chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia, Product administered at inappropriate site, Sluggishness
Clinical narrative: Pt reported that the vaccination was administered by the pharmacist on duty that day right above his elbow. This means that the pt may have received the vaccine Subq.  The patient had a tingling sensation in his hands and feet the night of receiving the vaccination. The pt was sluggish for 2 days and reported some swelling  at the injection region. Pt has since recovered and feels fine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Lethargy, Pyrexia
Clinical narrative: Lethargic, low grade fever, joint aches
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fatigue, chills, muscle ache, slight fever
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Disorientation, Dizziness, Gait disturbance
Clinical narrative: On days 3/4 began to feel "light headed".  Only comfortable lying done. Could not walk alone. Developed fever of 101 spiked to 102  days 5/6/7.  On days 5/6 developed very distressing chills - body was completely shaking out of control. Severe loss of appetite. Continued to be  lightheaded and disoriented.  Began feeling better on day  9.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Pyrexia
Clinical narrative: On days 3/4 began to feel "light headed".  Only comfortable lying done. Could not walk alone. Developed fever of 101 spiked to 102  days 5/6/7.  On days 5/6 developed very distressing chills - body was completely shaking out of control. Severe loss of appetite. Continued to be  lightheaded and disoriented.  Began feeling better on day  9.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Muscle soreness continued for appx. 1 week after injection, became a dull pain for several weeks . Thereafter became a sharper pain at different ranges of motion and arm positions limiting ability to lift, stretch, wash hair/back and raise left arm.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Facial paralysis, Headache, Magnetic resonance imaging, Nerve injury
Clinical narrative: About two weeks after getting the shot I started having really bad pain on the right side of my head for about 3 days. After the 3rd day I got Bell?s palsy on the right side. The pain in my head is now on both side and continues to this day. I have nerve damage on the right side of my face and chronic pain in both sides of my head.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Injection site pain
Clinical narrative: MUSCLE ACHES, JOINT ACHES, CHILLS, FEVER, INJECTION SITE TENDERNESS, STOMACH UPSET, DIARRHEA
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES, JOINT ACHES, CHILLS, FEVER, INJECTION SITE TENDERNESS, STOMACH UPSET, DIARRHEA
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Computerised tomogram abnormal, Computerised tomogram neck, Dysphagia, Laryngeal oedema, Laryngoscopy abnormal
Clinical narrative: On  11/4/20 at 2 am and then 6:30 am, he had difficultly swallowing, throat pain, swelling on one side of the face, tongue and throat.
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Oropharyngeal pain, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: On  11/4/20 at 2 am and then 6:30 am, he had difficultly swallowing, throat pain, swelling on one side of the face, tongue and throat.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states 3 days after vaccine was administered she started experiencing pain on the same arm( left arm) and the pain  extended to fingers , she states  the arm is a little swollen and she feels dizzy on and off. she states she has not been feeling well  since she got the vaccine as that entire arm is in pain constantly  .
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Tiredness,shivering,nausea,muscle pain
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: severe rash ,  pain and warm area around injection site
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain
Clinical narrative: pain upon injection, and continuous pain at injection site (until date of discovery 12/8/20). Pt has been on a maintenence dose of prednisone, she has had to increase dosage due to pain
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity, X-ray
Clinical narrative: Pain in left arm and shoulder, up and down arm 09/17/2020 @ 8:30. no redness, swelling, etc identified at any period of time.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema
Clinical narrative: Erythema- started about 2-3 days after vaccine administration. Area is 6 inches in length and 5.5 inches in width.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Angioedema, Chills, Eye swelling, Pyrexia
Clinical narrative: pt reports fever, GI upset, hives, eye swollen, chills, angeo edema
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: pt reports fever, GI upset, hives, eye swollen, chills, angeo edema
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Malaise
Clinical narrative: malaise, fatigue, felt like coming down with terrible cold
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pruritus, Rash erythematous, Rash macular, Swelling
Clinical narrative: Shingrix -50 mcg Sore am muscle, red, swelling in area, whole body broke out, looked like sun burn and blotchy, whole body itching.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Per patient, she has been experiencing pain near the injection site area ever since she got her flu shot. Her upper arm is in pain - unable to move it around as much, difficult to sleep on it, continuous pain. Patient occasionally took ibuprofen 200 mg, 2 tablets by mouth once daily to help with the pain. This does alleviate the pain, but patient does not wish to take this on a daily basis for her pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The Patient had Swelling, redness, itchiness, bruising and his left arm was warm to the touch.  He also had a headache and low grade fever. The above were all noted the very next day by his mother and reported to the clinic.  She was advised to give him some fever reducer and benadryl and to continue to monitor him.  The next day mom reported that the swelling had gone down but his arm was still warm to the touch and has discoloration.  He was brought back to the clinic on  09/28/2020 and his left upper arm was noted to have erythema and echymosis spanning about 7 cm and it was warm to the touch.  There was a noted crusted area as well.  He was given Keflex Suspension, 250 MG/5ML, 5.5 ml, Orally,TID,7 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Injection site warmth, Pyrexia, Scab, Skin discolouration
Clinical narrative: The Patient had Swelling, redness, itchiness, bruising and his left arm was warm to the touch.  He also had a headache and low grade fever. The above were all noted the very next day by his mother and reported to the clinic.  She was advised to give him some fever reducer and benadryl and to continue to monitor him.  The next day mom reported that the swelling had gone down but his arm was still warm to the touch and has discoloration.  He was brought back to the clinic on  09/28/2020 and his left upper arm was noted to have erythema and echymosis spanning about 7 cm and it was warm to the touch.  There was a noted crusted area as well.  He was given Keflex Suspension, 250 MG/5ML, 5.5 ml, Orally,TID,7 days.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Impaired work ability, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain
Clinical narrative: Immediate pain and muscle stiffness over 5 days, much worse than normal soreness experienced after previous flu shots. Increasing pain and stiffness over next two weeks, to the point of constant pain with any motion with the arm over 90 degrees, any lifting, or any pushing. Career (Dance Professor) affected. All dancing/teaching had to be modified. At 5 weeks everyday activities completed limited and sought orthopedic doctor's care. Stopped dancing starting 11/13/20. Started advised 8 weeks of physical therapy on 11/24/20. Spoke to head pharmacist on 12/4/2020 who indicated I would be given a call by their Immunization Team and that she would file a VAERS report. Have not heard back, so wanted to make sure the report got filed. Also spoke to Pharmacy head feedback department who created a case file and contacted the division head of the Pharmacy location, who was supposed to call within 24 hours but has not.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Physical examination, Physiotherapy, Product administered at inappropriate site, Tendonitis
Clinical narrative: Immediate pain and muscle stiffness over 5 days, much worse than normal soreness experienced after previous flu shots. Increasing pain and stiffness over next two weeks, to the point of constant pain with any motion with the arm over 90 degrees, any lifting, or any pushing. Career (Dance Professor) affected. All dancing/teaching had to be modified. At 5 weeks everyday activities completed limited and sought orthopedic doctor's care. Stopped dancing starting 11/13/20. Started advised 8 weeks of physical therapy on 11/24/20. Spoke to head pharmacist on 12/4/2020 who indicated I would be given a call by their Immunization Team and that she would file a VAERS report. Have not heard back, so wanted to make sure the report got filed. Also spoke to Pharmacy head feedback department who created a case file and contacted the division head of the Pharmacy location, who was supposed to call within 24 hours but has not.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT HAD SORE ARM DAY AFTER INJECTION, AFTER A FEW DAYS GOT A LITTLE BETTER AND NOW PATIENT SAYS IT HAS GOTTEN WORSE. TO THE POINT OF HAVING DIFFICULTY LIFTING ARM
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: redness, warm,  tenderness, swelling, itchiness on the left upper arm injection site
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of sore arm and unable to lift arm up above shoulder for months
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that she noticed her arm getting sore and swollen in a couple of days and 6 of her lymph nodes were swollen and went to her PCP Dr. to get it checked. They checked her and performed some scans to ensure everything was okay  and the vaccine didn't affect her adversely.  They found the scan and results to be normal per Pt.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Whole body hurts Low fever
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain with limited range of motion and tingling extending to fingertips, developed around 3 weeks following the administration.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Pt called following day reporting symptoms of tingling in arm after receiving vaccine day prior
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Just a round circle. It was warm to the touch and had a small lump at the site of the injection. It was very sore for 3 days especially if you bumped your arm. But, I had no sick symptoms at all so it was worth getting the injection. Of note: on my 1st injection I had no problems.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient received flu shot on 11/8/20 and was feeling fine the days after but then started experiencing pain in his shoulder. When he would turn his head to the right he would feel a tingling from his neck down to the injection site. Some days he experiences tingling in his right arm and fingertips. It has only gotten worse since the vaccination. I (pharmacist) instructed patient to see a doctor for his symptoms and will report to VAERS.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Pain and Black Spot at the sight of the Injection
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Nausea, headache, chills overall aching.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Client reports pain at site of injection started immediate up receiving vaccine and has continued to be very painful to move upper arm, tender to touch.  Reports pain has worsened and has interfered with ability to lift things.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal death, Foetal hypokinesia, Induced labour, Malaise
Clinical narrative: On October 1st, 2020 I received the flu shot at my work and I was currently 27 weeks pregnant. A couple hours later, I started to not feel so well but I tried to keep something on my stomach and kept working at the office for the rest of the day. That night I took a bath, and tried getting a video of my baby moving in my belly. That was 7:15 pm that night, and that was the last time I felt my baby move. I went to my doctor's appointment 5 days later after realizing I hadn't felt her move in that long, and she had past. I had to be induced that night and my daughter was delivered the next morning at about 10:00 am on October 7th, 2020. She weighed 2 lbs 1 oz.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Stillbirth
Clinical narrative: On October 1st, 2020 I received the flu shot at my work and I was currently 27 weeks pregnant. A couple hours later, I started to not feel so well but I tried to keep something on my stomach and kept working at the office for the rest of the day. That night I took a bath, and tried getting a video of my baby moving in my belly. That was 7:15 pm that night, and that was the last time I felt my baby move. I went to my doctor's appointment 5 days later after realizing I hadn't felt her move in that long, and she had past. I had to be induced that night and my daughter was delivered the next morning at about 10:00 am on October 7th, 2020. She weighed 2 lbs 1 oz.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Skin warm
Clinical narrative: Pt stated her arm felt super heavy before going to bed. She also stated her arm is red from her shoulder down to her elbow, also slightly warm to touch.  RPH instructed her to take benadryl and ice her arm. Please keep the pharmacy updated.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast swelling, Pruritus, Urticaria
Clinical narrative: I awakened finding myself itching on my right breast. It was slightly swollen. I also had three small hive looking places just below my rib cage.  At that point I decided to take a Benadryl, waited five minutes and noticed I now had three small hive looking places on my right rib cage. So I took another Benadryl and within 5/10 minutes the itching faded. Everything seem to be under control so I went back to sleep. Upon awakening in the morning there were no more signs of hives and I had no further symptoms. The injection  site was never any problem.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Erythema, Hypotonia, Hypotonic-hyporesponsive episode, Immediate post-injection reaction
Clinical narrative: Patient experienced a hypotonic hyporesponsive episode immediately following vaccine administration. He stopped crying after just a second or two and had a blank stare on his face. He felt limp in my arms when I picked him up. He maintained the blank stare while being dressed and placed into his carseat, until he fell asleep in the car ride home about 10-15 minutes following administration. About 3-4 hours later he awoke and his thigh was swollen, red and warm to the touch. He started intensely crying. He cried persistently and inconsolably for about 2 hours. Patient given age/weight dose appropriate Tylenol and put in warm bath per nurses instruction with no change in behavior. Patient finally fell asleep after over an hour of skin to skin time.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Peripheral swelling, Skin warm, Staring
Clinical narrative: Patient experienced a hypotonic hyporesponsive episode immediately following vaccine administration. He stopped crying after just a second or two and had a blank stare on his face. He felt limp in my arms when I picked him up. He maintained the blank stare while being dressed and placed into his carseat, until he fell asleep in the car ride home about 10-15 minutes following administration. About 3-4 hours later he awoke and his thigh was swollen, red and warm to the touch. He started intensely crying. He cried persistently and inconsolably for about 2 hours. Patient given age/weight dose appropriate Tylenol and put in warm bath per nurses instruction with no change in behavior. Patient finally fell asleep after over an hour of skin to skin time.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Autoimmune disorder, Chills, Computerised tomogram, Dementia
Clinical narrative: Mother received the vaccine on 10/26/20 and had a series of issues that resulted in hospitalizations, but finally diagnosed with "suspected" viral meningitis/encephalitis. Diagnosed with pneumonia and UTI on 10/29, released on 10/31 with dementia symptoms attributed to UTI. However, rushed back to hospital 11/1 unconscious, shivering, seizing, sweating. rushed to ICU @  Hospital where neurological symptoms became serious, including brain seizures that would not subside. Induced into a medical coma to ease . Lumbar punctures show no bacterial or viral evidence. Autoimmune suspected as well but no real diagnosis as of yet. She remains in a minimally conscious state as a result of the neurological stresses that remain undiagnosed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Electroencephalogram, Encephalitis, Hyperhidrosis, Intensive care, Loss of consciousness
Clinical narrative: Mother received the vaccine on 10/26/20 and had a series of issues that resulted in hospitalizations, but finally diagnosed with "suspected" viral meningitis/encephalitis. Diagnosed with pneumonia and UTI on 10/29, released on 10/31 with dementia symptoms attributed to UTI. However, rushed back to hospital 11/1 unconscious, shivering, seizing, sweating. rushed to ICU @  Hospital where neurological symptoms became serious, including brain seizures that would not subside. Induced into a medical coma to ease . Lumbar punctures show no bacterial or viral evidence. Autoimmune suspected as well but no real diagnosis as of yet. She remains in a minimally conscious state as a result of the neurological stresses that remain undiagnosed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lumbar puncture normal, Magnetic resonance imaging, Medical induction of coma, Meningitis viral, Neurological symptom
Clinical narrative: Mother received the vaccine on 10/26/20 and had a series of issues that resulted in hospitalizations, but finally diagnosed with "suspected" viral meningitis/encephalitis. Diagnosed with pneumonia and UTI on 10/29, released on 10/31 with dementia symptoms attributed to UTI. However, rushed back to hospital 11/1 unconscious, shivering, seizing, sweating. rushed to ICU @  Hospital where neurological symptoms became serious, including brain seizures that would not subside. Induced into a medical coma to ease . Lumbar punctures show no bacterial or viral evidence. Autoimmune suspected as well but no real diagnosis as of yet. She remains in a minimally conscious state as a result of the neurological stresses that remain undiagnosed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Seizure, Urinary tract infection, X-ray
Clinical narrative: Mother received the vaccine on 10/26/20 and had a series of issues that resulted in hospitalizations, but finally diagnosed with "suspected" viral meningitis/encephalitis. Diagnosed with pneumonia and UTI on 10/29, released on 10/31 with dementia symptoms attributed to UTI. However, rushed back to hospital 11/1 unconscious, shivering, seizing, sweating. rushed to ICU @  Hospital where neurological symptoms became serious, including brain seizures that would not subside. Induced into a medical coma to ease . Lumbar punctures show no bacterial or viral evidence. Autoimmune suspected as well but no real diagnosis as of yet. She remains in a minimally conscious state as a result of the neurological stresses that remain undiagnosed.
Age: 1.25
Sex: M
Vaccine: HIBV, MMRV, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Enlargement of lymph nodes in groin
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Nausea
Clinical narrative: Uncontrollable chills, fever, nausea. Dizziness, weak, shaking, loss of appetite.  Duration of symptoms from 5am 11/28 to 9am 11/29.  Slept under the blankets for duration of symptoms. Did not go to the doctor.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Uncontrollable chills, fever, nausea. Dizziness, weak, shaking, loss of appetite.  Duration of symptoms from 5am 11/28 to 9am 11/29.  Slept under the blankets for duration of symptoms. Did not go to the doctor.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headaches, nausea, lightheaded.  Started 15 minutes after vaccine administered but not reported until the following day.  Patient treated with ibuprofen, hydration, and rest.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site plaque
Clinical narrative: "shingles vaccine" given to patient at the Pharmacy on 12/9/2020 patient developed a 11cm x 15cm erythematous plaque distal to the administration site. I am not the vaccine administrator so i do not know the vaccine information beyond this.
Age: 52.0
Sex: F
Vaccine: HPV9
Symptoms: Immune thrombocytopenia, Increased tendency to bruise, Platelet count decreased, Purpura
Clinical narrative: Pupura, easily bruising which turned out to be ITP (autoimmune disease) low platelets.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness/swelling at injection site
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV1
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt given HIB vaccine instead of Hep B. Given a HIB and given in Pentacel. (HIB administed twice at same visit)
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: No adverse event
Clinical narrative: Pts father was given VIS, vaccine was verified by LVN, waited 10-15 minutes with no reaction
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red & warm to the touch. Redness spread. Mom gave tylenol & benadryl. Also some swelling. Told to treat with Ibuprofen, oral benadryl, cool compresses. Mark the spot & follow up if there is spreading. Also come in if a fever develops or other concerns arose.
Age: 56.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Contusion, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Pt. stated (R) arm was hot, Red, had a big knot that was hard like a rock, swollen & painful. Also had chills. Used ice & took Aspirin & Allertec. Started soon after vaccines & said she felt terrible the next day but today (12/9) is much better - Arm still red & has bruise but not painful or knot.
Age: 56.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Pt. stated (R) arm was hot, Red, had a big knot that was hard like a rock, swollen & painful. Also had chills. Used ice & took Aspirin & Allertec. Started soon after vaccines & said she felt terrible the next day but today (12/9) is much better - Arm still red & has bruise but not painful or knot.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: (1) Redness / itching night of vaccination @ injection site applied Benadryl cream + took Benadryl tablet  (2) symptoms lessened over next couple days
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Complex regional pain syndrome, Injection site discomfort, Injection site pain, Limb discomfort, Muscle tightness
Clinical narrative: I immediately felt a "charge" go down my arm to my wrist and my wrist muscles tightened. (My wrist was fractured January 2016, the fracture subseqently "settled" followed by Complex Regional Pain Syndrome (CRPS) to that arm and hand.)  Later in the day, I used KT Tape (kinesiology tape) to help alleviate the wrist discomfort and took ibuprofen for injection site pain.   Some discomfort in my wrist continues. Injection site pain continued for more than two weeks. There continues to be occasional discomfort at the injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrist fracture
Clinical narrative: I immediately felt a "charge" go down my arm to my wrist and my wrist muscles tightened. (My wrist was fractured January 2016, the fracture subseqently "settled" followed by Complex Regional Pain Syndrome (CRPS) to that arm and hand.)  Later in the day, I used KT Tape (kinesiology tape) to help alleviate the wrist discomfort and took ibuprofen for injection site pain.   Some discomfort in my wrist continues. Injection site pain continued for more than two weeks. There continues to be occasional discomfort at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Disease recurrence, Herpes zoster, Rash
Clinical narrative: recurrence of shingles; she was diagnosed with shingles due to back pain and a rash; This spontaneous report was received from a consumer referring to herself, a 70-year-old female patient. The patient's concurrent conditions included depression, hypertension, blood cholesterol increased, lung disorder, arthropathy and drug hypersensitivity (demerol, morphine, versed, penicillin, statins). The patient's concomitant therapies included gabapentin, tramadol hydrochloride, diclofenac, acetaminophen (TYLENOL), duloxetine hydrochloride, hydrochlorothiazide, potassium chloride, montelukast sodium (SINGULAIR), omeprazole and cholecalciferol. Information regarding the patient's medical history and historical drugs was not provided.   The patient reported that on an unknown date in December 2016, she received a dose of zoster vaccine live (ZOSTAVAX) for immunisation (strength, dose, frequency, route of administration, lot number and expiration date were not reported), and on an unknown date in July 2017, she was diagnosed with shingles due to back pain and a rash. Then in July 2020 (reported as "3 years later"), she had a recurrence of shingles. She reported the pain was affecting her every day life. She believed the zoster vaccine live (ZOSTAVAX) had caused her to develop shingles. The patient reported during her first episode of shingles she spoke with a lawyer in regards to a class action suit for zoster vaccine live (ZOSTAVAX), but she was not included in the suit due to the time frame of her diagnosis. She was no longer pursuing legal action. She would like reimbursement for zoster vaccine live (ZOSTAVAX).  At the time of reporting, the outcome of the event shingles was unknown.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Monoplegia
Clinical narrative: arm felt "frozen" after received PNEUMOVAX 23/ arm immobility.; This spontaneous report was received from a consumer via a pharmacist and refers to a 50 year old male patient. No information regarding the patient's medical history, concurrent conditions or allergies/drug reactions was provided. The patient did not have concomitant medications.   On 01-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) which had a lot # T028093 with expiration date on 24-APR-2022, given intramuscularly (dosage,  as prevention of pneumococcal disease.   On 02-DEC-2020, the patient's arm felt "frozen" after vaccination. It was described it as arm immobility(monoplegia). At the time of reporting, the outcome of monoplegia was reported as not recovered. The causality assessment between monoplegia with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  Upon internal review, monoplegia was considered a medically significant event. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: PPV, UNK
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: diaphoresis; flushed; dizziness; This spontaneous report was received from a Registered nurse concerning  a 71 year old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 03-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, 0 .5 milliliter ,lot # T027110,expiration date: 23-MAR-2022, intramuscular in the right arm for Routine immunization.  On the same date the patient experienced hyperhidrosis, dizziness and flushing, after injection. Patient was given diphenhydramine hydrochloride (BENADRYL) 50 mg tablet, was able to recover and ambulate on her own at discharge. No laboratory/diagnostic tests were reported. The outcome of hyperhidrosis, dizziness and flushing was reported as recovered, on the same date. The patient seek unspecified medical attention. The causal relationship between the aforementioned events and  polyvalent (23-valent)(PNEUMOVAX23)was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 27-NOV-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1637642 with expiration date 28-MAY-2022) via an unknown route for prophylaxis (product storage error). The administered dose experienced a temperature excursion for unknown time. It was reported that there were previous temperature excursions. The temperature excursions were detected by a data logger.  This is one of the three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA003160: US-009507513-2012USA003525:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 2 weeks ago his wife had developed shingles; 2 weeks ago his wife had developed shingles; This spontaneous report as received from a consumer via a company representative, referring to a 71-year-old female patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were reported as none. The patient's concurrent conditions were not reported. Laboratory diagnostics and studies performed were reported as none.  In approximately 2015 (also reported as over 5 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection, 1 time injection, subcutaneously (strength, vaccination scheme and anatomical site of injection were not reported; lot number and expiration date were unknown by the reporter) as a routine vaccination (prophylaxis).  On 23-NOV-2020 (also reported as 2 weeks ago), the patient had developed shingles (herpes zoster), despite taking the vaccine over 5 years ago (vaccination failure). Gabapentin, at a dose of 100 milligram (mg) (taken at bed), was given as a treatment for the adverse event (AE).  The outcome of herpes zoster and vaccination failure was reported as not recovered. The causal relationship between the aforementioned events and the suspect therapy was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive pain at injection site with some lasting for days; redness have spread for several inches around the injection site; swelling have spread for several inches around the injection site; redness and sweling have spread for several inches around the injection site; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via email on 16-Oct-2020.  This case is linked to cases 2020SA293763 and 2020SA293704.  This case involves a female patient of an unknown age who experienced excessive pain at injection site with some lasting for days (Vaccination site pain), redness and swelling have spread for several inches around the injection site (Vaccination site reaction, erythema, swelling), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient developed excessive pain at injection site with some lasting for days (Vaccination site pain), redness  and swelling have spread for several inches around the injection site (Vaccination site reaction, erythema, swelling).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of all the events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from consumer (patient).  This case is linked to case 2020SA296404.  This case involves a patient of an unknown demographic who got the flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations,concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) within 24 hours following the administration of INFLUENZA VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: did not get the flu until got the shot; Initial information regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media on 20-Oct-2020.  This case involves a patient of an unknown age and gender who did not get the flu until got the shot (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient did not get the flu until got the shot (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was unknown for the event of influenza, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient gots it every time he gets a flu shot.; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2020SA300039.  This case involves a male patient who got it every time he gets a flu shot (influenza), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got it every time he gets a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: get sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 23-Dec-2020.  This case is linked to case 2020SA300682.  This case involves a patient of unknown demographics who developed get sick (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown) after the administration of suspect the patient got sick (illness).  It was not reported if the patient received a corrective treatment.  The outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Feeling abnormal
Clinical narrative: chills; shakes ten blankets blankets and setting next to heaters; took one that same night I about died; Initial information received on 23-Oct-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer (Patient).  This case is linked to case 2020SA300682.  This case involved a patient who experienced chills and shakes ten blankets and setting next to heaters (Tremor) and felt about died (Unevaluable event), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s)and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced a feeling of about died (Unevaluable event), had chills and shakes ten blankets and setting next to heaters (Tremor), (unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient became very sick after the three flu shots; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer/non-hcp.  This case involves a patient who became very sick after the three flu shots (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became very sick after the three flu shots (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was illness.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got a flu three days after getting the shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media from on 23-Dec-2020.  This case is linked to case 2020SA300682.   This case involves a patient of unknown demographics who got a flu three days after getting the shot (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza Vaccin for 2 years. The patient's medical history, medical treatment(s), concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown) after the administration of suspect the patient got a flu three days after getting the shot (Influenza).   It was not reported if the patient received a corrective treatment.  The outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced got the flu, when received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction Influenza .   The patient's medical history, past medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (unknown demographics) got the flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: fever spiked to 99.7; felt bad; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced fever spiked to 99.7 (pyrexia) and felt bad (feeling abnormal), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever spiked to 99.7 (pyrexia) and felt bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.