chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Chills, Dyspepsia, Feeling hot, Influenza like illness
Clinical narrative: The next morning after the shot the patient experienced extreme heat in head and neck as well as flu like symptoms with chills. Nerve endings on fire in the stomach and under the breast area. Very painful to the touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: The next morning after the shot the patient experienced extreme heat in head and neck as well as flu like symptoms with chills. Nerve endings on fire in the stomach and under the breast area. Very painful to the touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Feeling hot, Headache, Middle insomnia
Clinical narrative: Began with very sore arm/shoulder at and around the vaccination site. No noticeable redness or swelling. Took ibuprofen about 10:00 PM just before going to bed for the night. Woke up from sound sleep about 4-4:30 AM. Arm throbbing, head throbbing, muscle aches everywhere. Took more ibuprofen. Restless night, got out of bed about 7:30 AM. Severe muscle aches, headache, nausea, sore arm, (but less severe). Took temperature 101.2 F. Took ibuprofen. Went back to bed. Eventually got up and laid on the sofa. Drank coffee, but still nauseous. Continued ibuprofen every 3-4 hours throughout the day. Able to have a bowl of cereal with milk around noon. Feeling a little better for a short time. Thought maybe I would be able to shower and shop as planned. Took temp. 99.8 F. About 1:00 PM feeling tired, hot and achy, temp back to 101 F. back to sleep. Continued like this all day. Went to sleep for good about 9:30 PM. Woke on 6/29/2018 feeling much improved. Carried out normal activities. A little achy late in the day, temp. 99.2 F. I did not expect this. I am glad I didn't have to work on the day after the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Restlessness
Clinical narrative: Began with very sore arm/shoulder at and around the vaccination site. No noticeable redness or swelling. Took ibuprofen about 10:00 PM just before going to bed for the night. Woke up from sound sleep about 4-4:30 AM. Arm throbbing, head throbbing, muscle aches everywhere. Took more ibuprofen. Restless night, got out of bed about 7:30 AM. Severe muscle aches, headache, nausea, sore arm, (but less severe). Took temperature 101.2 F. Took ibuprofen. Went back to bed. Eventually got up and laid on the sofa. Drank coffee, but still nauseous. Continued ibuprofen every 3-4 hours throughout the day. Able to have a bowl of cereal with milk around noon. Feeling a little better for a short time. Thought maybe I would be able to shower and shop as planned. Took temp. 99.8 F. About 1:00 PM feeling tired, hot and achy, temp back to 101 F. back to sleep. Continued like this all day. Went to sleep for good about 9:30 PM. Woke on 6/29/2018 feeling much improved. Carried out normal activities. A little achy late in the day, temp. 99.2 F. I did not expect this. I am glad I didn't have to work on the day after the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Began with very sore arm/shoulder at and around the vaccination site. No noticeable redness or swelling. Took ibuprofen about 10:00 PM just before going to bed for the night. Woke up from sound sleep about 4-4:30 AM. Arm throbbing, head throbbing, muscle aches everywhere. Took more ibuprofen. Restless night, got out of bed about 7:30 AM. Severe muscle aches, headache, nausea, sore arm, (but less severe). Took temperature 101.2 F. Took ibuprofen. Went back to bed. Eventually got up and laid on the sofa. Drank coffee, but still nauseous. Continued ibuprofen every 3-4 hours throughout the day. Able to have a bowl of cereal with milk around noon. Feeling a little better for a short time. Thought maybe I would be able to shower and shop as planned. Took temp. 99.8 F. About 1:00 PM feeling tired, hot and achy, temp back to 101 F. back to sleep. Continued like this all day. Went to sleep for good about 9:30 PM. Woke on 6/29/2018 feeling much improved. Carried out normal activities. A little achy late in the day, temp. 99.2 F. I did not expect this. I am glad I didn't have to work on the day after the vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Mild headache; mild nausea; soreness at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient got vaccinated on 06/26/18.Patient came to the Pharmacy on 06/28/18 with a complaint of soreness of the left arm and also a fever.I promptly advised pt to see primary care  physician.Patient went to urgent care today per pt where she was taken care of cos fever per Patient went over 103.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pyrexia, Skin warm, Tenderness
Clinical narrative: 6 cm hive, Tenderness to right arm, warm to touch, fever, difficulty raising arm, and numbness to right hand.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: 6 cm hive, Tenderness to right arm, warm to touch, fever, difficulty raising arm, and numbness to right hand.
Age: 97.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Patient arrived at geriatric clinic for lower back pain and was worked up for preventative health. He was indicated for PNEUMOVAX 23 having received PREVNAR 13 on year prior. After arriving to the ER for what seemed to be a hypersensitivity reaction, he was admitted for concern of cellulitis. When blood cultures showed no growth and patient's symptoms were resolving, he was discharged. Redness, pain/tenderness at injection site.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patient received 2 vaccinations at same time. Both vaccines were administered in (L) deltoid. Patient reports localized bruising/redness on 6/29/18. Patient reports bruising/redness presented same day vaccine was administered. The reaction presented 2-3 hours after administration and progressively got worse over 2-3 days. Patient reports injection site was painful as well for 1 day, localized bruising/redness presented as 2 bruises. Bruise 1 presents on upper deltoid about 1 inch in size. Bruise 2 presents 2-3 inches below injection site about 4 inches in size.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Peripheral swelling
Clinical narrative: Swollen arm. Slight, small bruise (about 1 inch) at site of the drug administration. It happened right after the drug was administered. We recommended ice pack and BENADRYL for treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. here with (L) thigh swollen and red and hot since yesterday and day of vaccine 6/27. Received DTaP and MMR at the site (2 days ago). No fever, denies pain, normal gait, no hx reaction in the past to any vaccines. Plan: Diphenhydramine 12.5 mp/5 ml liquid-7 ml-po 3 times per day for 5 days prn allergic reaction. Ice. F/U ER if worsening.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch to anterior surface of left thigh tender approx. 10cm in diameter Patient Diagnosed with Cellulitis prescribed CLEOCIN 75/5 10ml TID for 10 days.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Muscle pain, muscle ache on left hand.
Age: 28.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Hep B vaccine initially given on 06/27/18, second Hep B vaccine given on 6/29/18. No adverse reactions noted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Chills; Severe headache, 10 to 30 hours post vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Body temperature increased, Chills, Claustrophobia, Fatigue
Clinical narrative: On June 28, I woke up feeling nauseated, chilled and very tired and sluggish as described in CDC information vaccine sheet. Went to dental appointment between 9:00 and 11:00 for initial crown repair on two teeth and was only given NOVOCAIN. At noon, I walked with friends over the noon hour, but did not feel well and did not feel like climbing stairs or going up hills. When I returned to office, I felt as though I was going to pass out in elevator and felt very claustrophobic. After getting off elevator and getting back to my office in another building, I placed my head down on desk for a few minutes because I was not feeling well and 10 minutes later, called a family member to pick me up and take me home. When I arrived home, I slept for approximately 4 hours, woke up and ate dinner. After dinner, I measured my temperature which was 99.6 and took TYLENOL. I also noticed that my lymph nodes under my right arm ached. I returned to bed. Felt better than the prior day on Friday, but still had ache in right armpit lymph node area and also noted a slight pain in my upper spinal cord area. I decided to go to work and walked with friends at lunch and did fine with that. I did still feel chilled; however, on Friday. I did not report this to my PCP, Dr., but will next week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Lymph node pain, Malaise, Nausea, Sluggishness
Clinical narrative: On June 28, I woke up feeling nauseated, chilled and very tired and sluggish as described in CDC information vaccine sheet. Went to dental appointment between 9:00 and 11:00 for initial crown repair on two teeth and was only given NOVOCAIN. At noon, I walked with friends over the noon hour, but did not feel well and did not feel like climbing stairs or going up hills. When I returned to office, I felt as though I was going to pass out in elevator and felt very claustrophobic. After getting off elevator and getting back to my office in another building, I placed my head down on desk for a few minutes because I was not feeling well and 10 minutes later, called a family member to pick me up and take me home. When I arrived home, I slept for approximately 4 hours, woke up and ate dinner. After dinner, I measured my temperature which was 99.6 and took TYLENOL. I also noticed that my lymph nodes under my right arm ached. I returned to bed. Felt better than the prior day on Friday, but still had ache in right armpit lymph node area and also noted a slight pain in my upper spinal cord area. I decided to go to work and walked with friends at lunch and did fine with that. I did still feel chilled; however, on Friday. I did not report this to my PCP, Dr., but will next week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: On June 28, I woke up feeling nauseated, chilled and very tired and sluggish as described in CDC information vaccine sheet. Went to dental appointment between 9:00 and 11:00 for initial crown repair on two teeth and was only given NOVOCAIN. At noon, I walked with friends over the noon hour, but did not feel well and did not feel like climbing stairs or going up hills. When I returned to office, I felt as though I was going to pass out in elevator and felt very claustrophobic. After getting off elevator and getting back to my office in another building, I placed my head down on desk for a few minutes because I was not feeling well and 10 minutes later, called a family member to pick me up and take me home. When I arrived home, I slept for approximately 4 hours, woke up and ate dinner. After dinner, I measured my temperature which was 99.6 and took TYLENOL. I also noticed that my lymph nodes under my right arm ached. I returned to bed. Felt better than the prior day on Friday, but still had ache in right armpit lymph node area and also noted a slight pain in my upper spinal cord area. I decided to go to work and walked with friends at lunch and did fine with that. I did still feel chilled; however, on Friday. I did not report this to my PCP, Dr., but will next week.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Burning sensation, Chills
Clinical narrative: Shivering, face burning up, every joint in my body hurt.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity
Clinical narrative: Shingles shot... pain left arm, level 7...... severe headache, already into 2nd day........joint aches (gone by second day..........very tired throughout the day.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Upset stomach, chills, fever, head ache,muscleache, and tiredness.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Upset stomach, chills, fever, head ache,muscleache, and tiredness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Muscle spasms, Pain
Clinical narrative: Body pain particularly joints, vomiting, cramping and diarrhea, headache.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Body pain particularly joints, vomiting, cramping and diarrhea, headache.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Rash, Rash pruritic
Clinical narrative: Hard itchy bumps on back with no concurrent redness. Started 5-7 days after vaccination and lasted over 30 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash that started around injection site the night of vaccination or morning after and lasted 5 to 7 days.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Inflammation
Clinical narrative: Labored breathing, unable to get a deep breath, and the feeling of heavy weight on my chest.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Labored breathing, unable to get a deep breath, and the feeling of heavy weight on my chest.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No event so far but Child was given MMR and MMRV along with Hep A at the same time (MMRV was administered instead of Varicella)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient reports severe burning down the spinal cord for several days and is still happening as of 6-29. She went to the Dr. and received cyclobenzaprine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had come in today, after talking to a nurse hotline about a possible allergic reaction to the vaccine. I guess the symptoms had been worse at first the day after the shot, but had decreased in severity when patient presented. Red left deltoid around injection area, about 6 inches in diameter. Patient reported that it felt hot and was itchy, but no other central symptoms and after using a topical gel (pt was unsure what she used) it had helped with the itchiness. Instructed patient to follow up with MD on Monday about event (and possibility of second shot in 2-6 months) and to take an anti-histamine for further symptom reduction.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: My wife fainted the day after having both the first and second shingles vaccine. The first time was blamed on low blood pressure from being overheated, but the second time was unrelated to heat. She does have chronically low blood pressure. First event in April resulted in visit to emergency room, x-rays for spinal injury from fall. No fracture, but recovery from muscle sprain still on-going after 10 weeks. Did not go to emergency room after second event.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Nausea, Pruritus, Pyrexia
Clinical narrative: Rash/itchy legs on 6/26/18, cold/shivering/chills on 6/27/18, fever (100.9 degrees F) on 6/27/18, slight nausea 6/28/18.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash/itchy legs on 6/26/18, cold/shivering/chills on 6/27/18, fever (100.9 degrees F) on 6/27/18, slight nausea 6/28/18.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Red raised lesion that has continued to expand on right deltoid that is now as big as a baseball. Warm to the touch. Pt complains of fever and malaise. Lower than normal blood pressure. Soreness but no known decrease in arm mobility. Because of the presentation of adverse effect and continued expansion along with patient reported fever, the patient was referred to a walk in clinic to be evaluated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia, Skin lesion
Clinical narrative: Red raised lesion that has continued to expand on right deltoid that is now as big as a baseball. Warm to the touch. Pt complains of fever and malaise. Lower than normal blood pressure. Soreness but no known decrease in arm mobility. Because of the presentation of adverse effect and continued expansion along with patient reported fever, the patient was referred to a walk in clinic to be evaluated.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Insomnia, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Had shot approx. between 8-9 a.m. Sometime during the day my shoulder started to ache like it usually does with other shots. Certainly around 3 pm it seemed achier than usual. At 6 p.m. it was really sore and my shoulder was stiff and it hurt when I moved my arm. The soreness and stiffness seemed to be going up the left side of my neck. Had trouble going to sleep at night because my shoulder was throbbing. About 11 p.m. I felt a little chill. About 1 a.m. (3/24/2018) my shoulder stopped throbbing. About 4 a.m. I woke up a little sweaty; shoulder still a little stiff and achy but a lot better. 3/24 & 3/25 It felt more like "normal" post-vaccination soreness. Some "point" tenderness on touching at anterior acromioclavicular joint. 3/29/18: No more pain or tenderness.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Neck pain, Pain, Tenderness
Clinical narrative: Had shot approx. between 8-9 a.m. Sometime during the day my shoulder started to ache like it usually does with other shots. Certainly around 3 pm it seemed achier than usual. At 6 p.m. it was really sore and my shoulder was stiff and it hurt when I moved my arm. The soreness and stiffness seemed to be going up the left side of my neck. Had trouble going to sleep at night because my shoulder was throbbing. About 11 p.m. I felt a little chill. About 1 a.m. (3/24/2018) my shoulder stopped throbbing. About 4 a.m. I woke up a little sweaty; shoulder still a little stiff and achy but a lot better. 3/24 & 3/25 It felt more like "normal" post-vaccination soreness. Some "point" tenderness on touching at anterior acromioclavicular joint. 3/29/18: No more pain or tenderness.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling near injection site on right arm medial side.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Insomnia
Clinical narrative: 6/27/18 patient received shingles shot. 6/29/18 patient experience redness, pain at site of injection and unable to sleep at night. Patient used TYLENOL and/or ADVIL, and placed ice on site of injection 15 min on and then off 4 times daily. 6/30/18 patient still has redness and pain and she went to see doctor. 6/30/18 doctor prescribed amoxicillin 500 mg 3 times daily for 10 days and told her to wait 6 months for 2nd shingles shot and told she might experience the same reaction again.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Painful, itchy rash on back/left side.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling abnormal, Rash, Skin ulcer
Clinical narrative: Painful, itchy rash on back/left side.
Age: 76.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Fatigue, Muscular weakness, Myalgia
Clinical narrative: Muscle weakness and soreness. Patient feels very tired and without energy.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Red, swollen rash on upper arm, approximately 6 inches across. Warm to the touch and slightly swollen but no pain or irritation. Pt went to ER before consulting pharmacist.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and tenderness in bicep of injected arm, away from injection site at deltoid; unresponsive to NSAID and antihistamine therapy; worsening from Saturday through Monday. No symptoms at deltoid, nor on any other body parts.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pruritus, Injection site rash
Clinical narrative: Patient developed rash on her left arm just below the site of injection, said that it was not too sore, no heat radiating from the site, just a little bit itchy.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash on upper arm, approximately 6 inches across below injection site. Rash slightly warm to the touch, not painful or irritating. Also soreness of deltoid muscle at injection site persisting for a few days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient awoke the day after the immunization and had developed a golf ball sized spot on her arm,  the spot was red, slightly raised, with some heat coming off of it, and "a little" sore per the patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: Day 1 - very slight nausea, fatigue. Day 2 - fatigue, shivers, fever (101 degrees), lack of appetite. Day 3 - no symptoms.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: PT WAS FINE ON DAY 1. SLIGHTLY SORE ON DAY 2, SORER ON DAY 3, ON DAY 4 SHOULDER AREA WAS HOT TO TOUCH, RED AND SLIGHTLY SWOLLEN.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Red island like rash around site of immunization. Fever that abated with use of Ibuprofen, and rash was warm and caused pruritus.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia, Skin reaction, Swelling
Clinical narrative: PATIENT REPORTS HAVING FEVER AND INJECTION SITE REACTION THE NIGHT AFTER THE IMMUNIZATION ON 6/27. ON 6/30/18 PATIENT CALLED SAYING FEVER HAS RESOLVED BUT ARE STILL SWOLLEN AND RED.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Skin warm, Swelling
Clinical narrative: 6/28 red, swollen. 6/29 red, swollen. 6/30 increasing in size, red, swollen, welts, warm to touch. MD notes: Onset of erythema and induration right upper arm secondary to tetanus vaccination.  Md ordered KEFLEX and ATARAX.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: 6/28 red, swollen. 6/29 red, swollen. 6/30 increasing in size, red, swollen, welts, warm to touch. MD notes: Onset of erythema and induration right upper arm secondary to tetanus vaccination.  Md ordered KEFLEX and ATARAX.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash generalised
Clinical narrative: Our son has full body rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: I received the SHINGRIX Injection on 06/12/2018 at approx. 4:40 PM. Previously, 5 years ago in 2013, I had the ZOSTAVAX Live injection and had no side effects. I kept moving my R arm and put ice on it and kept ice on it until I went to bed that night. The spot where I had the injection was very sore, swollen, deep red/purple in color, and felt very warm to the touch. The next morning when I woke up, a small blister appeared on the red spot on my R arm. Each hour, the blister grew to 2 large blisters and eventually, it grew in size until it was almost the size of the top of a COKE can. I went to healthcare facility to have a nurse look at it. They advised me to take Diphenhydramine and Cetirizine Hydrochloride. This didn't really help at all. Eventually, the blister got so full, that it popped. I put NEOSPORIN on it daily with a larger BAND-AID to keep it protected during the day. At night, I removed the BAND-AID so that it could breathe. After 2.5 weeks it is now dry and healing.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, MMRV, UNK
Symptoms: Asthma, Condition aggravated, Ear infection, Injection site urticaria, Malaise
Clinical narrative: Fever from about hour after shots given lasted for four days, ear infections in Both ears no previous signs of it in either ear. Hives all over his arms back face legs, hives are still present today. Son also became very ill affecting asthma bringing lost of congestion and these symptoms are still present as well. He was given 6 vaccines not given paperwork in the injection clinic.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, MMRV, UNK
Symptoms: Pyrexia, Respiratory tract congestion, Urticaria
Clinical narrative: Fever from about hour after shots given lasted for four days, ear infections in Both ears no previous signs of it in either ear. Hives all over his arms back face legs, hives are still present today. Son also became very ill affecting asthma bringing lost of congestion and these symptoms are still present as well. He was given 6 vaccines not given paperwork in the injection clinic.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Softball size red spot. Raised and hot - started approx. 24 hrs after shot.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness at injection site. Tenderness / pain at injection site. Mild fever, Mild headache.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Pain
Clinical narrative: Chills,profuse sweating, soreness throughout body, weakness.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Blister, Induration, Inflammation, Pain, Pruritus
Clinical narrative: Inflammation, swelling, hardness, blistering, pain, itching. Treated with 1 tsp ZYRTEC Children's oral solution 6/30/2018. 7:00 a.m swelling and inflammation had decreased, but had multiple large blisters.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Swelling
Clinical narrative: Inflammation, swelling, hardness, blistering, pain, itching. Treated with 1 tsp ZYRTEC Children's oral solution 6/30/2018. 7:00 a.m swelling and inflammation had decreased, but had multiple large blisters.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm, headaches, flu like symptoms throughout body. Fever, sore muscles throughout.
Age: 43.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Malaise, Nausea, Pallor, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: After 1 minute after I injected the vaccine into her left arm 1 inch apart from the Tdap Vaccine (Boostrix) she started having a reaction to the vaccine. I was going to inject the MMR vaccine into her right arm as she was getting 3 vaccines in total. She first said she wasn't feeling well and then her face turned white and her eyes opened wide and she said she feels nauseous. I asked her to stay seated and breathe and then she said that she cannot see anymore. I told her that I am going to call 911 and she initially said no and then she stopped breathing while still awake, her ribcage was not moving and she stopped responding and her husband told me it is okay to call 911. I called them and while they were on the way, her husband and I had to talk to her and shake her under she drew a breath every 1 minute. I had the EPIPEN ready incase she totally stopped breathing. The paramedics came and took her vital signs and said that all her vitals are low and she needs to go to the hospital but she refused as she didn't have insurance. They put an oxygen mask on her and she started to feel better. After 15 minutes from the start of the reaction, she was responsive again and left the store. I refused to give her the third vaccine even though she insisted to take it. I called the patient later on the day and the next day to check on her and her husband picked up and said she was doing fine.
Age: 43.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Vaccination complication, Visual impairment
Clinical narrative: After 1 minute after I injected the vaccine into her left arm 1 inch apart from the Tdap Vaccine (Boostrix) she started having a reaction to the vaccine. I was going to inject the MMR vaccine into her right arm as she was getting 3 vaccines in total. She first said she wasn't feeling well and then her face turned white and her eyes opened wide and she said she feels nauseous. I asked her to stay seated and breathe and then she said that she cannot see anymore. I told her that I am going to call 911 and she initially said no and then she stopped breathing while still awake, her ribcage was not moving and she stopped responding and her husband told me it is okay to call 911. I called them and while they were on the way, her husband and I had to talk to her and shake her under she drew a breath every 1 minute. I had the EPIPEN ready incase she totally stopped breathing. The paramedics came and took her vital signs and said that all her vitals are low and she needs to go to the hospital but she refused as she didn't have insurance. They put an oxygen mask on her and she started to feel better. After 15 minutes from the start of the reaction, she was responsive again and left the store. I refused to give her the third vaccine even though she insisted to take it. I called the patient later on the day and the next day to check on her and her husband picked up and said she was doing fine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Muscle spasms, Nausea
Clinical narrative: Nausea and vomiting, shivers, headache, pain at injection site, leg and feet cramps.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting, shivers, headache, pain at injection site, leg and feet cramps.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swelling of the face around cheeks and chin - right side greater than left. No pain or discomfort.  Just swelling.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported some pain, redness, warmth at injection site, slight head ache, some upset stomach with no vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: The next day I was extremely tired, had muscle aches, and headache. I couldn't do anything except lay on the couch for the entire day. The next day I was much better. This was my first SHINGRIX shot. I subsequently had a second SHINGRIXx shot on June 29, 2018 and had the same reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Pain, Peripheral swelling
Clinical narrative: Arm swollen. Red color around injection site. Black area in center. Soreness.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Middle insomnia, Tremor
Clinical narrative: Patient states they woke up in the middle of the night shaking unconrollably for about 20 minutes without control of his body. States it was almost as if he was having a seizure, but had never experienced this before in his life. Patient states they felt "beat up" this morning and quite exhausted after the event, but has had no other lasting side effects. I instructed the patient to partner with their doctor to determine if any follow up is required and whether his doctor wants him to get the second shot in 2 months when it is due.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest X-ray normal, Computerised tomogram normal, Laboratory test normal, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: On 06/28/2018 two different Meningococcal/BEXSERO shots were given. One in each arm. On 06/29/2018 around 11:45 a.m. my child's right hand started curling up towards her chest and she then became unresponsive for what seemed like several minutes but probably a minute at the most. She regained consciousness and did not remember anything that happened during the twitching and black out. She was rushed to the ER and several tests were done. CT Scan, lab work, chest Xrays, 2 rounds of Saline IV. All tests were negative and the only explanation was an adverse reaction to the vaccinations and fainting. The pediatrician was called. To say the least he was baffled and stated "He never heard of anything like that ever happening ". The ER physician advised us to follow up with her pediatrician.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Muscle twitching, Syncope, Unresponsive to stimuli, Vaccination complication
Clinical narrative: On 06/28/2018 two different Meningococcal/BEXSERO shots were given. One in each arm. On 06/29/2018 around 11:45 a.m. my child's right hand started curling up towards her chest and she then became unresponsive for what seemed like several minutes but probably a minute at the most. She regained consciousness and did not remember anything that happened during the twitching and black out. She was rushed to the ER and several tests were done. CT Scan, lab work, chest Xrays, 2 rounds of Saline IV. All tests were negative and the only explanation was an adverse reaction to the vaccinations and fainting. The pediatrician was called. To say the least he was baffled and stated "He never heard of anything like that ever happening ". The ER physician advised us to follow up with her pediatrician.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe body aches. Headache. Exhausted. Fever. Chills
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Tremor
Clinical narrative: Less than 5 minutes after patient received the vaccine, he began to feel lightheaded and his vision became narrow. He leaned against the pharmacy counter and lost consciousness. He hit his head on the counter, bumped into the nearby display, and hit his head on the floor. Customer standing nearby called 911. Attended to patient and he was unconscious, shaking, and his eyes were open. A few seconds later, he regained consciousness, but immediately became unconscious again. Tried feeling for a pulse but he regained consciousness a few seconds later for good. He asked what happened, but remembers that his vision became narrow. Patient was alert/oriented x3. Brought him to a nearby chair and gave him some water and a Poptart and told him to wait for EMS to arrive. It was a hot day and he had only had a bagel/some water before work that morning. He let EMS check him out but refused transport to the hospital. Tried reaching out to patient the morning after x2 but his phone mailbox was full.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Visual impairment
Clinical narrative: Less than 5 minutes after patient received the vaccine, he began to feel lightheaded and his vision became narrow. He leaned against the pharmacy counter and lost consciousness. He hit his head on the counter, bumped into the nearby display, and hit his head on the floor. Customer standing nearby called 911. Attended to patient and he was unconscious, shaking, and his eyes were open. A few seconds later, he regained consciousness, but immediately became unconscious again. Tried feeling for a pulse but he regained consciousness a few seconds later for good. He asked what happened, but remembers that his vision became narrow. Patient was alert/oriented x3. Brought him to a nearby chair and gave him some water and a Poptart and told him to wait for EMS to arrive. It was a hot day and he had only had a bagel/some water before work that morning. He let EMS check him out but refused transport to the hospital. Tried reaching out to patient the morning after x2 but his phone mailbox was full.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Cold sweat, Depressed level of consciousness, Dizziness
Clinical narrative: Patient was extremely light headed, clammy, and dizzy. She never lost consciousness, but said she felt like she may pass out.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: About 12 hours after the vaccination the patient woke up with Flu like symptoms and a high fever. When the patient measured the fever later in the day he states it was higher than 103 F. The fever continued until about 12 noon on Friday. when the patient measured his temperature on Friday morning it was just over 100 F. The patient treated his symptoms with 650mg of TYLENOL taken at 3 separate times on Thursday. He has reported no further symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Entire body pruritis, redness especially upper chest, shoulders, and ankles.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: IMZ injection error. Indicated for SC, but was administered IM. Patient was fine leaving the pharmacy.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called on 10/3/2017 stating that her left arm is still hurting after flu shot given on 9/23/2017 at flu clinic. Patient states she is a nurse and says pharmacy student intern administering the flu shot (in her opinion) was too high on the shoulder, causing bursitis. Patient feels this is due to incorrect technique, rather than adverse reaction. Patient was given claim number to get expenses covered to see a physician. Patient did not call back about further pain.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Muscle pain, stomach pain, loss of appetite, fatigue.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site. Headache, fever, body aches, fatigue. Lasted 24 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site. Headache, fever, body aches, fatigue. Lasted 24 hours.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: Patient's son came to pharmacy in the morning of 6/29/2018 and showed pictures of slight swelling after SHINGRIX vaccination with no pain. Vaccination was accidentally administered subcutaneously rather than intramuscularly. Advised patient to take BENADRYL and use cool compress. Followed up with patient later in the day, and son stated that the swelling was mostly gone.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness in face and itching on left scapula.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Body, joint and muscle pain.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Severe chills. Fever of 101.5 at worse. Muscle pain especially lower extremities. Severe headache.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Have red, itchy, swelled and, pain 3/4 of the way around my arm. It is very uncomfortable. Should I get the second shot?
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt returned to pharmacy today 7/1/18 with redness and swelling in upper left arm. He said the symptoms started that night after the vaccine was administered 6/29. His wife received the same vaccine, same lot, and had no reaction besides local soreness. Advised pt to visit urgent care for possible infection. NP, sent Rx for BACTRIM DS. I called and spoke to on-call Dr.about drug interaction with one of pt's other meds. Changed to doxycycline. Pt will pick up today.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient came back to clinic day after receiving vaccine, Complaints of Fever, Chills, headache date after receiving Vaccine.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Aphonia, Arthralgia, Fatigue, Myalgia, Nasal congestion
Clinical narrative: Productive deep cough, mild sore throat, loss of full voice, fatigue. Slight nasal congestion, sore joints and muscles.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Oropharyngeal pain, Productive cough
Clinical narrative: Productive deep cough, mild sore throat, loss of full voice, fatigue. Slight nasal congestion, sore joints and muscles.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The site of the injection was very sore when I went to bed at 10. In the morning I noticed that the area around the injection was red and swollen. I felt muscle pain all over my body, I was very fatigued and weak. I stayed in bed all day. I was feeling better the next day, though it was still red and sore at the site of the injection.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: The site of the injection was very sore when I went to bed at 10. In the morning I noticed that the area around the injection was red and swollen. I felt muscle pain all over my body, I was very fatigued and weak. I stayed in bed all day. I was feeling better the next day, though it was still red and sore at the site of the injection.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever,pain and soreness in arm. Chills and fever went away by the next morning 8AM. Pain went away after 48 hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: At 8 hours post vaccination headaches, muscle pain in L arm proceeding to fever and chills...chills progressed in severity for almost 3 hours until relieved with ibuprofen.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Presyncope
Clinical narrative: Presyncope shortly after injection, Dizziness x 3 days, Feeling faint x 3 days.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oropharyngeal pain
Clinical narrative: Hives on both thighs; red, warm, swollen, and tender injection site 2 inches in diameter; low grade fever; sore throat. Treated with topical corticosteroid and ibuprofen...fever persisted as well as redness and swelling of the site.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives on both thighs; red, warm, swollen, and tender injection site 2 inches in diameter; low grade fever; sore throat. Treated with topical corticosteroid and ibuprofen...fever persisted as well as redness and swelling of the site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site macule, Injection site nodule, Local reaction, White blood cell count normal
Clinical narrative: Local reaction. 8.5cm erythematous macule nodule left deltoid.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pharyngeal oedema, Pruritus, Pyrexia
Clinical narrative: Patient came to pharmacy on 6/20/2018 and reported side effects associated with SHINGRIX vaccination (1st dose) administered on 5/19/2018. Patient complained of rash (10 inches diameter) at the site of injection, itching, fever, body ache and swollen throat that required physician visit.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 25th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced skin discoloration. On 5th June 2018, the patient experienced shingles. In June 2018, the patient experienced pain and blister. On an unknown date, the patient experienced injection site pain. The patient was treated with VALTREX, NORCO and prednisone. On an unknown date, the outcome of the injection site pain, pain and blister were recovered/resolved and the outcome of the shingles was recovering/resolving and the outcome of the skin discoloration was not recovered/not resolved. The reporter considered the injection site pain, shingles, pain and blister to be related to SHINGRIX. It was unknown if the reporter considered the skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported case for herself. On 2nd March 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose SHINGRIX in the left arm. Less than a month after receiving SHINGRIX, the patient experienced pain in her arm at site of injection, pain and blister from the outbreak and patch of discoloration. The patient experienced Shingles on her right abdomen and was seen by her physician and treated with antiviral, steroids and pain medication. The patient reported that the pain and blisters from the outbreak had resolved but patch of discoloration was still visible. On the date of reporting, the patient developed another shingles outbreak very close to the first location on her right abdomen. The patient's pharmacy already had submitted a VAERS form for the first shingles outbreak. For tolerance after 1st dose refer US2018GSK116103.