chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysphagia, Dysphonia, Erythema, Hypoaesthesia
Clinical narrative: Patient called to report that her face got red and swollen within 45 minutes of vaccine and she had a rash on her face and she had a little bit of throat swelling and was speaking like a frog and it was hard to swallow. She said within 3 days her legs started to go numb and especially her thigh muscles and her veins in her left foot were engorged. She said she went to the ER and they rxed 40mg prednisone for 4 days and her papers from the ER read "allergy."  When I spoke to her for the second time and advised her she does not qualify for a second moderna vaccine, patient said that when she went to the ER she went for abdominal swelling, leg swelling, leg numbness, and swelling of the left ankle and foot. I confirmed with her that her symptoms have all improved and she said "yes, tremendously." She said she spoke to her PCP and at least one additional doctor yesterday.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Pharyngeal swelling, Rash, Swelling face
Clinical narrative: Patient called to report that her face got red and swollen within 45 minutes of vaccine and she had a rash on her face and she had a little bit of throat swelling and was speaking like a frog and it was hard to swallow. She said within 3 days her legs started to go numb and especially her thigh muscles and her veins in her left foot were engorged. She said she went to the ER and they rxed 40mg prednisone for 4 days and her papers from the ER read "allergy."  When I spoke to her for the second time and advised her she does not qualify for a second moderna vaccine, patient said that when she went to the ER she went for abdominal swelling, leg swelling, leg numbness, and swelling of the left ankle and foot. I confirmed with her that her symptoms have all improved and she said "yes, tremendously." She said she spoke to her PCP and at least one additional doctor yesterday.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills headache fever joints muscle pain fatigue
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills headache fever joints muscle pain fatigue
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: 12 hours after my shot I developed a severe headache and fever of 102. This persisted for about 7 hours. Then the fever decreased to about 100.5 for the next 24 hours.  After my fever broke, however, I developed a chest cough with some phlegm. This feels like bronchitis and my doctor has prescribed azithromycin. I also feel rolling fatigue, which comes on randomly. The cough and fatigue has persisted so far for 6 days. In addition, though I do not have a fever most of the day, on some nights my fever spikes (last night, reaching 102 for a short period of time while trying to sleep). It has been 8 days since my injection. I have very little appetite (though I can smell and taste fine).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia
Clinical narrative: 12 hours after my shot I developed a severe headache and fever of 102. This persisted for about 7 hours. Then the fever decreased to about 100.5 for the next 24 hours.  After my fever broke, however, I developed a chest cough with some phlegm. This feels like bronchitis and my doctor has prescribed azithromycin. I also feel rolling fatigue, which comes on randomly. The cough and fatigue has persisted so far for 6 days. In addition, though I do not have a fever most of the day, on some nights my fever spikes (last night, reaching 102 for a short period of time while trying to sleep). It has been 8 days since my injection. I have very little appetite (though I can smell and taste fine).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Friday: 3/12/2021: 4:30 PM mild headache and right arm pain, 6:30 PM no headache but then body aches, 8:00 PM chills, all over severe joint and body aches, temperature, chills, nausea, and no sleep due to symptoms that 3/12 Friday night.   Saturday: 3/13/2021: Friday PM severe symptoms continued (reasonable left arm pain from injection, severe joint and body aches, temperature, chills, nausea, no sleep due to pain) all day.  Sunday: 3/14/2021   (milder systems of those I experienced on 3/13/2021)  All symptoms eased up around 8:00 PM  Left corner of upper and lower lip numbness and left tip of tongue numbness started at ~5:00 PM)  Was able to sleep. Monday: 3/15/2021  tired, left side of upper and lower lip numbness and left tip of lounge numbness continued but went away by 5:00 PM
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Injection site pain, Insomnia, Nausea, Pain
Clinical narrative: Friday: 3/12/2021: 4:30 PM mild headache and right arm pain, 6:30 PM no headache but then body aches, 8:00 PM chills, all over severe joint and body aches, temperature, chills, nausea, and no sleep due to symptoms that 3/12 Friday night.   Saturday: 3/13/2021: Friday PM severe symptoms continued (reasonable left arm pain from injection, severe joint and body aches, temperature, chills, nausea, no sleep due to pain) all day.  Sunday: 3/14/2021   (milder systems of those I experienced on 3/13/2021)  All symptoms eased up around 8:00 PM  Left corner of upper and lower lip numbness and left tip of tongue numbness started at ~5:00 PM)  Was able to sleep. Monday: 3/15/2021  tired, left side of upper and lower lip numbness and left tip of lounge numbness continued but went away by 5:00 PM
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Friday: 3/12/2021: 4:30 PM mild headache and right arm pain, 6:30 PM no headache but then body aches, 8:00 PM chills, all over severe joint and body aches, temperature, chills, nausea, and no sleep due to symptoms that 3/12 Friday night.   Saturday: 3/13/2021: Friday PM severe symptoms continued (reasonable left arm pain from injection, severe joint and body aches, temperature, chills, nausea, no sleep due to pain) all day.  Sunday: 3/14/2021   (milder systems of those I experienced on 3/13/2021)  All symptoms eased up around 8:00 PM  Left corner of upper and lower lip numbness and left tip of tongue numbness started at ~5:00 PM)  Was able to sleep. Monday: 3/15/2021  tired, left side of upper and lower lip numbness and left tip of lounge numbness continued but went away by 5:00 PM
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I week after getting the shot my left around around the area of injection swelled, turned red and warm, and was very itchy.  4 days later the swelling went down, but still was itchy and my joints ached.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: To clarify I had tested positive for COVID 1/4/2021 was sick with symptoms for 16 days.  Received vaccine on 3/1 experienced within 24 hours fever high as 102.5, exhaustion, aches in legs, pain in back and a severe headache these lasted for about 24 hours. After the 24 hours I experienced 2 days of complete malaise.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: To clarify I had tested positive for COVID 1/4/2021 was sick with symptoms for 16 days.  Received vaccine on 3/1 experienced within 24 hours fever high as 102.5, exhaustion, aches in legs, pain in back and a severe headache these lasted for about 24 hours. After the 24 hours I experienced 2 days of complete malaise.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Headache, Hyperhidrosis, Incontinence
Clinical narrative: weakness started at 9:00-9:30 pm, she said she started having trouble standing up to go to the bathroom. ?hit me like a ton of bricks?. she was able to get back in bed and sleep but she called me at midnight saying she was stuck half on and half off the bed. she was having difficulty sitting up, had tried to get up and got stuck diagonally half on and half off of her bed. her heart rate was 110, but she said that?s not unusual for her. she was sweaty, possibly had a fever, and said she had thrown up. she was having trouble holding her bladder, which she said she usually is able to make it to the bathroom but couldn?t last night. this morning she tried to get up and her feet couldn?t support her and she went down to her knees and got stuck until we got help to get het back up. this morning she is still nauseous, weak, and has a bad headache
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: weakness started at 9:00-9:30 pm, she said she started having trouble standing up to go to the bathroom. ?hit me like a ton of bricks?. she was able to get back in bed and sleep but she called me at midnight saying she was stuck half on and half off the bed. she was having difficulty sitting up, had tried to get up and got stuck diagonally half on and half off of her bed. her heart rate was 110, but she said that?s not unusual for her. she was sweaty, possibly had a fever, and said she had thrown up. she was having trouble holding her bladder, which she said she usually is able to make it to the bathroom but couldn?t last night. this morning she tried to get up and her feet couldn?t support her and she went down to her knees and got stuck until we got help to get het back up. this morning she is still nauseous, weak, and has a bad headache
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: A few minutes after the pt received his first dose of the Moderna COVID19 he began to feel light headed and nearly passed out. Pt was laid on cot. BP 100/60 HR 91 RR 16 O2Sat 99% . EMS called and evaluated pt. Pt reported feeling "much better." Pt signed refusal with EMS for transport to the hospital. RN called pt's mother to come pick him up. Pt was advised not to drive.  Pt was given ED precautions and advised to contact his PCP. Pt was also given the contact information to have his second dose at the high risk clinic.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Peripheral swelling, Rash papular
Clinical narrative: Modern Arm...extreme raised rash and swelling. Brushing and muscle soreness at injection site.  Symptoms continue after 16 days and subsides and rein-flames continuously..
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Loss of hearing/ hearing accuity in right ear
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vital signs measurement
Clinical narrative: dizziness with normal vital signs
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: diphenhydramine 50mg given at 12:20 PO, epinepherine injection at 12:22 IM, ambulance arrived at 12:35 for transport to local hospital.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient self-scheduled for the Janssen COVID-19 Vaccine. She had the 1st dose Moderna COVID-19 Vaccine on 01/18/2021. She stated she did not "know where to get the 2ns dose of Moderna" . She just wanted a second dose and choose to get the Janssen d/t availability at the time. No adverse reactions noted after 15 minutes of monitoring post vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient self-scheduled for the Janssen COVID-19 Vaccine. She had the 1st dose Moderna COVID-19 Vaccine on 01/18/2021. She stated she did not "know where to get the 2ns dose of Moderna" . She just wanted a second dose and choose to get the Janssen d/t availability at the time. No adverse reactions noted after 15 minutes of monitoring post vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Patient received her first dose of the Pfizer vaccine today.  About five minutes after injection, patient developed shortness of breath and a burning chest pain. She was talking in complete sentences without any issues. She had no other symptoms.  Call placed to 911.  Her lungs were clear through out, her heart rate and rhythm was regular. See vitals below.  A 20g IV was placed to her L AC and Benadryl 25 mg IVP, Solumedrol 125 mg IVP and Famotidine 20 mg IVP was given by the RN. Her shortness of breath improved, the burning to her chest persisted.  EMS arrived at 0914 and she was transferred to the nearest hospital for further evaluation and treatment. Patient declined contacting any family members by the staff, she requested to call her husband herself.   03/17/21 0923 BP: (!) 162/70 Pulse: 110 Resp: 22 SpO2: 98%
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen at shot area  itching red with fever
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Swollen at shot area  itching red with fever
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Numbness in lips and tongue, tingling and numbness in right arm and 3rd and 4th fingers on both hands, raised blood pressure, broke out in hives all over body. Two weeks later and still no feeling in tips of fingers
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Numbness in lips and tongue, tingling and numbness in right arm and 3rd and 4th fingers on both hands, raised blood pressure, broke out in hives all over body. Two weeks later and still no feeling in tips of fingers
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash
Clinical narrative: Skin rash on upper arm around injection site
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: 4 PINK CIRCLES. APROX. THE SIZE OF A DIME, NICKLE, AND  QUARTER.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Nasal congestion, Oral pruritus, Rhinorrhoea, Tongue pruritus
Clinical narrative: Moderna COVID-19 Vaccine  Allergic reaction happened about 2:30 min after the injection, with eyes swelling, right eye more than half covered. Congestion, runny nose, itchy back of tongue and palate. I consulted with my healthcare provider (Dr, not the pharmacy that administered the shot) to know what to do and since I didn't have any noticeable breathing problem, she advised to take some Benadryl and monitor. Lot number was handwritten so 1st, 2nd, fifth and sixth characters have been interpreted as above. first character could be a O, 0 or D. Second and sixth character could be a I or 1. Fifth character could be a 2 or Z.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Paraesthesia
Clinical narrative: I received my second Covid Vaccine on 2-22-2021 I had no symptoms just the usual anxiety so just tingly, I did not report this to my nurse there with me at the time because I believed it to be my usual anxiety attacks I get. The next day 2-23-2021 I noticed the left side of my face feeling rather numb and two of my fingers on the left side kinda numb as well. I am still experiencing these symptoms as of today not as severe as before.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperacusis, Nausea, Pain, Photophobia
Clinical narrative: I had chills, nausea, body pain, headaches, and over-sensitivity to lights and sounds. The symptoms lasted more than 36 hours but less than 48 hours. I haven't eaten anything yet, but I am feeling better today.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch.   March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.  March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pallor
Clinical narrative: March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch.   March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.  March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Severe chills, overall muscle aches and debilitating fatigue that started around 10:30 on the morning after the vaccination date. After going to bed early, I awoke still fatigued and did not sufficiently awaken until near noon. It was not until the following morning that I felt sufficiently better to return to near normal activities.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Woke up with hives covering most of my entire body
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Round bumps on my legs and my arms
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Craniotomy, Magnetic resonance imaging head abnormal, Subdural haematoma, Subdural haematoma evacuation
Clinical narrative: 03/15/2021: Presented to the emergency department after an outpatient MRI showed a subdural hematoma and the patient has expressive and receptive aphasia. Patient admitted for a craniotomy with evacuation of chronic subdural hematoma. The patient remains admitted at this time.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Slightly itchy rash on neck, face, shoulders and chest.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Injection site vesicles, Pain in extremity
Clinical narrative: Patient called this morning to report waking in the middle of the night due to severe arm pain. When the patient checked the injection site she noted a ruptured blister under the bandage. She stated it was about the size of a quarter. She also noted that there was another blister developing right near the other one. She noted that her upper arm was very red . She was advised to contact her physician for further inspection.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful glass in left armpit
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Hyperhidrosis, Vital signs measurement
Clinical narrative: diaphoresis and dizziness with normal vital signs
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: The day following the vaccine, February 16, I experienced fever and chills lasting for 2 days.  Low grade fever has persisted everyday since the vaccine.  My normal body temp is 97.5.  My temperature every day has been in a range from 99.1 - 100.  Also feeling very fatigued.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: Extreme fatigue Lightheaded, especially upon standing Migraine (persisted for more than 24 hours) Fever, first taken at 100.8 but went as high as 104.2 (Fluctuated throughout the day, but did not break until more than 24 hours after first fever recorded) Nausea
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Intense chills started about 5 hours after vaccine injection and lasted on/off through the night.  Fever at 9 pm was 102 degrees.  Felt tired but chills and fever were gone by morning and felt relatively back to normal.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: I was given the Covid19, Moderna, Vaccine on 10MAR2021.  On 17MAR2021 (0700 hrs), I woke up and my arm, at the injection site, was itchy.  By 1100hrs, the injection site was swollen and warm to the touch.  It was similar to a mosquito bite with swelling around it.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Tenderness at injection site  Light throbbing headache Strong throbbing headache Fatigue
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Sore injection site 3+ days  Fever 24 hours  Chills 24 hours  Headache 36 hours  Higher than typical heart rate while sleeping first 24 hours
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 3 inch area around injection was erythematous, indurated, and itchy for 2 days post injection
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Arterial thrombosis, Pain in extremity, Ultrasound Doppler
Clinical narrative: Patient developed intense bilateral leg pain, right greater than left.  Physical exam consistent with acute arterial thrombosis of both lower extremities.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Pt has history of mast cell disease and has numerous medication, food and environmental allergies. She also develops histamine related reactions to stress. She has a history of recurrent anaphylaxis  and carries an epipen. She notes that she felt anxious prior to the shot and developed lightheadedness several minutes after injection. Symptoms were mild to moderate but did not resolve. The pt declined EMS services and decided to go home after approximately 40 minutes. She is aware of the risks. BP 140/90, SP02: 98%, HR: 80
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Urinary incontinence, Vital signs measurement
Clinical narrative: During the waiting period after receiving the immunization, the patient had a syncopal episode in the waiting area. The syncopal episode lasted only a few seconds and the patient had loss of bladder control. This was witnesses by the waiting area staff. The patient was immediately evaluated by an RN and EMS that was present at the facility. The patient stated that he has had similar reactions to vaccinations in the past except the loss of bladder control was new. The patient quickly recovered and stated he felt fine but embarrassed and wanted to call his wife and go home. He refused further treatment stating that he feels fine now and that this has happened before. After observing the patient for approximately fifteen more minutes and ambulating him to the restroom to clean up, the patient's wife arrived and he ambulated out to the car without difficulty.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had itching after shot, Next day swollen at injection site and soreness. By day 3 seemed to have gone away. On day 8, swelling / hotness / hardness / itching returned at site of injection. Swelling was size of tennis ball
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; multiple temperature excursions for VARlVAX/Total vaccine Accumulative excursion time for this patient: -14 C to - 10 C: 1425 minutes (23.75 hours); This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # S032355, expiration date 14-OCT-2021 (route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was stored from 01-NOV-2020 to 16-DEC-2020 in the improper temperature ranging from minus 14 degrees Celsius (C) to minus 10 degrees C for accumulative time of 23 hours and 45 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA000942: US-009507513-2103USA000947: US-009507513-2103USA000993: US-009507513-2103USA001002: US-009507513-2103USA001024: US-009507513-2103USA001088: US-009507513-2103USA001166: US-009507513-2103USA001184: US-009507513-2103USA001192: US-009507513-2103USA001209: US-009507513-2103USA001343: US-009507513-2103USA002929:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Heart rate increased, Malaise, Rash, Rash pruritic
Clinical narrative: severe, rash when I work out on my arms, legs and trunk / light rash on my arms; I am not active; rapid worsening of my vision in the past week; my heart rate is now faster than it has previously been / resting pulse in 72 / my pulse is 85; sedentary all morning; This case was reported by a consumer and described the occurrence of itchy rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included menopause. Previously administered products included Shingrix with an associated reaction of burning sensation (received 1st dose in October 2020, refer case US2021AMR025898). Concurrent medical conditions included allergy to antibiotic (allergies are vibramiacin and gantrin).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary were unknown.   It was unknown if the reporter considered the itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary to be related to Shingrix.  Additional details were provided as follows: The patient had no other underlying health issues other than menopause muffin top. The patient received Shingrix in pharmacy and get a severe rash when work out on patient's arms, legs and trunk.  The patient was not active and had light rash on arms. The reporter started on Claritin for the rash and was on one pill and increased the dosage to two pills with the advent of the rash for no reason. The patient experienced a rapid worsening of vision in the past week. The patient heart rate was faster than it had previously been. The patient normal resting pulse in 72 and patient pulse was 85 and had been sedentary almost all with only one cup of tea as a stimulant. The reporter asked how long these effects would last. The patient reported doomed to a lifetime of itchy rash when try to did any exercise that makes perspire or when go into a hot environment. The patient work with a caterer doing events in non-COVID years and cannot imagine anyone wanting around covered head to toe in rash.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025898:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: severe, rash when I work out on my arms, legs and trunk / light rash on my arms; I am not active; rapid worsening of my vision in the past week; my heart rate is now faster than it has previously been / resting pulse in 72 / my pulse is 85; sedentary all morning; This case was reported by a consumer and described the occurrence of itchy rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included menopause. Previously administered products included Shingrix with an associated reaction of burning sensation (received 1st dose in October 2020, refer case US2021AMR025898). Concurrent medical conditions included allergy to antibiotic (allergies are vibramiacin and gantrin).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary were unknown.   It was unknown if the reporter considered the itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary to be related to Shingrix.  Additional details were provided as follows: The patient had no other underlying health issues other than menopause muffin top. The patient received Shingrix in pharmacy and get a severe rash when work out on patient's arms, legs and trunk.  The patient was not active and had light rash on arms. The reporter started on Claritin for the rash and was on one pill and increased the dosage to two pills with the advent of the rash for no reason. The patient experienced a rapid worsening of vision in the past week. The patient heart rate was faster than it had previously been. The patient normal resting pulse in 72 and patient pulse was 85 and had been sedentary almost all with only one cup of tea as a stimulant. The reporter asked how long these effects would last. The patient reported doomed to a lifetime of itchy rash when try to did any exercise that makes perspire or when go into a hot environment. The patient work with a caterer doing events in non-COVID years and cannot imagine anyone wanting around covered head to toe in rash.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025898:same reporter
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: I have a red rash on my arm surrounding  the injection site.  It is an area of approximately 3 inches by 5 inches. I noticed it on TU morning after my shower. It has increased in size and feels quite itchy.   I have placed a cold compress on it and today I began taking Benedryl.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Gave pt adult dose in stead of child's dose of Hep A
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Hepatic pain, Nausea
Clinical narrative: Nausea, upper abdominal pain, chest pain, liver pain, back pain.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching that began on right arm and has since spread to left arm. Taking Benadryl and hydrocortisone cream otc.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: PATIENT REPORTS HAVING A GOLF BALL SIZED RASH AT THE INJECTION SITE 10 DAYS POST VACCINATION. ALSO EXPERIENCED REDNESS AT THE INJECTION SITE.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Deafness, Injection site pain, Tinnitus
Clinical narrative: Tinnitus, hearing loss, joint pain, sore at injection
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Skin warm, Swelling face
Clinical narrative: feeling of warmth and swelling on the face
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot waas incredibly painful. I took Tylenol ,it subsided it has continued to hurt since then.  If I touch the spot above my shot it hurts worse. When I received a shot it did hurt when she stuck me, but I do have upper arm  muscles .I am in shape, no fat on my arm. Some wondering if injecting it into my muscle is the reason why my arm hurts so bad. I compared notes with my friend whose 40 also in shape and his arm hurts like heck also.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Tachycardia
Clinical narrative: Nausea, tachycardia, dizziness
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Heart rate increased, Nausea
Clinical narrative: Nausea, tachycardia, dizziness
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Discomfort, Fatigue
Clinical narrative: I started feeling subtle flu-like symptoms about 6 hours after receiving shot. At first I thought it was in my head but by the early evening I felt like I had a full blown fever even though I never actually had a fever at any point.  I had chills, muscles aches, head aches, and extreme fatigue. My back hurt especially and overall I felt very weak. I also had pain at the injection site that got worse the following day. I had trouble even lifting my arm to reach a drink just a few feet away from me.  The arm soreness lasted through the Monday following my vaccination (I received it on a Friday). All my symptoms were at their worst on Saturday. I felt much better on Sunday but still had the arm pain through Monday. Motrin did help relieve the worst my symptoms. I thought that was the end of my symptoms but that last week I have noticed what I believe to be a lingering fatigue from the vaccination. While it's not usual for me to feel tired at points throughout the day, I have been feeling a heavier and more full body fatigue than I usually experience. I have had to take naps more often, sometimes multiple times in a day.  During these bouts of fatigue, my whole body feels heavy and somewhat weak. It's similar to the exhausted feeling someone might have after they've been crying for a while but I haven't been crying or emotionally taxed in anyway.  Normally when I wake up in the morning, I might feel tired for the first 30 minutes to an hour but once I get moving, I feel better and more alter. I have been having a harder time feeling rested or awake in the mornings and even if I get more sleep than normal, I still feel exhausted. I did not change my routine or diet which I why I think this is related to the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: I started feeling subtle flu-like symptoms about 6 hours after receiving shot. At first I thought it was in my head but by the early evening I felt like I had a full blown fever even though I never actually had a fever at any point.  I had chills, muscles aches, head aches, and extreme fatigue. My back hurt especially and overall I felt very weak. I also had pain at the injection site that got worse the following day. I had trouble even lifting my arm to reach a drink just a few feet away from me.  The arm soreness lasted through the Monday following my vaccination (I received it on a Friday). All my symptoms were at their worst on Saturday. I felt much better on Sunday but still had the arm pain through Monday. Motrin did help relieve the worst my symptoms. I thought that was the end of my symptoms but that last week I have noticed what I believe to be a lingering fatigue from the vaccination. While it's not usual for me to feel tired at points throughout the day, I have been feeling a heavier and more full body fatigue than I usually experience. I have had to take naps more often, sometimes multiple times in a day.  During these bouts of fatigue, my whole body feels heavy and somewhat weak. It's similar to the exhausted feeling someone might have after they've been crying for a while but I haven't been crying or emotionally taxed in anyway.  Normally when I wake up in the morning, I might feel tired for the first 30 minutes to an hour but once I get moving, I feel better and more alter. I have been having a harder time feeling rested or awake in the mornings and even if I get more sleep than normal, I still feel exhausted. I did not change my routine or diet which I why I think this is related to the vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Chest discomfort, Chest pain
Clinical narrative: 03/16/2021: Presented to the emergency department with substernal chest pain/pressure. Patient was admitted for non-ST elevation MI, and currently awaiting cardiac catheterization.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Tachycardia
Clinical narrative: 47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine.  Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation.  In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid.  Patient has history of anxiety and jittery as well as nervousness after epinephrine.  Patient was then given 1 mg p.o. Ativan for her symptom.     On my evaluation, patient is not in respiratory distress, She is still  Tachycardic in the 110s-120s  Which is likely from the EpiPen.  Patient stated that she normally stays tachycardic for a while after the epipen.  Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling.  Patient also has no wheezing on auscultation exam.  We discussed the possibility of staying in the hospital under observation versus going home.  Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Cough, Dizziness, Fatigue
Clinical narrative: 47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine.  Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation.  In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid.  Patient has history of anxiety and jittery as well as nervousness after epinephrine.  Patient was then given 1 mg p.o. Ativan for her symptom.     On my evaluation, patient is not in respiratory distress, She is still  Tachycardic in the 110s-120s  Which is likely from the EpiPen.  Patient stated that she normally stays tachycardic for a while after the epipen.  Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling.  Patient also has no wheezing on auscultation exam.  We discussed the possibility of staying in the hospital under observation versus going home.  Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip pruritus, Lip swelling, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: 47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine.  Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation.  In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid.  Patient has history of anxiety and jittery as well as nervousness after epinephrine.  Patient was then given 1 mg p.o. Ativan for her symptom.     On my evaluation, patient is not in respiratory distress, She is still  Tachycardic in the 110s-120s  Which is likely from the EpiPen.  Patient stated that she normally stays tachycardic for a while after the epipen.  Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling.  Patient also has no wheezing on auscultation exam.  We discussed the possibility of staying in the hospital under observation versus going home.  Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Swollen tongue, Urticaria
Clinical narrative: 47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine.  Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation.  In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid.  Patient has history of anxiety and jittery as well as nervousness after epinephrine.  Patient was then given 1 mg p.o. Ativan for her symptom.     On my evaluation, patient is not in respiratory distress, She is still  Tachycardic in the 110s-120s  Which is likely from the EpiPen.  Patient stated that she normally stays tachycardic for a while after the epipen.  Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling.  Patient also has no wheezing on auscultation exam.  We discussed the possibility of staying in the hospital under observation versus going home.  Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood test, Cerebrovascular accident, Computerised tomogram head, Dysarthria
Clinical narrative: pt started slurring his words and his face started drooping about 8 hours after taking the covid vax.  pts wife took him to ER.  They did a CT which did not show a hemorrhage.  He was admitted to the floor but had a 'Stroke Code' so was transferred to ICU.  Next day he had an MRI which showed he had a stroke.  The following day he was given another MRI since his symptoms were getting worse and it showed additional bleeding.  Pt is awake and starting to move around some but unable to communicate which speech at this time.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electroencephalogram, Facial paralysis, Haemorrhage, Intensive care
Clinical narrative: pt started slurring his words and his face started drooping about 8 hours after taking the covid vax.  pts wife took him to ER.  They did a CT which did not show a hemorrhage.  He was admitted to the floor but had a 'Stroke Code' so was transferred to ICU.  Next day he had an MRI which showed he had a stroke.  The following day he was given another MRI since his symptoms were getting worse and it showed additional bleeding.  Pt is awake and starting to move around some but unable to communicate which speech at this time.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: pt started slurring his words and his face started drooping about 8 hours after taking the covid vax.  pts wife took him to ER.  They did a CT which did not show a hemorrhage.  He was admitted to the floor but had a 'Stroke Code' so was transferred to ICU.  Next day he had an MRI which showed he had a stroke.  The following day he was given another MRI since his symptoms were getting worse and it showed additional bleeding.  Pt is awake and starting to move around some but unable to communicate which speech at this time.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: JANSSEN COVID-19 VACCINE EUA: The patient received her vaccine dose on 030221 and within 3 hours, shortly after lunch, complained of not feeling well and nausea. She subsequently went home early from work. At about midnight, approximately 12 hours post-dose, she awakened with fever to 102.  She subsequently presented to an emergency department at about 01:30 on 030321. She remained there for about 3 hours during which time she was monitored and received IV fluids, ibuprofen and acetaminophen. She returned to work on 030421 with improvement of symptoms.
Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death
Clinical narrative: DEATH
Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death
Clinical narrative: Death
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Arthralgia, Fatigue, Gait disturbance, Headache
Clinical narrative: Shot delivery was great, felt a little soreness in arm  that evening then started to get a headache. Developed sore throat and tiredness day later.  08 march went to ER due to headach at hospital. 12 March started to develop extreme flu like symptoms. Joints hurt. No fever. Whole body felt like skin had sunburn and hurt to touch. By 13 March it was extremely hard to walk up and down the stairs.  Took over the counter Mucilex and Vick's thera- flu for pain and headache. Went to the Clinic on 15 March because I still had symptoms. MTF put me on 10 day quarantine and tested me for covid. Test results were Negative, but stated I still need to quarantine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Shot delivery was great, felt a little soreness in arm  that evening then started to get a headache. Developed sore throat and tiredness day later.  08 march went to ER due to headach at hospital. 12 March started to develop extreme flu like symptoms. Joints hurt. No fever. Whole body felt like skin had sunburn and hurt to touch. By 13 March it was extremely hard to walk up and down the stairs.  Took over the counter Mucilex and Vick's thera- flu for pain and headache. Went to the Clinic on 15 March because I still had symptoms. MTF put me on 10 day quarantine and tested me for covid. Test results were Negative, but stated I still need to quarantine.