chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Blood test, Dyskinesia, Obsessive-compulsive disorder, Tic
Clinical narrative: Case number PHHY2015US172591, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606330) website on 29 Dec 2015. This report refers to a 03 year old male patient. Past medical history included rheumatic fever, paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection and strep cough. The concomitant medication included penicillin shots (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Dec 2013. On 20 Dec 2013, the patient started to have behavior issues, and then over the next few days and months continued to experience arm movements, tics, obsessive compulsive disorder and whole body movements of arms and legs at night. There were many blood tests done and results were not provided. The patient was taken to an emergency room. The patient was treated with antibiotic and started to receive vitamins. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. The seriousness of the events dyskinesia and obsessive-compulsive disorder was upgraded to medically significant based on the information available in the source document.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Muscular weakness, Pain in extremity, X-ray limb
Clinical narrative: Case number PHHY2015US173069 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 606879) on 29 Dec 2015. This report refers to a 57 year old male patient. He had no medical history or current conditions. His concomitant medications included low dose Aspirin. The patient was vaccinated with FLUVIRIN (batch number: not reported) in the left arm on 20 Oct 2015. It was reported that the patient was seated during vaccination and the nurse was standing. Nurse had him roll up shirt sleeve much higher than he had ever done for a shot which he thought was odd. He had initial soreness at injection site which was not uncommon with injections in the past. However, the soreness persisted and it led to arm strength weakness and pain pings. He went to emergency room. On 01 Nov 2015, arm weakness and pain were so bad and he called 24 hour facility advise nurse to get recommendation on what to do and get a doctor appointment to have it looked at and discussed. She suggested heat and to also try alternating with ice compress. On 02 Nov 2015, he was given a strong NSAID and suggested to use rotator cuff exercises on the print out. He was referred for shoulder x-rays (results pending) and said to contact in 2 weeks (one month from events onset), if pain continued for likely referral to orthopedics. On his way out of facility, he stopped and talked with one of the two nurses handling flu vaccine intake and related his Shoulder Injury Related to Vaccine Administration (SIRVA) to her and she stated that she would convey the injury information resulted due to high shoulder stick to the nurse who vaccinated him. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the event SIRVA was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited misuse report received from a nurse practitioner on 05 November 2015. This case involves a 67-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch number- UI481AB, expiry date - 15 May 2016) intramuscularly in the left arm on 06 October 2015 at 11:00 am. The patient's illness at the time of vaccination was reported as none, medical history and concomitant medications were not provided. On an unspecified date following the vaccination, the patient had experienced pain and loss of mobility in left arm. It was reported that pain was due to location where the shot was given. The shot was given too high in the arm and may have entered bursa. Thus it was a wrong injection technique. It was suspected that the patient had possible bone infection. The patient required doctor visit. Laboratory data was not reported. The patient's corrective treatment included physical therapy. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event: suspected possible bone infection. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain lower, Back pain, Blister, Herpes zoster, Muscle strain
Clinical narrative: Case number PHHY2015US172484, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608790) website on 29 Dec 2015. This report refers to a 25-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 26 Oct 2015. On 02 Nov 2015, she felt her back as if she pulled a muscle to the left side of her spine. The next day, it hurt and began to itch accompanied with pain around left side of lower abdomen, red itchy bumps turned into clusters of red, painful, blistery bumps covering lower abdomen, left side and long left side of spine. She was taken to the emergency room. On 09 Nov 2015, she was diagnosed with shingles. She was treated with steroid cream (unspecified) and Valacyclovir one gram three times a day for seven days. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness of the events was upgraded based on the information available in the source document.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2015US172484, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608790) website on 29 Dec 2015. This report refers to a 25-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 26 Oct 2015. On 02 Nov 2015, she felt her back as if she pulled a muscle to the left side of her spine. The next day, it hurt and began to itch accompanied with pain around left side of lower abdomen, red itchy bumps turned into clusters of red, painful, blistery bumps covering lower abdomen, left side and long left side of spine. She was taken to the emergency room. On 09 Nov 2015, she was diagnosed with shingles. She was treated with steroid cream (unspecified) and Valacyclovir one gram three times a day for seven days. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness of the events was upgraded based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Infection, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician referring to a 62 year old female patient. Information concerning medical history and concurrent condition was not reported. On 07-NOV-2015 the patient was vaccinated with ZOSTAVAX (dose, strength, lot # and route not unknown). There was no concomitant therapy reported. On 08-NOV-2015, the patient developed a rash, a blister, redness, warm and pain at the injection site following the administration of ZOSTAVAX. A pharmacist mentioned the rash was spreading down the patient's arm. Ice and BENADRYL were given as treatment for the events. Lab diagnostics studies were not performed. The patient had sought medical attention via office visit. The outcome of the events was reported as not recovered. Additional information has been requested. The follow-up information was received on 05-JAN-2016 from a physician. Patient demographics were updated. The patient was not previously vaccinated with ZOSTAVAX (first dose). On 08-NOV-2015, the patient developed localised rash on arm, infection with cellulitis like reaction, blister and local pain. The reporting physician and a dermatologist treated the patient. The outcome of the events was reported as recovered (also reported that at the time of report, the patient was better). The reporter considered all the events to be serious (medically significant) as the events required medical/surgical intervention. Additional information has been requested. Patient details, product details, Events and Narrative has been updated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Rash
Clinical narrative: Information has been received from a physician referring to a 62 year old female patient. Information concerning medical history and concurrent condition was not reported. On 07-NOV-2015 the patient was vaccinated with ZOSTAVAX (dose, strength, lot # and route not unknown). There was no concomitant therapy reported. On 08-NOV-2015, the patient developed a rash, a blister, redness, warm and pain at the injection site following the administration of ZOSTAVAX. A pharmacist mentioned the rash was spreading down the patient's arm. Ice and BENADRYL were given as treatment for the events. Lab diagnostics studies were not performed. The patient had sought medical attention via office visit. The outcome of the events was reported as not recovered. Additional information has been requested. The follow-up information was received on 05-JAN-2016 from a physician. Patient demographics were updated. The patient was not previously vaccinated with ZOSTAVAX (first dose). On 08-NOV-2015, the patient developed localised rash on arm, infection with cellulitis like reaction, blister and local pain. The reporting physician and a dermatologist treated the patient. The outcome of the events was reported as recovered (also reported that at the time of report, the patient was better). The reporter considered all the events to be serious (medically significant) as the events required medical/surgical intervention. Additional information has been requested. Patient details, product details, Events and Narrative has been updated.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Fatigue, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2015US172551, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609180) 29 Dec 2015. This report refers to a 55-year-old female patient. Historical condition included Sjogren's. Vaccination history included administration of seasonal influenza vaccine and she could not raise arm above shoulder for one month. Current conditions included hypertension, allergy to ampicillin and asthma. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) into left arm intramuscularly on 06 Nov 2015. On the same day after vaccination the patient had short asthmatic symptom and experienced few hives over weekend (unspecified date). The patient also experienced fatigue and body aches which progressed through to 11 Nov 2015 with throbbing pain in left arm (injection arm) and down into shoulder blade and still had some body aches till 12 Nov 2015 but it was much improved. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event asthma and urticaria and was upgraded based on the information available in the source document.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Case number PHHY2015US172551, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609180) 29 Dec 2015. This report refers to a 55-year-old female patient. Historical condition included Sjogren's. Vaccination history included administration of seasonal influenza vaccine and she could not raise arm above shoulder for one month. Current conditions included hypertension, allergy to ampicillin and asthma. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) into left arm intramuscularly on 06 Nov 2015. On the same day after vaccination the patient had short asthmatic symptom and experienced few hives over weekend (unspecified date). The patient also experienced fatigue and body aches which progressed through to 11 Nov 2015 with throbbing pain in left arm (injection arm) and down into shoulder blade and still had some body aches till 12 Nov 2015 but it was much improved. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event asthma and urticaria and was upgraded based on the information available in the source document.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Injection site nodule, Injection site pain, Injection site reaction, Muscle atrophy
Clinical narrative: Case number PHHY2015US172521, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609336) website on 29 Dec 2015. This report refers to a 49-years-old female patient. Past medical history included environmental allergies to CLARITIN, grass, cats and dust. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly into left arm on 28 Sep 2015. On the same day after vaccination, the patient felt shock and pain in the deltoid of left shoulder when the nurse injected and ping pong size knot developed. On 16 Oct 2015, she experienced significant pain in arm and muscle atrophy in deltoid. On 11 Nov 2015, she experienced atrophy in shoulder blade. On an unknown date, she experienced constant burning in entire area, side of neck and shoulder blade and pain. On the same day physical therapy and unspecified pain medication was started for pain. She was taken to the emergency room. Laboratory data included magnetic resonance imaging (MRI), nerve conduction test and X rays (results unspecified). The outcome of the events was unknown. The seriousness assessment of the event was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event muscle atrophy was upgraded to medically significant based on the information available in the source document.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US172521, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609336) website on 29 Dec 2015. This report refers to a 49-years-old female patient. Past medical history included environmental allergies to CLARITIN, grass, cats and dust. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly into left arm on 28 Sep 2015. On the same day after vaccination, the patient felt shock and pain in the deltoid of left shoulder when the nurse injected and ping pong size knot developed. On 16 Oct 2015, she experienced significant pain in arm and muscle atrophy in deltoid. On 11 Nov 2015, she experienced atrophy in shoulder blade. On an unknown date, she experienced constant burning in entire area, side of neck and shoulder blade and pain. On the same day physical therapy and unspecified pain medication was started for pain. She was taken to the emergency room. Laboratory data included magnetic resonance imaging (MRI), nerve conduction test and X rays (results unspecified). The outcome of the events was unknown. The seriousness assessment of the event was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event muscle atrophy was upgraded to medically significant based on the information available in the source document.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US172521, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609336) website on 29 Dec 2015. This report refers to a 49-years-old female patient. Past medical history included environmental allergies to CLARITIN, grass, cats and dust. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly into left arm on 28 Sep 2015. On the same day after vaccination, the patient felt shock and pain in the deltoid of left shoulder when the nurse injected and ping pong size knot developed. On 16 Oct 2015, she experienced significant pain in arm and muscle atrophy in deltoid. On 11 Nov 2015, she experienced atrophy in shoulder blade. On an unknown date, she experienced constant burning in entire area, side of neck and shoulder blade and pain. On the same day physical therapy and unspecified pain medication was started for pain. She was taken to the emergency room. Laboratory data included magnetic resonance imaging (MRI), nerve conduction test and X rays (results unspecified). The outcome of the events was unknown. The seriousness assessment of the event was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event muscle atrophy was upgraded to medically significant based on the information available in the source document.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Malaise, Nausea, Paraesthesia, Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date approximately in 2015 (also reported as a few weeks ago), the patient was vaccinated with GARDASIL dose 1, intramuscularly (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in 2015 (also reported as the day after receiving the vaccine), the patient experienced nausea and broke out in hives. It was reported that the patient sought medical attention and called the physician. The patient was directed to an unspecified dermatologist. It was reported that the therapy with GARDASIL was discontinued and not reintroduced. The outcome of nausea and urticaria was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. Follow-up information was received from the physician on 05-JAN-2016. Patient demographics were provided. It was confirmed that on 14-OCT-2015, the patient was vaccinated with a first dose of GARDASIL with a lot number # K010215 (expiry date unknown) at around 13:44 hours in the left deltoid muscle. On 15-OCT-2015, the patient experienced vomiting (medically significant), general malaise (medically significant), had tingling (medically significant), and full body hives (medically significant) which lasted for 3 weeks. On an unknown date in November 2015, the outcome of these events was reported as recovered. The causality of the events was not provided. The events were considered serious as they required medical/surgical intervention. Additional information has been requested. Patient, events and narrative updated.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date approximately in 2015 (also reported as a few weeks ago), the patient was vaccinated with GARDASIL dose 1, intramuscularly (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in 2015 (also reported as the day after receiving the vaccine), the patient experienced nausea and broke out in hives. It was reported that the patient sought medical attention and called the physician. The patient was directed to an unspecified dermatologist. It was reported that the therapy with GARDASIL was discontinued and not reintroduced. The outcome of nausea and urticaria was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. Follow-up information was received from the physician on 05-JAN-2016. Patient demographics were provided. It was confirmed that on 14-OCT-2015, the patient was vaccinated with a first dose of GARDASIL with a lot number # K010215 (expiry date unknown) at around 13:44 hours in the left deltoid muscle. On 15-OCT-2015, the patient experienced vomiting (medically significant), general malaise (medically significant), had tingling (medically significant), and full body hives (medically significant) which lasted for 3 weeks. On an unknown date in November 2015, the outcome of these events was reported as recovered. The causality of the events was not provided. The events were considered serious as they required medical/surgical intervention. Additional information has been requested. Patient, events and narrative updated.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm painful, hot to touch and swollen.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Neuralgia, Neurological examination
Clinical narrative: Severe pain down arm, then numbness and neuralgia and muscle at top of arm was as though it was frozen. Kept me awake at night. Visited Dr twice. He finally sent me to neurologist after 8 weeks. He did full neurological exam and send the vaccine administrator nailed my axillary nerve (spelling ?) in my upper arm with the vaccine.  I am taking gabapentin and it is slowly getting less painful. I have trouble carrying anything with the right arm, and difficulty raising it up to put things in microwave, or pull laundry out of machine etc.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Severe pain down arm, then numbness and neuralgia and muscle at top of arm was as though it was frozen. Kept me awake at night. Visited Dr twice. He finally sent me to neurologist after 8 weeks. He did full neurological exam and send the vaccine administrator nailed my axillary nerve (spelling ?) in my upper arm with the vaccine.  I am taking gabapentin and it is slowly getting less painful. I have trouble carrying anything with the right arm, and difficulty raising it up to put things in microwave, or pull laundry out of machine etc.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal discomfort, Eye pain, Feeling drunk, Headache, Upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from a non-health care professional on 13 November 2015. This case involves an 18-year-old male patient who was vaccinated with a dose of MENACTRA (batch number was unknown, route and site of administration was not reported) on an unspecified date in end of August. Patient denies providing illness at time of vaccination pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medication. On an unspecified date, few days following the vaccination, the patient developed upset stomach sometime then URI (upper respiratory infection) after that. Following the URI he started having "bizarre" headaches with a drunk like feeling, eyes hurt also. The patient was seen several physicians, neurologist, psychiatrist, general practitioner, internal medicine and is going to see neuro surgeon next. Lab data was not reported. The patient had tried several medications including, but not limited, to antidepressants and anti-anxiety. Outcome of events was unknown. Upon internal review, the company decided to consider the event serious because of important medical event: Upper respiratory infection. List of documents held by sender: none.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced cellulitis, very high fever, redness, swelling all on an unspecified date with outcome of unknown. The patient was treated with antibiotics for cellulitis. The events were assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Rash
Clinical narrative: SHE REPORTS SHOULDER PAIN. LITTLE BUMPS ON HER ABDOMEN. SHE STATES THAT THE PAIN CONTINUES IN HER RT. SHOULDER AND IT IS PAINFUL TO RAISE HER RT ARM UP.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Cough, Musculoskeletal chest pain, Oropharyngeal pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received PREVNAR 13 (Lot # L93594; Expiration Date Jan2017) via an unspecified route of administration on 22Oct2015 at 0.5 ml single. Medical history included lung cancer from Mar2013 to 08Nov2014 (she had had radiation and chemo for a year and a half after diagnosis), chronic obstructive pulmonary disease (COPD) from Mar2013 and ongoing, emphysema from Mar2013 and ongoing, ongoing colitis since about 20-25 years ago and under control. The patient was on oxygen at the time of this report as she was a lung cancer survivor. Concomitant medications, all ongoing, included APRISO (caplets) at 0.375 mg once daily for colitis, clonazepam (manufacturer unknown) at 0.5 mg once daily to settle her down, SYNTHROID at 0.075 mg once daily for thyroid, SPIRIVA daily for emphysema, ADVAIR daily for emphysema, PROAIR as needed for emphysema. The patient experienced cough in Oct2015, and low grade fever, rib sore and throat sore on an unspecified date in 2015. The admission to hospital in Oct2015 was involved for cough, throat sore and rib sore. The patient had a bad cough about a week after getting PREVNAR 13. The cough got so bad she couldn't talk sometimes. She had had a bronchitis like cough that made her ribs sore and her throat sore. She also had a low grade fever with the cough. She then called her pulmonary specialist and he gave her nitrates and started her on prednisone (manufacturer unknown), both for cough. The cough had started getting to the point it was not so bad. She no longer coughed for 20 minutes at a time. No treatment was received for throat sore and rib sore. The patient was still experiencing cough, throat sore and rib sore. The outcome of low grade fever was unknown. Follow-up (30Dec2015): New information reported from a contactable consumer includes: PREVNAR 13 details (vaccination date, Lot # and Exp Date), concomitant details (ongoing), events details (seriousness, treatment and outcome).
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site discomfort, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US022846 is an initial spontaneous report received from a nurse on 11 Nov 2014. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 11 Nov 2014, she was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly after the nurse aspirated the pre-filled syringe (drug administration error). The reporter stated that there was no blood prior to the administration. There was no blood at the site of injection or on the needle but there was some blood in the syringe. The patient reported minor discomfort at the vaccination site. The outcome of the event was not reported. The seriousness and causality of the event was not reported.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US023467 is an initial spontaneous report from a nurse received on 20 Nov 2014 and with a follow-up from a nurse received on 26 Dec 2014. this report refers to a male patient of an unknown age. Concurrent condition included allergies to hydrocodone. The patient had tolerated vaccines (no further details provided) well in the past. On 20 Nov 2014, the patient received an intramuscular dose of expired FLUVIRIN (batch number: 13474P, expiry date: May 2014) at a dose of 0.5 ml into right deltoid in error. No adverse event reported following this medication error (expired vaccine used). Follow-up from a nurse received on 26 Dec 2014: Patient's demographics (weight and height), vaccine details (dose and site) and concurrent condition were updated.
Age: 11.0
Sex: M
Vaccine: HEP, HPV9, TDAP
Symptoms: Abdominal pain, Dysstasia, Groin pain, Headache, Moaning
Clinical narrative: Mom reports yesterday she thought he had a fever and gave a fever reducing medicine.  States he woke during middle of night c/o headache and blurry vision.  She had him go back to sleep. Woke this am with fever and abdominal pain. Mom brought patient back to this health dept where he received his vaccines on 1/6/2016-HPV9, Hep B, and Tdap.  Child doubled over holding abdomen, fever of 103.1, complained of headache and right groin pain. History of Sickle Cell Disease and I encouraged mom to bring to Urgent care or Emergency room now for medical treatment.  Mom without transportation.  States she can have family member take them.  Declined 911 service.  Child continue to moan and hold abdomen.  Could not stand up without support and severe abdominal pain.  Family member arrived and assisted to vehicle via wheelchair, mom reports they are bringing to ER now at 1125 am on 1/8/2016. Advised mom to call this nurse with update as soon as she is able later today.
Age: 11.0
Sex: M
Vaccine: HEP, HPV9, TDAP
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Mom reports yesterday she thought he had a fever and gave a fever reducing medicine.  States he woke during middle of night c/o headache and blurry vision.  She had him go back to sleep. Woke this am with fever and abdominal pain. Mom brought patient back to this health dept where he received his vaccines on 1/6/2016-HPV9, Hep B, and Tdap.  Child doubled over holding abdomen, fever of 103.1, complained of headache and right groin pain. History of Sickle Cell Disease and I encouraged mom to bring to Urgent care or Emergency room now for medical treatment.  Mom without transportation.  States she can have family member take them.  Declined 911 service.  Child continue to moan and hold abdomen.  Could not stand up without support and severe abdominal pain.  Family member arrived and assisted to vehicle via wheelchair, mom reports they are bringing to ER now at 1125 am on 1/8/2016. Advised mom to call this nurse with update as soon as she is able later today.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood creatine phosphokinase MB, Blood pressure increased, Blood thyroid stimulating hormone, Blood urine present
Clinical narrative: Case number PHEH2014US023773, is an initial spontaneous report from a medical assistant received on 21 Nov 2014 with a follow up information from a medical assistant received on 29 Dec 2014. This report refers to an 80-years-old female patient. On 09 Mar 2012, she had swelling in the dorsum of the left hand from a rooster. She was put on antibiotic and tetanus (manufacturer and batch number: not reported). No concomitant medication was reported. On 10 Apr 2012, she had second dose of tetanus diphtheria vaccine (other manufacturer, batch number: U3769BA, expiry date: 26 Jan 2013) at a dose of 0.5 ml in the left deltoid. On 20 Apr 2012, she was contacted to notify that she required a third tetanus in Aug 2012. The patient received FLUVIRIN (batch number: G34A4, expiry date: 30 May 2015) multidose vial intramuscularly at a dose of 0.5 ml in the left arm on 23 Oct 2014. On the same day after vaccination, the patient experienced soreness in the arm and she could not lift her arm. Her blood pressure on 21 Nov 2014 was 130/80 (right arm sitting position). She performed a lab draw for complete blood count (CBC), complete lipid, T2, thyroid stimulating hormone (TSH), vitamin D, sedimentation rate and blood creatine phosphokinase MB (CPK-MB) isoenzymes. Urinalysis revealed specific gravity as 1.030 and PH as 5. Glucose, ketones, nitrate, bilirubin and urobilinogen were nil with large number of leukocytes and small amount of blood and proteins. Culture and sensitivity was done and results were not reported. She was treated with ciprofloxacin. On 05 Dec 2014, laboratory results were rechecked. Her left arm was still hurting and she had limited ROM. Her blood pressure was 140/70 (right arm sitting position). On 16 Dec 2014, she had back pain and suspected urinary tract infection. Her weight reduced to 128 pounds from 132 pounds. Her body temperature was 97.7. Blood pressure was 126/70 (left arm in sitting position). Urinalysis on 16 Dec 2014 revealed specific gravity as 1.025, pH was 6, glucose, nitrate, bilirubin and urobilinogen were nil, ketone was 5, leukocytes were Lg (large) +++, blood: 250 (hemolyzed) and protein was 300. It was reported that events got better, but she had trouble in urinating. She was treated with MACROBID 1 DF twice daily for 10 days with no refills. The final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. Follow up information from a medical assistant received on 29 Dec 2014: Updated patient demographics (weight of patient), medical history, historical drug, vaccination history, dose and site, expiry date of suspect vaccination, laboratory values, events (back pain, blood pressure increased, weight decreased, trouble urination, urinary tract infection, joint range of motion decreased) and treatment.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Culture urine, Dysuria, Full blood count, Glucose urine absent, Lipids
Clinical narrative: Case number PHEH2014US023773, is an initial spontaneous report from a medical assistant received on 21 Nov 2014 with a follow up information from a medical assistant received on 29 Dec 2014. This report refers to an 80-years-old female patient. On 09 Mar 2012, she had swelling in the dorsum of the left hand from a rooster. She was put on antibiotic and tetanus (manufacturer and batch number: not reported). No concomitant medication was reported. On 10 Apr 2012, she had second dose of tetanus diphtheria vaccine (other manufacturer, batch number: U3769BA, expiry date: 26 Jan 2013) at a dose of 0.5 ml in the left deltoid. On 20 Apr 2012, she was contacted to notify that she required a third tetanus in Aug 2012. The patient received FLUVIRIN (batch number: G34A4, expiry date: 30 May 2015) multidose vial intramuscularly at a dose of 0.5 ml in the left arm on 23 Oct 2014. On the same day after vaccination, the patient experienced soreness in the arm and she could not lift her arm. Her blood pressure on 21 Nov 2014 was 130/80 (right arm sitting position). She performed a lab draw for complete blood count (CBC), complete lipid, T2, thyroid stimulating hormone (TSH), vitamin D, sedimentation rate and blood creatine phosphokinase MB (CPK-MB) isoenzymes. Urinalysis revealed specific gravity as 1.030 and PH as 5. Glucose, ketones, nitrate, bilirubin and urobilinogen were nil with large number of leukocytes and small amount of blood and proteins. Culture and sensitivity was done and results were not reported. She was treated with ciprofloxacin. On 05 Dec 2014, laboratory results were rechecked. Her left arm was still hurting and she had limited ROM. Her blood pressure was 140/70 (right arm sitting position). On 16 Dec 2014, she had back pain and suspected urinary tract infection. Her weight reduced to 128 pounds from 132 pounds. Her body temperature was 97.7. Blood pressure was 126/70 (left arm in sitting position). Urinalysis on 16 Dec 2014 revealed specific gravity as 1.025, pH was 6, glucose, nitrate, bilirubin and urobilinogen were nil, ketone was 5, leukocytes were Lg (large) +++, blood: 250 (hemolyzed) and protein was 300. It was reported that events got better, but she had trouble in urinating. She was treated with MACROBID 1 DF twice daily for 10 days with no refills. The final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. Follow up information from a medical assistant received on 29 Dec 2014: Updated patient demographics (weight of patient), medical history, historical drug, vaccination history, dose and site, expiry date of suspect vaccination, laboratory values, events (back pain, blood pressure increased, weight decreased, trouble urination, urinary tract infection, joint range of motion decreased) and treatment.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nitrite urine absent, Pain in extremity, Protein urine present, Red blood cell sedimentation rate
Clinical narrative: Case number PHEH2014US023773, is an initial spontaneous report from a medical assistant received on 21 Nov 2014 with a follow up information from a medical assistant received on 29 Dec 2014. This report refers to an 80-years-old female patient. On 09 Mar 2012, she had swelling in the dorsum of the left hand from a rooster. She was put on antibiotic and tetanus (manufacturer and batch number: not reported). No concomitant medication was reported. On 10 Apr 2012, she had second dose of tetanus diphtheria vaccine (other manufacturer, batch number: U3769BA, expiry date: 26 Jan 2013) at a dose of 0.5 ml in the left deltoid. On 20 Apr 2012, she was contacted to notify that she required a third tetanus in Aug 2012. The patient received FLUVIRIN (batch number: G34A4, expiry date: 30 May 2015) multidose vial intramuscularly at a dose of 0.5 ml in the left arm on 23 Oct 2014. On the same day after vaccination, the patient experienced soreness in the arm and she could not lift her arm. Her blood pressure on 21 Nov 2014 was 130/80 (right arm sitting position). She performed a lab draw for complete blood count (CBC), complete lipid, T2, thyroid stimulating hormone (TSH), vitamin D, sedimentation rate and blood creatine phosphokinase MB (CPK-MB) isoenzymes. Urinalysis revealed specific gravity as 1.030 and PH as 5. Glucose, ketones, nitrate, bilirubin and urobilinogen were nil with large number of leukocytes and small amount of blood and proteins. Culture and sensitivity was done and results were not reported. She was treated with ciprofloxacin. On 05 Dec 2014, laboratory results were rechecked. Her left arm was still hurting and she had limited ROM. Her blood pressure was 140/70 (right arm sitting position). On 16 Dec 2014, she had back pain and suspected urinary tract infection. Her weight reduced to 128 pounds from 132 pounds. Her body temperature was 97.7. Blood pressure was 126/70 (left arm in sitting position). Urinalysis on 16 Dec 2014 revealed specific gravity as 1.025, pH was 6, glucose, nitrate, bilirubin and urobilinogen were nil, ketone was 5, leukocytes were Lg (large) +++, blood: 250 (hemolyzed) and protein was 300. It was reported that events got better, but she had trouble in urinating. She was treated with MACROBID 1 DF twice daily for 10 days with no refills. The final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. Follow up information from a medical assistant received on 29 Dec 2014: Updated patient demographics (weight of patient), medical history, historical drug, vaccination history, dose and site, expiry date of suspect vaccination, laboratory values, events (back pain, blood pressure increased, weight decreased, trouble urination, urinary tract infection, joint range of motion decreased) and treatment.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Specific gravity urine normal, Thyroid function test, Urinary tract infection, Urine bilirubin decreased, Urine ketone body present
Clinical narrative: Case number PHEH2014US023773, is an initial spontaneous report from a medical assistant received on 21 Nov 2014 with a follow up information from a medical assistant received on 29 Dec 2014. This report refers to an 80-years-old female patient. On 09 Mar 2012, she had swelling in the dorsum of the left hand from a rooster. She was put on antibiotic and tetanus (manufacturer and batch number: not reported). No concomitant medication was reported. On 10 Apr 2012, she had second dose of tetanus diphtheria vaccine (other manufacturer, batch number: U3769BA, expiry date: 26 Jan 2013) at a dose of 0.5 ml in the left deltoid. On 20 Apr 2012, she was contacted to notify that she required a third tetanus in Aug 2012. The patient received FLUVIRIN (batch number: G34A4, expiry date: 30 May 2015) multidose vial intramuscularly at a dose of 0.5 ml in the left arm on 23 Oct 2014. On the same day after vaccination, the patient experienced soreness in the arm and she could not lift her arm. Her blood pressure on 21 Nov 2014 was 130/80 (right arm sitting position). She performed a lab draw for complete blood count (CBC), complete lipid, T2, thyroid stimulating hormone (TSH), vitamin D, sedimentation rate and blood creatine phosphokinase MB (CPK-MB) isoenzymes. Urinalysis revealed specific gravity as 1.030 and PH as 5. Glucose, ketones, nitrate, bilirubin and urobilinogen were nil with large number of leukocytes and small amount of blood and proteins. Culture and sensitivity was done and results were not reported. She was treated with ciprofloxacin. On 05 Dec 2014, laboratory results were rechecked. Her left arm was still hurting and she had limited ROM. Her blood pressure was 140/70 (right arm sitting position). On 16 Dec 2014, she had back pain and suspected urinary tract infection. Her weight reduced to 128 pounds from 132 pounds. Her body temperature was 97.7. Blood pressure was 126/70 (left arm in sitting position). Urinalysis on 16 Dec 2014 revealed specific gravity as 1.025, pH was 6, glucose, nitrate, bilirubin and urobilinogen were nil, ketone was 5, leukocytes were Lg (large) +++, blood: 250 (hemolyzed) and protein was 300. It was reported that events got better, but she had trouble in urinating. She was treated with MACROBID 1 DF twice daily for 10 days with no refills. The final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. Follow up information from a medical assistant received on 29 Dec 2014: Updated patient demographics (weight of patient), medical history, historical drug, vaccination history, dose and site, expiry date of suspect vaccination, laboratory values, events (back pain, blood pressure increased, weight decreased, trouble urination, urinary tract infection, joint range of motion decreased) and treatment.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Urobilinogen urine decreased, Vitamin D, Weight decreased, White blood cells urine positive, pH urine normal
Clinical narrative: Case number PHEH2014US023773, is an initial spontaneous report from a medical assistant received on 21 Nov 2014 with a follow up information from a medical assistant received on 29 Dec 2014. This report refers to an 80-years-old female patient. On 09 Mar 2012, she had swelling in the dorsum of the left hand from a rooster. She was put on antibiotic and tetanus (manufacturer and batch number: not reported). No concomitant medication was reported. On 10 Apr 2012, she had second dose of tetanus diphtheria vaccine (other manufacturer, batch number: U3769BA, expiry date: 26 Jan 2013) at a dose of 0.5 ml in the left deltoid. On 20 Apr 2012, she was contacted to notify that she required a third tetanus in Aug 2012. The patient received FLUVIRIN (batch number: G34A4, expiry date: 30 May 2015) multidose vial intramuscularly at a dose of 0.5 ml in the left arm on 23 Oct 2014. On the same day after vaccination, the patient experienced soreness in the arm and she could not lift her arm. Her blood pressure on 21 Nov 2014 was 130/80 (right arm sitting position). She performed a lab draw for complete blood count (CBC), complete lipid, T2, thyroid stimulating hormone (TSH), vitamin D, sedimentation rate and blood creatine phosphokinase MB (CPK-MB) isoenzymes. Urinalysis revealed specific gravity as 1.030 and PH as 5. Glucose, ketones, nitrate, bilirubin and urobilinogen were nil with large number of leukocytes and small amount of blood and proteins. Culture and sensitivity was done and results were not reported. She was treated with ciprofloxacin. On 05 Dec 2014, laboratory results were rechecked. Her left arm was still hurting and she had limited ROM. Her blood pressure was 140/70 (right arm sitting position). On 16 Dec 2014, she had back pain and suspected urinary tract infection. Her weight reduced to 128 pounds from 132 pounds. Her body temperature was 97.7. Blood pressure was 126/70 (left arm in sitting position). Urinalysis on 16 Dec 2014 revealed specific gravity as 1.025, pH was 6, glucose, nitrate, bilirubin and urobilinogen were nil, ketone was 5, leukocytes were Lg (large) +++, blood: 250 (hemolyzed) and protein was 300. It was reported that events got better, but she had trouble in urinating. She was treated with MACROBID 1 DF twice daily for 10 days with no refills. The final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. Follow up information from a medical assistant received on 29 Dec 2014: Updated patient demographics (weight of patient), medical history, historical drug, vaccination history, dose and site, expiry date of suspect vaccination, laboratory values, events (back pain, blood pressure increased, weight decreased, trouble urination, urinary tract infection, joint range of motion decreased) and treatment.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023516 is an initial spontaneous report from a medical assistant received on 20 Nov 2014. This report refers to a 52-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1413101, expiry date: Jun 2015) on 17 Nov 2014. The FLUVIRIN vaccine given to the patient was stored out of range at 60 F before vaccination. No adverse event reported following this medication error.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024275, is an initial spontaneous report received from a nurse on 02 Dec 2014, and with a follow up report received from nurse on 21 Jan 2015. This report refers to a 53 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into left deltoid at a dose of 0.5 ml on 16 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report received from nurse on 21 Jan 2015. Updated site of vaccination.