chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Balance disorder, Chills, Death, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 84-year-old male patient of unknown race/ethnicity received in Mar2016 (during 6 month home visit) a single dose of PREVNAR 13 for immunization. Medical history included dementia. Concomitant medications were not reported. On an unspecified date in 2016, the patient reported initially pain at injection site then became sick within couple of days and fever and chills and stiff neck and pain in joints also reported balance problems. Patient was visited at the emergency room where they really couldn't find anything wrong with him. Symptoms persisted, may be got little better over time. In Jul2016 patient died. No autopsy was performed. Reported Cause(s) of Death: unknown cause of death.
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 84-year-old male patient of unknown race/ethnicity received in Mar2016 (during 6 month home visit) a single dose of PREVNAR 13 for immunization. Medical history included dementia. Concomitant medications were not reported. On an unspecified date in 2016, the patient reported initially pain at injection site then became sick within couple of days and fever and chills and stiff neck and pain in joints also reported balance problems. Patient was visited at the emergency room where they really couldn't find anything wrong with him. Symptoms persisted, may be got little better over time. In Jul2016 patient died. No autopsy was performed. Reported Cause(s) of Death: unknown cause of death.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable Nurse Practitioner via a Pfizer sales representative. This nurse reported the same event for 2 patients. This is the 2nd of two reports. A patient of an unspecified age, gender and race received TRUMENBA for Immunisation at 0.5ml single dose on unknown date via intramuscular route. No concomitant medications, other medical conditions, or testing/investigations known at this time. Within an hour of receiving the first dose of vaccine, on unknown date, the patient experienced pain, headache, vomiting and dizziness. The patient went to the Emergency Room. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017465772 Same reporter/drug/event, different patients.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after use of the product, the patient experienced nausea and pain at the injection site. It was reported that the patient was okay. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation, Diagnostic procedure, Myocarditis
Clinical narrative: Initial unsolicited report received from a patient (consumer) on 18-Oct-2017. This case involves a 68-year-old male patient, who was vaccinated once with FLUZONE HIGH-DOSE via intramuscular route (batch number: UI691AA, expiry date: Apr-2017; dose not reported) in left arm on 24-Oct-2016. Patient's medical history was not reported. Concomitant medications were not reported. Patient denied receiving any other vaccinations at the time. On an unknown date, following the vaccination, the patient developed myocarditis and A-fib that required hospitalization on 06-Dec-2016. Multiple diagnostic tests were performed. As part of corrective treatment patient took ELOQUIS and SOTALOL. On an unknown date, patient recovered from the events fully and discharged from hospital on 09-Dec-2016. Documents held by sender: none. Sender's Comments: The patient experienced events myocarditis and atrial fibrillation post vaccination with FLUZONE HIGH-DOSE. Time to onset is too long with the role of the vaccine. Myocarditis which may suggest a possible underlying cardiac condition hence needed investigation results ruling out a concurrent infection, past medical history, any cardiac disorder and other etiologies would be helpful to further assess this case.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: R upper arm cellulitis.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pt. noticed redness and swelling in area of right arm where subq Pneumo was given at about 9pm. It spread from site of injection around back of the arm and it was sore. He c/o "chills" keeping him up all night, but he took his temp and it was about 98.4 - 98.7. He put a heating pad on it for comfort. He got up at 8am and had a terrible H/A, and he had "really achy joints, knees and hands. " And his hands hurt so bad "he could hardly open them." Due to a problem with our phones I did not speak to him until much later in the day though he had started calling us in the morning. By the time I spoke with him, 4:40pm, he was "much better," though the H/A "still comes" back when he stands."
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: Pt. noticed redness and swelling in area of right arm where subq Pneumo was given at about 9pm. It spread from site of injection around back of the arm and it was sore. He c/o "chills" keeping him up all night, but he took his temp and it was about 98.4 - 98.7. He put a heating pad on it for comfort. He got up at 8am and had a terrible H/A, and he had "really achy joints, knees and hands. " And his hands hurt so bad "he could hardly open them." Due to a problem with our phones I did not speak to him until much later in the day though he had started calling us in the morning. By the time I spoke with him, 4:40pm, he was "much better," though the H/A "still comes" back when he stands."
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports sore arm lasting more than one month, starting at the shoulder.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Hyperhidrosis, Tunnel vision
Clinical narrative: Patient stated they felt dizzy, had tunnel vision and was drenched in sweat. He then fell and hit head. Patient was given an ice pack for head and was given an ice pop to chew. He was watched for approx. 15-20 minutes and walked out without assistance.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Faeces discoloured, Feeling abnormal, Feeling jittery, Frequent bowel movements, Hyperhidrosis
Clinical narrative: Already shown previously.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Tremor, Vomiting
Clinical narrative: Already shown previously.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Two hours after the shot was administered, I was unable to lift my left arm (the shot was given in upper left arm near the shoulder). The muscular pain continued to get worse and make my arm more unusable. By the end of the night, 9/29/17, I was unable to use the arm at all. I could not brush my hair, wash my hair, sleep on my left side, or, most importantly, hold my infant baby. The pain lasted for about two weeks and then started to subside. The pain never completely dissipated. It was always lingering, making me unable to use the arm to full capacity. The pain returned, full strength, on 10/28/17. It is much worse that it was when the shot was first administered. It is a muscular pain making me unable to lift my arm over my head, or out to the side of my body, without aid.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Tremor
Clinical narrative: Pt got shot on 10/25/2017. His wife called in the afternoon and said that pt is complaining about shivering, Headache and left hand shaking (where he got Flu shot ). But she did give him Ibuprofen just few mins ago. We recommended her to see dr. I Called back after 2 hrs to check and his wife said that he is feeling much better now so did not see a dr. Also they do not have any primary physician. But he is much better. Pt also Informed to his dr (who does treatment of his MS). I just spoke with him today again and he said that he is completely ok now.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Advised to take Ibuprofen by nurse that gave injection, took 2 ADVIL about 2 pm. Starting at 7 pm: feverish, achiness all over, right deltoid began to swell/get red/be tender. By 9 pm nausea began and the swelling to the right deltoid was approximately 4 inches in diameter from injection site. By the next morning, temperature was between 102 to 103 degrees Fahrenheit, called the Nurse Hotline and was advised to take TYLENOL. Began TYLENOL every 6 hours with Ibuprofen in the middle. Symptoms lasted for about 3 days. Today, October 30, 2017, the right deltoid is still swollen about 6 inches around the injection site with mild bruising and redness, tenderness. No streaking noted. Warmth noted in a 2 inch diameter around injection site.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Advised to take Ibuprofen by nurse that gave injection, took 2 ADVIL about 2 pm. Starting at 7 pm: feverish, achiness all over, right deltoid began to swell/get red/be tender. By 9 pm nausea began and the swelling to the right deltoid was approximately 4 inches in diameter from injection site. By the next morning, temperature was between 102 to 103 degrees Fahrenheit, called the Nurse Hotline and was advised to take TYLENOL. Began TYLENOL every 6 hours with Ibuprofen in the middle. Symptoms lasted for about 3 days. Today, October 30, 2017, the right deltoid is still swollen about 6 inches around the injection site with mild bruising and redness, tenderness. No streaking noted. Warmth noted in a 2 inch diameter around injection site.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Impaired work ability, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: 10-28-17 patient wrote: "I was wondering if there was a way I could get the vaccine name and dosage for my flu shot on September 26, 2017 at High School at 6am. I was not provided with this information, and need to present it to my general care practitioner--since that day, I have had pain in my arm between my elbow and shoulder, sometimes to the point of being debilitating. It is preventing me from performing my job as I normally would sometimes, and I am not able to perform some of my recreational activities. I have never had an issue before, so this to me is quite surprising. I would appreciate it if you could respond in a timely matter. Thank you!"
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, PNC13
Symptoms: Computerised tomogram head normal, Developmental hip dysplasia, Endotracheal intubation, Intensive care, Seizure
Clinical narrative: Congenital dislocation of hip - was seen 8/23/16 by Dr., used double diaper for 4 weeks, f/u 9/27/16 was normal, will f/u again at 12 months old. Seizure - (10/17/2017) a few hours after DTaP, PREVNAR, and Flu. Generalized complex, status, Head CT normal, intubated at ED, flown to another hospital, spent the night in the PICU, d/c 10/19.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Death, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: Friday- complained of leg cramps and the sensation of "not being able to move"; Saturday- tired, complained of pain in legs, "feet were tingly" and "calves were tight"; Monday- worked, but Dr could not see until Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday- complained of arms tingling; "legs were like noodles" and "couldn't stand"; Friday- no strength in arms or legs, had trouble breathing,  called ambulance at 1:09 pm; died at 2 pm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Intervertebral disc disorder, Mobility decreased, Muscle spasms, Muscle tightness, Muscular weakness
Clinical narrative: Friday- complained of leg cramps and the sensation of "not being able to move"; Saturday- tired, complained of pain in legs, "feet were tingly" and "calves were tight"; Monday- worked, but Dr could not see until Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday- complained of arms tingling; "legs were like noodles" and "couldn't stand"; Friday- no strength in arms or legs, had trouble breathing,  called ambulance at 1:09 pm; died at 2 pm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Paraesthesia, Syncope
Clinical narrative: Friday- complained of leg cramps and the sensation of "not being able to move"; Saturday- tired, complained of pain in legs, "feet were tingly" and "calves were tight"; Monday- worked, but Dr could not see until Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday- complained of arms tingling; "legs were like noodles" and "couldn't stand"; Friday- no strength in arms or legs, had trouble breathing,  called ambulance at 1:09 pm; died at 2 pm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tremor
Clinical narrative: Patient received FLUZONE HIGH DOSE in the AM at the office. She called on the way to the ER stating she was having symptoms of shaking and body severe pain.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Full blood count, Immunoglobulin therapy, Increased tendency to bruise, International normalised ratio, Platelet count decreased
Clinical narrative: Reported to a satellite clinic on 10/13/17 with complaint of 2 day history increased bruising. Labs were drawn that day. Critical lab value of low platelet count (3,000) was called to clinic. Patient was referred to Hospital where critical labs were confirmed. Hematology was consulted. IVIG X 1 given in hospital on 10/14/2017. Patient has followed with Hematology weekly for lab work and monitoring of platelet count.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Prothrombin time
Clinical narrative: Reported to a satellite clinic on 10/13/17 with complaint of 2 day history increased bruising. Labs were drawn that day. Critical lab value of low platelet count (3,000) was called to clinic. Patient was referred to Hospital where critical labs were confirmed. Hematology was consulted. IVIG X 1 given in hospital on 10/14/2017. Patient has followed with Hematology weekly for lab work and monitoring of platelet count.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased, Red blood cell count normal, White blood cell count normal
Clinical narrative: Reported to a satellite clinic on 10/13/17 with complaint of 2 day history increased bruising. Labs were drawn that day. Critical lab value of low platelet count (3,000) was called to clinic. Patient was referred to Hospital where critical labs were confirmed. Hematology was consulted. IVIG X 1 given in hospital on 10/14/2017. Patient has followed with Hematology weekly for lab work and monitoring of platelet count.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, Injection site urticaria, Urticaria
Clinical narrative: Approximately 10 minutes after injection was given, patient complained of burning sensation at site of injection. When examined by RN, he had localized urticaria above site of injection and on upper chest wall. Parent was notified of reaction and came and transported child to local ER. He was then seen in ER and given Benadryl by mouth and advised Ibuprofen for discomfort and discharged home.   Approximately 3 hours later, RN called to check on patient and mother stated that he was improved and rash was almost gone.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccine on 10/05/17 and experience pain on the left arm that has not resolved till date.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, Peripheral coldness, Sensory disturbance
Clinical narrative: 10/19/17 Left arm numbness, tingling with cold sensation and decreased sensation. Very mild swelling possibly. Weakness of arm. 10/24/17 Weakness, tingling and cold sensation only to part of left arm/hand now. #3-#5 digits in left hand have resolved. 10/25/17 Total resolution of symptoms.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Streptococcal infection, Streptococcus test positive, Urticaria, Vomiting
Clinical narrative: Patient developed hives soon after getting the flu shot. He had the same reaction last year but was worse this year. Dad gave him benadryl. Didn't have breathing issues. Patient was seen that night by dr. at which time he felt bad all day. He also threw up twice this afternoon. We did a strep test which was positive. Patient is being treated for strep.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient complains of Left shoulder pain since the night of vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Erythema, Induration
Clinical narrative: Patient sates an extremely large, red, hard area going down the arm to the elbow. And a lump under the left armpit. She stated the injection was given low on her deltoid. Felt it wasn't given in the heart of the muscle. Wondered if that had something to do with it.
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an over 65-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, route of administration was reported as intramuscular or subcutaneous injection, in arm, as an active immunization for the prevention of pneumococcal disease (dose, lot# and expiration date were not provided). On an unknown date, after receiving an injection of the PNEUMOVAX 23, the patient completely blew up in a rash. The patient saw his physician and was given an unspecified antibiotic to treat his arm. The outcome of rash was reported as recovered/resolved. The causal relationship between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age concerning herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In approximately 2016 (reported as "about a year ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. Since an unknown date (reported as "now"), the patient had shingles (herpes zoster). At the time of reporting, the patient did not recover from the herpes zoster. The causality between the event and ZOSTAVAX was not provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: This spontaneous report was received from a the patient's daughter, who was also a nursing student, and refers to a 66-year-old female patient. The patient's concurrent conditions included hypertension, hypolipidaemia, osteoarthritis, and heartburn. The patient reacted to metformin. The patient's medical history included gallbladder removal, anxiety, and squamous cell carcinoma on face. On 30-APR-2017, the patient was vaccinated with ZOSTAVAX, one shot once (dose, route of administration, lot # and expiration date were not reported) to prevent shingles. Concomitant therapies included oxybutynin, lisinopril (+) hydrochlorothiazide (manufacturer unknown, reported as lisinopril with HCPV), acyclovir (reported as acyclovir PRN), gabapentin, pravastatin, insulin, LEVEMIR, glimepiride, loratadine (manufacturer unknown), baby aspirin (manufacturer unknown), docusate, calcium (+) vitamin D, citalopram, omeprazole and medication reported as CYCLOVIN. On 07-MAY-2017 (reported as one week after getting ZOSTAVAX), the patient developed the first case of shingles. The patient was treated with acyclovir. When one instance of shingles resolved, it re-occurred in one of two locations: on the patient's middle finger or the lower back (unspecified dates). The patient got shingles 7 times. The patient sought medical attention by seeing a doctor. Unspecified tests were performed to help doctors verify if the patient developed shingles. The outcome of herpes zoster was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 22-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N015477, expiry date: 18-MAY-2019 (dose and route of administration were not provided). The properly stored sterile diluent (STERILE DILUENT) was used to reconstitute the vaccine. The vaccine had been stored in temperature of 11.5 Fahrenheit degrees for 15 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Erythema, Injection site discolouration, Peripheral swelling, Skin warm
Clinical narrative: Sat. morning (Left arm) arm swelled red and hot. Bowels let loose all over couldn't get to bathroom exploded. Contact clinic Nurse Practitioner, went back and showed her red hot swollen said to put ice on it and take BENADRYL. Went back Oct 9 2017 I don't own a computer. My arm is discolored yet where had shot all around top.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Laceration, Syncope, Vertigo
Clinical narrative: Fainted. 10/7/2017 10:30 PM fell and cut nose open. 10/10/2017 6:00 AM fell and cut leg open. 10/16/2017 2:15 PM vertigo, fell and cut both arms open.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dry mouth, Dyspnoea, Swollen tongue
Clinical narrative: Received vaccine and within 5 mins complained of chest pain, tightness, SOB, throat tightness, tongue swelling and dry mouth. Gave .5ml epinephrine in (L) arm and called squad who transported her to ER.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Received vaccine and within 5 mins complained of chest pain, tightness, SOB, throat tightness, tongue swelling and dry mouth. Gave .5ml epinephrine in (L) arm and called squad who transported her to ER.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Myalgia
Clinical narrative: Had terrible headache in back of head and neck. Also extreme muscle aches. Lasted for 48 hrs.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patients Right arm was swollen and red and warm to touch. She reported this 10/28/17 and received vaccine 10/23/2017. She picked up KEFLEX 500mg 2BIDx10d for treatment and from another physician. Diagnosed with cellulitis.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: Severe dizziness. Looked online and did positional treatment for vertigo. Never had vertigo before! Husband affected even worse!
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Client had complaint of whelps after leaving clinic, itching, and rash covering body. Continues to have flares of whelps and itching rash.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis, Nasal ulcer, Tongue ulceration
Clinical narrative: Three days after receiving flu shot? sores stated to develop in one area and resolve then appear in another area. First on tongue - resolved and then inner lip - resolved, inside of left nostril, outside up; all have resolved with med. x 2 1/2 wks.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: After receiving Flu shot pt. broke out in hives inside (L) arm down to (L) wrist with some itching on back. Pt. took BENADRYL and symptoms resolved after 2 hours.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Couple hours after vaccine - itching at site; Later arm (around site) was red, swollen diameter, itching. (Upper arm swelling) and hot. 10/24 - Patient doing ok, taking BENADRYL PRN for itching.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Guillain-Barre syndrome, Pneumonia, Respiratory failure
Clinical narrative: Admitted to hospital on 10/14/17-Acute hypoxic respiratory failure secondary to pneumonia/COPD. Bil sacroilitis, H/O prostate CA discharge summary 10/26/17 list Guillain-Barre Syndrome as one of the discharge diagnosis.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Sacroiliitis
Clinical narrative: Admitted to hospital on 10/14/17-Acute hypoxic respiratory failure secondary to pneumonia/COPD. Bil sacroilitis, H/O prostate CA discharge summary 10/26/17 list Guillain-Barre Syndrome as one of the discharge diagnosis.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Presyncope, Vision blurred
Clinical narrative: The patient experienced sweating, dizziness, nausea and blurred vision upon injection of the BOOSTRIX vaccine. She nearly fainted at one point. We had her lie down and applied cold compresses to her forehead and the back of her neck. 911 was called and when they arrived they checked her out and offered to transport her to the hospital for treatment. She refused, saying that she was feeling much better.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: PATIENT SAID RED AND SORE, REDNESS LARGER THAN EXPECTED, SWELLING.
Age: 56.0
Sex: F
Vaccine: FLUR4, HEP, PPV
Symptoms: Chest X-ray normal, Chills, Fatigue, Flushing, Injection site pain
Clinical narrative: Sunday, October 1, about 5:00 pm, started chills, fatigued by 7:00 pm, retired to bed 8:30pm. Monday, October 2, morning and throughout the day experienced swollen and painful axillary lymph nodes, left greater than right, and swollen and painful biceps, left greater than right. Bilateral tinnitus noticed. No fever noticed or recorded, but experienced chills. In the evening, right side of face (cheek) flushed, but not left side. Fatigued enough retire at 6:30 pm. The chills remained for an hour after retiring and prevented sleep. Tuesday, October 3, still experiencing tender and swelling in axilla and pain in biceps, still left side greater than right. Appointment with Dr. Recorded blood pressure and temperature. Palpated axilla, Ordered chest x-ray, results were normal. Noted ongoing bilateral tinnitus. Still fatigued and retired at 8:30 pm. Wednesday, October 4, Still some swelling in axilla and tenderness in biceps. Not so fatigued. Thursday, October 5, well enough to go to work. Today, October 30, bilateral tinnitus remains.
Age: 56.0
Sex: F
Vaccine: FLUR4, HEP, PPV
Symptoms: Injection site swelling, Insomnia, Lymph node pain, Lymphadenopathy, Tenderness
Clinical narrative: Sunday, October 1, about 5:00 pm, started chills, fatigued by 7:00 pm, retired to bed 8:30pm. Monday, October 2, morning and throughout the day experienced swollen and painful axillary lymph nodes, left greater than right, and swollen and painful biceps, left greater than right. Bilateral tinnitus noticed. No fever noticed or recorded, but experienced chills. In the evening, right side of face (cheek) flushed, but not left side. Fatigued enough retire at 6:30 pm. The chills remained for an hour after retiring and prevented sleep. Tuesday, October 3, still experiencing tender and swelling in axilla and pain in biceps, still left side greater than right. Appointment with Dr. Recorded blood pressure and temperature. Palpated axilla, Ordered chest x-ray, results were normal. Noted ongoing bilateral tinnitus. Still fatigued and retired at 8:30 pm. Wednesday, October 4, Still some swelling in axilla and tenderness in biceps. Not so fatigued. Thursday, October 5, well enough to go to work. Today, October 30, bilateral tinnitus remains.
Age: 56.0
Sex: F
Vaccine: FLUR4, HEP, PPV
Symptoms: Tinnitus
Clinical narrative: Sunday, October 1, about 5:00 pm, started chills, fatigued by 7:00 pm, retired to bed 8:30pm. Monday, October 2, morning and throughout the day experienced swollen and painful axillary lymph nodes, left greater than right, and swollen and painful biceps, left greater than right. Bilateral tinnitus noticed. No fever noticed or recorded, but experienced chills. In the evening, right side of face (cheek) flushed, but not left side. Fatigued enough retire at 6:30 pm. The chills remained for an hour after retiring and prevented sleep. Tuesday, October 3, still experiencing tender and swelling in axilla and pain in biceps, still left side greater than right. Appointment with Dr. Recorded blood pressure and temperature. Palpated axilla, Ordered chest x-ray, results were normal. Noted ongoing bilateral tinnitus. Still fatigued and retired at 8:30 pm. Wednesday, October 4, Still some swelling in axilla and tenderness in biceps. Not so fatigued. Thursday, October 5, well enough to go to work. Today, October 30, bilateral tinnitus remains.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Mass, Ultrasound scan abnormal
Clinical narrative: Patient was given vaccine 9-22-17. Mother reports patient started having pain in left deltoid on 10-25-17 and went to urgent care on 10-26-17.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Malaise
Clinical narrative: Patient reported a severe headache along with chills and general malaise. She received the vaccine at about 10 AM and by 1 PM she was in bed with acute flu-like symptoms. Symptoms resolved by the next morning. Patient also reported significant pain at the injection site that radiated up from her left deltoid to her neck. Patient stated that the worst symptom was the severe headache. Patient took acetaminophen to mitigate the symptoms, but did not seek medical care. She reports today (10/30/2017) that she feels absolutely normal with no symptoms of the adverse event lingering.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Patient reported a severe headache along with chills and general malaise. She received the vaccine at about 10 AM and by 1 PM she was in bed with acute flu-like symptoms. Symptoms resolved by the next morning. Patient also reported significant pain at the injection site that radiated up from her left deltoid to her neck. Patient stated that the worst symptom was the severe headache. Patient took acetaminophen to mitigate the symptoms, but did not seek medical care. She reports today (10/30/2017) that she feels absolutely normal with no symptoms of the adverse event lingering.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, arm redness, warm to touch, arm hardness,
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Cellulitis, Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: Began experiencing swelling, redness, and fever starting early afternoon on 10/25/17. Called local doctor's office on 10/26/17 at end of day, and because they did not have any appointments, she went to the ER. Symptoms include temp of 102.5, achy, extreme swelling, redness and itching at injection site. Patient was given IV fluids, IV antibiotic, and sent home on oral antibiotic of KEFLEX. Diagnosis was cellulitis.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia, Swelling
Clinical narrative: Began experiencing swelling, redness, and fever starting early afternoon on 10/25/17. Called local doctor's office on 10/26/17 at end of day, and because they did not have any appointments, she went to the ER. Symptoms include temp of 102.5, achy, extreme swelling, redness and itching at injection site. Patient was given IV fluids, IV antibiotic, and sent home on oral antibiotic of KEFLEX. Diagnosis was cellulitis.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Myalgia, Myosclerosis, Pain in extremity, Skin warm
Clinical narrative: Patient reported the evevning after the flu shot, her deltoid muscle was hard, warm and shore. She also developed a rash before the site of injection, about 2 inches in diameter. Today (6 days after injection) she came by to report these symptoms. Symptoms are getting better but she still experiences some soreness on her arm.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Lip swelling, Pharyngeal oedema
Clinical narrative: Patient presented to the ER on the evening of Oct 27th after having her flu shot that morning with difficulty breathing, and swelling of the lips and throat.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot, sore. After 4 days it has improved but has not gone away fully yet.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site inflammation, Injection site pain, Malaise
Clinical narrative: Patient's husband states malaise, inflamed injection site area, soreness/pain, flu-like symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient stated that she developed achy joints following the vaccination. She talked to her doctor about it and received a prescription for prednisone that we filled today.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Discomfort, Dyspepsia, Injection site pain
Clinical narrative: Three hours after the injection, I had swelling, burning, and heat at injection site. Minutes after this, the pain spread to my upper chest and lungs and I developed severe heart burn. An hour later, I vomited and started getting aches and pains in all the joints in my body. My discomfort was such that I had to go to bed.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Pulmonary pain, Vomiting
Clinical narrative: Three hours after the injection, I had swelling, burning, and heat at injection site. Minutes after this, the pain spread to my upper chest and lungs and I developed severe heart burn. An hour later, I vomited and started getting aches and pains in all the joints in my body. My discomfort was such that I had to go to bed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Induration, Pain, Peripheral swelling
Clinical narrative: Adverse events: blister, whole upper arm swollen and hard, red, hot to touch. Low grade fever aches (lower back and hips). Treatment: triamcinolone cream and prednisone and AUGMENTIN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Adverse events: blister, whole upper arm swollen and hard, red, hot to touch. Low grade fever aches (lower back and hips). Treatment: triamcinolone cream and prednisone and AUGMENTIN.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient requested a PCV 13 dose. The clerk and nurse both completed the enrollment and administration before history showed that patient had received 1st dose on 10-28-2015.
Age: 26.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: This is a 26 year old male who states that he received the flu vaccination in the L upper arm and the PNEUMOVAX in the R upper arm. All was fine until approx 36 to 48 hrs after injections, the R arm where he received the PNEUMOVAX started aching, then within 12 more hrs the entire R arm was hurting. There was some itching at the site, he has noticed a red spot where the shot was given on the R arm. In the last 24 hrs he has noticed slight swelling of the R hand and it hurts the forearm with gripping. He denies any fevers, chills, wheezing, tongue swelling, hives or other rashes, CP, previous blood clot issues, red streaks on R arm. He has never had reaction to a vaccine prior. He relates the L arm flu vaccine site is not bothering him at all. Skin and Subcutaneous Tissue General Inspection: R arm upper lateral aspect (deltoid region) is a 5cm x11cm region of slight pink the R arm is tender in diffuse nature circumferentially from the above mentioned superficial pink discolored spot upper arm down to mid forearm, no edema of hand, the R forearm is 1 cm larger diam than L forearm, the biceps region is same size L and R, no cords, grip is 5/5 bilaterally symmetric, light touch is intact and symmetric in hand/forearm/ upper arms. Radial pulses intact bilateral, good symmetric temp to palpation of both hands and upper arms, no crepitus of skin, no red streaks, no palpable abscess noted, FROM shoulder, elbow, wrist and fingers.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Detoxification, Infection, Rash, Skin warm
Clinical narrative: My son was given the flu shot (unknown which type, the office isn't answering). The day after receiving the shot in his thigh 3/4 of his leg developed rash like symptoms and was extremely hot to the touch. We drew a perimeter around the area and let him sleep it off. He seems to feel normal and well but the next day the area of infection slightly grew past the perimeter marked and was still hot to the touch. He still seems well but we are monitoring the area. We have him a detoxifying bath today and essential oils topically. Lots of water. We wanted to report this in case it gets worse and in case he develops a sickness as a result. Health care provider recommended cold compress and TYLENOL.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given Adult dose of Hepatitis A, instead of the Pediatric dose that was ordered. The patient did not have any symptoms or signs. Mom was made aware of the mistake on 10/26/17 after going to the Health Department for some other immunizations that the patient needed.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, VARCEL
Symptoms: Henoch-Schonlein purpura, Urine analysis normal
Clinical narrative: Patient developed HSP later that evening after the vaccines were given.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site pruritus, Nausea
Clinical narrative: Severe chills, fever, nausea on evening of and day after vaccinations. Two days after vaccinations and continuing for 36 hours, left arm from shoulder to elbow was extremely inflamed, red and itchy.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Severe chills, fever, nausea on evening of and day after vaccinations. Two days after vaccinations and continuing for 36 hours, left arm from shoulder to elbow was extremely inflamed, red and itchy.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain onset about 2 hours after the injection from shoulder to elbow. Ongoing shoulder pain. Orthopedist treated with prednisone, celecoxib. Internist just increased gabapentin dose. Physical therapy. Continues to have shoulder pain interfering with pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: This spontaneous report was received from nurse via a sales representative referring to a 11 year old female patient. The patient's medical history and drug reactions and allergies were not provided. On 16-OCT-2017, the patient was vaccinated with the second dose of GARDASIL 9 for Human Papilloma Virus (HPV) prevention (route, lot# and expiry date were unknown). On the same date, after the second dose vaccination, the patient immediately "fainted and hit her head". The patient did not seek medical attention. The outcome of syncope and head injury was reported as recovering. The causality assessment between GARDASIL 9 and the aforementioned events was unknown.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 53 year old female patient with gastrooesophageal reflux disease. Her medical history included nephrolithiasis. Her concomitant therapies included FLEXERIL, PROZAC, PRILOSEC and IMITREX. On 20-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N022703 expiry date on 27-FEB-2019, intramuscularly,  for prophylaxis and FLUZONE (dose, route, indication were not provided) at the same deltoid area of the same arm. Thereafter on 21-OCT-2017, the patient developed "cellulitis like symptoms" from the area below the injection site down to the elbow. The reporting nurse mentioned that the patient received unspecified treatment for the adverse event and no laboratory test was perform. At the time of the report, the outcome of cellulitis was unknown. The causal relationship between the above mentioned event and suspect therapies was not provided. Upon internal review, the event cellulitis was considered to be medically significant.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Insomnia, Pain in extremity, Skin warm
Clinical narrative: During the evening on the same day as immunization administered she began having left arm pain, states she had difficulty sleeping both Thursday and Friday evening and difficulty raising arm more than level with chest. Arm red, she marked area with black marker on Sunday, and the redness has traveled down arm outside of marking. Area red, hot to touch.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm pain, limited shoulder range of motion.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site pruritus, Skin discolouration
Clinical narrative: Daughter brought in a picture of a red area with a white spot in the center. Site was itchy and red. Told daughter to take her mother to a clinic and have it looked at. Area looked irritated from possible scratching.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised, Rash morbilliform
Clinical narrative: Patient has complained of itchiness all over her body starting within 24 hours of the vaccine. With in 3 days, a large majority of her body was covered in a rash that started on her trunk and spread to her extremities. Symptoms persisted for 2 weeks. Dr. prescribed clotrimazole/betamethasone cream. The topical eliminated the symptoms in 7 days. Patieint described the rash resembled measles.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Blood gases, Death, Resuscitation, Sudden infant death syndrome
Clinical narrative: Found apneic and unresponsive. CPR was run x 2h but patient never revived. Cause of death was determined to be SIDS. No other SIDS risk factors were present. Baby was asleep on back in proper bed without blankets or pillows.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Found apneic and unresponsive. CPR was run x 2h but patient never revived. Cause of death was determined to be SIDS. No other SIDS risk factors were present. Baby was asleep on back in proper bed without blankets or pillows.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient was experiencing a lot of muscle pain and difficulty in raising her arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever starting few hours after vaccine, then fever with seizures the day after. Child was in preschool at the time of seizure, parents did not witness.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Malaise
Clinical narrative: Dizziness, malaise....he planned to go home and rest.  He will let us know if he has anymore problem.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient noticed a red, swollen area on the same area as the 2 vaccines were administered. However, it did not occur until the day after the vaccination. It also was not in the same spot as the injection site. It was further down her arm, towards the elbow. She did not come to me until Monday afternoon. She said the site was not any larger than last night. I advised her, after talking to my clinical coordinator, so check with her doctor just to see if he would like to check it out also. She indicated she would do that tomorrow, if it was not better.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported redness, swelling and burning sensation on site of injection, swelling described as "bigger than golf ball" and painful. No itching or shortness of breath. Patient took benadryl but did not help. Per patient, she can take tylenol or motrin with no problem, not pregnant or diabetic, to help with pain and swelling. Also advised patient to see a doctor, if needed.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, ache, chills.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema, edema, warmth of left deltoid at injection site - spreading - consistent with cellulitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Nausea, Night sweats, Vomiting
Clinical narrative: Night sweats, Nausea, vomiting, muscle aches and joint pain. Adverse reaction subsided after 3rd day.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Hyperhidrosis, Pallor
Clinical narrative: Per patient approximately 2-3 minutes after injection, patient became pale, diaphoretic, stomach pain. This RN in to exam room at 5 minutes post injection. Patient then states she is having trouble breathing, feels short of breath, coughing/clearing her throat. Benadryl 50 mg given IM, Epinepherine 0.3mg given IM. Patient's condition improved, released home at approximately 1 hour post vaccination and reaction.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Per patient approximately 2-3 minutes after injection, patient became pale, diaphoretic, stomach pain. This RN in to exam room at 5 minutes post injection. Patient then states she is having trouble breathing, feels short of breath, coughing/clearing her throat. Benadryl 50 mg given IM, Epinepherine 0.3mg given IM. Patient's condition improved, released home at approximately 1 hour post vaccination and reaction.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Injection site pain, Nausea, Pallor
Clinical narrative: Approximately 5 minutes after receiving a Hepatitis A vaccine this patient c/o to her mother of immediate pain at the injection site, nausea and weakness- nurse was alerted and observed the patient's color becoming pale, she was then assisted to the ground. No loss of consciousness- VS monitored and stable throughout, gave juice and felt better, observed by nursing for approximately 15 minutes- patient was discharged in stable condition-repeat vital signs stable- left ambulatory and fully oriented with her mother and sister accompanied by nursing staff.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying for >/=3 hours.