chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # L024252 with expiration date 30-JUN-2017; dose and route were not provided). The product had a temperature excursion with temperature -3.7 degrees C for 16 hours (the door was open). VARIVAX was supported until expiry. There was no previous temperature excursion. No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Red/warm/swollen/lumpy at both legs/injection sites.
Sex: U
Vaccine: HEPA
Symptoms: Product quality issue
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA (strength, dose, frequency and route were not reported, lot number 1030442 and expiry date 19-DEC-2016). On unspecified dates, there were two instances in which the Hepatitis A "pre-filled vials broke off at the base" (the company representative stated that he was assuming that the healthcare worker was speaking of VAQTA). It was not reported whether this occurred during administration to patients. Product quality compliant (PQC) was involved. On 20-JAN-2016 at 10:45 AM: PQC was filed. No further adverse event (AE) information was filed. The outcome of the event two instances in which the Hepatitis A "pre-filled vials broke off at the base" was unknown. The reporter did not provide causal relationship between the event two instances in which the Hepatitis A "pre-filled vials broke off at the base" and suspect therapy. A "pre-filled vials broke off at the base" and suspect therapy. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old female patient. The patient's concurrent conditions and medical history were not reported. On 26-OCT-2015 at 04:15PM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, left arm, subcutaneous, dose 1). No adverse event was reported in the patient after receiving viable ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX was given between 22-SEP-2015 to 09-NOV-2015 after temperature excursion). Additional information is not expected as follow up already received (this was received as a follow up for the related master case).
Sex: U
Vaccine: HPV9
Symptoms: Injection site movement impairment
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of GARDASIL 9 (lot #, dose and route not reported). Subsequently, on an unspecified date, the patient had a local reaction to the vaccine as she/he was not able to raise his/her arm for 10 to 14 days after injection. The patient followed up with the physician on unknown date and event had resolved. This is one of three reports from the same source. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Joint pain (knees}, chills, body aches, fever 101.1, fatigue, headache, general flu-like symptoms.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Joint pain (knees}, chills, body aches, fever 101.1, fatigue, headache, general flu-like symptoms.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Fever 102, chills, body aches, joint pain, fatigue, flu like symptoms, arm pain.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 102, chills, body aches, joint pain, fatigue, flu like symptoms, arm pain.
Age: 22.0
Sex: F
Vaccine: HPVX
Symptoms: Dysphagia, Infectious mononucleosis, Pain, Pyrexia
Clinical narrative: Glandular fever, high fever. Difficulty swallowing, body aches and pains.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Grunting, Heart rate increased, Protrusion tongue, Pyrexia
Clinical narrative: Mild tongue swelling (tongue sticking out of mouth), low-grade fever (100), elevated heart rate (150-160), sleepiness, grunting, and strange raising of shoulders to the ears.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Swollen tongue
Clinical narrative: Mild tongue swelling (tongue sticking out of mouth), low-grade fever (100), elevated heart rate (150-160), sleepiness, grunting, and strange raising of shoulders to the ears.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood test abnormal, Musculoskeletal pain, Polymyalgia rheumatica
Clinical narrative: A pain first occurred in the hips/buttocks and over the following 2-3 days spread up to my shoulders. Over the course of about two weeks the intensity of the pain became unbearable and I went to my primary physician. After some blood tests, he diagnosed Polymyalgia Rheumatica and prescribed 20mg of Prednisone, which did nothing to suppress the pain. I was referred to a rheumatologist who increased the Prednisone treatment to 40mg. This suppressed the pain by about 80%. After about 1-2 weeks at that dosage, I started a reduced dosage to wean me from the Prednisone and at the same time was prescribed a progressively increased amount of Gabapentin over about a three week period. Over that period, the pain started to become more intense. I'm currently in intense pain and awaiting a doctor's visit.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: ERYTHEMA AT INJECTION SITE.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2cm by 2cm red raised area to injection site.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Musculoskeletal pain
Clinical narrative: Patient experinced tightness in chest, shoulder pain, and felt as if she were going to pass out.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Biopsy skin, Blister, Pruritus, Rash
Clinical narrative: Blisters on skin.  This started not quite 2 weeks after the injection.  Rash on upper torso including back and buttocks and back of legs.  Severe itching. It took me 1 year going to my PCP, Allergist and dermatologist to confirm the s&s were allergy related.  I even had skin biopsies to rule out other pathology.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: During the course of 2 weeks following the injection my arm, shoulder, shoulder joint and radiating up my neck and down my biceps was unbearable. Given pain meds, no help.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: During the course of 2 weeks following the injection my arm, shoulder, shoulder joint and radiating up my neck and down my biceps was unbearable. Given pain meds, no help.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Following the vaccination, patient awoke in the middle of the night with redness, pain and swelling at the injection site. The following morning, the entire left arm was red, swollen and hot to the touch from just below the left shoulder down the inside of the forearm to the wrist. She experienced discomfort from the swelling were totally resolved after 7 days.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Sleep disorder
Clinical narrative: Following the vaccination, patient awoke in the middle of the night with redness, pain and swelling at the injection site. The following morning, the entire left arm was red, swollen and hot to the touch from just below the left shoulder down the inside of the forearm to the wrist. She experienced discomfort from the swelling were totally resolved after 7 days.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Vaccination site warmth
Clinical narrative: Swelling to vaccination site at the left upper outer arm approx. 3cm x 4cm warm to touch.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, FLUN4, HEP, HEPA, MMRV
Symptoms: Pain, Pyrexia
Clinical narrative: Reported pain and fever that occurred day after vaccination. Fever resolved by 1/20/2016 when seen by provider.
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue at first onset, body aches by afternoon, chills by early evening, fever. Second day, continued fatigue, body aches, fever, but with a headache. After letting my immune system fight it off naturally with no progress...I opted for Tylenol which decreased symptoms almost immediately.
Age: 0.7
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, malaise, runny nose...ongoing still on 01/31/2016 at 0130 am. Treating with Advil and Tylenol.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Asthma, Blood test, Diarrhoea, Dyspnoea, Ear infection
Clinical narrative: My son received the DTaP/DTP/DT, the Hib and PCV vaccine on 7/14/2011 within the week or so he immediately started having diarrhea a case so bad it lasted several weeks the doctors had no idea what was causing it, the diarrhea subsided to turn into chronic ear infections that lasted from September until January and swollen lymph nodes that have never subsided in his neck and groin area. In February of 2012 he had tubes put in his ears to try to stop the ear infections and also was officially diagnosed with asthma he was wheezing and having problems breathing they checked him and he did not have pneumonia - he also has eczema.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Ear tube insertion, Eczema, Lymphadenopathy, Wheezing
Clinical narrative: My son received the DTaP/DTP/DT, the Hib and PCV vaccine on 7/14/2011 within the week or so he immediately started having diarrhea a case so bad it lasted several weeks the doctors had no idea what was causing it, the diarrhea subsided to turn into chronic ear infections that lasted from September until January and swollen lymph nodes that have never subsided in his neck and groin area. In February of 2012 he had tubes put in his ears to try to stop the ear infections and also was officially diagnosed with asthma he was wheezing and having problems breathing they checked him and he did not have pneumonia - he also has eczema.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Pt has a red swollen area around the injection site that is tender for the Zostavax. She also said she bled a lot at the time of injection for the Adacel.
Age: 49.0
Sex: F
Vaccine: DPP
Symptoms: Headache, Impaired work ability, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Mild headache beginning around 11 am which progressed into a moderate headache at 2 Pm that caused me to leave work. The headache persisted throughout the night prevented me from going to work on 01/29/2016.  Headache subsided around 3:30pm on the 29th.  I also experienced pain at the injection site and swelling.  It was difficult the move my arm shoulder height. Both the pain and swelling subsided coincident with the headache.
Age: 1.0
Sex: F
Vaccine: DTPIHI
Symptoms: Blood test normal, Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes on pelvic area.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site inflammation, Injection site pain, Periarthritis
Clinical narrative: Pain at injection site felt after injection in upper left shoulder.  Pain got progressively worse and developed decreased range of motion.  Saw PCP after 4 months.  Referred to Orthopedic doctor who took xrays and who said flu shot had been injected into shoulder bursa instead of into muscle, causing inflammation and "frozen shoulder".  I was given cortisone shot and referred for physical therapy.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray abnormal
Clinical narrative: Pain at injection site felt after injection in upper left shoulder.  Pain got progressively worse and developed decreased range of motion.  Saw PCP after 4 months.  Referred to Orthopedic doctor who took xrays and who said flu shot had been injected into shoulder bursa instead of into muscle, causing inflammation and "frozen shoulder".  I was given cortisone shot and referred for physical therapy.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm- could not lift arm- above the normal soreness.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: Pt states that she had a rapid heart rate which dissipated after a short time and has not re-occurred since. Upon follow up call on 1/31/16 pt states no re-occurrence of symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Haemorrhage, Pruritus, Scab, Urticaria
Clinical narrative: Extreme itching and red, hive-like bumps on arms, back, shoulders, neck, sides of hips and groin area.  Woke up with scabbed scratch marks and small blood spots on my clothing and sheets.  Saw my doctor on 10/9/15, and she prescribed Fluocinonide (LIDEX / FLUEX) 0.05 % Top Crea, which has not helped.  After seeing her twice since then in January 2016, she prescribed hydrOXYzine Pamoate (VISTARIL) 25 mg Oral Cap (1 capsule orally at bedtime when needed for itching) and instructed me to purchase generic Zyrtec, which I did.  So far, neither product has helped the itching.  During my office visit on 1/8/16, she also ordered my regular series of lab tests that I believe were irrelevant to this problem.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Day following immunization, patient had soreness of arm when lifting, pain that caused restlessness when lying on that side, small bump at site.  The following day (1/30/16) bump had turned into hard nodule.  No fever.  Unable to reach mfg to determine whether nodule development would necessitate urgent care or if she should follow up in 2 days when ob/gyn available.  Called local ER to inquire about the protocol they follow post imz reactions, and referred pt to call to determine need to be seen.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Restlessness
Clinical narrative: Day following immunization, patient had soreness of arm when lifting, pain that caused restlessness when lying on that side, small bump at site.  The following day (1/30/16) bump had turned into hard nodule.  No fever.  Unable to reach mfg to determine whether nodule development would necessitate urgent care or if she should follow up in 2 days when ob/gyn available.  Called local ER to inquire about the protocol they follow post imz reactions, and referred pt to call to determine need to be seen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Periarthritis, X-ray
Clinical narrative: I began having extreme pain in my left shoulder, radiating down my arm, and severely limited range of motion. I have been to a physician, an orthopedic doctor and to physical therapy. I am still being treated with physical therapy after orthopedic doctor diagnosed my condition as "frozen" shoulder and took X-rays.
Age: 1.3
Sex: F
Vaccine: PNC13
Symptoms: Abnormal faeces, Crying, Dermatitis diaper, Diarrhoea, Fatigue
Clinical narrative: After two individual Prevnar 13 shots, a toddler experienced foul-smelling poop and diarrhea and a very bad diaper rash with red raised bumps for 5 days. A previously unvaccinated, breastfed girl was given 2 doses of Prevnar13 (a full series of two shots since it was delayed). The first was at age 12 months (10/30/15), and the second was at age 15 months (01/22/2016).  Her health and temperature at both visits were normal, and there were no diet or diapering changes before or after either visit. About one day after the 10/15 shot, she experienced foul-smelling poop. There were about 2 poops in one day that had less water than usual, then later that day or the next day there were about 3 soft (but not fully runny) foul-smelling poops every 2-3 hours. The parents believed it was a coincidence, and the girl showed no other symptoms apart from slight tiredness, that may have been unrelated. She was treated at home with almond oil, A&D, baths, air drying, and Triple Paste. While the rash was painful and bright red the first day, the next day it turned into red raised bumps from anus to genitals that lasted about 2-3 days. As it showed improvement and seemed to not be painful after the first day of discovery, she was treated at home, and the rash was fully gone at the end of a week. The same symptoms (but with more severity) happened after her 1/22 shot. This time, the foul-smelling runny poops started the morning of the 23rd, and there were about 4-5 of them, one every 2 hours. The rash this time, however, was more severe. After the first runny poop (the morning of the 23rd), a larger diaper area turned bright solid red, and she screamed and cried when it was touched. By the 24th, the rash again turned into bright red raised bumps (very numerous and close together) from anus to genitals, spreading out to inner thigh, but there was no more diarrhea or signs of her discomfort. The bright red color was gone by the morning of the 27th, and the rash was gone fully by the 28th. Again, she showed slight signs of tiredness, but no other symptoms. Lastly, the parents primarily cloth diaper, and the father reported that his clothes severely itched him on the 26th. They wondered if this was because the clothes he was wearing were washed in a separate load after a diaper load from the 25th. However, they do not know if the itchy clothes are related directly to Prevnar 13, as it could easily be unrelated.
Age: 1.3
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Screaming
Clinical narrative: After two individual Prevnar 13 shots, a toddler experienced foul-smelling poop and diarrhea and a very bad diaper rash with red raised bumps for 5 days. A previously unvaccinated, breastfed girl was given 2 doses of Prevnar13 (a full series of two shots since it was delayed). The first was at age 12 months (10/30/15), and the second was at age 15 months (01/22/2016).  Her health and temperature at both visits were normal, and there were no diet or diapering changes before or after either visit. About one day after the 10/15 shot, she experienced foul-smelling poop. There were about 2 poops in one day that had less water than usual, then later that day or the next day there were about 3 soft (but not fully runny) foul-smelling poops every 2-3 hours. The parents believed it was a coincidence, and the girl showed no other symptoms apart from slight tiredness, that may have been unrelated. She was treated at home with almond oil, A&D, baths, air drying, and Triple Paste. While the rash was painful and bright red the first day, the next day it turned into red raised bumps from anus to genitals that lasted about 2-3 days. As it showed improvement and seemed to not be painful after the first day of discovery, she was treated at home, and the rash was fully gone at the end of a week. The same symptoms (but with more severity) happened after her 1/22 shot. This time, the foul-smelling runny poops started the morning of the 23rd, and there were about 4-5 of them, one every 2 hours. The rash this time, however, was more severe. After the first runny poop (the morning of the 23rd), a larger diaper area turned bright solid red, and she screamed and cried when it was touched. By the 24th, the rash again turned into bright red raised bumps (very numerous and close together) from anus to genitals, spreading out to inner thigh, but there was no more diarrhea or signs of her discomfort. The bright red color was gone by the morning of the 27th, and the rash was gone fully by the 28th. Again, she showed slight signs of tiredness, but no other symptoms. Lastly, the parents primarily cloth diaper, and the father reported that his clothes severely itched him on the 26th. They wondered if this was because the clothes he was wearing were washed in a separate load after a diaper load from the 25th. However, they do not know if the itchy clothes are related directly to Prevnar 13, as it could easily be unrelated.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of increasing swelling/warmness/pain/redness in the area surrounding the injection site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Patient came into the pharmacy on 1/31/2016 stating his right arm was still sore "a deep sore" where vaccine was given he said, since he received the flu shot on 1/2/16. nothing unusual about his month, job related activities or current illnesses that could indicate why his arm was still sore.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained of sore arm for 2 weeks. Then reported severe pain and unable to move her arm (L). Going to MD on 2/1/16.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Atrial fibrillation, Blood count abnormal, Blood urine present, Body temperature increased, Confusional state
Clinical narrative: My wife went to the local pharmacy to get the PREVNAR13 vaccine based on the advice of our primary care doctor. She took the PREVNAR13 shot in the arm about noon on December 17, 2015. We went home had lunch, watched TV, and talked awhile until she decided to take a nap. About 5:45 P.M. that evening, I went to the bedroom to wake her up and I returned to another room. I went back to check on her twice until the third time of no response; I tried to get her to get out of bed. She was not responsive to my directions, disoriented, and confused. At this time, I called 911 for an ambulance. When the medics arrived her body temperature was 101.5 F degrees. I told them about the vaccine that she had earlier that day. They gave her TYLENOL and started an IV and took her to hospital. At hospital she was treated in the ER after drawing blood and getting urine samples. About 10:00 P.M. the nurse said that she had some type of infection. While in the ER she was given MOTRIN and various antibiotics (ZOYSN). It was decided later that she needed to be admitted for at least one day. About 1:20 A.M. December 18, 2015, she was admitted into the ICU Unit for treatment. Patient was treated here at hospital from 12/17/2015-12/28/2015. My first meeting with Dr. we talked about why she was brought to the hospital and her medical history. During the time she was at this hospital her medical diagnosis and conditions were changed several times such as rapid heart rate, unknown virus, rhinovirus, atrial fibrillation, fluid in lungs, high blood pressure 189/107, bleeding mouth, blood in the urine, low blood count, diffused pneumonia, and common cold. Numerous lab test were done while she was being treated here. She was also given blood while she was here. During my visits with patient, I have noticed that she is having difficulty remembering things. It appears that this may be as ongoing problem. On December 28, 2015, she was transferred to another hospital. Patient was cared for from 12/28/15-01/11/2016. While at hospital, she continued treatments to clear the fluids in the lungs and started the initial physical and occupational therapies. On January 11, 2016, she was transferred to Skilled Nursing and Rehabilitation. During her stay here, she is receiving her follow-up medications for the heart and lungs. She is also doing occupational and physical therapy. The Nurse Practitioner has noticed that patient is having memory issues. Last week, the nurse practitioner asked me about her memory and if it was like it is now before she became sick or if it is worse. It is possible that, she may be released to go home next week after this long ordeal.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Disorientation, Heart rate increased, Hypertension, Infection, Intensive care
Clinical narrative: My wife went to the local pharmacy to get the PREVNAR13 vaccine based on the advice of our primary care doctor. She took the PREVNAR13 shot in the arm about noon on December 17, 2015. We went home had lunch, watched TV, and talked awhile until she decided to take a nap. About 5:45 P.M. that evening, I went to the bedroom to wake her up and I returned to another room. I went back to check on her twice until the third time of no response; I tried to get her to get out of bed. She was not responsive to my directions, disoriented, and confused. At this time, I called 911 for an ambulance. When the medics arrived her body temperature was 101.5 F degrees. I told them about the vaccine that she had earlier that day. They gave her TYLENOL and started an IV and took her to hospital. At hospital she was treated in the ER after drawing blood and getting urine samples. About 10:00 P.M. the nurse said that she had some type of infection. While in the ER she was given MOTRIN and various antibiotics (ZOYSN). It was decided later that she needed to be admitted for at least one day. About 1:20 A.M. December 18, 2015, she was admitted into the ICU Unit for treatment. Patient was treated here at hospital from 12/17/2015-12/28/2015. My first meeting with Dr. we talked about why she was brought to the hospital and her medical history. During the time she was at this hospital her medical diagnosis and conditions were changed several times such as rapid heart rate, unknown virus, rhinovirus, atrial fibrillation, fluid in lungs, high blood pressure 189/107, bleeding mouth, blood in the urine, low blood count, diffused pneumonia, and common cold. Numerous lab test were done while she was being treated here. She was also given blood while she was here. During my visits with patient, I have noticed that she is having difficulty remembering things. It appears that this may be as ongoing problem. On December 28, 2015, she was transferred to another hospital. Patient was cared for from 12/28/15-01/11/2016. While at hospital, she continued treatments to clear the fluids in the lungs and started the initial physical and occupational therapies. On January 11, 2016, she was transferred to Skilled Nursing and Rehabilitation. During her stay here, she is receiving her follow-up medications for the heart and lungs. She is also doing occupational and physical therapy. The Nurse Practitioner has noticed that patient is having memory issues. Last week, the nurse practitioner asked me about her memory and if it was like it is now before she became sick or if it is worse. It is possible that, she may be released to go home next week after this long ordeal.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Memory impairment, Mouth haemorrhage, Nasopharyngitis, Pleural effusion
Clinical narrative: My wife went to the local pharmacy to get the PREVNAR13 vaccine based on the advice of our primary care doctor. She took the PREVNAR13 shot in the arm about noon on December 17, 2015. We went home had lunch, watched TV, and talked awhile until she decided to take a nap. About 5:45 P.M. that evening, I went to the bedroom to wake her up and I returned to another room. I went back to check on her twice until the third time of no response; I tried to get her to get out of bed. She was not responsive to my directions, disoriented, and confused. At this time, I called 911 for an ambulance. When the medics arrived her body temperature was 101.5 F degrees. I told them about the vaccine that she had earlier that day. They gave her TYLENOL and started an IV and took her to hospital. At hospital she was treated in the ER after drawing blood and getting urine samples. About 10:00 P.M. the nurse said that she had some type of infection. While in the ER she was given MOTRIN and various antibiotics (ZOYSN). It was decided later that she needed to be admitted for at least one day. About 1:20 A.M. December 18, 2015, she was admitted into the ICU Unit for treatment. Patient was treated here at hospital from 12/17/2015-12/28/2015. My first meeting with Dr. we talked about why she was brought to the hospital and her medical history. During the time she was at this hospital her medical diagnosis and conditions were changed several times such as rapid heart rate, unknown virus, rhinovirus, atrial fibrillation, fluid in lungs, high blood pressure 189/107, bleeding mouth, blood in the urine, low blood count, diffused pneumonia, and common cold. Numerous lab test were done while she was being treated here. She was also given blood while she was here. During my visits with patient, I have noticed that she is having difficulty remembering things. It appears that this may be as ongoing problem. On December 28, 2015, she was transferred to another hospital. Patient was cared for from 12/28/15-01/11/2016. While at hospital, she continued treatments to clear the fluids in the lungs and started the initial physical and occupational therapies. On January 11, 2016, she was transferred to Skilled Nursing and Rehabilitation. During her stay here, she is receiving her follow-up medications for the heart and lungs. She is also doing occupational and physical therapy. The Nurse Practitioner has noticed that patient is having memory issues. Last week, the nurse practitioner asked me about her memory and if it was like it is now before she became sick or if it is worse. It is possible that, she may be released to go home next week after this long ordeal.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Rhinovirus infection, Transfusion, Unresponsive to stimuli, Urine analysis
Clinical narrative: My wife went to the local pharmacy to get the PREVNAR13 vaccine based on the advice of our primary care doctor. She took the PREVNAR13 shot in the arm about noon on December 17, 2015. We went home had lunch, watched TV, and talked awhile until she decided to take a nap. About 5:45 P.M. that evening, I went to the bedroom to wake her up and I returned to another room. I went back to check on her twice until the third time of no response; I tried to get her to get out of bed. She was not responsive to my directions, disoriented, and confused. At this time, I called 911 for an ambulance. When the medics arrived her body temperature was 101.5 F degrees. I told them about the vaccine that she had earlier that day. They gave her TYLENOL and started an IV and took her to hospital. At hospital she was treated in the ER after drawing blood and getting urine samples. About 10:00 P.M. the nurse said that she had some type of infection. While in the ER she was given MOTRIN and various antibiotics (ZOYSN). It was decided later that she needed to be admitted for at least one day. About 1:20 A.M. December 18, 2015, she was admitted into the ICU Unit for treatment. Patient was treated here at hospital from 12/17/2015-12/28/2015. My first meeting with Dr. we talked about why she was brought to the hospital and her medical history. During the time she was at this hospital her medical diagnosis and conditions were changed several times such as rapid heart rate, unknown virus, rhinovirus, atrial fibrillation, fluid in lungs, high blood pressure 189/107, bleeding mouth, blood in the urine, low blood count, diffused pneumonia, and common cold. Numerous lab test were done while she was being treated here. She was also given blood while she was here. During my visits with patient, I have noticed that she is having difficulty remembering things. It appears that this may be as ongoing problem. On December 28, 2015, she was transferred to another hospital. Patient was cared for from 12/28/15-01/11/2016. While at hospital, she continued treatments to clear the fluids in the lungs and started the initial physical and occupational therapies. On January 11, 2016, she was transferred to Skilled Nursing and Rehabilitation. During her stay here, she is receiving her follow-up medications for the heart and lungs. She is also doing occupational and physical therapy. The Nurse Practitioner has noticed that patient is having memory issues. Last week, the nurse practitioner asked me about her memory and if it was like it is now before she became sick or if it is worse. It is possible that, she may be released to go home next week after this long ordeal.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Viral infection
Clinical narrative: My wife went to the local pharmacy to get the PREVNAR13 vaccine based on the advice of our primary care doctor. She took the PREVNAR13 shot in the arm about noon on December 17, 2015. We went home had lunch, watched TV, and talked awhile until she decided to take a nap. About 5:45 P.M. that evening, I went to the bedroom to wake her up and I returned to another room. I went back to check on her twice until the third time of no response; I tried to get her to get out of bed. She was not responsive to my directions, disoriented, and confused. At this time, I called 911 for an ambulance. When the medics arrived her body temperature was 101.5 F degrees. I told them about the vaccine that she had earlier that day. They gave her TYLENOL and started an IV and took her to hospital. At hospital she was treated in the ER after drawing blood and getting urine samples. About 10:00 P.M. the nurse said that she had some type of infection. While in the ER she was given MOTRIN and various antibiotics (ZOYSN). It was decided later that she needed to be admitted for at least one day. About 1:20 A.M. December 18, 2015, she was admitted into the ICU Unit for treatment. Patient was treated here at hospital from 12/17/2015-12/28/2015. My first meeting with Dr. we talked about why she was brought to the hospital and her medical history. During the time she was at this hospital her medical diagnosis and conditions were changed several times such as rapid heart rate, unknown virus, rhinovirus, atrial fibrillation, fluid in lungs, high blood pressure 189/107, bleeding mouth, blood in the urine, low blood count, diffused pneumonia, and common cold. Numerous lab test were done while she was being treated here. She was also given blood while she was here. During my visits with patient, I have noticed that she is having difficulty remembering things. It appears that this may be as ongoing problem. On December 28, 2015, she was transferred to another hospital. Patient was cared for from 12/28/15-01/11/2016. While at hospital, she continued treatments to clear the fluids in the lungs and started the initial physical and occupational therapies. On January 11, 2016, she was transferred to Skilled Nursing and Rehabilitation. During her stay here, she is receiving her follow-up medications for the heart and lungs. She is also doing occupational and physical therapy. The Nurse Practitioner has noticed that patient is having memory issues. Last week, the nurse practitioner asked me about her memory and if it was like it is now before she became sick or if it is worse. It is possible that, she may be released to go home next week after this long ordeal.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to an 86 year old male patient. The patient had no pertinent medical history and no drug reactions or allergies. The pharmacist did not know if this patient had ever received PNEUMOVAX 23 in the past. On 13-JAN-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K010465, expired date 23-MAR-2016, route was not provided) 1 dose. The patient had no concomitant medication. The patient developed a 4-inch-diameter area of redness and warmth at the injection site. The pharmacist thought that the redness and warmth might have developed as soon as the day after the patient received the dose of PNEUMOVAX 23 on 14-JAN-2016, though he was not certain. The patient showed the pharmacist his injection site on 21-JAN-2016 ("today"), because the injection site redness and warmth was not improving. The patient believed that the injection site redness and warmth was getting worse. No lab diagnostics studies were performed. No treatment was given for the events. Causality was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chest discomfort, Cough, Eyelid oedema, Immediate post-injection reaction, Ocular hyperaemia
Clinical narrative: Walked to clinic by principal. After receiving immunizations student began to cough immediately, eyes puffy and red. Student complained of chest tightness. BENADRYL 25mg oral liquid given at 1154 AM for itching.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: Walked to clinic by principal. After receiving immunizations student began to cough immediately, eyes puffy and red. Student complained of chest tightness. BENADRYL 25mg oral liquid given at 1154 AM for itching.
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Blood electrolytes, Chills, Electrocardiogram
Clinical narrative: Case number PHHY2015US009881 is an initial spontaneous report received via Vaccine Adverse Reporting System (VAERS ID: 547976 on 06 JAN 2015). This report refers to a 79 years old male patient. His medical history was not reported and concomitant medications included PRILOSEC, VOLTAREN, ASA 81 mg, glucosamine/chondroitin, finasteride and simvastatin. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 14 OCT 2014. On the same day after vaccination, he had a general feeling of not feeling well, weakness, generalized tingling, achy joints and muscles, hard chills, shivering and shaking for hours, nausea and vomiting. The events progressed very rapidly and it was very frightening. He went to the emergency room of hospital and was treated with intravenous medications for nausea. Electrocardiogram (EKG) was done to rule out any other cause. He also underwent electrolytes, complete blood count (CBC) and troponin labs and the results were not reports. He left hospital some hours later. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Full blood count, Malaise, Myalgia, Nausea, Paraesthesia
Clinical narrative: Case number PHHY2015US009881 is an initial spontaneous report received via Vaccine Adverse Reporting System (VAERS ID: 547976 on 06 JAN 2015). This report refers to a 79 years old male patient. His medical history was not reported and concomitant medications included PRILOSEC, VOLTAREN, ASA 81 mg, glucosamine/chondroitin, finasteride and simvastatin. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 14 OCT 2014. On the same day after vaccination, he had a general feeling of not feeling well, weakness, generalized tingling, achy joints and muscles, hard chills, shivering and shaking for hours, nausea and vomiting. The events progressed very rapidly and it was very frightening. He went to the emergency room of hospital and was treated with intravenous medications for nausea. Electrocardiogram (EKG) was done to rule out any other cause. He also underwent electrolytes, complete blood count (CBC) and troponin labs and the results were not reports. He left hospital some hours later. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Tremor, Troponin, Vomiting
Clinical narrative: Case number PHHY2015US009881 is an initial spontaneous report received via Vaccine Adverse Reporting System (VAERS ID: 547976 on 06 JAN 2015). This report refers to a 79 years old male patient. His medical history was not reported and concomitant medications included PRILOSEC, VOLTAREN, ASA 81 mg, glucosamine/chondroitin, finasteride and simvastatin. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 14 OCT 2014. On the same day after vaccination, he had a general feeling of not feeling well, weakness, generalized tingling, achy joints and muscles, hard chills, shivering and shaking for hours, nausea and vomiting. The events progressed very rapidly and it was very frightening. He went to the emergency room of hospital and was treated with intravenous medications for nausea. Electrocardiogram (EKG) was done to rule out any other cause. He also underwent electrolytes, complete blood count (CBC) and troponin labs and the results were not reports. He left hospital some hours later. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Incorrect route of drug administration, Pruritus, Swelling
Clinical narrative: Case number PHHY2015US007210, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548404) website on 06 Jan 2015. This report refers to a 52 year old female patient. Current conditions included multiple sclerosis, osteoporosis and upper respiratory infection with cough. Concomitant medications included Neurontin, WELLBUTRIN, ZOLOFT, potassium, CYMBALTA, NORCO, tramadol, trazodone, LASIX fluid pill, blood pressure medication, BICILLIN 2.4 million units, Albuterol and 6 more medications (unknown). On 12 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) subcutaneous into right arm. On the same day post vaccination she developed swelling, redness, itching and hot. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US007284, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548415) website on 06 Jan 2015. This report refers to a 63 year old female patient. She was allergic to sulfa drugs. Current condition included multiple sclerosis. Concomitant medication included atenolol, chlorthalidone and KLOR CON. On 13 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown). On the same day post vaccination she experienced swollen and sore arm with limited mobility and pain. She went to the emergency room. Final outcome of the events was not reported. Causality assessment was not reported. Events were reported as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: Case number PHHY2015US007437 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548526) on 06 Jan 2015. This report refers to a 58 years old female patient. Her medical history included flushing and current conditions included high blood pressure, depression, fibromyalgia, asthma, hypothyroidism, allergy to FLAGYL, SEPTRA, penicillin and NEOSPORIN, lactose, latex, soy and gluten. Her concomitant medications were WELLBUTRIN, metoprolol, phenoxybenzamine, cyclobenzamine, HCTC/Triam and vitamin B. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Sep 2014. On 23 Sep 2014, she had heart palpitations which began about 1:15 and it continued through until about 7:50 am. The event outcome was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Musculoskeletal chest pain
Clinical narrative: Case number PHHY2015US007285, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548609) website on 06 Jan 2015. This report refers to a 49 year old female patient. Medical history was not reported. Concomitant medication included FEMARA, NASONEX, ADVAIR, NEXIUM, alendronate, MVI, vitamin D3, calcium, EFFEXOR. On 15 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) subcutaneous into left arm. On 16 Oct 2014, she experienced pain in joint to shoulder, scapula and ribs on same side as shot. 34 hours later fever, headache, muscle aches, joint aches, fatigue, stuffy nose and dizziness. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Case number PHHY2015US007285, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548609) website on 06 Jan 2015. This report refers to a 49 year old female patient. Medical history was not reported. Concomitant medication included FEMARA, NASONEX, ADVAIR, NEXIUM, alendronate, MVI, vitamin D3, calcium, EFFEXOR. On 15 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) subcutaneous into left arm. On 16 Oct 2014, she experienced pain in joint to shoulder, scapula and ribs on same side as shot. 34 hours later fever, headache, muscle aches, joint aches, fatigue, stuffy nose and dizziness. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Case number PHHY2015US006160, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548638) website on 06 Jan 2015. This report refers to a 2-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 16 Oct 2014. On the same day about 13 hours after the vaccination, the patient experienced fever that peaked at 101.5 degrees and redness around the injection site. The final outcome of the events was recovered. The events were reported as non-serious. Causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bone pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US006146, is an initial spontaneous report from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 548641) website received on 06 Jan 2015. This report refers to a 29-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 17 Oct 2014. On the same day after the vaccination, the patient's arm bones started hurting (similar to when a broken bone hurts in the cold) and shoulder feels very sore to the point where she can only lift up arm half the distance and move her fingers. Also, the patient's elbow hurts too. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.