chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Dysphagia, Faeces discoloured, Feeding disorder
Clinical narrative: 10/01/15: Day 1; Weight: 184 lbs; 3:00pm Received vaccine; 8:00pm Reactions began: 102F fever, Choking, Unable to swallow (except liquids); 11:00pm Went to bed. Unable to sleep, pain in stomach; unable to lay on side or on my stomach pain persisted through the night, no sleep. 10/02/15: Day 2; Unable to eat, attempted to eat 1/2 banana, but no success. Unable to eat anything for the rest of the day. Persistent abdominal pain and dizziness lasting all day. 10/03/15: Day 3; Fried 2 eggs in morning, but barely managed to eat one. Throat feels as though it is swollen shut. Able to drink liquids with some difficulty. 10/04/15: Day 4; Made a bland smoothie, less constriction on my throat, however, the smoothie felt as though it wasn't passing into my stomach. It felt like there was no peristalsis. 10/05/15: Day 5; First bowel movement since vaccine date. Stools were black, tarry and loose. Diarrhea quickly developed. 10/06/15: Day 6; Weight: 175 lbs; Continuing black, tarry diarrhea. 10/07/15: Day 7; Woke up quite hungry and cooked 4 eggs over easy. Painful swallowing so I only was able to eat 2 of the 4 eggs.  I bought protein powder to make a smoothie, which I was able to drink successfully. 10/08/15: Day 8; Woke up and noticed a thick, heavy, white coating on my tongue, which prompted me to go purchase probiotic capsules called Culterelle, of which I took 2. No change in my stools, still black, tarry and loose. 10/09/15: Day 9; Fried up 3 eggs and boiled white rice in the morning. I was able to eat this meal, but it was the only meal I was able to have that day. 10/10/15: Day 10; Stools return to normal. However, noticing pain in my kidneys and lower back developing. 10/11/15-10/13/15 Days 11-13; Weight: 177 lbs; Stools remain normal, 2 pounds gained. 10/17/15: Day 17; Experiencing afternoon headache and noticeable discomfort in left side of chest and what feels to be heart minor heart palpitations.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Insomnia, Melaena, Palpitations, Pharyngeal oedema
Clinical narrative: 10/01/15: Day 1; Weight: 184 lbs; 3:00pm Received vaccine; 8:00pm Reactions began: 102F fever, Choking, Unable to swallow (except liquids); 11:00pm Went to bed. Unable to sleep, pain in stomach; unable to lay on side or on my stomach pain persisted through the night, no sleep. 10/02/15: Day 2; Unable to eat, attempted to eat 1/2 banana, but no success. Unable to eat anything for the rest of the day. Persistent abdominal pain and dizziness lasting all day. 10/03/15: Day 3; Fried 2 eggs in morning, but barely managed to eat one. Throat feels as though it is swollen shut. Able to drink liquids with some difficulty. 10/04/15: Day 4; Made a bland smoothie, less constriction on my throat, however, the smoothie felt as though it wasn't passing into my stomach. It felt like there was no peristalsis. 10/05/15: Day 5; First bowel movement since vaccine date. Stools were black, tarry and loose. Diarrhea quickly developed. 10/06/15: Day 6; Weight: 175 lbs; Continuing black, tarry diarrhea. 10/07/15: Day 7; Woke up quite hungry and cooked 4 eggs over easy. Painful swallowing so I only was able to eat 2 of the 4 eggs.  I bought protein powder to make a smoothie, which I was able to drink successfully. 10/08/15: Day 8; Woke up and noticed a thick, heavy, white coating on my tongue, which prompted me to go purchase probiotic capsules called Culterelle, of which I took 2. No change in my stools, still black, tarry and loose. 10/09/15: Day 9; Fried up 3 eggs and boiled white rice in the morning. I was able to eat this meal, but it was the only meal I was able to have that day. 10/10/15: Day 10; Stools return to normal. However, noticing pain in my kidneys and lower back developing. 10/11/15-10/13/15 Days 11-13; Weight: 177 lbs; Stools remain normal, 2 pounds gained. 10/17/15: Day 17; Experiencing afternoon headache and noticeable discomfort in left side of chest and what feels to be heart minor heart palpitations.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Renal pain, Tongue coated, Weight increased
Clinical narrative: 10/01/15: Day 1; Weight: 184 lbs; 3:00pm Received vaccine; 8:00pm Reactions began: 102F fever, Choking, Unable to swallow (except liquids); 11:00pm Went to bed. Unable to sleep, pain in stomach; unable to lay on side or on my stomach pain persisted through the night, no sleep. 10/02/15: Day 2; Unable to eat, attempted to eat 1/2 banana, but no success. Unable to eat anything for the rest of the day. Persistent abdominal pain and dizziness lasting all day. 10/03/15: Day 3; Fried 2 eggs in morning, but barely managed to eat one. Throat feels as though it is swollen shut. Able to drink liquids with some difficulty. 10/04/15: Day 4; Made a bland smoothie, less constriction on my throat, however, the smoothie felt as though it wasn't passing into my stomach. It felt like there was no peristalsis. 10/05/15: Day 5; First bowel movement since vaccine date. Stools were black, tarry and loose. Diarrhea quickly developed. 10/06/15: Day 6; Weight: 175 lbs; Continuing black, tarry diarrhea. 10/07/15: Day 7; Woke up quite hungry and cooked 4 eggs over easy. Painful swallowing so I only was able to eat 2 of the 4 eggs.  I bought protein powder to make a smoothie, which I was able to drink successfully. 10/08/15: Day 8; Woke up and noticed a thick, heavy, white coating on my tongue, which prompted me to go purchase probiotic capsules called Culterelle, of which I took 2. No change in my stools, still black, tarry and loose. 10/09/15: Day 9; Fried up 3 eggs and boiled white rice in the morning. I was able to eat this meal, but it was the only meal I was able to have that day. 10/10/15: Day 10; Stools return to normal. However, noticing pain in my kidneys and lower back developing. 10/11/15-10/13/15 Days 11-13; Weight: 177 lbs; Stools remain normal, 2 pounds gained. 10/17/15: Day 17; Experiencing afternoon headache and noticeable discomfort in left side of chest and what feels to be heart minor heart palpitations.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: After 4 days arm is still swollen, red and painful.  She believes she had a reaction to vaccine.
Age: 22.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Blood glucose, Pallor, Syncope
Clinical narrative: Turned pale, fainted but slightly conscious.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, and hot to the touch radiating down her arm. Pt says the area has been growing this this morning. The area is away from the injection site. Pt is afebrile and reports no other symptoms.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Insomnia, Malaise, Pyrexia
Clinical narrative: Since I am over 65 this year they gave me the super flu shot. I started feeling sick with chills and fever of 100 about dinner time. I took Tylenol for fever but couldn't sleep all night. My fever spiked to almost 103 at 3 am. Took more Tylenol. Next day I am feeling very weak with slight fever. Still taking Tylenol. My previous regular flu shots I would sometimes feel chills and get slight fever. This super flu shot made me very sick with a dangerously high fever. I was almost ready to go to the hospital. People should be told that the super flu shot can have very bad side effects. I will not get the super flu shot ever again since this is as bad as having the flu. I might take the regular shot next year.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm, radiating from deep in shoulder joint and to elbow, and all the way down the arm, to the fingers.  Strongest pain in first few days.  Pain is now less but there is still sharp pain across front of arm from shoulder to above the elbow, which feels like tendon or muscle pain but if very sharp, and lingers.  This happens if I lift arm up too far or also if I use the muscle required to pull my pants up. I also experienced many of the other side effects for the first 3 days and they subsided.  I had a pnuemonia vaccine in 2000 and had 3 days of side effects, including severe arm pain, but then it subsided. This time it was much worse and it has not gone away yet.  I will be making an appointment to see a doctor if it does not go away.  If this is considered to be a normal and acceptable side effect I think there needs to be a better warning of the possibility it might occur, especially for those that have had it before.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Bacterial infection, Chills, Erythema, Injection site reaction, Pain in extremity
Clinical narrative: Chills, fever 102, swelling of vaccinations its (right arm), increasing pain and redness over next 2 days. Redness and pain spread down arm.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pyrexia, Vaccination site swelling, Wound contamination
Clinical narrative: Chills, fever 102, swelling of vaccinations its (right arm), increasing pain and redness over next 2 days. Redness and pain spread down arm.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: 10/13/15 Immunization given about 4:28 pm. 10/15/15 9:58 am patients daughter called and said patient was experiencing pain and stiffness from injection site of left deltoid up shoulder to back of neck. Pt applied ice and had taken ALEVE and at afternoon was not getting worse and doing better. At 8:00 pm patients daughter said patient was feeling better.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: 10/3/15 had immunization at retail pharmacy. 10/5/15 came into pharmacy and described having pain and stiffness going from site of injection up arm, across shoulders and up neck; pharmacist called covering MD who verified no red line from injection site and gave pager # if needed and advised ER if condition worsens. Pt iced and took acetaminophen and reported continuing improvement/complete recovery.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Nausea, Throat irritation, Tremor
Clinical narrative: Shaking arms, throat irritation, nausea and vomiting, aching back, chills.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Shaking arms, throat irritation, nausea and vomiting, aching back, chills.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: FLUZONE HD was given to patient on 10/14/15 after 3 days her arm was still red and hot at the site of injection. Patient said she'd been icing it for 3 days....no improvement.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt came to pharmacy 10/14/15. Pt's arm (right) became very red about 3.5 inch around injection site. She stated  itchy and hot.
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Tenderness
Clinical narrative: Swelling and tenderness on right side of face along jawline in front of the ear. Resolved after 48 hrs Kw/cool compresses.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain, Pyrexia, Swelling face
Clinical narrative: < 24 hrs after PNEUMOVAX and flu vaccine pt became ill - body aches, facial swelling. States she had fever, but no thermometer to verify.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Dizziness, Migraine, Myalgia
Clinical narrative: Night after injection continuing until 10AM: shaking, chills, vomiting, fainting, dizzy, "giddy", stomach cramping, muscle aches throughout especially neck, migraine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Night after injection continuing until 10AM: shaking, chills, vomiting, fainting, dizzy, "giddy", stomach cramping, muscle aches throughout especially neck, migraine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Pain, Pyrexia, Viral infection
Clinical narrative: Fever, aches, headache, fatigue.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Flushing, Injection site bruising
Clinical narrative: Patient received FLUZONE HD and PREVNAR 13 on left deltoid on 10/15/15 12:10 pm. On morning of 10/16/15 she noticed red/flush skin and bruised from left deltoid down to almost her elbow. No raised rash, no itching, no pain. Patient didn't take anything for it. She came to report this on 10/17/15 at 12:30 pm.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site abscess, Injection site cellulitis, Injection site swelling, Pain
Clinical narrative: Received vaccine 10/13/2015 8:55 AM. At time of administration no pain but then noted pain that increased within 3 hrs and site swelling noted. More swelling as day progressed. 10/14/2015 9:05 AM went to walk in medical clinic. No testing. Visual assessment made by MD of cellulitis and abscess right arm bicep to fingers. Treatment: Prednisone 50mg QD x 5 days - started 10/15/2015 - 10AM. Cephalexin 500mg PO QID x 7 days - started 10/15/2015 8PM.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rt upper back of arm injection site red rash from injection site covering back of arm. Warm to touch.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding two patients of unspecified age and gender. No concurrent condition and medical history of the patients were not reported. On an unknown date two patients were vaccinated with PNEUMOVAX23 (lot no and expiry date not provided) (dosing regiment not provided). Concomitant medications were not provided. On an unspecified date after the administration of PNEUMOVAX23, the patients experienced 'shooting pain" at the injection site and down their arms. It was also reported that both the patients' pain resolved in one day. The relatedness of the events to the therapy with PNEUMOVAX23 was unknown. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K003422, 06-MSAR-2016. No symptoms were reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Bruising, swelling, redness of injection site.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Feeling abnormal, Headache, Influenza virus test negative, Limb discomfort
Clinical narrative: Legs felt as if I couldn't pick them up...weighed 500 pounds each. Headache, severe and progressed to worse. Tightness in chest and fever(ranging from 100.5 to 104.7) and all over aches and pain. Felt like I wanted to die.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Legs felt as if I couldn't pick them up...weighed 500 pounds each. Headache, severe and progressed to worse. Tightness in chest and fever(ranging from 100.5 to 104.7) and all over aches and pain. Felt like I wanted to die.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever, chills, myalgias.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Throat irritation
Clinical narrative: Fever, scratching throat, and diarrhea.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting nightly for three nights in a row.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Night sweats, Oropharyngeal pain, Pain, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Sore throat, low grade fever, night sweats, body aches, sinus drippings.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Confusional state, Crying, Mental disorder, Nervousness
Clinical narrative: Extreme confusion, Mental breakdown, nervousness, crying. Lasted for 3 days.
Age: 3.0
Sex: F
Vaccine: DTAP, FLUX, MMR
Symptoms: Erythema, Injection site extravasation, Pain, Pruritus, Swelling
Clinical narrative: Large red area-painful-itchy-raised area. Approx 3inches in diameter. Immunization possibly given in sub Q tissue. Large part leaked out of site when given. Given closer to inner thigh.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: Developed a pustule on his forehead, concerned that he may have spread infection from the site of his smallpox vaccination.
Age: 1.25
Sex: F
Vaccine: DTAPH
Symptoms: Asthenia, Blood test, Computerised tomogram, Immediate post-injection reaction, Nuclear magnetic resonance imaging
Clinical narrative: Right after the Vax patient was weak and spiked a high fever. From that day on she was just not her normal happy self. On 06/15/2015 she had 3 seizures. From that day on she has daily seizures.
Age: 1.25
Sex: F
Vaccine: DTAPH
Symptoms: Personality change, Pyrexia, Seizure
Clinical narrative: Right after the Vax patient was weak and spiked a high fever. From that day on she was just not her normal happy self. On 06/15/2015 she had 3 seizures. From that day on she has daily seizures.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Eye pruritus, Ocular hyperaemia, Oculorespiratory syndrome, Throat tightness
Clinical narrative: Symptoms similar to those of Oculo-respiratory syndrome: itchy red eyes, constricted airway.
Age: 79.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: First a red circle then over 4 days spread on his upper arm. Patient complained of a little itching and once in a while a shooting pain. Benadryl for reaction but no other symptoms.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, chills, sweating, upset stomach.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Musculoskeletal pain, Myalgia
Clinical narrative: As an elementary school teacher, I don't hesitate to get the flu shot every year.  However, this year I am experiencing something quite different.  I have been experiencing muscle pain in my left arm since I had the shot 2 weeks ago.  I woke the next morning with severe back and shoulder pain radiating from my left arm for over 2 weeks.  My muscles and joints ache all the time and grow worse with long periods of standing.  The pain keeps me from performing daily activities and sleeping.  It awakens me in the night.   I have been taking Advil several times daily to function and have seen my chiropractor with little relief.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: As an elementary school teacher, I don't hesitate to get the flu shot every year.  However, this year I am experiencing something quite different.  I have been experiencing muscle pain in my left arm since I had the shot 2 weeks ago.  I woke the next morning with severe back and shoulder pain radiating from my left arm for over 2 weeks.  My muscles and joints ache all the time and grow worse with long periods of standing.  The pain keeps me from performing daily activities and sleeping.  It awakens me in the night.   I have been taking Advil several times daily to function and have seen my chiropractor with little relief.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Fatigue, Impaired work ability, Injection site bruising
Clinical narrative: Patient reported a bruise at the injection site about the size of a quarter that didn't resolve for over a week. She also stated that her blood pressure was elevated and she was very fatigued - she missed 2 days of work.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives on hands and feet, mild hives elsewhere. Still in existence but lessened two days later. Took antihistamines.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, followed by additional diarrhea in the AM of the following morning of the 17th and then repeated diarrhea last night and into this morning (10/18/15). After each episode I took two Loperamides. Now seems to have finally abated.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells palsy.  7th CN palsy on ipsalateral side of injection approximately 2-3 weeks later.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Sudden hearing loss and tinnitus.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Sudden hearing loss and tinnitus.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Syncope
Clinical narrative: SYNCOPE AND POSSIBLE SEIZURE WITH HOT FLASHES.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth, Vessel puncture site erythema
Clinical narrative: Two days after vaccine, patient noticed he hadn't taken off the bandage, when he did he saw a large red area around the site of venipuncture. It was hot to the touch. There were no other symptoms noted.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hyperhidrosis, Pallor, Tremor
Clinical narrative: Headache, sweating, shaking, paleness, fatigue. ER choose not to provide anything since they didn't know what caused the reaction.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Chills, Eye pruritus, Eye swelling
Clinical narrative: BEGAN WITH BEING TIRED, NEXT DAY BUMPS ON FACE LIKE BEING BITE BY A SPIDER, TIREDNESS, WEAKNESS & ACHES, ON 10/9 EYES STARTED ITCHING, FACE WAS GETTING ITCHY AND TO FEEL LIKE A SNAKE SKIN DAY TO DAY, ON NIGHT OF 10/11 WOKE UP @ MIDNIGHT EYES EXTREMELY ITCHING, BY THE AM FACE FLAKEY ALL OVER, EYES & FACE SWOLLEN & ITCHING, PLUS HEADACHES, BACKACHES, HOT SWEATS, CHILLS.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling hot, Headache, Hyperhidrosis, Pain
Clinical narrative: BEGAN WITH BEING TIRED, NEXT DAY BUMPS ON FACE LIKE BEING BITE BY A SPIDER, TIREDNESS, WEAKNESS & ACHES, ON 10/9 EYES STARTED ITCHING, FACE WAS GETTING ITCHY AND TO FEEL LIKE A SNAKE SKIN DAY TO DAY, ON NIGHT OF 10/11 WOKE UP @ MIDNIGHT EYES EXTREMELY ITCHING, BY THE AM FACE FLAKEY ALL OVER, EYES & FACE SWOLLEN & ITCHING, PLUS HEADACHES, BACKACHES, HOT SWEATS, CHILLS.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Skin disorder, Skin exfoliation, Swelling face
Clinical narrative: BEGAN WITH BEING TIRED, NEXT DAY BUMPS ON FACE LIKE BEING BITE BY A SPIDER, TIREDNESS, WEAKNESS & ACHES, ON 10/9 EYES STARTED ITCHING, FACE WAS GETTING ITCHY AND TO FEEL LIKE A SNAKE SKIN DAY TO DAY, ON NIGHT OF 10/11 WOKE UP @ MIDNIGHT EYES EXTREMELY ITCHING, BY THE AM FACE FLAKEY ALL OVER, EYES & FACE SWOLLEN & ITCHING, PLUS HEADACHES, BACKACHES, HOT SWEATS, CHILLS.
Age: 60.0
Sex: M
Vaccine: FLUR3
Symptoms: Headache, Hyperhidrosis, Malaise, Nausea, Vomiting
Clinical narrative: HEADACHE, SWEATING, NAUSEA, VOMITING.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: PATIENT REPORTED SHE BROKE OUT IN HIVES.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Nausea, Pain in extremity, Vaccination site pain, Vomiting
Clinical narrative: PT REPORTED NAUSEA AND VOMITING, AND FATIGUE. ACHING SORENESS ALL DOWN VACCINATED ARM (LEFT) X 3 DAYS. SHE FELT THIS WAS VERY SIGNIFICANT AS SHE HAD BOTH VACCINES IN SAME ARM.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Headache, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient reporting post injection pain/soreness in arm.  Shoulder pain and throughout body (wrist, ankles, hip).  Headache.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reporting post injection pain/soreness in arm.  Shoulder pain and throughout body (wrist, ankles, hip).  Headache.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site movement impairment, Injection site pain, Migraine
Clinical narrative: Left arm of injection site extremely painful. Little to no movement. Painful to the touch. Severe headache/Migraine since the day of vaccine injection.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Entire thigh was bright red;  caused him pain;  on the following day, it became less red, but still continued to cause him pain and itching.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Lacrimation increased
Clinical narrative: Severe soreness in left shoulder, all around the joint and the injection site. Pain continued to worsen throughout the night. By the next morning the pain level was so high that I had tears in my eyes. The next day, the shoulder was frozen up to the point where I couldn't move it or use it at all. I have been using a heating pad and muscle relaxers to control the pain, but the pain is still debilitating. The pain was even worse the next day.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Severe soreness in left shoulder, all around the joint and the injection site. Pain continued to worsen throughout the night. By the next morning the pain level was so high that I had tears in my eyes. The next day, the shoulder was frozen up to the point where I couldn't move it or use it at all. I have been using a heating pad and muscle relaxers to control the pain, but the pain is still debilitating. The pain was even worse the next day.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: ADM IMMUNIZATION 10/13, CAME TO PHARMACY 10/16 OR 17 SEEKING ADVICE ON FACIAL RASH- COUNSELED ON ANTIHISTAMINE USE, S/S ANAPHYLAXIS, ETC, CAME BACK 10/18 MORE ADV RASH AND RX FOR PREDNISONE.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Uncontrolled shivering. Lasted for 3 1/2 hours. Room temp 77 deg F. Under blanket and comforter at 10 PM.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Nausea followed by severe vomiting, chills, followed by severe shaking, and high fever which lasted two hours.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Hives, swollen face, rash, itching, racing heart--Benadryl and steroids.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Emotional distress, Erythema, Flushing, Irritability, Pyrexia
Clinical narrative: Fever: (102 degrees) Day 7 till currently Day 12. Rash: Flushed Red & Raised Bumps starting Day 12. Unusually cranky, upset, sleeping more.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Somnolence
Clinical narrative: Fever: (102 degrees) Day 7 till currently Day 12. Rash: Flushed Red & Raised Bumps starting Day 12. Unusually cranky, upset, sleeping more.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Intense pain radiating down to wrist. Shoulder pain and immobility, limited range of motion over the course of the next month and still persisting.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: PATIENT DEVELOPED FEVER, CHILLS THAT BEGAN ON THURSDAY 10/15/15 AND CONTINUED THROUGH FRIDAY PM 10/16/15.  SHE ALSO DEVELOPED EXTREME SORENESS, PAIN, INFLAMMATION AND SWELL AT THE INJECTION SITE.  THE INFLAMMATION AND SWELLING RADIATED DOWN HER ARM AND CAUSED HER MUSCLES TO HURT AND BE TENDER TO TOUCH (ESP. IN THE BICEP MUSCLE REGION).  THE PATIENT TOOK TYLENOL AND BENADRYL FOR THE ALLERGIC SYMPTOMS AND PAIN.  WHEN THE PATIENT CONTACTED OUR PHARMACY THE INJECTION SITE WAS STILL RED AND SWOLLEN BUT APPEARED TO BE GETTING BETTER ACCORDING TO THE CUSTOMER.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: PATIENT DEVELOPED FEVER, CHILLS THAT BEGAN ON THURSDAY 10/15/15 AND CONTINUED THROUGH FRIDAY PM 10/16/15.  SHE ALSO DEVELOPED EXTREME SORENESS, PAIN, INFLAMMATION AND SWELL AT THE INJECTION SITE.  THE INFLAMMATION AND SWELLING RADIATED DOWN HER ARM AND CAUSED HER MUSCLES TO HURT AND BE TENDER TO TOUCH (ESP. IN THE BICEP MUSCLE REGION).  THE PATIENT TOOK TYLENOL AND BENADRYL FOR THE ALLERGIC SYMPTOMS AND PAIN.  WHEN THE PATIENT CONTACTED OUR PHARMACY THE INJECTION SITE WAS STILL RED AND SWOLLEN BUT APPEARED TO BE GETTING BETTER ACCORDING TO THE CUSTOMER.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Injection site pain, Pain
Clinical narrative: Severely sore left shoulder. Could not move shoulder without pain. Difficulty putting on shirts/jackets.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills. Fever as high as 103.6 but constant since PM on 15 OCT to 18 Oct (and maybe longer - currently running 102 fever).
Age: 26.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Unevaluable event
Clinical narrative: No thing.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: 101 Fever along with the chills. Sweating began around 3:00 AM. Fever began to subside around 9:00 am. Fever was gone around 12:00 PM.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye swelling, Fatigue, Injection site pain
Clinical narrative: Raging pain in shoulder and arm muscle where I received the injection.  Followed by fatigue, coughing, chills, fever, then extreme swelling of tongue, eyes, lips and face.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Lip swelling, Myalgia, Pyrexia, Swelling face
Clinical narrative: Raging pain in shoulder and arm muscle where I received the injection.  Followed by fatigue, coughing, chills, fever, then extreme swelling of tongue, eyes, lips and face.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Raging pain in shoulder and arm muscle where I received the injection.  Followed by fatigue, coughing, chills, fever, then extreme swelling of tongue, eyes, lips and face.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Eye allergy, Eye swelling, Ocular hyperaemia, Vision blurred
Clinical narrative: Red swollen eyes with noticeable blurred vision and difficulty focusing.
Sex: M
Vaccine: MMR
Symptoms: Contusion, Immune thrombocytopenic purpura, Laboratory test
Clinical narrative: Information has been received from a physician and a healthcare worker (certified medical assistant) referring to a currently 5 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On an unspecified date the patient was vaccinated with a dose of M-M-R II injection (unspecified lot and expiration date, Albumin status, dose, frequency and route were not provided). The patient had no concomitant medication. On an unspecified date, the patient was diagnosed with persistent autoimmune thrombocytopenia after an unspecified amount of time following the M-M-R II administration. Healthcare worker reported that the mother of the patient recalled that bruising started about a week after M-M-R II administration. On an unspecified date, the patient had an unspecified lab work done at the pediatrician office. The outcome of persistent autoimmune thrombocytopenia was unknown. Upon internal review, the event persistent autoimmune thrombocytopenia was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain
Clinical narrative: Patient was given FLUZONE HD on 9/19 - patient states arm felt uncomfortable shortly after getting shot but pain really increased on Monday 9/21. Pain was localized to area around injection site. Patient states she was unable to lift arm or rotate arm without having discomfort. Patient sought treatment from pharmacist while visiting another country. Pt was given itami 140mg patch. Pt still having pain and discomfort in upper arm and ROM limited.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Hard, warm, rash, size of tennis ball at injection site. No fever.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: Patient stated he began "shivering" around 5AM (roughly 12 hours after immunization). He said this lasted roughly 1 hour. He also complained of general malaise/fatigue.
Age: 56.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased
Clinical narrative: He says that since he got the flu shot (a month ago) he has not been able to lift his left arm up at the shoulder. He can bend the elbow, but no flex in left upper arm. Has tried some warm water (in shower) with little relief. Looking for some help. Has not seen MD.
Age: 56.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: He says that since he got the flu shot (a month ago) he has not been able to lift his left arm up at the shoulder. He can bend the elbow, but no flex in left upper arm. Has tried some warm water (in shower) with little relief. Looking for some help. Has not seen MD.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Constipation, Pyrexia
Clinical narrative: After getting flu shot she got fevers in 2 hours. Fever goes up and down for 7 days and also she got constipated for 5 days. So she took stool softener on 5th day to recover constipation. She took 3 TYLENOL total in week.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Administration site haemorrhage, Cold sweat, Injection site pain, Lethargy, Rash erythematous
Clinical narrative: Site of administration bled after administered. A few hours after admin, pt felt lethargic and had cold sweats. Next morning, pt vomited. Pt also reports red rash and severe soreness at site of administration 3 days after admin.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Site of administration bled after administered. A few hours after admin, pt felt lethargic and had cold sweats. Next morning, pt vomited. Pt also reports red rash and severe soreness at site of administration 3 days after admin.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Chills, Diarrhoea, Injection site oedema, Injection site pain
Clinical narrative: Patient is a 55-year-old female presents here with right deltoid swelling and edema and tenderness which is radiating diffusely to the neck and the right chest wall following TDAP inj in the deltoid region. Patient also had systemic reaction with fever chills diarrhea and currently is having increased pain involving the right shoulder and neck and chest region. Patient had similar reaction in the past for tetanus injection. She had a laceration for which he had to take this vaccine. Advised patient to continue ibuprofen and cold copresses. Will observe the site. Does not appear to be inected at this time. TRAMADOL p.r.n. for pain along with TYLENOL ordered. The above treatment plan and goals were discussed with the patient and he clearly verbalizes understanding. Nausea, Vomiting and edema/tenderness of right deltoid radiating to neck and right chest; fever/chills.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local swelling, Localised oedema, Musculoskeletal chest pain, Nausea
Clinical narrative: Patient is a 55-year-old female presents here with right deltoid swelling and edema and tenderness which is radiating diffusely to the neck and the right chest wall following TDAP inj in the deltoid region. Patient also had systemic reaction with fever chills diarrhea and currently is having increased pain involving the right shoulder and neck and chest region. Patient had similar reaction in the past for tetanus injection. She had a laceration for which he had to take this vaccine. Advised patient to continue ibuprofen and cold copresses. Will observe the site. Does not appear to be inected at this time. TRAMADOL p.r.n. for pain along with TYLENOL ordered. The above treatment plan and goals were discussed with the patient and he clearly verbalizes understanding. Nausea, Vomiting and edema/tenderness of right deltoid radiating to neck and right chest; fever/chills.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: Patient is a 55-year-old female presents here with right deltoid swelling and edema and tenderness which is radiating diffusely to the neck and the right chest wall following TDAP inj in the deltoid region. Patient also had systemic reaction with fever chills diarrhea and currently is having increased pain involving the right shoulder and neck and chest region. Patient had similar reaction in the past for tetanus injection. She had a laceration for which he had to take this vaccine. Advised patient to continue ibuprofen and cold copresses. Will observe the site. Does not appear to be inected at this time. TRAMADOL p.r.n. for pain along with TYLENOL ordered. The above treatment plan and goals were discussed with the patient and he clearly verbalizes understanding. Nausea, Vomiting and edema/tenderness of right deltoid radiating to neck and right chest; fever/chills.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of VAQTA (lot # k018181 with expiration 04-JUN-2017; lot # L028666 with expiration 04-NOV-2016; lot # K026529 with expiration 02-JUN-2017; lot#/batch# was reported as L007569 with expiration date 01-JUN-2017, dose, frequency and route were not reported, which had been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a physician via a company representative referring to a 9  year old male patient. The patient did not have any drug reactions/allergies. The patient received the first vaccination with (Oka/Merck) VARIVAX on 28-MAY-2007 and his second vaccination with (Oka/Merck) VARIVAX on 10-AUG-2010 subcutaneously (dose and lot # unknown). There was no concomitant therapy. On 05-OCT-2015, the patient came into the physician's offic4e with a rash which was diagnosed as chickenpox. Lab test was not performed. The outcome of chickenpox was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. in 2015 these patients were vaccinated with does of PNEUMOVAX23 (dose, frequency and route were not reported, lot#/batch# was reported as K018294 with expiration 28-APR-2016; lot#L011531 with expiration 07-JAN-2017), which had been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of M-M-R II (lot #K011317 with expiration 13-JUN-2016; dose, frequency and route were not reported) which has been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses ROTATEQ (lot #K010222 with expiration 12-JUN-2018;lot#/batch# was reported as K022986 with expiration date 22-JUL-2016;  dose, frequency and frequency were not reported) which has been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of RECOMBIVAX HB (lot 007558 with expiration 1o-NOV-2016; lot#/batch# was reported as L010896 with expiration 12-NOV-2016;  dose, frequency and route were not reported) which has been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of GARDASIL (lot# K023432 with expiration 18-JUN-2016; lot# was reported as K028247 with expiration 29-JAN-2017; lot # L010696 with expiration 06-APR-2017; dose, frequency and route were not reported), which had been improperly stored since January 2015. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were unknown. On unknown dates in June 2015 the patients were vaccinated with improperly stored GARDASIL (lot # K006960, expiration date 19-FEB-2017, dose and route were unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were unknown. On unknown dates in June 2015 the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010535, expiration date 27-AUG-2016, dose and route   were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were unknown. On unknown dates in June 2015 the patients were vaccinated with improperly stored ROTATEQ (lot#K017575, expiration date 01-JUN-2016, dose and route were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were unknown. On unknown dates in June 2015 the patients were vaccinated with improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017, dose and route were unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Biopsy muscle, Fatigue, Limb operation, Myalgia
Clinical narrative: This spontaneous report as received from an office manager who was a healthcare worker, refers to a currently 25 year old female patient. There were no pertinent medical history, drug allergies/drug reactions. In 2008 (reported as sometime in 2008), the patient was vaccinated with a GARDASIL series (3 doses) (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date (reported as 1 and 1/2 to 2 months after the third dose of GARDASIL, the patient experienced extreme muscle pain and exhaustion. The reporter stated that the muscle pain initially involved both legs and then progressed upward to the patient's upper body and jaw. The patient went to several unspecified healthcare providers and it was thought that the patient could possibly have Compartment syndrome, fibromyalgia or Lyme disease, but, at the reporting time, it was unspecified the actual diagnosis for her. The office manager also stated that the patient used to be very athletic but, at this time, she could no longer play sports. The patient sought medical attention with office visits. The patient treatment included NEURONTIN, LYRICA, stem cell infusion treatment, 3 surgeries on the patient's legs and a sympathetic nerve block (unspecified). Laboratory tests performed included a biopsy of arm and leg muscles. At the time of the report, the outcome of extreme muscle pain, general body pain, pain in jaw and fatigue was reported as not recovered. Upon internal review, the extreme muscle pain, general body pain, pain in jaw and fatigue were considered as disabling events. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nerve block, Pain, Pain in jaw, Stem cell transplant
Clinical narrative: This spontaneous report as received from an office manager who was a healthcare worker, refers to a currently 25 year old female patient. There were no pertinent medical history, drug allergies/drug reactions. In 2008 (reported as sometime in 2008), the patient was vaccinated with a GARDASIL series (3 doses) (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date (reported as 1 and 1/2 to 2 months after the third dose of GARDASIL, the patient experienced extreme muscle pain and exhaustion. The reporter stated that the muscle pain initially involved both legs and then progressed upward to the patient's upper body and jaw. The patient went to several unspecified healthcare providers and it was thought that the patient could possibly have Compartment syndrome, fibromyalgia or Lyme disease, but, at the reporting time, it was unspecified the actual diagnosis for her. The office manager also stated that the patient used to be very athletic but, at this time, she could no longer play sports. The patient sought medical attention with office visits. The patient treatment included NEURONTIN, LYRICA, stem cell infusion treatment, 3 surgeries on the patient's legs and a sympathetic nerve block (unspecified). Laboratory tests performed included a biopsy of arm and leg muscles. At the time of the report, the outcome of extreme muscle pain, general body pain, pain in jaw and fatigue was reported as not recovered. Upon internal review, the extreme muscle pain, general body pain, pain in jaw and fatigue were considered as disabling events. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.