. Medical history and concomitant medication was not reported, historical drug included Atenolol; Clindamycin; Codeine; FOSAMAX; Sulfa; LEVAQUIN. The patient was vaccinated FLUVIRIN (batch number: 1618401) intramuscular left arm on 09 Nov 2016. On 10 Nov 2016 patient experienced redness, fever on the arm where the injection was administered. The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Case number PHHY2017US029474 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 666444) website on 21 Feb 2017. This report refers to 24 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 168802) intramuscular into left arm on 15 Nov 2016. On the same day, the patient experienced syncope paleness, sweating, lightheadedness. The patient received treatment with cold compresses which was applied to her head and neck. The outcome of the events was complete recovery on an unknown date. The seriousness of the events was non serious and causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2017US029380 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 666638) website on 21 Feb 2017. This report refers to a 22 year old female patient. Historical condition was not reported. Current condition included codeine allergy and current illness were reported as none. Concomitant medications included MINASTRIN 24 FE. The patient was vaccinated with FLUVIRIN (batch number: 169005) intramuscularly into left arm on 26 Oct 2016. After vaccination on 27 Oct 2016 (reported as the next day), the patient presented with complaints of left shoulder pain and decreased range of motion. Patient was prescribed with Naproxen, and was advised heating pad and arm exercises. Following the events patient visited emergency room. It was reported that upon follow up appointment on 01 Nov 2016, the patient was diagnosed with bursitis and was advised to continue the anti-inflammatory medication and exercises. The lab data of the patient was reported as none. The final outcome of the events was reported unknown. Seriousness of the event was reported as non serious and causality was not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Chills, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: Case number PHHY2017US030690 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (Vaers number: 666663) website on 21 Feb 2017. This report refers to 71 year old female patient. Medical history was not reported, concurrent condition included as sulfa-allergy and chronic erythema nodosum. Prior vaccination history included flu shot in 2014 and experienced same event (please refer this case: PHHY2017US031387). Concomitant medication included as prednisone 5mg daily; LIPITOR 10 mg 3 week. The patient was vaccinated with FLUVIRIN (batch number: 1619021) intramuscular into left arm on 14 Oct 2016. On the same day, patient experienced chills, fever (102) unit and normal range were not reported, nausea, she was bed-ridden for 36 hours. Patient felt bad another 24 hours. The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Case number PHHY2017US027021, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667015) website on 21 Feb 2017. This report refers to a 44 years old female patient. Medical history was not reported. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1619521) intramuscularly into the left arm on 07 Nov 2016. After vaccination, on the same day, she experienced itchy throat and hives. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US029973, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668175) website on 21 Feb 2017. This report refers to a 59 years old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 168901), intramuscularly on 10 Oct 2016. After vaccination, on 11 Oct 2016, she experienced sore arm for about 3 days that progressed to very painful arm that she was unable to lift her arm over her head. She went to the urgent care and they prescribed antibiotic (unspecified) and prednisone. Prednisone relieved the pain. After she finished with treatment with prednisone, she developed migraine. She went to family physician and they prescribed her EXCEDRIN MIGRAINE. It was reported that her arm was still sore as of 07 Nov 2016. The outcome of the event painful arm was reported as condition unchanged as of 07 Nov 2016 while it was complete recovery for other events. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Oral mucosal eruption, Pruritus
Clinical narrative: Case number PHHY2017US030011, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668202) website on 21 Feb 2017. This report refers to a 60 years old female patient. Medial history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1620601), intramuscularly into left arm and ZOSTAVAX (other manufacturer, batch number: M035692) subcutaneously; both vaccines on 20 Nov 2016. After vaccination on the same day, she experienced rash on arm by ZOSTAVAX injection site and rash by mouth and itching. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure decreased, Fear of injection, Visual impairment
Clinical narrative: Case number PHHY2017US030447 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668348) website on 21 Feb 2017. This report refers to a 22 year old male patient. Historical condition included drop in blood pressure. Current condition included GAD (generalized anxiety disorder), panic disorder and current illness were reported as none. Concomitant medications included NORCO, ADDERALL and LEXAPRO. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscularly on 09 Nov 2016. It was reported that the patient was feeling fine before the shot. On the same day, during the administration the patient expressed his fear of needles. On the same day, after administration, patient walked out of the room and to the end of the aisle and started to feel vision going in and out. Patient tried to lower his body to the ground so he would not pass out and then sat down near front register. It was reported that the manager gave patient water and banana. Patient stated that this was not the first time he had experienced this drop in BP and anxiety setting in. It was reported that the patient declined ambulance, to call 911. On 09 Nov 2016 at 1:33 PM, the blood pressure of the patient was 108/90 (normal range and units unspecified) and pulse was 84 (normal range and units unspecified). Patient stated that he was feeling fine after sitting, drinking water and eating banana and stated that he was ok to drive and left the store after checking his pressure at 1:33 PM. The final outcome of the events fear of injection, anxiety and visual impairment was reported as complete recovery on 09 Nov 2016 and for the event blood pressure decreased was reported as condition unchanged. The events were assessed as non serious by the reporter and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US028922, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number 668572) website on 21 Feb 2017. This report refers to a 45 years old female patient. Past medical history included a rotator cuff injury to right arm. Current condition was not reported. Concomitant medication included zolpidem. The patient was vaccinated with AGRIFLU (batch number: not reported) intramuscularly on 07 Nov 2016. On the same day after vaccination the pharmacist old that she did not needle in all the way. Her left upper arm started hurting shortly after and had begun to get worse since. The patient stated that it was feeling worse than when she had a rotator cuff injury to right arm. The patient also experienced limited range of motion and could not sleep. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Case number PHHY2017US029588 is initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 669004) website on 21 Feb 2017. This report refers to a 61 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620201) intramuscularly into right arm on 27 Sep 2016. On the same day, patient reports right arm pain. She was seen by her primary care physician (PCP) and was referred for physician therapy. She visited the emergency room on an unknown date. Primary care physician commented examination (unspecified) was consistent with adhesive capsulitis. The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Myotonia, Syncope
Clinical narrative: Case number PHHY2017US029539 is initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 669124) website on 21 Feb 2017. This report refers to 19 year old male patient. Medical history and concomitant medication was not reported. The patient prior vaccination history included fainting at unspecified age vaccine not specified. The patient was vaccinated with FLUVIRIN (batch number: 166304) intramuscular into left arm on 29 Nov 2016. On the same day, patient experienced vasovagal syncope with myotonic activity. The outcome of the events was unknown, seriousness of the events was non serious and causality of the events was not reported.
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood glucose, Electrocardiogram, Loss of consciousness
Clinical narrative: This initial spontaneous case, was received on 12-Apr-2017 via health authority (VAERS ID: 669151) and concerns a 23-years-old adult male patient. The patient's historical condition included latex and nickel allergies. On 01-Dec-2016 the patient received FLUVIRIN THIOMERSAL (batch number: 1619521, dose: 0.5 ml, expiry date: not reported) at left arm via intramuscular route (represented as drug administration error). On 01-Dec-2016 the patient also received BOOSTRIX (batch number: F7YE3, dose, expiry date: not reported) at left arm via intramuscular route. On 01-Dec-2016 after administration of influenza vaccine and diphtheria vaccine, pertussis vaccine, tetanus vaccine, the patient experienced loss of consciousness for approximately 10 seconds. On an unspecified date, electrocardiogram and finger stick blood glucose test were done by emergency medical services. On an unspecified date, the patient was recovered from the event loss of consciousness and drug administered at inappropriate site was not reported. The reporter did not provide the causality of the event in relation to the influenza vaccine. This case was non-serious. Significant case correction received on 17-May-2017: The causality of the event loss of consciousness was updated from not related to related. The coding of event AFLURIA QUAD and TDAP were administered at same site and same arm was changed from drug administered at inappropriate site to drug administration error. Significant case correction received on 23-Jun-2017: Using the batch number the suspect product AFLURIA was changed to FLUVIRIN THIOMERSAL and was coded accordingly. The listedness was updated.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Asthenia, Immediate post-injection reaction, Pain, Visual impairment
Clinical narrative: Case number PHHY2017US028050 is initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 669584) website on 21 Feb 2017. This report refers to a 14 years female patient. Medical history and concomitant medication were reported as none. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscularly into the left arm on 04 Dec 2016. On the same day, immediately after the shot patient had pain on left side. She had vision seeing black, weak and she almost passed out. The outcome of the events was complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis, Lethargy
Clinical narrative: Case number PHHY2017US028785 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 669619) website on 21 Feb 2017. This report refers to a 10 years old female patient. Historical condition was not reported. Current illness were reported as none. Concomitant medications included CONCERTA. The patient was vaccinated with FLUVIRIN (batch number: 1618401) intramuscularly into the left arm on 30 Nov 2016. On the same day after vaccination, the patient experienced lethargy, visual disturbances, dizziness, weakness, cold, clammy and profuse perspiration. It was reported that the pharmacist called 911 for emergency medical service (EMS). Following the events patient visited emergency room. The final outcome of the events was reported unknown. The events were assessed as non serious by the reporter and causality was not reported.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Case number PHHY2017US028785 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 669619) website on 21 Feb 2017. This report refers to a 10 years old female patient. Historical condition was not reported. Current illness were reported as none. Concomitant medications included CONCERTA. The patient was vaccinated with FLUVIRIN (batch number: 1618401) intramuscularly into the left arm on 30 Nov 2016. On the same day after vaccination, the patient experienced lethargy, visual disturbances, dizziness, weakness, cold, clammy and profuse perspiration. It was reported that the pharmacist called 911 for emergency medical service (EMS). Following the events patient visited emergency room. The final outcome of the events was reported unknown. The events were assessed as non serious by the reporter and causality was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Case number PHHY2017US030080 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 670161) website on 21 Feb 2017. This report refers to 79 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620301) into left arm on 17 Nov 2016. On 21 Nov 2016 patient complain of bruising after receiving vaccine; bruise was 2 inch x 2 inch square with clots at bottom; it was painful the first day but not anymore as of 23 Nov 2016. Patient still had bruise as of 23 Nov 2016. The outcome of the events was condition unchanged; seriousness of the events was non serious and causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood test normal, Dizziness, Gait disturbance, Headache
Clinical narrative: Case number PHHY2017US026625, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671841) on 23 Jan 2017. This report refers to a 56 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with first dose FLUVIRIN (batch number: 1619601) on 06 Dec 2016. On same date after vaccination, the patient started seeing stars in right eye, which continued to blur her vision, felt dizzy, a severe headache in left temple and nauseous. She had to have two people help her walk also felt as if someone was controlling her right leg when she walked also could not balance herself. Patient was concerned of having a stroke and about Guillain-Barre Syndrome, so went to the emergency room, blood test was performed and results came back normal. It was reported that the patient took off work the next day to rest, but it did take most of the day before she felt was normally walking. The patient fully recovered from all events on an unknown date. These events were considered non-serious. The causality of these events were not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vision blurred, Visual impairment, Walking aid user
Clinical narrative: Case number PHHY2017US026625, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671841) on 23 Jan 2017. This report refers to a 56 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with first dose FLUVIRIN (batch number: 1619601) on 06 Dec 2016. On same date after vaccination, the patient started seeing stars in right eye, which continued to blur her vision, felt dizzy, a severe headache in left temple and nauseous. She had to have two people help her walk also felt as if someone was controlling her right leg when she walked also could not balance herself. Patient was concerned of having a stroke and about Guillain-Barre Syndrome, so went to the emergency room, blood test was performed and results came back normal. It was reported that the patient took off work the next day to rest, but it did take most of the day before she felt was normally walking. The patient fully recovered from all events on an unknown date. These events were considered non-serious. The causality of these events were not reported.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Cyst, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This non-serious initial spontaneous case, was received on 10-Jul-2017, from other non-health professional via health authority (VAERS ID: 689049), concerning a 29-year-old male patient. The patient had no current illness and medical history. On 16-Oct-2016, the patient received FLUVIRIN (dose: 0.5ml, batch number: 168701, expiry date: not reported, route of administration: intramuscular). On same day, after administration of FLUVIRIN, the patient had limited movement of shoulder with pain (9/10 scale). On an unspecified date, MRI (Magnetic resonance imaging) was performed which showed a cyst adjacent to the posterior superior labrum (measuring 4mm), representing a tiny para-labral cyst, however a definite labral tear was not visualised. The outcome of the events was not recovered. Reporter's comment: The health authority assessed this case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: This non-serious initial spontaneous case, received from other non-health professional via health authority (VAERS ID: 696153) on 08-Aug-2017, concerning a 36-year-old female patient. The patient's historical condition included dust allergy. The patient had no current illness. On 28-Oct-2016, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location; left arm, batch number: 1620201 and expiry date: not reported). On the same day, the patient had pain in her left arm, which was progressively worsened and limited range of motion. She pointed the acromial area as the site of injection. The patient was diagnosed with left deltoid bursitis. It was reported that, the symptoms were improved with physical therapy (PT) and once physical therapy completed, her symptoms were gradually returned. On 14-Nov-2016, X-ray was found normal. On 03-Dec-2016, An MRI (magnetic resonance image) was performed and showed supple focal of T2 intensity in the posterior infraspinatus tendon, which was proximal to the insertion with underlying tiny focus of subcortical edema in the humeral head and mild subacromial and sub deltoid bursitis. On 29-Jun-2017 she was diagnosed with left shoulder impingement and adhesive capsulitis and received a steroid injection. On the same day she restarted her PT. At the time of this report, the patient had not yet recovered from the events. The health authority assessed the report as non-serious.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, Rotator cuff syndrome, X-ray normal
Clinical narrative: This non-serious initial spontaneous case, received from other non-health professional via health authority (VAERS ID: 696153) on 08-Aug-2017, concerning a 36-year-old female patient. The patient's historical condition included dust allergy. The patient had no current illness. On 28-Oct-2016, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location; left arm, batch number: 1620201 and expiry date: not reported). On the same day, the patient had pain in her left arm, which was progressively worsened and limited range of motion. She pointed the acromial area as the site of injection. The patient was diagnosed with left deltoid bursitis. It was reported that, the symptoms were improved with physical therapy (PT) and once physical therapy completed, her symptoms were gradually returned. On 14-Nov-2016, X-ray was found normal. On 03-Dec-2016, An MRI (magnetic resonance image) was performed and showed supple focal of T2 intensity in the posterior infraspinatus tendon, which was proximal to the insertion with underlying tiny focus of subcortical edema in the humeral head and mild subacromial and sub deltoid bursitis. On 29-Jun-2017 she was diagnosed with left shoulder impingement and adhesive capsulitis and received a steroid injection. On the same day she restarted her PT. At the time of this report, the patient had not yet recovered from the events. The health authority assessed the report as non-serious.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Limb mass, Pain, Pain in extremity
Clinical narrative: The initial spontaneous case, was received via health authority (VAERS ID: 696274) on 08-Aug-2017, concerning a 70-year-old elderly female patient. The patient had no medical history and current illness. The patient's concomitant medications included: Vitamin D3, Biotin, TUMS, Probiotic, multivitamin, OGEN, lisinopril with hydrochlorothiazide, gabapentin, pantoprazole, ZANTAC all given for unknown indications. On 31-Oct-2016, the patient was administered with FLUVIRIN THIOMERSAL (reported as AFLURIA QUADRIVALENT), dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, lot number: 1618801, expiry date: not reported). The patient developed lump in arm since the flu shot and very painful. She also experienced right arm aches which hurt when she laid on, throbbing and shooting pain if she would lift something. The patient used ice and ibuprofen which was found to be helpful and reported that topical diclofenac cream and physical therapy had not helped. At the time of this report, the patient had not yet recovered from the events. Health authority assessed the report as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site discolouration, Mobility decreased, Neck pain
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 699729) on 08-Aug-2017, concerning a 64-year-old female patient. The patient's current condition included diabetes. On 13-Nov-2016, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, anatomical location: right arm, batch number: 1620301, route of administration and expiry date: not reported). On 14-Nov-2016, after 2 days of vaccination, the patient had neck and back pain and reported that, the area where shot was given appeared blue-black circle, size of a quarter, and she could not turn to the right-side due to pain. The outcome of the event was not reported. The health authority assessed the report as non-serious.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Laboratory test normal, Pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 64 year old female patient. There were no concomitant therapies, medical history allergies, drug reactions or concurrent conditions. On 30-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N014018, expiration date of 04-JUL-2018 (dose, route and concentration were not provided), for vaccination. Approximately in 2017 (reported as " few days later"), the patient complained of pain, and saw her physician who performed unspecified tests and found no abnormal findings. Also, an unspecified treatment was provided and there were no lab diagnostics performed to the patient. Then in "late November" the patient was still complaining of pain at the injection site. At the time of reporting, the patient had not recovered from injection site pain. The reporter did not provide a causality assessment between ZOSTAVAX and injection site pain.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Laboratory test, Pallor, Seizure like phenomena, Syncope, Yawning
Clinical narrative: Patient was given the vaccine, and while waiting for her sister to receive her shot she stood while watching her sister. After about 5 minutes patient stated she didn't feel well, at which point I looked at her and noticed she was pale. Once I stood in front of her to get a good look at her she passed out in my arms. She turned purple and was not breathing and her eyes rolled back in head. She was non responsive for at least 60 seconds. Once I laid her on the ground she started to breathe and came to.  I then let her lay on the ground for about 5 minutes then let her sit in a chair for another 10 minutes. She was then given a bottle of water and a granola bar. We left pharmacy and went to the ER.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Eye movement disorder, Full blood count normal, Loss of consciousness, Metabolic function test normal, Pallor
Clinical narrative: Patient was given the vaccine, and while waiting for her sister to receive her shot she stood while watching her sister. After about 5 minutes patient stated she didn't feel well, at which point I looked at her and noticed she was pale. Once I stood in front of her to get a good look at her she passed out in my arms. She turned purple and was not breathing and her eyes rolled back in head. She was non responsive for at least 60 seconds. Once I laid her on the ground she started to breathe and came to.  I then let her lay on the ground for about 5 minutes then let her sit in a chair for another 10 minutes. She was then given a bottle of water and a granola bar. We left pharmacy and went to the ER.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Respiratory arrest, Skin discolouration, Syncope, Unresponsive to stimuli
Clinical narrative: Patient was given the vaccine, and while waiting for her sister to receive her shot she stood while watching her sister. After about 5 minutes patient stated she didn't feel well, at which point I looked at her and noticed she was pale. Once I stood in front of her to get a good look at her she passed out in my arms. She turned purple and was not breathing and her eyes rolled back in head. She was non responsive for at least 60 seconds. Once I laid her on the ground she started to breathe and came to.  I then let her lay on the ground for about 5 minutes then let her sit in a chair for another 10 minutes. She was then given a bottle of water and a granola bar. We left pharmacy and went to the ER.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Eye pruritus, Eyelid oedema, Injection site erythema, Injection site induration
Clinical narrative: On January 10th in the evening about 5 hours after the vaccinations, I noticed I was itching around my neck. Just a little redness on the vaccination sites. Around 6 am in the morning of January 11, I had severe itching on my throat and around my eyes. Checking the mirror, major redness, rash on my neck and eyelids were quite swollen. Injection site on the right arm was more red. Per advice nurse, we made an appointment and as directed took an antihistamine loratadine. By the afternoon at 3:30 when I saw the Dr. the redness was more and now tonight January, 11 pm more red, hard, more sore when touched. Use hydrocortisone ointment and antihistamine as needed.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site pain, Pruritus, Rash, Throat irritation
Clinical narrative: On January 10th in the evening about 5 hours after the vaccinations, I noticed I was itching around my neck. Just a little redness on the vaccination sites. Around 6 am in the morning of January 11, I had severe itching on my throat and around my eyes. Checking the mirror, major redness, rash on my neck and eyelids were quite swollen. Injection site on the right arm was more red. Per advice nurse, we made an appointment and as directed took an antihistamine loratadine. By the afternoon at 3:30 when I saw the Dr. the redness was more and now tonight January, 11 pm more red, hard, more sore when touched. Use hydrocortisone ointment and antihistamine as needed.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 29 year old non-pregnant female patient. There were no concurrent conditions, no pertinent medical history and no drug reactions or allergies. On 01-MAY-1998, the patient was vaccinated with the first dose of VARIVAX Subcutaneous injection, for prophylaxis (reported as "prevent chicken pox") (strength, dose, route, anatomical location, lot # and expiration date not reported). Other suspect products included sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, route, lot, expiration date, and indication were not reported). There were no concomitant drugs or vaccines. The registered nurse reported that on an unknown date, the patient had a varicella titre completed which showed a "very low titre" (antibody test negative). Subsequently, the patient received on an unknown date a booster dose of VARIVAX (strength, dose, route, anatomical location, lot # and expiration date not reported), which the patient tolerated. No Product Quality Complaint was involved. The outcome of the event and the causality assessment between the event of very low titre and the suspect products were not provided.
Sex: U
Vaccine: HEP, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and drug reactions or allergies for the patient involved were not reported. The medical assistant reported that on unspecified dates an unspecified number of patients received improperly stored doses of the vaccines listed below: ROTATEQ lot number: M043838 (expiration date: 18-FEB-2018), orally, for prophylaxis (strength and dosage schedule were not provided). RECOMBIVAX HB lot number: N002914 (expiration date: 04-NOV-2019), for prophylaxis (strength, route and dosage schedule were not provided). GARDASIL 9 lot number: N000326 (expiration date: 14-OCT-2019), for prophylaxis (strength, route and dosage schedule were not provided). The storage characteristics were the following: Temperature: 32 F to 35 F (33.69 F) for 601 hours and 47F to 77F (55.63 F) for 15 minutes.  Previous temperature excursion: No. There was digital data logger involved. No adverse effects were reported. Follow-up information was received on 10-JAN-2018 from the medical assistant. The reporter reported that no additional information was available in reference to the event. Additional information is not expected. This case was previously considered valid but per current process it was determined to be non-valid as no patient identifier, therefore it is being sent to distribution for the last time to notify all recipients.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist, referring to one unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JAN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L023594 with expiration date on 26-JUN-2017 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-JAN-2018, the patient was inadvertently vaccinated with a fourth dose of ROTATEQ per oral, lot # N012757 with expiration date January 2019, for prophylaxis at the patient's 1 year checkup. No adverse effects were reported in the patient. The physician stated that the initial three doses were given at the appropriate intervals stated in the prescribing information.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash vesicular, Varicella virus test
Clinical narrative: This spontaneous report was received from a physician and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, approximately in December 2017, about two and a half weeks ago, the patient was vaccinated with ZOSTAVAX in the left upper arm (dose, frequency, route of administration, lot# and expiration date were not reported). The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). On an unknown date, in January 2018, about 5 days ago, the patient experienced a burning sensation in his left upper thigh. On 09-JAN-2018 the patient was seen by the physician who observed a vesicular rash on the patient's upper left thigh.  On 09-JAN-2018, Varicella-zoster virus (VZV) packet was offered to the patient and the physician stated it was "not needed". On 09-JAN-2018, in the morning, the patient had performed a rapid culture for varicella, the result was not provided. The outcome of burning sensation and rash vesicular was unknown. The relatedness between burning sensation and vesicular rash and ZOSTAVAX was not reported.
Sex: M
Vaccine: DTAP, HPV9
Symptoms: Fall, Head injury, Nausea, Syncope, Vomiting
Clinical narrative: This spontaneous report has been received from a physician via company representative referring to a 22 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified day in September 2017, the patient was vaccinated with the second dose of GARDASIL 9 by intramuscular route,(strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid,in the opposite arm.  It was reported that, 10 minutes after vaccination, the patient walked to check out and "experienced syncope, fell and hit head (head injury)". The patient refused to go to hospital and "drove himself home". Later at home, the patient developed nausea and vomiting and went to hospital emergency room. The outcome of syncope, vomiting, nausea and head injury was unknown. The causality assessment between therapy with GARDASIL 9 was not reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to a 14 year old male patient. Information about patient's concurrent condition, concomitant medication and medical history was not provided. On unknown date, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of GARDASIL 9 (lot # M043731, expiration date: 22-JUN-2019; dose and route were not reported) for prophylaxis on an unspecified date after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursion and there was a data logger involved. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006271:
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to a 14 year old male patient. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of GARDASIL 9 (lot # M043731, expiration date: 22-JUN-2019; the dose and route were not reported) for prophylaxis on an unspecified date after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursions and there was a data logger involved. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1707USA006271.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an approximately 13 year old ("reported as over a year ago, an unspecified 12 year old patient") of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In approximately January 2017 (reported as "over a year ago"), the patient was vaccinated with GARDASIL (strength, dose, route, lot number and expiration date were not reported)  for prophylaxis. On 10-JAN-2017, the patient returned to the physician's office to received the second dose of GARDASIL 9 lot number N012093, expiration date: 13-JAN-2020 (strength, dose and route were not reported). No adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a patient of an unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 09-JAN-2018, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # N022584 with expiration date in 15-JUN-2020 (dose, dose number, route of administration and anatomical location were not provided) for prophylaxis. There was no previous temperature excursion and the call was not because of a data logger. The primary reporter denied any adverse effects reported by patient.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) and (batch number 5942P, expiry date 30th January 2020. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved. The reporter considered the injection site pain and fever to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient had injection site pain for three days and also said the patient had a fever but did not take an actual temperature. The lot for SHINGRIX diluent was 5942P and has the same expiration date as provided above.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of vaccine ( Expiration date: December 2nd, 2017).
Age: 1.83
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 30-NOV-2017, the patient was vaccinated with a dose of improperly VARIVAX, lot # M017292, expiration date 07-APR-2018 (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002139: US-009507513-1801USA002137: US-009507513-1801USA002138.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 22-NOV-2017, the patient was vaccinated with a dose of improperly stored PROQUAD (albumin status rHA) lot # N001488, expiration date 12-JUL-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine had been reconstituted with properly stored sterile diluent (MRK). The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006828: US-009507513-1801USA002138: US-009507513-1801USA002139.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 28-NOV-2017, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N001488, expiration date 12-JUL-2018 (route of administration was not reported) for prophylaxis. The vaccine had been reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006828: US-009507513-1801USA002139: US-009507513-1801USA002137.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 06-DEC-2017, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N001488, expiration date 12-JUL-2018 (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006828: US-009507513-1801USA002138: US-009507513-1801USA002137.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose (02 December 2017).