chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Bronchitis, CSF test normal, Fistulogram, Guillain-Barre syndrome
Clinical narrative: Seen in ED 10/28/2016 for weakness in legs, admitted to Hospital 10/29/16 from ED. Admit note: 68yoF who presented with leg weakness. About 2 weeks ago, the patient received a flu shot. She then developed URI symptoms and treated with Z-pack as an outpatient. Over the past 2 weeks, she says that her legs have been progressively weaker. She used to be ambulatory with a cane and able to walk around and perform ADLs such as walking to the mailbox. Now, she says her legs are so weak that she needs help even with minimal ambulation. She was seen by her PCP yesterday for the leg weakness, who sent her to the ED. Aside from the bronchitis/URI, she had been otherwise well. No N/V, HA, diarrhea, fever, chills, dysuria, CP, SOB. She has not had any recent travel nor known sick contacts. 10/13/16 flu shot, Post flu shot note by Dr: He felt that she had Guillain-Barre syndrome. He recommended IVIG. The patient received 5 doses of IVIG. Was in hospital til 11/3/16 but had fistulogram during this admit because she is dialysis pt.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging, Renal function test, Upper respiratory tract infection
Clinical narrative: Seen in ED 10/28/2016 for weakness in legs, admitted to Hospital 10/29/16 from ED. Admit note: 68yoF who presented with leg weakness. About 2 weeks ago, the patient received a flu shot. She then developed URI symptoms and treated with Z-pack as an outpatient. Over the past 2 weeks, she says that her legs have been progressively weaker. She used to be ambulatory with a cane and able to walk around and perform ADLs such as walking to the mailbox. Now, she says her legs are so weak that she needs help even with minimal ambulation. She was seen by her PCP yesterday for the leg weakness, who sent her to the ED. Aside from the bronchitis/URI, she had been otherwise well. No N/V, HA, diarrhea, fever, chills, dysuria, CP, SOB. She has not had any recent travel nor known sick contacts. 10/13/16 flu shot, Post flu shot note by Dr: He felt that she had Guillain-Barre syndrome. He recommended IVIG. The patient received 5 doses of IVIG. Was in hospital til 11/3/16 but had fistulogram during this admit because she is dialysis pt.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: Seen in ED 10/28/2016 for weakness in legs, admitted to Hospital 10/29/16 from ED. Admit note: 68yoF who presented with leg weakness. About 2 weeks ago, the patient received a flu shot. She then developed URI symptoms and treated with Z-pack as an outpatient. Over the past 2 weeks, she says that her legs have been progressively weaker. She used to be ambulatory with a cane and able to walk around and perform ADLs such as walking to the mailbox. Now, she says her legs are so weak that she needs help even with minimal ambulation. She was seen by her PCP yesterday for the leg weakness, who sent her to the ED. Aside from the bronchitis/URI, she had been otherwise well. No N/V, HA, diarrhea, fever, chills, dysuria, CP, SOB. She has not had any recent travel nor known sick contacts. 10/13/16 flu shot, Post flu shot note by Dr: He felt that she had Guillain-Barre syndrome. He recommended IVIG. The patient received 5 doses of IVIG. Was in hospital til 11/3/16 but had fistulogram during this admit because she is dialysis pt.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram normal, Contusion, Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizure causing multiple bruises. Dr did catscan and blood work and put patient on Dilantin for the short term.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Widespread Hives.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: On 11/3/16, pt began to develop hives around her eye.  On 11/4/16 the had spread to other areas of her face and neck.  There is no lip involvement or difficulty breathing.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient's mother reports within several minutes of receiving her seasonal influenza vaccine she noted patient to have redness and itching of her face, neck, upper arms, chest, and upper back associated with scattered hives. No nasal, ocular, lip/tongue/oral/laryngeal, pulmonary, neurologic, GI, or CV symptoms. No illness, exercise, medication use, latex exposure, or known insect bites/stings today. By report patient has received seasonal influenza vaccines in the past without adverse reactions. No prior adverse vaccine reactions. No history of egg allergy or known medication allergy.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in the shoulder down to elbow. Could not lift arm. Painful to move the arm especially to pick something up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: RASH AT INJECTION SITE AND PAIN.  PATIENT ALSO DEVELOPED RASH IN THE ABDOMEN THE NEXT DAY.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Blood test normal, Chills, Computerised tomogram normal, Electroencephalogram normal
Clinical narrative: Started getting severe chills which I could not stop. Fever of 101.1 about two hours later. Fever and chills which made me shake uncontrollably until after midnight when I fell asleep. Awoke about 4:25 AM with horrible headache and a continuing fever. Slept on and off all day 10/26/2016 until son arrived that evening. Fever did drop to 99.9 before I went back to sleep. When I got up in morning, my son felt I was not acting normally and after checking with other family members, they decided I might be having a stroke. Went to Hospital and was admitted. CAT Scan, Ultrasound, MRI, EEG, and blood drawn. Tests were negative.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nuclear magnetic resonance imaging normal, Pyrexia, Somnolence, Tremor
Clinical narrative: Started getting severe chills which I could not stop. Fever of 101.1 about two hours later. Fever and chills which made me shake uncontrollably until after midnight when I fell asleep. Awoke about 4:25 AM with horrible headache and a continuing fever. Slept on and off all day 10/26/2016 until son arrived that evening. Fever did drop to 99.9 before I went back to sleep. When I got up in morning, my son felt I was not acting normally and after checking with other family members, they decided I might be having a stroke. Went to Hospital and was admitted. CAT Scan, Ultrasound, MRI, EEG, and blood drawn. Tests were negative.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal
Clinical narrative: Started getting severe chills which I could not stop. Fever of 101.1 about two hours later. Fever and chills which made me shake uncontrollably until after midnight when I fell asleep. Awoke about 4:25 AM with horrible headache and a continuing fever. Slept on and off all day 10/26/2016 until son arrived that evening. Fever did drop to 99.9 before I went back to sleep. When I got up in morning, my son felt I was not acting normally and after checking with other family members, they decided I might be having a stroke. Went to Hospital and was admitted. CAT Scan, Ultrasound, MRI, EEG, and blood drawn. Tests were negative.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye movement disorder, Headache, Neck pain, Pruritus
Clinical narrative: Shortness of breath, headache, neck pain (soon following administration of vaccine), itching, rapid eye movement. Treatment: taking BENADRYL.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Pt stated that on Thursday morning, she noticed her right arm was sore. Then, when she got home from work that night, she noticed her arm was sore, and starting to get red above the injection site. Then on Friday morning, she noticed her arm was also swollen, and seemed to be 'moving around her arm into her underarm area'.
Age: 49.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Induration, Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Left Arm where PNEUMOVAX 23 was administered was red and swollen the morning after administration. Patient came back to the pharmacy 20 hours after administration and her arm presented with inflammation, erythema and induration. Patient went to her physicians office. Blood pressure normal, physician recommended diphenhydramine oral capsules.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: About 3 inches down from injection arm is swollen and red. Doesn't hurt or itch and has gotten a little better. Talked to patient and told her if doesn't go away in the next day to call physician and follow up to make sure nothing serious.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient has extreme redness and swelling all over her upper arm from the shoulder to the elbow.
Age: 48.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Local redness, warmth, fever, and swelling.
Age: 77.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Fatigue, Feeling abnormal, Malaise, Pain
Clinical narrative: By Noon she noted that her right arm was painful and the pain worsened as the day wore on. By 2 PM she began to chill and by 4 PM she ached all over. She felt as though she had a fever but did not take her Temp. She believes she may have taken a dose of  Ibuprofen and went to bed by 7 PM. She slept fair, getting up in the night to the Bathroom 2 or 3 times compared to normally getting up 1 or 2 times. The next morning the arm continued to ache and she still felt lousy in general. She continued to be fatigued and still did not feel well. That night she slept better and by Noon the following day (10/07/16) she began to slowly began to feel better. It took a full week for the arm to finally recover, with the pain gone. The client did not ever notice if the arm was swollen or reddened. Client felt she had fully recovered one week later.
Age: 77.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: By Noon she noted that her right arm was painful and the pain worsened as the day wore on. By 2 PM she began to chill and by 4 PM she ached all over. She felt as though she had a fever but did not take her Temp. She believes she may have taken a dose of  Ibuprofen and went to bed by 7 PM. She slept fair, getting up in the night to the Bathroom 2 or 3 times compared to normally getting up 1 or 2 times. The next morning the arm continued to ache and she still felt lousy in general. She continued to be fatigued and still did not feel well. That night she slept better and by Noon the following day (10/07/16) she began to slowly began to feel better. It took a full week for the arm to finally recover, with the pain gone. The client did not ever notice if the arm was swollen or reddened. Client felt she had fully recovered one week later.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Med Error: PPD 0.5mL IM administered by medical assistant instead of Tdap. Primary provider notified, patient assessed and observed.   Follow up call to patient made on 11/04/2016. No adverse reactions noted.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PPD 0.5 mL IM administered by RMA instead of Tdap per orders.  Primary provider notified; patient assessed and observed.  Follow up call made 11/4/2016 by RN; no adverse reactions noted.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Injection site reaction, Local reaction
Clinical narrative: Local site reaction, headache, feeling bad. Lasted 2 day. Resolved now.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Anion gap normal, Blood alkaline phosphatase normal, Blood osmolarity decreased, Cough, Death
Clinical narrative: Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Neutrophil count increased, Pain in extremity, Platelet count increased, Protein total increased, Pyrexia
Clinical narrative: Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Somnolence, Vomiting, White blood cell count increased
Clinical narrative: Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Symptoms (tingling and numbness) presented intermittently at first, beginning in my feet and progressed up my legs. Then included my hands, arms, face and mouth. Symptoms were progressive, becoming more sustained with less remittance. Symptoms were experienced on both sides of my body, sometimes unilaterally and sometimes bilaterally. Had some subjective weakness but neurology exam was clear.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral
Clinical narrative: Symptoms (tingling and numbness) presented intermittently at first, beginning in my feet and progressed up my legs. Then included my hands, arms, face and mouth. Symptoms were progressive, becoming more sustained with less remittance. Symptoms were experienced on both sides of my body, sometimes unilaterally and sometimes bilaterally. Had some subjective weakness but neurology exam was clear.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Mononucleosis heterophile test negative, Rash erythematous, Scratch, Streptococcus test negative
Clinical narrative: Approx. 15 hrs later (Saturday), diffuse red spots all over back &  torso and near hands. Injection site negative for any rxn. Pt took two BENADRYLS (7 hrs apart) which helped. But, rash returned "angrier" ~30 hrs later. Next AM, campus health (Monday) Rx for Prednisone taper. On Thurs, rash clearing up in "less affected" areas, added ZYRTEC to prednisone & BENADRYL at night. Thurs night/Friday, good improvement in less affected area and from angry red to light pink in worse areas. Monday, rash mostly resolved with some sensitive areas due to scratching.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Broke out in hives/ itchy blotches all over body.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Herpes zoster, Musculoskeletal chest pain, Rash, Skin irritation
Clinical narrative: Shingles. Began as a back ache, ache continued and developed into feeling of deep skin irritation. Spanning from center of back, around rib cage, to sternum. Visible rash present 10/16/2016, cluster of raised bumps, 2 inch diameter. Pain increased and became concerning.  Diagnosed with shingles on 10/21/2016 at an Urgent Care facility. Prescribed acyclovir for 7 days and a MEDROL dose pack.  Majority of symptoms have resolved, minor pain in rib cage and visible rash remains but asymptomatic as of 11/4/2016.
Age: 0.17
Sex: F
Vaccine: 6VAX-F, HIBV, IPV, RV5
Symptoms: No adverse event, Overdose
Clinical narrative: NO KNOWN ADVERSE EFFECTS AT THIS TIME AS A RESULT OF INADVERTENTLY RECEIVING TWO DOSES OF IPV (PEDIARIX AND IPOL ADMINISTERED TOGETHER).
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Rash papular, Rash pruritic
Clinical narrative: RED PAPULAR RASHES AROUND INJECTION SITE. AREA AROUND INJECTION SITE IS REDDISH. RASHES WERE VERY ITCHY.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warm, red, slightly itchy area surrounding injection site.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Blood pressure increased, Chills, Decreased appetite
Clinical narrative: iIjection site swollen, hard and red; chills, joint pain, weakness, nausea and loss of appetite, dizziness, fever, headache, elevated Blood Pressure. Still fighting symptoms, dr has now prescribed antibiotics.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site swelling, Nausea
Clinical narrative: iIjection site swollen, hard and red; chills, joint pain, weakness, nausea and loss of appetite, dizziness, fever, headache, elevated Blood Pressure. Still fighting symptoms, dr has now prescribed antibiotics.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Patient suffered from diffuse, warm rash spreading from the top of her left arm where the vaccine was given down to her elbow, with increased redness and bruising around the site of injection. She was said to feel fine outside of this ailment.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: The patient reported a possible injection site reaction due to vaccination. Patient was diagnosed as having cellulitis on the site of injection by her physician. Patient is taking antibiotic therapy.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Upper arm (above the elbow) was red, swollen, and slightly warm to the touch.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Arm red and warm.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: Extreme ache all over body, very weak, slight nausea.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Inflammation, Peripheral swelling
Clinical narrative: Patient came into the Pharmacy at approximately 3pm on 11/4/2016.  She showed me her arm which had redness on her upper arm, but little to no swelling. She then showed me a picture of her arm the day after she received the shot and it was red and inflamed. She also stated that she had to use her inhaler because she had trouble breathing. She told me that she was fine now and had no lingering effects except for the slight redness. She was just wanting to know if she should take a flu shot the following year.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported doctor confirmed shingles exacerbation from getting shingles vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Eye pruritus, Eye swelling, Lip swelling, Urticaria
Clinical narrative: Swollen itchy eyes, hives to back of neck. These symptoms went away after 24 hours. Friday 11/4/16 5:30 PM-Eyes itchy, right eye pain, bottom lip swollen, hives on entire back and abdomen.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Ear pain, Fatigue, Headache
Clinical narrative: Within one hour, I felt dizzy, completely drained, headache, body aches, fever, chills, stuffy and runny nose, sinus congestion, sensitivity to light and sound, swollen and sore throat, chest congestion, increased heart rate of 120-140BPM, decreased O2 sat of 95% and earache pain. I did not lift my head or been able to get up until 11/4 @7:15PM.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Hyperacusis, Mobility decreased, Nasal congestion, Oropharyngeal pain
Clinical narrative: Within one hour, I felt dizzy, completely drained, headache, body aches, fever, chills, stuffy and runny nose, sinus congestion, sensitivity to light and sound, swollen and sore throat, chest congestion, increased heart rate of 120-140BPM, decreased O2 sat of 95% and earache pain. I did not lift my head or been able to get up until 11/4 @7:15PM.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Oxygen saturation decreased, Pain, Pharyngeal oedema, Photophobia, Pyrexia
Clinical narrative: Within one hour, I felt dizzy, completely drained, headache, body aches, fever, chills, stuffy and runny nose, sinus congestion, sensitivity to light and sound, swollen and sore throat, chest congestion, increased heart rate of 120-140BPM, decreased O2 sat of 95% and earache pain. I did not lift my head or been able to get up until 11/4 @7:15PM.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sinus congestion
Clinical narrative: Within one hour, I felt dizzy, completely drained, headache, body aches, fever, chills, stuffy and runny nose, sinus congestion, sensitivity to light and sound, swollen and sore throat, chest congestion, increased heart rate of 120-140BPM, decreased O2 sat of 95% and earache pain. I did not lift my head or been able to get up until 11/4 @7:15PM.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Local reaction, Streptococcal infection
Clinical narrative: Local immunization reaction at site of injection with hives on 11/3/16. Patient was diagnosed with strep and is now on antibiotics.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Pain
Clinical narrative: Pt called 10/31 complained of pain joint/swelling. (after 30 days). Told to follow up with MD.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Feeling cold, Hyperhidrosis, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Fever, chills, sweats, redness around vaccine site that extended about 3-4 inches all around injection site and was drowsy and nauseous and fainted morning after vaccine.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Somnolence, Syncope
Clinical narrative: Fever, chills, sweats, redness around vaccine site that extended about 3-4 inches all around injection site and was drowsy and nauseous and fainted morning after vaccine.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chills, Headache, Hepatitis viral test
Clinical narrative: Chills with fever, headache, body ache fever every 6 hours for over 2 weeks.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Chills with fever, headache, body ache fever every 6 hours for over 2 weeks.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: C-reactive protein, Full blood count, Influenza virus test, Injection site erythema, Injection site pain
Clinical narrative: Morning after injection joints started to ache and felt feverish w/chills. He then noticed his arm where the injection was given became stiff, swollen, red and warm to the touch.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: Morning after injection joints started to ache and felt feverish w/chills. He then noticed his arm where the injection was given became stiff, swollen, red and warm to the touch.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Morning after injection joints started to ache and felt feverish w/chills. He then noticed his arm where the injection was given became stiff, swollen, red and warm to the touch.
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Pt. complained of burning sensation at time of injection and continues to complain of arm pain.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Rotator cuff syndrome
Clinical narrative: Patient states after vaccination same day she could "not lift my arm!" She said that she went to the doctor and has 3 tears in her rotator cuff which she is attributing to the flu shot.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Patient states after vaccination same day she could "not lift my arm!" She said that she went to the doctor and has 3 tears in her rotator cuff which she is attributing to the flu shot.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported pain in the injected arm throughout the night, swelling and difficulty moving same arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle strain, Pain in extremity
Clinical narrative: Around 11am I administered FLUZONE HD into the patient's left deltoid IM. Patient reported feeling pain (down to her toes). I believe this is what she said-around 240pm patient reported having to hold her arm up at the elbow and had a pulling feeling from neck/upper arm area. I called the patient's Dr approximately 245pm and spoke to nurse to report this.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient states that her arm (Left) hurt bad a few hours after receiving the flu shot. She also states that she had tingling and numbness in the left arm.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 101.1 the evening following the vaccine and continued into the next day. Hives all over body, started the next morning. BENADRYL given.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient received PPSV23 at regular office visit on 11-2/16. Later that day - pt noted swelling itching in arm. Seen at walk-in services today 11/4/16 for increased redness, heat, swelling on inside aspect of arm extending down to mid lower 6m.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Localized reaction mild. No fever. Erythema in area surrounding the initial PNEUMOVAX vaccine. No treatment.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local mild reaction, 2 inch circular area red, indurated, no drainage, no fever KEFLEX 125mg/5ml Susp.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain, Injection site joint swelling, Injection site warmth
Clinical narrative: Severe left shoulder joint pain and swelling, palpable heat.
Sex: U
Vaccine: HEP, HPVX
Symptoms: Incorrect product storage, Vaccination site pain
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 25-JUL-2016, the patient was vaccinated with human papillomavirus HPV vaccine (manufacturer unknown) and RECOMBIVAX HB adult (dose, route, lot number and expiration date were unknown for both vaccines), both of which experienced temperature excursion. On an unknown date in 2016, the patient experienced soreness at the vaccine site, which lasted for 2 days. The patient wanted to check a titer for RECOMBIVAX HB, after a series of 3. The causal relationship between soreness for 2 days at the vaccine site and the both therapies was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and 59.4 for 4,5 hours) doses of ROTATEQ (orally, lot # M006111 with expiration date 18-NOV-2017 or lot # M019707 with expiration date 25-OCT-2017; dose was not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an adult patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the adult patient was vaccinated with PROQUAD (lot, expiry date and dosing regimen were unknown). No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients;' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses improperly stored PROQUAD (lot # M011661 with expiration date 08-SEP-2017; dose and route were unknown). The vaccines were exposed under temperature of 18 degrees Fahrenheit for 72 hours and 15 minutes. There were no previous temperature excursions. Data logger was involved. It was unknown if the patients had adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot #, expiration date and dose were unknown) via intramuscular injection which was outside of the prescribing information of administering via a subcutaneous injection. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with M-M-R II (lot #, expiration date and dose were unknown) via intramuscular injection which was outside of the prescribing information of administering via a subcutaneous injection. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L039066, expiration date 19-MAR-2017, dose and route not reported). The doses of vaccine were improperly stored at 48.9 degree Fahrenheit for 8 hours. No adverse effects were reported. This is one of two reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004014, expiration date 04-MAR-2017) (dose and route unknown). The vaccine was exposed to a temperature described as" "max 47.6F for 10 minutes with three previous excursions of 10 minutes each exposed to a max of 47.6F each time". Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # M023169, expiration date 13-JUN-2018; dose and route of administration were not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions of 24 hours each one. The lowest recorded temperature for both excursions was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB which had a lot number of K018986 and expiration date on 04-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursion, one for 168 hours with a lowest temperature of 33 F (0.555555556 Celsius) and the other one for 264 hour with a lowest recorded temperature of 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of VAQTA (lot # M027879, expiration date 24-JAN-2018; dose and route of administration were not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 48 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (clinic supervision) refers to a 44 year old male patient who was reported to be student. The patient had azithromycin allergy. On 26-AUG-2016, the patient was vaccinated with the third dose of hepatitis b vaccine (manufacturer unknown) (intramuscular, lot # reported as C7EPS, expiration date reported as July 2016, dose not reported). The vaccine was administered in the left deltoid. It was reported that the office was notified the vaccine was still effective. The patient was notified that he received an expired vaccine and was told to call the office if he had any issues. Until the reporting time (21-OCT-2016), no adverse events were aware of. On the same day, the patient was also inadvertently received a dose of VARIVAX (related case ID: 1608USA015764). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown date, the patients were vaccinated with unspecified number of improperly stored doses of (Oka/Merck) VARIVAX injection, lot # reported as M105731, expiration date 30-MAR-2018 or lot # M009766, expiration date 23-FEB-2018 (dose, route and site of administration were not reported). No adverse effect were reported. Product quality complaint was not involved. The administered doses of (Oka/Merck) VARIVAX were stored in the temperature of 10 degrees Fahrenheit for 3 hours and in the temperature of 14 degrees Fahrenheit for 17 minutes. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to three unspecified patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with a first dose of GARDASIL 9 (dose, route of administration. lot # and expiration date were not reported). On an unknown date, more than 12 months after the first dose, the patients were vaccinated with a second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported), which was reported as being outside of the recommendations in the GARDASIL 9 prescribing information. NO adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified date, the patients were administered doses of improperly stored (Oka/Merck) VARIVAX (lot # L048465, expiration date 02-DEC-2017; lot # M009765, expiration date 23-FEB-2018); which were exposed to temperature of 11F for 30 minutes. There was not previous temperature excursion and the call was because of a data logger. No adverse effect were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 11-OCT-2016 from a nurse. She reported that an unknown number of patients, names and demographics unknown, were administered one or more Merck vaccines following a temperature excursion to 62.7 degrees Fahrenheit for 9.5 hours and 53.1 degrees Fahrenheit for 2 hours for refrigerated vaccines; and a freezer excursion of 37.2 degrees Fahrenheit for 9.5 hours and 22.1 degrees Fahrenheit for 2 hours and 30 minutes. On an unknown date VARIVAX (Lot # M006156, expiration date 05-FEB-2018) was administered (patient age and gender unknown). No adverse effects were reported. No other information was available. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative regarding an 80 year old female patient. No pertinent medication history, drug reactions/allergies and concomitant medications were reported. On 06-JUL-2012, the patient was vaccinated with ZOSTAVAX, (lot and expiration date were unknown). On 17-OCT-2016, the patient developed a case of shingles. The patient sought medical attention to the physician and received unspecified treatment. The outcome of the event was unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's concurrent conditions, concomitant therapies or medical history was reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot# M001745 with an expiration date 07-APR-2016 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit for 13 hours and then 20 degrees Fahrenheit for 6 hours. Data logger was not involved. The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This literature marketed report as received from the authors of the below published article, refers to 55 students (young adults) of unknown age and gender, who had received RECOMBINANT (manufacturer unknown) and no longer had therapeutic levels of anti-HBs. It was reported that on an unknown date in 2014, an estimated 19,200 persons were newly infected with hepatitis B virus (HBV). While the rate of new infections had declined steeply since the implementation of a national HBV vaccination program, HBV continued to represent a potentially serious health threat. The HBV vaccination schedule most often used for children and adults was 3 intramuscular injections, with the second and third doses administered 1 month and 6 months, respectively, after the first dose. The retrospective chart review of 256 graduate students entered into a physician assistant program at a university had their hepatitis B surface antibody levels evaluated for positive immune responses. The resulting data suggested waning immunity 15 year after completing the primary HBV vaccination series. Test results revealed statistically significant differences (P=0.001) in the number of years since completion of the HBV vaccination series between participants who had therapeutic levels of anti-HBs and those who did not. The results showed that the students with therapeutic levels(n=201) had received their final injection of the vaccination series an average of 14.7 years prior, while students who were no longer at therapeutic levels of anti-HBS (55 students) (Hepatitis B surface antibody negative) had received their final injection an average of 17.3 years prior. The outcome was unknown. The study results suggested that there may be a need to have a universal booster approximately 15 years after completion of the initial childhood series of HBV immunizations. Immune memory was demonstrated in only 67% of population 15 years after vaccinate series completion. The data suggested that administering a booster dose of HBV during the typical person's college years may be more effective in protecting the population against a disease that is acquired mainly through adult behaviors, including sexual activity, tattooing, body piercing, medical mission travel, study abroad, and adventure travel. Additionally, health care professional students must be able to prove immunity with positive HBV titer test results in order to complete their education and clinical requirements. More clinical studies need to be completed to ascertain at what point after vaccination HBV antibody protection wanes. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions, one for 384 hours with a lowest temperature recorded of 34 F (1.111111111 Celsius) and the other one for 168 hours with a lowest temperature recorded of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5 mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.