chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Cold sweat, Drug interaction, Dyspnoea, Tremor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT for prophylaxis and PNEUMOVAX 23 for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX, FLUARIX QUADRIVALENT and PNEUMOVAX 23. In September 2018, less than a day after receiving SHINGRIX and FLUARIX QUADRIVALENT, the patient experienced shortness of breath, cold sweat, tremor and drug interaction. On an unknown date, the outcome of the shortness of breath, cold sweat, tremor and drug interaction were unknown. The reporter considered the shortness of breath, cold sweat, tremor and drug interaction to be related to SHINGRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: In September 2018, the patient received administered influenza vaccine (brand or manufacturer unknown, dose unknown) and PNEUMOVAX-23 at the same time as SHINGRIX (co-administered during same office visit). In the same evening after receiving the SHINGRIX, influenza vaccine, and PNEUMOVAX-23, the patient went to the emergency room with symptoms of shortness of breath, cold sweats, and shaking really bad. The emergency room health care professional was caring for her told her that the reactions were due to her receiving all 3 vaccines at the same time. On the date of reporting, the outcomes of the reactions are unknown. The reporter considered the shortness of breath, cold sweat, tremor and drug interaction to be related to PNEUMOVAX 23.
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dry mouth in a adult female patient who received FLUARIX QUADRIVALENT (batch number 4ZY53, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced dry mouth. The patient was treated with BENADRYL. On an unknown date, the outcome of the dry mouth was recovered/resolved. It was unknown if the reporter considered the dry mouth to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The patient experienced dry or cotton mouth that was resolved after a dose of BENADRYL. The reporter also said that the employee health nurse at her facility felt that they were having more reactions to the vaccine than normal. The reporter did not have patient's date of birth. No further details available about the statement more reactions to the vaccine than normal. This case was linked with the case US2018GSK175707, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Neutrophil count increased, White blood cell count normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neutrophils increased in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included osteoarthritis. Concomitant products included CELEBREX. In May 2018, the patient received SHINGRIX (intramuscular). On 14th September 2018, less than 5 months after receiving SHINGRIX, the patient experienced neutrophils increased. On an unknown date, the patient experienced discomfort and injection site pain. On an unknown date, the outcome of the neutrophils increased, discomfort and injection site pain were unknown. It was unknown if the reporter considered the neutrophils increased, discomfort and injection site pain to be related to SHINGRIX. Additional details were provided as follows: In March 2018, the patient had normal white blood cell count. In early May 2018, he received SHINGRIX in right deltoid. On 14th September 2018, bloodwork was done and it showed elevated neutrophils. He did not have any acute illness. Other bloodwork was all normal. The only change he could thought of was he discontinued CELEBREX a month before the date of reporting. The patient also reported intermittent pain in arm where he received the injection.
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site nodule, Peripheral swelling
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of swelling arm in a infant male patient who received INFANRIX for prophylaxis. Co-suspect products included PEDIARIX for prophylaxis. On an unknown date, the patient received the 2nd dose of INFANRIX (intramuscular) and the 2nd dose of PEDIARIX (intramuscular). On an unknown date, less than 6 months after receiving INFANRIX and PEDIARIX, the patient experienced swelling arm and injection site mass. On an unknown date, the outcome of the swelling arm and injection site mass were unknown. It was unknown if the reporter considered the swelling arm and injection site mass to be related to INFANRIX and PEDIARIX. Additional details were provided as follows: The reporter was patient's mother. The patient age was reported as in the range of 4 to 6 months. It was not reported if the patient received any other vaccine or medication. The reporter reported that the patient received a DTaP vaccine but it was not a Sanofi Pasteur product. The reporter was not sure if the DTaP vaccine given to the patient was INFANRIX or PEDIARIX. The patient received DTaP vaccine on an unknown arm. After receiving DTaP vaccine, the patient's arm was swollen and had a knot at the site of injection. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vaccination site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced a local reaction with redness and swelling. This case has been linked with case US2018GSK169678, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of upset stomach in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown. It was unknown if the reporter considered the upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case has been linked with case US2018GSK169677, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever. The patient was treated with Aspirin. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient recently had the first dose of SHINGRIX. That evening, the patient ran a slight fever of 100.5 degree F. After taking 3 doses of aspirin over the next 12 hours, fever was gone. The patient was asking that this was just a known side effect, not an allergy and should proceed to have the second dose of SHINGRIX when it was due. Lab Comments: On an unknown date, the patient's body temperature was recorded as 100.5 degree F.
Sex: M
Vaccine: VARZOS
Symptoms: Allodynia, Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of allodynia (at least 5 years ago) and VALTREX (treatment for allodynia). On 19th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue. On an unknown date, the outcome of the chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue were recovered/resolved. It was unknown if the reporter considered the chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient previously received ZOSTAVAX at least 5 years ago. About 3 years after receiving ZOSTAVAX, he developed allodynia on the left side of his head that radiated to his ear. He felt it was zoster and was treated with VALTREX. The patient reports that after receiving SHINGRIX, he developed the same allodynia in the same location, with neuralgia lasting 1 day. It was relieved with rubbing the area (neuralgia pain would fatigue). In 2018, less than a month after receiving SHINGRIX vaccine the patient experienced chills, myalgia, and arthralgia which resolved in 36 hours. In 2018, less than a 5 month after receiving SHINGRIX vaccine the patient experienced allodynia, neuralgia and fatigue. Approximately 3 weeks after the injection, he developed synovitis in his MCP joint on his right hand, which has persisted for 4 months. The patient had never experienced that pain or inflammation previously. The patient saw rheumatologist. The patient was a physician and was somewhat hesitant to receive the 2nd dose for fear of additional joint issues.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Synovitis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of allodynia (at least 5 years ago) and VALTREX (treatment for allodynia). On 19th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue. On an unknown date, the outcome of the chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue were recovered/resolved. It was unknown if the reporter considered the chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient previously received ZOSTAVAX at least 5 years ago. About 3 years after receiving ZOSTAVAX, he developed allodynia on the left side of his head that radiated to his ear. He felt it was zoster and was treated with VALTREX. The patient reports that after receiving SHINGRIX, he developed the same allodynia in the same location, with neuralgia lasting 1 day. It was relieved with rubbing the area (neuralgia pain would fatigue). In 2018, less than a month after receiving SHINGRIX vaccine the patient experienced chills, myalgia, and arthralgia which resolved in 36 hours. In 2018, less than a 5 month after receiving SHINGRIX vaccine the patient experienced allodynia, neuralgia and fatigue. Approximately 3 weeks after the injection, he developed synovitis in his MCP joint on his right hand, which has persisted for 4 months. The patient had never experienced that pain or inflammation previously. The patient saw rheumatologist. The patient was a physician and was somewhat hesitant to receive the 2nd dose for fear of additional joint issues.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Feeling jittery, Palpitations, Throat irritation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of jitteriness in a 27-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. Concurrent medical conditions included food allergy (allergy to sunflower oil/product).  On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, 1 hr after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced jitteriness, heart pounding, feeling anxious and throat irritation. On an unknown date, the outcome of the jitteriness, heart pounding, feeling anxious and throat irritation were recovered/resolved. It was unknown if the reporter considered the jitteriness, heart pounding, feeling anxious and throat irritation to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The cae was reported by the nurse who was the patient. The patient received the vaccine in 2018. The patient was experiencing feelings of anxiousness, heart pounding, jitteriness and scratchy throat after 1 to 2 hours of vaccination. The patient took Benadryl shortly after noticing symptoms and reported relief within about 10 to 15 minutes. At the reporting time, all symptoms were resolved and no further details were reported regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: In June or July 2018, the patient received 1st dose of SHINGRIX injection in left arm. In 2018, the patient's arm hurt when the vaccine was injected. Later that evening, the patient's arm became very sore and lasted for a couple of days. The patient did not had a primary physician. She goes to a clinic only when she needs to and she said she was in good health. For tolerance to 2nd dose refer linked case US2018169203, reported for the same patient.
Sex: U
Vaccine: FLU4
Symptoms: Dry mouth, Dysphagia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dry mouth in a patient who received FLUARIX QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dry mouth and swallowing difficult. On an unknown date, the outcome of the dry mouth and swallowing difficult were unknown. It was unknown if the reporter considered the dry mouth and swallowing difficult to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The reporter also said that the employee health nurse at her facility felt that they were having more reactions to the vaccine than normal. The reported said that he reported one reaction that was felt to be serious and requiring a visit to the emergency room. The patient experienced dry and cotton mouth and difficulty swallowing. No further details available about the statement more reactions to the vaccine than normal. This case was linked with the case US2018GSK169505, reported by the same reporter.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: While giving the AFLURIA vaccine to member is was discovered that the vaccine was partially frozen due to improper storage.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: Montelukast 4 mg chewable tablet 1 tablet every day at bedtime for 30 days, cetirizine 5 mg/5 mL oral solution 5 mL every day at bedtime.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Hypokinesia, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Patient phoned on 9/20/18 at 4:07 PM stating she developed soreness, tightness and tingling in legs last night approximately 11 hours after receiving the flu vaccine. States at one point she had difficulty moving right foot and ankle. Also had back pain that interfered with sleep. She took ADVIL which helped but then symptoms returned. Legs felt stiff and tight with tingling radiating up legs, with stiffness and tingling also in arms on 9/20/18 at time of call with low back pain. Describes "very strange deep muscle pain like nothing ever felt before." Per doctor, advised to rest, push fluids, avoid excessive heat and activity, go to E/R if symptoms worsen. Called patient the following day (9/21/18) to obtain update and she states symptoms were the same with flares of tingling and cramping pain in low back, arms and legs; constant tingling and cramping in right ankle and foot, and right hand and finger tips. Called patient on 9/25/18 and patient states she continues to feel uncomfortable, continues to have stiffness and tingling in legs, hands and feet. Back pain has subsided. Sleeping well. Taking ADVIL as needed. Doctor prescribed prednisone to take if symptoms become significant.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Patient phoned on 9/20/18 at 4:07 PM stating she developed soreness, tightness and tingling in legs last night approximately 11 hours after receiving the flu vaccine. States at one point she had difficulty moving right foot and ankle. Also had back pain that interfered with sleep. She took ADVIL which helped but then symptoms returned. Legs felt stiff and tight with tingling radiating up legs, with stiffness and tingling also in arms on 9/20/18 at time of call with low back pain. Describes "very strange deep muscle pain like nothing ever felt before." Per doctor, advised to rest, push fluids, avoid excessive heat and activity, go to E/R if symptoms worsen. Called patient the following day (9/21/18) to obtain update and she states symptoms were the same with flares of tingling and cramping pain in low back, arms and legs; constant tingling and cramping in right ankle and foot, and right hand and finger tips. Called patient on 9/25/18 and patient states she continues to feel uncomfortable, continues to have stiffness and tingling in legs, hands and feet. Back pain has subsided. Sleeping well. Taking ADVIL as needed. Doctor prescribed prednisone to take if symptoms become significant.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: PATIENT NOTICED A RASH ON THE UPPER LEFT SIDE HER FORHEAD WITHIN 3 DAYS OF RECEIVING THE SHINGRIX VACCINE. SHE HAD A CASE OF SHINGLES 17 MONTHS PRIOR AND THE RASH APPEARED IN THE SAME AREA. SHE WAS NOT EXPERIENCING ANY KIND OF RASH/PAIN/NEURALGIA UPON ADMINISTRATION OF THE VACCINE. SHE CONTACTED HER DOCTOR UPON NOTICING THE RASH AND THE DR ADVISED THAT SHE DID NOT GET THE SECOND DOSE OF THE VACCINE UNTIL THE RASH HAD SUBSIDED FOR AT LEAST ONE MONTH. SHE STILL HAS THE RASH TO THIS DATE (9/27/18). PHARMD ADVISED ANTIVIRALS.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT SAYS SHE HAD SWELLING, REDNESS, AND ITCHING AT THE INJECTION SITE LATER IN THE DAY AFTER RECEIVING THE PNEUMONIA VACCINE. SHE SAYS THE SWELLING WENT AWAY THE NEXT MORNING, BUT IT MOVED DOWN HER ARM TO CLOSE TO HER ELBOW.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Pt had dark pink/red rash from shoulder down to elbow on left side.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: PT STATES THAT FIRST COURSE WAS OK. THE SECOND HURT, HAD A BIG ROUND RED SPOT THAT WAS SENSITIVE, THEN SHARP AGGRAVATING PAIN THAT RADIATES TO THE NECK. VERY DIFFICULT TO RAISE HER LEFT ARM ABOVE HER HEAD.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Fatigue, Injection site pain, Injection site warmth
Clinical narrative: 7/25/18 PM: Burning feeling during shot. NP said it was probably the alcohol she cleaned my arm with. It was internal burning, not the alcohol. By bedtime I was running a fever, arm was tender.  7/26/18: Redness and swelling began, injection site warm to touch, fever increased, felt fatigued.  7/27/18 AM: Called my primary physician left message for nurse. PM Nurse returned my call, advised to go to minor care, make sure it's not cellulitis. I went to Immediate Care, and was given prescription for BACTRIM Sulphur antibiotic for 7 days. Began feeling better after 3 to 4 days, was doing paperwork, reached into my trash can and felt a pop and burn in my shoulder few inches above injection site. Subsequently felt like a catch in my shoulder, tried exercises and chiropractic care over approx. 5 weeks with ibuprofen. Mobility continued to decrease. Went to my family doctor on 9/14, took x-rays and checked range of motion, possible rotator cuff tear due to infection from vaccine weakening the muscle. Have appt with orthopedist for Oct 3rd, 2018.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pyrexia, Swelling, Tenderness, X-ray limb
Clinical narrative: 7/25/18 PM: Burning feeling during shot. NP said it was probably the alcohol she cleaned my arm with. It was internal burning, not the alcohol. By bedtime I was running a fever, arm was tender.  7/26/18: Redness and swelling began, injection site warm to touch, fever increased, felt fatigued.  7/27/18 AM: Called my primary physician left message for nurse. PM Nurse returned my call, advised to go to minor care, make sure it's not cellulitis. I went to Immediate Care, and was given prescription for BACTRIM Sulphur antibiotic for 7 days. Began feeling better after 3 to 4 days, was doing paperwork, reached into my trash can and felt a pop and burn in my shoulder few inches above injection site. Subsequently felt like a catch in my shoulder, tried exercises and chiropractic care over approx. 5 weeks with ibuprofen. Mobility continued to decrease. Went to my family doctor on 9/14, took x-rays and checked range of motion, possible rotator cuff tear due to infection from vaccine weakening the muscle. Have appt with orthopedist for Oct 3rd, 2018.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site nodule, Palpitations
Clinical narrative: BIG KNOT AT INJECTION SITE, REDNESS ON UPPER ARM, AND HEART PALPITATIONS.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth, Nausea
Clinical narrative: Daughter called pharmacy to indicate patient experienced an approximate 4 x 4" slightly raised "bubble" on inside of left arm in the approximate location of the vaccines. Area was red, warm, and with associated pain. Redness has improved throughout the morning and is now more pinkish. Reported pain is approximately the same as first experienced. Potentially some transient associated nausea but appears to have subsided. No fever reported, no other symptoms reported. Patient was concerned with the swelling on the inside of the arm. Patient was advised to avoid ice and to ensure movement of the arm to allow the vaccine to dissipate out of the muscle. Ibuprofen or TYLENOL was recommend for the pain. Patient was advised to call the pharmacy if symptoms change or worsen. Informed patient all symptoms appear to be reported, most common reactions per major compendia. Daughter requested that I report anyway.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Daughter called pharmacy to indicate patient experienced an approximate 4 x 4" slightly raised "bubble" on inside of left arm in the approximate location of the vaccines. Area was red, warm, and with associated pain. Redness has improved throughout the morning and is now more pinkish. Reported pain is approximately the same as first experienced. Potentially some transient associated nausea but appears to have subsided. No fever reported, no other symptoms reported. Patient was concerned with the swelling on the inside of the arm. Patient was advised to avoid ice and to ensure movement of the arm to allow the vaccine to dissipate out of the muscle. Ibuprofen or TYLENOL was recommend for the pain. Patient was advised to call the pharmacy if symptoms change or worsen. Informed patient all symptoms appear to be reported, most common reactions per major compendia. Daughter requested that I report anyway.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dry skin, Erythema, Pruritus generalised, Rash generalised
Clinical narrative: Rash, redness, itching, burning, dry skin all over the body.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Local reaction, Pruritus, Swelling
Clinical narrative: Patient received the FLUZONE High Dose and had a severe local reaction on her right arm, including redness, swelling, localized warmth and itching. She had received the FLUZONE High Dose vaccine many times in the past and had no reaction.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Culture urine, Dizziness, Drug screen
Clinical narrative: Fatigued, headache, dizziness on 9/21/18 - 9/24/18. Altered mental status, incoherent, syncope, slurred speech - 9/24/18. Then admitted to medical center.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dysarthria, Electrocardiogram, Fatigue, Full blood count, Headache
Clinical narrative: Fatigued, headache, dizziness on 9/21/18 - 9/24/18. Altered mental status, incoherent, syncope, slurred speech - 9/24/18. Then admitted to medical center.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Incoherent, Mental status changes, Nuclear magnetic resonance imaging brain, Syncope, Urine analysis
Clinical narrative: Fatigued, headache, dizziness on 9/21/18 - 9/24/18. Altered mental status, incoherent, syncope, slurred speech - 9/24/18. Then admitted to medical center.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nausea, Pain, Testicular swelling
Clinical narrative: BOOSTRIX side effect: Very swollen testicles and groin lymph nodes, accompanied by severe pain and nausea in my 12yr old.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin normal, Culture negative, Secondary transmission, Skin lesion, Staphylococcal skin infection
Clinical narrative: My spouse first saw strange lesions on his face. A couple weeks later I also saw these on my face. I went to a dermatologist for biopsy which was negative except for a staph infection from scraping the lesions. I took KEFLEX which cured the staph but the lesions increased. The dermatologist had never seen anything like this. I saw family doctor and he cultured a lesion and it was negative. We both are using Tretinoin with no improvement. We think this is Molluscum Contagiosum contracted from my spouse's Shingles vaccine. He was very sick from the 2 shots and this skin issue began about two weeks after the first shot.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Staphylococcus test positive
Clinical narrative: My spouse first saw strange lesions on his face. A couple weeks later I also saw these on my face. I went to a dermatologist for biopsy which was negative except for a staph infection from scraping the lesions. I took KEFLEX which cured the staph but the lesions increased. The dermatologist had never seen anything like this. I saw family doctor and he cultured a lesion and it was negative. We both are using Tretinoin with no improvement. We think this is Molluscum Contagiosum contracted from my spouse's Shingles vaccine. He was very sick from the 2 shots and this skin issue began about two weeks after the first shot.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Fever, extremely tired, chills, body aches, dizzy, light-headed, intermittent ringing in ears. Headache for 48 hours.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Fever, extremely tired, chills, body aches, dizzy, light-headed, intermittent ringing in ears. Headache for 48 hours.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site, redness, pain, warm to touch, fever of 100, itching x 3 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Swelling at site, redness, pain, warm to touch, fever of 100, itching x 3 days.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Rash, Skin warm
Clinical narrative: Patient developed a warm rash on the back of her vaccinated arm 2 days after vaccination.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Rash
Clinical narrative: Patient developed a warm rash on the back of her vaccinated arm 2 days after vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: The patient developed a rash on the upper part of her left arm 6 days after the injection. The area was large, red, and warm to the touch. The patient went to the doctor for them to determine if it was an allergic reaction and if the patient should receive the 2nd dose in the future. Patient did not complain of a fever or shortness of breath.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: Patient was vaccinated at about 12 noon and developed a rash about 2 hours later.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ear swelling, Pruritus, Urticaria
Clinical narrative: Patient was vaccinated at about 12 noon and developed a rash about 2 hours later.
Age: 87.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received 2 flu shots. She told the 2nd person she was with that she needed a flu shot, and received it. No symptoms, no adverse reaction whatsoever. I called the patient 2 hours later and she had no maleffects at that time - told to contact us if she had any symptoms.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient's daughter reported a fever of 102  at 12:00 (measured at patient's home). She stated he woke up at 7 a.m. with chills and was given 1000mg acetaminophen right after. She gave him another 1000mg acetaminophen at 11:45.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Lip swelling, Pyrexia
Clinical narrative: Red face, puffy lips, fever for 2 days.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Patient called clinic on 9/27/2018 to report that her arm where she had her chicken pox vaccine was swollen. She reports on 9/26/2018 she noticed a quarter size area of pinkness/redness and some swelling and the area did itch. Today 9/27/2018 she reports she noticed soreness and more swelling. Swelling of the area is described as tennis ball size. There is pinkness/redness and soreness when she touches the area. There is also some harness to the skin. She denies any fever or ill feeling. No other discomfort elsewhere in body. Clinic directed her apply cold compress on the area for 10 mins at a time. To take TYLENOL or ibuprofen which ever her health care provider allows her to take and to seek medical care. 9/27/2018 148pm clinic contacted client to see how her arm is doing and also if she seeked medical care. Reports she did not go to MD. She did apply cold compress to area and notes the swelling has actually gone down some. She does report it is still sore to touch and her arm does hurt. Clinic suggested she seek medical care. She report she has not taken anything for it as it is not a pain that she cannot deal with. She also plans on just applying cold compress to the area on and off until tomorrow. She reports it her arm does not look or feel any better tomorrow 9/28/2018 she will then seek medical care.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Listeriosis, Myalgia, Pneumonia
Clinical narrative: Patient has received ZOSTAVAX and Flu in the past. On 7/18 Per reporter, patient had vomited, had fever, headaches and myalgia. On 7/19 since patient was not responding to calls or emails, they checked-in on him and was taken to ER by ambulance and was admitted. 7/21 Per reporter, patient was being treated for listeria, had collapsed lung and could not breathe on his own, and was being treated for pneumonia. 7/29 patient alert and trying to communicate, test results found West Nile virus, and had a tracheotomy that week. Patient transferred to another hospital on 8/19 and have noticed marginal improvement to his condition. As of 9/9 patient was still in hospital. See attached letter for additional details.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pneumothorax, Pyrexia, Tracheostomy, Vomiting, West Nile viral infection
Clinical narrative: Patient has received ZOSTAVAX and Flu in the past. On 7/18 Per reporter, patient had vomited, had fever, headaches and myalgia. On 7/19 since patient was not responding to calls or emails, they checked-in on him and was taken to ER by ambulance and was admitted. 7/21 Per reporter, patient was being treated for listeria, had collapsed lung and could not breathe on his own, and was being treated for pneumonia. 7/29 patient alert and trying to communicate, test results found West Nile virus, and had a tracheotomy that week. Patient transferred to another hospital on 8/19 and have noticed marginal improvement to his condition. As of 9/9 patient was still in hospital. See attached letter for additional details.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: West Nile virus test positive
Clinical narrative: Patient has received ZOSTAVAX and Flu in the past. On 7/18 Per reporter, patient had vomited, had fever, headaches and myalgia. On 7/19 since patient was not responding to calls or emails, they checked-in on him and was taken to ER by ambulance and was admitted. 7/21 Per reporter, patient was being treated for listeria, had collapsed lung and could not breathe on his own, and was being treated for pneumonia. 7/29 patient alert and trying to communicate, test results found West Nile virus, and had a tracheotomy that week. Patient transferred to another hospital on 8/19 and have noticed marginal improvement to his condition. As of 9/9 patient was still in hospital. See attached letter for additional details.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: West Nile viral infection
Clinical narrative: Patient has received ZOSTAVAX and Flu in the past. On 7/18 Per reporter, patient had vomited, had fever, headaches and myalgia. On 7/19 since patient was not responding to calls or emails, they checked-in on him and was taken to ER by ambulance and was admitted. 7/21 Per reporter, patient was being treated for listeria, had collapsed lung and could not breathe on his own, and was being treated for pneumonia. 7/29 patient alert and trying to communicate, test results found West Nile virus, and had a tracheotomy that week. Patient transferred to another hospital on 8/19 and have noticed marginal improvement to his condition. As of 9/9 patient was still in hospital. See attached letter for additional details.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Neurological symptom
Clinical narrative: Patient was given influenza vaccine and subsequently developed possible Guillain Barre Syndrome (progressive weakness of the extremities, L sided numbness). He had a distant history of GBS at age 18. Now 1 wk out S/P Tx w/IVIG, w/improvement in neurological symptoms but residual hand/leg weakness.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram, Epidural lipomatosis, Guillain-Barre syndrome, Hypoaesthesia, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Patient complained of numbness in lower extremities and lower abdomen. Was admitted to hospital on 9-15-2018 with diagnosis of Guillan Barre Syndrome. Discharged from hospital on 9-25-2018 and transferred to Rehab.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Spinal column stenosis
Clinical narrative: Patient complained of numbness in lower extremities and lower abdomen. Was admitted to hospital on 9-15-2018 with diagnosis of Guillan Barre Syndrome. Discharged from hospital on 9-25-2018 and transferred to Rehab.
Age: 88.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Extra dose administered
Clinical narrative: Patient was seen by their PCP and given a flu shot. Patient then presented to the urgent care with his wife, who stated "I need a flu shot for me and my husband." Patient was given a flu shot by our clinical staff. As I was reviewing the note from our clinical staff, I recognized that the patient had already received a flu shot. Patient and his wife were contacted by the urgent care manager and was told to notify us if any issues arise.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Nausea, Pain, Vaccination site pain
Clinical narrative: Appx one hour after vaccination developed pain and site of vaccine administration as well and nausea. No vomiting. Next morning was complaining of left shoulder (contralateral to the site of the injection) radiating up to the region of the lateral trapezius and down to the mid upper arm. Continued with right shoulder region pain as well but pain on left was more significant. Two days after vaccination given complaining mostly left shoulder region pain, less right side. Left arm tender to palpation in region of the upper arm near distal insertion of the deltoid. Pain with elevation shoulder and ROM shoulder. Pain with movement right shoulder as well. right deltoid region is minimally warm, but not tender. no swelling. normal neurologic exam (strength, tone, sensation, CN, gait).
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral
Clinical narrative: Oh her way home (about 30 min after getting the injection) she developed tingling of her lips and tongue that lasted 15 minutes and spontaneously resolved without reoccurrence.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site discolouration, Injection site swelling, Pruritus
Clinical narrative: Patient has swelling and discoloration at injection site. Patient is also dizzy and itchy. Came in to the clinic the day after injection for evaluation.
Age: 68.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient received two vaccines, PREVNAR 13 and FLUZONE HD on 9/25/2018. The patient started to develop a rash the night of the vaccine, by the next day 9/26/2018 she had a large red rash approximately the size of a golf ball around the injection site. The rash was red and warm to the touch. The patient said that she also developed a headache and had flu like symptoms. She took TYLENOL the night of 9/26/2018 and started to feel better. By 9/27/2018 she had a rash and no other symptoms.
Age: 90.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient received FLUZONE HD on 9/25/2018, the next morning on 9/26/2018 she noticed a rash about the size of a baseball around the injection site that was still present on 9/27/2018. She did not report fever, pain or flu like symptoms. She did not have a rash at any other site on her body.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia
Clinical narrative: Shoulder:5cm in diameter circular area of decreased sensation to monofilament testing over the deltoid muscle.Not tender,no muscular changes.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Bladder catheterisation, Chills, Injection site pain
Clinical narrative: Severe anxiety, malaise, weakness, uncontrollable shivering, pain at injection site, urinary retention.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Urinary retention
Clinical narrative: Severe anxiety, malaise, weakness, uncontrollable shivering, pain at injection site, urinary retention.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Had muscle aches and pains, nausea, fever or 101.5, extreme fatigue. Symptoms lasted about 28 hours. Pharmacist called the day after the vaccine and we discussed effects, he advised ibuprofen and rest. (Slept about 16 to 17 hours during this period.)
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersomnia, Inflammation, Injected limb mobility decreased, Limb discomfort
Clinical narrative: Pt received shots 9/25 and when he woke on 9/26 arm was very sore and he was unable to move it. Pt states he slept the entire day 9/26. Arm is still slightly red/inflamed today, 9/27. Pt taking OTC NSAIDs for relief.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Pruritus generalised, Rash
Clinical narrative: About an  hour after the immunization, the patient began having swallowing problems, felt itchy all over, rash on her neck chest. She came back to administering RN who escorted her to the Emergency Room for treatment.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Asthenia, Body temperature decreased, Cerebrovascular accident, Computerised tomogram normal
Clinical narrative: I was given the Tdap vaccine at my 31 week prenatal checkup August 7, 2018. 72 hours later I had severe diarrhea and braxton hicks and temp dropped to 96.0 degrees, the symptoms lasted for 3 days, then got better, exactly 2 weeks after vaccine, while doing dishes I had a stroke effecting the entire right side of my body, causing complete numbness and weakness and an inability to speak (33 weeks pregnant at time of stroke) I was taken to the emergency room and hospitalized for 3 days, MRI showing a stroke. I have been otherwise completely healthy up until this point of my pregnancy. Due Date 10/10/2018.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Electrocardiogram normal, Exposure during pregnancy, Hypoaesthesia, Laboratory test normal
Clinical narrative: I was given the Tdap vaccine at my 31 week prenatal checkup August 7, 2018. 72 hours later I had severe diarrhea and braxton hicks and temp dropped to 96.0 degrees, the symptoms lasted for 3 days, then got better, exactly 2 weeks after vaccine, while doing dishes I had a stroke effecting the entire right side of my body, causing complete numbness and weakness and an inability to speak (33 weeks pregnant at time of stroke) I was taken to the emergency room and hospitalized for 3 days, MRI showing a stroke. I have been otherwise completely healthy up until this point of my pregnancy. Due Date 10/10/2018.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Ultrasound antenatal screen normal, Ultrasound scan normal, Uterine contractions during pregnancy
Clinical narrative: I was given the Tdap vaccine at my 31 week prenatal checkup August 7, 2018. 72 hours later I had severe diarrhea and braxton hicks and temp dropped to 96.0 degrees, the symptoms lasted for 3 days, then got better, exactly 2 weeks after vaccine, while doing dishes I had a stroke effecting the entire right side of my body, causing complete numbness and weakness and an inability to speak (33 weeks pregnant at time of stroke) I was taken to the emergency room and hospitalized for 3 days, MRI showing a stroke. I have been otherwise completely healthy up until this point of my pregnancy. Due Date 10/10/2018.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Fatigue, Influenza like illness, Myalgia, Poor quality sleep
Clinical narrative: Started feeling tired in evening, did not sleep well, strange dreams. Following day - tired, muscle aches, felt like I was coming down with the flu. Went back to bed. Took a 1.5 hour morning nap. Began to feel better in the afternoon. The next day was feeling better but skipped my 28 mile bike ride.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: PT PROJECTILE VOMITED AFTER VACCINE WAS ADMINISTERED.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported redness and swelling at and near the injection site.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: Patient complained of tingling in lips and hives. Patient had already taken Zyrtec before reporting event. Patient was offered oral Benadryl and informed of availability of Epipens. Patient declined use. Patient declined shortness of breath, throat swelling, and difficulty breathing. Patient counseled to monitor for shortness of breath, throat swelling, and difficulty breathing and to seek medical attention should they occur. Patient was followed up with 3 times over the course of 4 hours and she said she was fine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Eyelid pain, Injection site erythema, Injection site irritation
Clinical narrative: A couple of hours after vaccination the patient removed her non-latex Coverlet bandage and directly underneath her arm was quite red and irritated. The swelling continued in her arm and around bedtime that evening she had chills and uncontrolled shivering but no fever. The next morning ( 9/25/18 ) she states she was itchy all over and throughout the day the itching and swollen red arm worsened. When she woke up on 9/26/2018 she had a severe rash all over her body and the area under both her eyes was swollen and painful to the touch. She saw her PA and PMD later that morning and they told her they believed she had cellulitis in the arm and an allergic reaction to the vaccine. They referred her to the advice of her allergist as to whether or not she should have the booster dose of SHINGRIX, and prescribed her Prednisone 20 mg, 2 tablets once daily for 5 days, but did not prescribe an anti-biotic. They did mark the area on her arm where the reaction was occurring and told the patient to call if the swelling went outside the area. When spoken to today ( 9/27/2018 ) patient stated that she is feeling better and that the swelling on her arm, and the rash, do appear to be diminishing. The area directly under where the bandage was, is still is the most irritated.