chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: 2 days after receiving his 6th grade shots he developed huge hives on his left arm. at least 11.   did not have breathing problems.   plan was to give benadryl and call if worsens or no improvement - would assume this resulted in improvement as there was no return call and no visit to an urgent care clinic
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Cellulitis of right thigh. 1.5 cm in diameter of erythema on the top of the right thigh and 3 cm in diameter of induration. Cefdinir was prescribed for treatment.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Gait inability, Irritability, Lethargy, Pain in extremity
Clinical narrative: Lethargy, fussiness, spaced out, would not put her left foot down and could not walk. 102.1 fever. Screaming over and over her leg hurt until after she was given Tylenol and then again after 4 hours from the dose of Tylenol.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Screaming
Clinical narrative: Lethargy, fussiness, spaced out, would not put her left foot down and could not walk. 102.1 fever. Screaming over and over her leg hurt until after she was given Tylenol and then again after 4 hours from the dose of Tylenol.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Paraesthesia oral, Throat tightness
Clinical narrative: On 3/10 I woke up with a rash on the arm where I had the injection.  About 6:00 that evening I felt a tingling sensation in my upper lip.  As the evening progressed it seemed to start to swell.  About 9:00 my throat started to feel as though it was closing. I took 50 mg of Benadryl.  We went to the hospital and my blood pressure was 180/81.  They gave me an IV with Benadryl, Prednisone and Pepcid.  I was released about 1:00 with a prescription for Prednisone for 5 days.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Inflammation
Clinical narrative: Inflammation of hand Pain in wrist
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had fatigue and pretty significant swelling and also redness and pain at his right arm (to the wrist). He also had lower extremity edema
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site abscess, Injection site swelling
Clinical narrative: Developed swelling on left thigh 2 days later, got worse, turned into an abscess, seen at clinic and prescribed antibiotics
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Rash papular
Clinical narrative: fine papular red rash over all of body..since day after injection. fading by 3/13/20
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Disorientation, Hypoaesthesia, Hypoaesthesia oral, Rash
Clinical narrative: 15 min after injection, I noticed my tongue started to feel swollen and numb, the left side of my face became numb and swollen, I got hives/rash on the back of my neck and side of my face. I took 2 Benadryl by mouth within about an hour after injection. My family noted by 30 min after taking Benadryl,  I was acting confused, disoriented and the swelling and numbness had not receded.  They then took me to the local ER. By 1 hr after Benadryl the confusion was lifting and the swelling subsided. The ER administered a steroid shot, monitored symptoms for 30 min- 1 hr  and sent me home with a prescription for 5 day?s worth of oral steroids.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Swollen tongue, Urticaria
Clinical narrative: 15 min after injection, I noticed my tongue started to feel swollen and numb, the left side of my face became numb and swollen, I got hives/rash on the back of my neck and side of my face. I took 2 Benadryl by mouth within about an hour after injection. My family noted by 30 min after taking Benadryl,  I was acting confused, disoriented and the swelling and numbness had not receded.  They then took me to the local ER. By 1 hr after Benadryl the confusion was lifting and the swelling subsided. The ER administered a steroid shot, monitored symptoms for 30 min- 1 hr  and sent me home with a prescription for 5 day?s worth of oral steroids.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia, Swollen tongue, Urticaria
Clinical narrative: 15 min after injection, I noticed my tongue started to feel swollen and numb, the left side of my face became numb and swollen, I got hives/rash on the back of my neck and side of my face. I took 2 Benadryl by mouth within about an hour after injection. My family noted by 30 min after taking Benadryl,  I was acting confused, disoriented and the swelling and numbness had not receded.  They then took me to the local ER. By 1 hr after Benadryl the confusion was lifting and the swelling subsided. The ER administered a steroid shot, monitored symptoms for 30 min- 1 hr  and sent me home with a prescription for 5 day?s worth of oral steroids.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: 15 min after injection, I noticed my tongue started to feel swollen and numb, the left side of my face became numb and swollen, I got hives/rash on the back of my neck and side of my face. I took 2 Benadryl by mouth within about an hour after injection. My family noted by 30 min after taking Benadryl,  I was acting confused, disoriented and the swelling and numbness had not receded.  They then took me to the local ER. By 1 hr after Benadryl the confusion was lifting and the swelling subsided. The ER administered a steroid shot, monitored symptoms for 30 min- 1 hr  and sent me home with a prescription for 5 day?s worth of oral steroids.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Disorientation, Hypoaesthesia, Hypoaesthesia oral, Rash
Clinical narrative: Patient called a few hours after getting her second shingles vaccine stating that she went to the emergency room due to adverse reaction with her vaccine. She experienced swelling of the lips, tongue tingling, hives, and numbing on her left side. Her daughter took her to the ER when patient arrived home and patient was in the ER about an hour and a half after she received the vaccine to receive a steroid shot and a steroid prescription. We followed-up with the patient after she arrived home from the ER and she was feeling better.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Swollen tongue, Urticaria
Clinical narrative: Patient called a few hours after getting her second shingles vaccine stating that she went to the emergency room due to adverse reaction with her vaccine. She experienced swelling of the lips, tongue tingling, hives, and numbing on her left side. Her daughter took her to the ER when patient arrived home and patient was in the ER about an hour and a half after she received the vaccine to receive a steroid shot and a steroid prescription. We followed-up with the patient after she arrived home from the ER and she was feeling better.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia, Swollen tongue, Urticaria
Clinical narrative: Patient called a few hours after getting her second shingles vaccine stating that she went to the emergency room due to adverse reaction with her vaccine. She experienced swelling of the lips, tongue tingling, hives, and numbing on her left side. Her daughter took her to the ER when patient arrived home and patient was in the ER about an hour and a half after she received the vaccine to receive a steroid shot and a steroid prescription. We followed-up with the patient after she arrived home from the ER and she was feeling better.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient called a few hours after getting her second shingles vaccine stating that she went to the emergency room due to adverse reaction with her vaccine. She experienced swelling of the lips, tongue tingling, hives, and numbing on her left side. Her daughter took her to the ER when patient arrived home and patient was in the ER about an hour and a half after she received the vaccine to receive a steroid shot and a steroid prescription. We followed-up with the patient after she arrived home from the ER and she was feeling better.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired Gardasil.  Upon speaking with Father after administration, She didn't show any signs of adverse reactions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Patient reported pain, redness at and surrounding site of vaccination
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: Nausea, weakness, headache
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Papule, Rash
Clinical narrative: Rash to body - many small papules - a week after shot administered - likely from vaccine
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Neck pain, Pyrexia
Clinical narrative: Very sore in the area of the injection, initially.  Spread to neck and head.  Intense shivering, fever of 100 degrees fahrenheit that lasted for approximately 6 hours.  Intense headache initially.  Headache somewhat lessened by Tylenol and Ibuprofen.  Headache worse when sitting upright.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: weakness, fatigue, nausea injection site swelling and redness  painful arms and joints
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: weakness, fatigue, nausea injection site swelling and redness  painful arms and joints
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: LEFT DELTOID ERYTHEMA/ TENDERNESS/ INDURATION, ONSET WITHIN 24-36 HOURS OF VACCINE, TREATED EMPIRICALLY WITH TMP-SMX FOR SUSPECTED CELLULITIS
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was given Rota before recommended  min age for vaccine
Age: 42.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Pt went to emergency room to get antibiotics. fluid pooled in the back of his arm
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Flushing, Headache, Influenza like illness, Injection site pain
Clinical narrative: Chills, fever, flushing, injection site pain, nausea, all over body/muscle aches, sleeplessness, severe headache, lasting 48 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, flushing, injection site pain, nausea, all over body/muscle aches, sleeplessness, severe headache, lasting 48 hours.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain at site, shivering, fever (101.9), muscle aches.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling jittery, Lip swelling
Clinical narrative: Patient was administered the influenza vaccine IM in Right arm. Denied allergies. Signed consent. Stated had not previously received a flu vaccination. About 5 minutes later returned and stated felt like "lips swelling," dizzy and jittery.  Denied shortness of breath and non observed.  Blood pressure elevated. 145/90. 911 was called and transported to Emergency Department.  Report from workplace on 3/13/20 was that person was not hospitalized and was okay.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient reports rash on trunk.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product
Clinical narrative: Doctor did not order vaccine. Medical assistant administered flu vaccine to patient prior to discharging from clinic. Patient tolerated the vaccine, no immediate reaction noted.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Pain in extremity
Clinical narrative: no treatment left shoulder and arm killing me no strenght in that arm
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Bruise, lumpy swelling, soreness surrounding injection site. Soreness increased with movement of arm.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cough, Dyspnoea, Malaise, Productive cough
Clinical narrative: Patient reported on 2/10/2020 that 2 hours after receiving the injection on 2/4/20 he felt sick and then it got worse over the next two days. Patient states chills, fever, increased phlegm, difficulty breathing (requiring use of nebulizer) coughing and rectal bleeding. He reported this to the patient relations staff on 02/10/20, who in turn gave it to me to complete the VAERS.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rectal haemorrhage
Clinical narrative: Patient reported on 2/10/2020 that 2 hours after receiving the injection on 2/4/20 he felt sick and then it got worse over the next two days. Patient states chills, fever, increased phlegm, difficulty breathing (requiring use of nebulizer) coughing and rectal bleeding. He reported this to the patient relations staff on 02/10/20, who in turn gave it to me to complete the VAERS.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: not even 1 minute after admin patient leaned forward and passed out. Woke up about 1 min later.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Myalgia
Clinical narrative: Deltoid muscle pain. 0 skin changes. Pain continues after 1 month from Immunization
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt c/o pain left arm. Limited ROM. Arm is swollen and warm to touch. Ice area, take benadryl and Medrol dose pak prescribed for worsening symptoms
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Insomnia, Pain
Clinical narrative: Pain in the injection site and a flu-like reaction hours later. Chills and soreness that spread through out my body. It was difficult to sleep. This is the second in a series and the first injection had the same effect. I did not know about the reporting agency until informed by my Physician.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Pain in the injection site and a flu-like reaction hours later. Chills and soreness that spread through out my body. It was difficult to sleep. This is the second in a series and the first injection had the same effect. I did not know about the reporting agency until informed by my Physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: I had chills, a headache, body aches, and a temperature of 102. The temperature lasted for about 8 hours, and the symptoms were mostly resolved the next day (24 - 36 hours).
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Developed rash of small, raised, pink bumps covering arms, legs, across the shoulders on his back, and on his left cheek.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Induration, Lymphadenopathy, Musculoskeletal pain, Neuropathy peripheral
Clinical narrative: Severe pain from from shoulder to hand. Lasted 3 weeks. Large swollen (hard) cervical lymph nodes. After 2 weeks the lymph nodes reduced in size, but still swollen after 4 weeks.  Peripheral neuropathy (burning sensation in palms and feet). Started about a week after vaccination. Hasn?t subsided 4 weeks after vaccination.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Severe pain from from shoulder to hand. Lasted 3 weeks. Large swollen (hard) cervical lymph nodes. After 2 weeks the lymph nodes reduced in size, but still swollen after 4 weeks.  Peripheral neuropathy (burning sensation in palms and feet). Started about a week after vaccination. Hasn?t subsided 4 weeks after vaccination.
Sex: U
Vaccine: FLUC4
Symptoms: Back pain, Injection site pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Experiencing symptoms consistent with SIRVA. Muscle aches and sharp pain in left shoulder that radiates to left arm, neck and center back.
Sex: U
Vaccine: FLUC4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Experiencing symptoms consistent with SIRVA. Muscle aches and sharp pain in left shoulder that radiates to left arm, neck and center back.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Gait inability, Mobility decreased, Pain in extremity
Clinical narrative: patient states she could not get out of bed the following ,morning after shot, could not walk upstairs, excruciating pain in arm of injection, red extreemly red underneath arm
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient had soreness at injection site  with a red bump.  The following day the redness went down the arm and became swollen and hot to the touch.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient had soreness at injection site  with a red bump.  The following day the redness went down the arm and became swollen and hot to the touch.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Musculoskeletal pain, Paraesthesia, Sensory disturbance
Clinical narrative: One day following injection developed pain in the axilla, scapula with paresthesias and electrical sensation down the right arm to the thumb and first 3 fingers aggravated by any movement of the arm. Tapping on multiple locations on the arm elicits electrical shock sensation down the arm to the fingers. There has been a gradual improvement over the last 6 months with resolution of the axillary, scapular and upper arm pain and paresthesias. It persists in the forearm, thumb, index finger and third finger. Strength is preserved though there is some decrease in sensation in the thumb, index finger and. third finger.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site pain, Muscle spasms, Vomiting
Clinical narrative: Multiple episodes of vomiting and diarrhea starting approximately 7.5 hours after administration lasting throughout the night until around 0500 the next day; significant muscle cramping (Potassium depletion?), pain at the injection site still occurring; headache,
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient presented the next morning with a swollen area and pain around the injection site. She also found discomfort raising arm above her head. Recommended patient take some Diphenhydramine and contact her PCP for follow up. I have tried to follow up with her also with no response at this time.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hot flush, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid red, swollen, and warm. Redness looked to be traveling/spreading. Hot flushes. Advised medical attention patient said that she would go see a Dr. on Monday
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle pain, body aches, mild fever, tiredness
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: First got arm soreness, which got progressively worse. By 11pm, I couldn't move my left arm due to pain.  I also got fever and chills starting about 7pm. Joint pain in my right knee and fingers in my right hand started about 11pm. I woke up twice from arm pain during the night. I could  move the arm a little better after 24 hours, but it is still incredibly sore. I developed a very bad headaches approximately 30 hours after the shot.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: First got arm soreness, which got progressively worse. By 11pm, I couldn't move my left arm due to pain.  I also got fever and chills starting about 7pm. Joint pain in my right knee and fingers in my right hand started about 11pm. I woke up twice from arm pain during the night. I could  move the arm a little better after 24 hours, but it is still incredibly sore. I developed a very bad headaches approximately 30 hours after the shot.
Age: 1.0
Sex: M
Vaccine: FLUA3, MMR, VARCEL
Symptoms: Condition aggravated, Hypersensitivity, Rash, Respiratory tract congestion, Swelling face
Clinical narrative: We had an allergic reaction to something 3 days later, face swelled mildly,  got a rash on face. But his congestion worsened. Yes
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Fibromyalgia, Pain, Pain in extremity
Clinical narrative: Started with calf pain then progressed to widespread pain Fibromyalgia diagnosis in 2014
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test negative, Biopsy skin abnormal, Dermatitis atopic, Dry skin, Insomnia
Clinical narrative: Started with some itchy dry skin patches a few weeks after shot 1 on 10/24/19.   Within a week of having the second vaccine on 12/27/2019, the rash completely covered my torso then radiated down my limbs and onto my head over the next month.  The itching was unbearable to the point where I couldn't sleep at all. I initially saw my primary care physician on ~12/30 or 12/31, who prescribed oral steroids.  These had no effect on the rash or itching.  I also saw my dermatologist who gave me a steroid shot, and another shot the following week.   He then performed a biopsy. Three months after my second vaccine, the rash is not quite as widespread, but I am still covered with scabs and continue to itch all the time.  It has effected my quality of life significantly.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Quality of life decreased, Rash, Scab
Clinical narrative: Started with some itchy dry skin patches a few weeks after shot 1 on 10/24/19.   Within a week of having the second vaccine on 12/27/2019, the rash completely covered my torso then radiated down my limbs and onto my head over the next month.  The itching was unbearable to the point where I couldn't sleep at all. I initially saw my primary care physician on ~12/30 or 12/31, who prescribed oral steroids.  These had no effect on the rash or itching.  I also saw my dermatologist who gave me a steroid shot, and another shot the following week.   He then performed a biopsy. Three months after my second vaccine, the rash is not quite as widespread, but I am still covered with scabs and continue to itch all the time.  It has effected my quality of life significantly.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: about 24 hours after vaccination pt reported itching, redness and inflammation at site, reported headache and fatigue. 3 days after feels much better injection site is sore if pressed. only treatment Benadryl and rest
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus
Clinical narrative: about 24 hours after vaccination pt reported itching, redness and inflammation at site, reported headache and fatigue. 3 days after feels much better injection site is sore if pressed. only treatment Benadryl and rest
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, induration, pain, and warmth at site of injection. Pt also had fever of 100.0 po but that has now resolved.  Reaction continues to spread.  Vaccine give 5 days ago.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Erythema, swelling, induration, pain, and warmth at site of injection. Pt also had fever of 100.0 po but that has now resolved.  Reaction continues to spread.  Vaccine give 5 days ago.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: PATIENT WAS DIAGNOSED WITH SHINGLES 1 WEEK AFTER RECEIVING SHINGRIX VACCINE ... PRESENTED WITH LESIONS ON ABDOMEN AND TRUNK AND BACK
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lip swelling, Pain, Paraesthesia oral
Clinical narrative: Patient came to pharmacy on 3/14/2020 stating that she now has shingles even though she rec'd 2 shots of the shingrix.  On the 2nd shot of shingrix given on 2/15/2020, she felt body aches, soreness, and tingling of her lips (some swelling) the day after (2/16/2020). Patient is currently taking valcyclovir for shingles symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient presented to doctor's office with a red, heated area beneath the injection site on her upper left arm.  She stated that it began the day after the vaccine was administered, and she sought medical treatment 3 days after the vaccine was administered. The doctor that she visited decided to treat for potential cellulitis, and treated this with sulfamethoxazole/trimethoprim.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash pruritic
Clinical narrative: Presented to pharmacy 3/14 with redness / rash at injection site. Patient was told to monitor but redness at injection site was normal. n 3/15 presented to pharmacy with a large upper body rash and rash on neck. Rash is itchy.
Age: 1.17
Sex: M
Vaccine: HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Agitation, Decreased appetite, Diarrhoea, Irritability, Vomiting
Clinical narrative: Beginning 24 hours after the vaccines, the patient began throwing up once a day for 5 days.  He was fussy and distraught especially two days after the vaccines.  He had a low appetite and was not himself.  He also had 4 diapers of diarrhea.    He did not have a fever or difficulty sleeping thankfully.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Erythema, Pain, Swelling
Clinical narrative: chills, bodyaches, redness and swelling that is still present 5 days after administration. Per the patient, she is a nurse and it looks like cellulitis and the redness is spreading
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: vomited water all day long.  Headache the night before after this second booster vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle injury, Ultrasound scan
Clinical narrative: Muscle injury that radiates to the back of shoulder and finger tips.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, X-ray
Clinical narrative: SHARP PAIN IN LEFT ARM
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Magnetic resonance imaging whole body
Clinical narrative: Contracted Guillian Barre Syndrome body paralysis. Received seven treatments of IV IG (Immunoglobulin). In ICU for 106 days. Currently in rehabilitation to learn to walk unassisted.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Scan brain, Walking aid user
Clinical narrative: Contracted Guillian Barre Syndrome body paralysis. Received seven treatments of IV IG (Immunoglobulin). In ICU for 106 days. Currently in rehabilitation to learn to walk unassisted.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive
Clinical narrative: (1) Local Redness & Swelling 3/6 - 3/9  (2) Sudden onset Pulmonary Edema & CHF 2/15 6 AM. Healthy when I went to bed 2/14.  (3) Treated with Bumex IV, Complete work up CT, Chest X Ray, Echo, V-Q Test, labs, Cardiac Cath
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive, Catheterisation cardiac, Chest X-ray, Computerised tomogram, Echocardiogram
Clinical narrative: (1) Local Redness & Swelling 3/6 - 3/9  (2) Sudden onset Pulmonary Edema & CHF 2/15 6 AM. Healthy when I went to bed 2/14.  (3) Treated with Bumex IV, Complete work up CT, Chest X Ray, Echo, V-Q Test, labs, Cardiac Cath
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Laboratory test, Pulmonary oedema, Swelling, Ventilation/perfusion scan
Clinical narrative: (1) Local Redness & Swelling 3/6 - 3/9  (2) Sudden onset Pulmonary Edema & CHF 2/15 6 AM. Healthy when I went to bed 2/14.  (3) Treated with Bumex IV, Complete work up CT, Chest X Ray, Echo, V-Q Test, labs, Cardiac Cath
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Blood bicarbonate normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: vaccine received at 5:30pm on Thursday evening.  By 10:00pm patient put herself to bed stating she was extremely tired and wasn't feeling well.  Friday morning around 5:00am she had a fever of 99.7.  8:30am she was talking to me (mom) and said how poorly she was feeling, then passed out in front of me- we were in the bathroom, she hit here head on the wall, toilet, wall, and then floor. Her eyes rolled back, her breathing went from raspy to silent, she started convulsing. Then she shot straight up in a panic completely confused about what had happen. She had no memory of it. She was transported by ambulance to the hospital. She had another episode in the ER.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Blood urea normal, Chest X-ray normal, Pregnancy test negative, Pyrexia, Syncope
Clinical narrative: vaccine received at 5:30pm on Thursday evening.  By 10:00pm patient put herself to bed stating she was extremely tired and wasn't feeling well.  Friday morning around 5:00am she had a fever of 99.7.  8:30am she was talking to me (mom) and said how poorly she was feeling, then passed out in front of me- we were in the bathroom, she hit here head on the wall, toilet, wall, and then floor. Her eyes rolled back, her breathing went from raspy to silent, she started convulsing. Then she shot straight up in a panic completely confused about what had happen. She had no memory of it. She was transported by ambulance to the hospital. She had another episode in the ER.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: White blood cell count increased
Clinical narrative: vaccine received at 5:30pm on Thursday evening.  By 10:00pm patient put herself to bed stating she was extremely tired and wasn't feeling well.  Friday morning around 5:00am she had a fever of 99.7.  8:30am she was talking to me (mom) and said how poorly she was feeling, then passed out in front of me- we were in the bathroom, she hit here head on the wall, toilet, wall, and then floor. Her eyes rolled back, her breathing went from raspy to silent, she started convulsing. Then she shot straight up in a panic completely confused about what had happen. She had no memory of it. She was transported by ambulance to the hospital. She had another episode in the ER.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Blood test normal, Breath sounds abnormal, Chest X-ray normal, Confusional state, Electrocardiogram normal
Clinical narrative: vaccine received at 5:30pm on Thursday evening.  By 10:00pm patient put herself to bed stating she was extremely tired and wasn't feeling well.  Friday morning around 5:00am she had a fever of 99.7.  8:30am she was talking to me (mom) and said how poorly she was feeling, then passed out in front of me- we were in the bathroom, she hit here head on the wall, toilet, wall, and then floor. Her eyes rolled back, her breathing went from raspy to silent, she started convulsing. Then she shot straight up in a panic completely confused about what had happen. She had no memory of it. She was transported by ambulance to the hospital. She had another episode in the ER.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Eye movement disorder, Fatigue, Head injury, Loss of consciousness, Malaise
Clinical narrative: vaccine received at 5:30pm on Thursday evening.  By 10:00pm patient put herself to bed stating she was extremely tired and wasn't feeling well.  Friday morning around 5:00am she had a fever of 99.7.  8:30am she was talking to me (mom) and said how poorly she was feeling, then passed out in front of me- we were in the bathroom, she hit here head on the wall, toilet, wall, and then floor. Her eyes rolled back, her breathing went from raspy to silent, she started convulsing. Then she shot straight up in a panic completely confused about what had happen. She had no memory of it. She was transported by ambulance to the hospital. She had another episode in the ER.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Memory impairment, Panic reaction, Pyrexia, Seizure
Clinical narrative: vaccine received at 5:30pm on Thursday evening.  By 10:00pm patient put herself to bed stating she was extremely tired and wasn't feeling well.  Friday morning around 5:00am she had a fever of 99.7.  8:30am she was talking to me (mom) and said how poorly she was feeling, then passed out in front of me- we were in the bathroom, she hit here head on the wall, toilet, wall, and then floor. Her eyes rolled back, her breathing went from raspy to silent, she started convulsing. Then she shot straight up in a panic completely confused about what had happen. She had no memory of it. She was transported by ambulance to the hospital. She had another episode in the ER.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Red and swollen R upper arm
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a nurse referring to a 12 month old male patient. Information about patient's medical history, concurrent conditions and drug reactions/allergies was not reported.  On 03-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S015464 with an expiry date of 20-MAY-2021 (strength, dose, route and anatomical location were not provided) for prophylaxis (product storage error) which was reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion at 15.6 degree Fahrenheit for a time frame of 1 hour 16 minutes. There was no previous temperature excursion involved. The digital data logger was involved. It was reported that the patient did not experience any adverse event. There was no product quality complaint (PQC) associated with this report.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Injection site mass
Clinical narrative: A lump about a quarter inch by quarter inch in size developed under the skin at injection site; Patient received the second dose of Gardasil 9 late, with "about 6 months gap" between the first and second dose; This spontaneous report as received from a consumer referring to her daughter a 17 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. Drug reactions or allergies included amoxicillin and singulair (captured in case # 2003USA005460).  On an unknown date in 2019 (reported as "about 6 months gap"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 2 (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.   On 03-FEB-2020, the patient was vaccinated with the 2 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for cancer prevention.   On 08-FEB-2020, the patient developed a lump about a quarter inch by quarter inch in size developed under the skin at injection site; the lump can not be seen but can be palpated (Injection site mass). There was no pain, no swelling, no redness at injection site. It was also mentioned that the patient received her second dose late with "about 6 months gap" between the first and second dose. The outcome of injection site mass was reported as not resolved. The causality assessment was not provided.  This is one of two cases for the same patient.; Sender's Comments:  US-009507513-2003USA005460:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored VARIVAX was administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  Approximately on 01-MAR-2020, reported as "maybe 2 days ago", the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis lot # S020464 , that has been verified to be a valid lot number, expiration date on 02-JUL-2021 (strength, dose number, anatomical location, route of administration were not reported).  The vaccine was administered concomitantly with the sterile diluent (MERCK STERILE DILUENT) lot # S038150 with expiration date on 07-AUG-2022. The temperature of storage was  12 °c for a timeframe of 81 hours without previous temperature excursion and was called because a digital data logger.No adverse effects were reported
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Plaintiff was treated for zoster-related injuries; Information has been received on 04-MAR-2020 from a lawyer regarding a case in litigation. This case refers to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 07-DEC-2015, pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a local pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, pt was treated by a healthcare provider at a medical office for zoster-related injuries (herpes zoster). As direct and proximate result of use of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the pt was not recovered from the event and it was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received on 04-MAR-2020 from a lawyer regarding a case in litigation. This case refers to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2015, pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a local pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, pt was treated by a healthcare provider at a medical office for shingles (herpes zoster). As direct and proximate result of use of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the pt was not recovered from the event and it was related to zoster vaccine live (ZOSTAVAX).
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received pneumococcal vaccine on 03-MAY-2006, 14-APR-2015 and 12-SEP-2017; This spontaneous report has been received from an other health professional referring to a 67 year old male patient. The patient's medical history, concurrent condition and concomitant medication were not reported.     On 03-MAY-2006 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis. On 14-APR-2015 the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (dose 0.5 ml; batch/lot# and expiration date were unknown) intramuscularly in the left deltoid. On 12-SEP-2017 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose 0.5 ml) intramuscularly in the right deltoid for prophylaxis (inappropriate schedule of vaccine administration).  The case is linked to case# US-009507513-1811USA010091 due to the same patient.; Sender's Comments:  US-009507513-1811USA010091:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Bad case of shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On around 02-JUN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine heath maintenance and for the prevention of shingles (herpes zoster) (dose, strength, route of administration, expiration date and lot number were not reported).  On an unspecified date shortly after vaccination, the patient suffered a bad case of shingles. According to reporter, the patient sustained severe and permanent personal injuries. She suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoinment of life, physical impairment and injury. Additionally, suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages.   At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX). The event shingles was determined to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On around 24-MAR-2015, the patient was vaccinated as prescribed with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and/or zoster-related conditions (dose, strength, route of administration, expiration date and lot number were not reported).  On an unspecified date, the patient developed shingles and was treated by a doctor in an hospital. According to reporter, as a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of pre-existing conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future.  At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: postherpetic polyneuropathy; herpes zoster; This initial spontaneous report was received from a lawyer on 06-MAR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 02-MAR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for the prevention of shingles (herpes zoster). On an unknown date (also reported das "shortly after receiving the vaccine"), the patient suffered sudden pain in right flank and abrupt onset of a skin rash. The patient was diagnosed with herpes zoster with postherpetic polyneuropathy. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the vaccination, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.