chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Condition aggravated, Peripheral swelling
Clinical narrative: angioedema; arm swelled up; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) on 28-Dec-2020.  This case involves female patient of an unknown age who experienced arm swelled up (peripheral swelling) and angioedema, while she received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On 30-Sep-2013, the patient received suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [lot number: UH894AB and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date, (latency unknown) patient had a reaction as the arm swelled up (peripheral swelling). Patient was on a lot of vitamin D and then got the vaccines; that she had angioedema but had not had it in a few years.    The event angioedema was assessed as medically significant as per important medical event (IME) list. It was not reported if the patient received a corrective treatment. The outcome of the both events was unknown. There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a patient of unknown age who experienced swelling of her arm and had angioedema after vaccination with FLUZONE. The time to onset is unknown. Moreover, there is no information on patient's allergic history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Raised red, warm lump at injection site. About the size of golf ball
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Total body aches and chills, followed by 101.2 fever.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect noted.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Hypertension
Clinical narrative: 54yoM presented for a sudden-onset diaphoresis and loss of body strength. Pt had received COVID-19 vaccine this morning at the clinic and noted severe sweating all over the body while lying in bed @ approx 2030. Then pt described severe loss of body strength with dizziness as he was trying to sit up and get to his feet from the floor. Denied palpitation, chest pain, headache, N/V, LOC. His symptoms continued for 20mins until he drank a cup of water. At approx 2050, smoked E-cigarette and arrived at facility at 2100. On arrival, pt denied any symptoms, however, vitals indicated severe hypertension: BP 188/99, HR 56, T 97.6 F. Pt given 81mg ASA x2 and immediately transported to hospital.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effects noted.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Moderate persistent headaches which began several days post vaccination
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, immune response  due to covid-19, I believe from being sick with covid recently
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: Day 9 post-vaccine, employee developed a raised, red patch around injection site, approximately 3 inches wide by 5 inches long.  The area is not warm or painful.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effects noted.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 11 hours after injection: Pain and swelling at injection site. Blister at injection site. Itching of arm of injection site. 13 hour after injection: Chills and muscle aches 20 hour after injection: Fever (101.4 - 101.7), Nausea, Vomiting, Muscle cramping, diarrhea. Symptoms persisted 48 hours, until about 72 hours after injection
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles, Muscle spasms, Myalgia, Nausea, Pyrexia
Clinical narrative: 11 hours after injection: Pain and swelling at injection site. Blister at injection site. Itching of arm of injection site. 13 hour after injection: Chills and muscle aches 20 hour after injection: Fever (101.4 - 101.7), Nausea, Vomiting, Muscle cramping, diarrhea. Symptoms persisted 48 hours, until about 72 hours after injection
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 11 hours after injection: Pain and swelling at injection site. Blister at injection site. Itching of arm of injection site. 13 hour after injection: Chills and muscle aches 20 hour after injection: Fever (101.4 - 101.7), Nausea, Vomiting, Muscle cramping, diarrhea. Symptoms persisted 48 hours, until about 72 hours after injection
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Condition aggravated, Dizziness, Electrocardiogram normal, Sinus rhythm
Clinical narrative: Approximately 20 minutes after vaccination developed burning sensation in sternum. States non radiating. Felt similar to heartburn. Persistent. No SOB. No changes to pain with deep breathing. Approximately 445 mins post vaccination developed dizziness as well. Patient was seen in clinic and EKG performed. Noted to be SR. Vital signs stable. Patient sent via EMS to local hospital for full workup.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Fatigue, Hypersomnia
Clinical narrative: Approximately 20 minutes after vaccination developed burning sensation in sternum. States non radiating. Felt similar to heartburn. Persistent. No SOB. No changes to pain with deep breathing. Approximately 445 mins post vaccination developed dizziness as well. Patient was seen in clinic and EKG performed. Noted to be SR. Vital signs stable. Patient sent via EMS to local hospital for full workup.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Troponin
Clinical narrative: Approximately 20 minutes after vaccination developed burning sensation in sternum. States non radiating. Felt similar to heartburn. Persistent. No SOB. No changes to pain with deep breathing. Approximately 445 mins post vaccination developed dizziness as well. Patient was seen in clinic and EKG performed. Noted to be SR. Vital signs stable. Patient sent via EMS to local hospital for full workup.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: rash on body, pain in both arms
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: 24 hours after administration started having fever up to 101.5, chills, body aches, headache. Fever and chills lasted about 12 hours. Headache and body aches continue past 24 hours
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Lymph node pain, Lymphadenopathy, Pruritus
Clinical narrative: Painful swollen lymph nodes collar bone and underarm of Left side. Started 1/2 Injection site raised lumpy and itchy started 1/4 Raised itchy rash on R hip started 12/31.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: Painful swollen lymph nodes collar bone and underarm of Left side. Started 1/2 Injection site raised lumpy and itchy started 1/4 Raised itchy rash on R hip started 12/31.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect noted.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash pruritic
Clinical narrative: Patient is a 11y.o. female who complains of  rash. She got Tdap, menactra 12/30. That night started with little rash on forehead. Itchy and spread across face. 12/31 very itchy, spreading down neck. Used some hct.   Examined 1/4/2021. Rash does not come and go. Remains on face. Now nose, eyelids, ears, chin. Some bumps on arms.    Did not eat today, but feeling fine. No runny nose or cough, no sore throat, no abdominal pain or diarrhea.  Sleeping fine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence, Injection site pain, Nausea
Clinical narrative: Nausea, bloating, gas, and pain at the injection site. Nausea set in 3 hours after injection and lasted about 36 hours. Bloating and gas continue day 3. Pain set in 10 hours after injection and lasted 24 hours. No medical attention needed, tea, soup, fluids, moving the arm, and rest helped.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Moderate soreness at injection site.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing shortly after injection, lasted a few minutes but went away. Benadryl given
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effects noted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: Swollen painful eyes
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Arthralgia, Constipation, Fatigue, Feeling abnormal
Clinical narrative: Vaccine at 8:40 am.  1 pm same day started with headache that progressed to severe headache.  Marked pain in injection sight that radiated to neck and all the way to fingers. injection sight Felt warm, moderate swelling, not red. pain in arm lasted 2.5 day. Also Severe arthalgias and myalgia all over.  Extreme fatigue, Foggy head. Blurry vision mild 48 hr.  Very aggitated.  Slept more but disturbed sleep.  Could not work 24 hr.  Very tired at work 12/31/2020.  Naueas, no vomiting, mild constipation.   Patient still feels tired and foggy today 1/5/2021 but improving
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Impaired work ability, Injection site pain, Injection site swelling
Clinical narrative: Vaccine at 8:40 am.  1 pm same day started with headache that progressed to severe headache.  Marked pain in injection sight that radiated to neck and all the way to fingers. injection sight Felt warm, moderate swelling, not red. pain in arm lasted 2.5 day. Also Severe arthalgias and myalgia all over.  Extreme fatigue, Foggy head. Blurry vision mild 48 hr.  Very aggitated.  Slept more but disturbed sleep.  Could not work 24 hr.  Very tired at work 12/31/2020.  Naueas, no vomiting, mild constipation.   Patient still feels tired and foggy today 1/5/2021 but improving
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Nausea, Neck pain, Pain
Clinical narrative: Vaccine at 8:40 am.  1 pm same day started with headache that progressed to severe headache.  Marked pain in injection sight that radiated to neck and all the way to fingers. injection sight Felt warm, moderate swelling, not red. pain in arm lasted 2.5 day. Also Severe arthalgias and myalgia all over.  Extreme fatigue, Foggy head. Blurry vision mild 48 hr.  Very aggitated.  Slept more but disturbed sleep.  Could not work 24 hr.  Very tired at work 12/31/2020.  Naueas, no vomiting, mild constipation.   Patient still feels tired and foggy today 1/5/2021 but improving
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Vision blurred
Clinical narrative: Vaccine at 8:40 am.  1 pm same day started with headache that progressed to severe headache.  Marked pain in injection sight that radiated to neck and all the way to fingers. injection sight Felt warm, moderate swelling, not red. pain in arm lasted 2.5 day. Also Severe arthalgias and myalgia all over.  Extreme fatigue, Foggy head. Blurry vision mild 48 hr.  Very aggitated.  Slept more but disturbed sleep.  Could not work 24 hr.  Very tired at work 12/31/2020.  Naueas, no vomiting, mild constipation.   Patient still feels tired and foggy today 1/5/2021 but improving
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Vomiting
Clinical narrative: Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.   No adverse effect noted.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, SARS-CoV-2 test negative, Urine analysis, Vomiting
Clinical narrative: Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling of body temperature change, Flushing, Injection site rash
Clinical narrative: Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later.  Red rash disappeared within 1.5 hours after taking ibuprofen.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later.  Red rash disappeared within 1.5 hours after taking ibuprofen.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash, Malaise, Rash pruritic
Clinical narrative: Itchy rash formed at injection site 8 days after receiving the injection along with fatigue and overall not feeling well
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Severe, debilitating chills, mild fever (100.0).  Started just after midnight of 12/29/2020.  Took 800mg Motrin at approximately 12:45am.  Severe chills continued until approximately 02:30am, at which time they resolved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect noted.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever that lasts overnight after vaccination, pain in the left hand where the vaccine was administered, dizziness and headache
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: I had an episode of chills in the middle of the night (4:17 am), and I had a 100.9F fever at 6:20 a.m. on 1-5-2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect noted.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face swelling several days after receiving the vaccine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Pain
Clinical narrative: woke up at 3 am 1/3/21 with flu like symptoms: chills, fever, body aches, weakness and headache which lasted all day. woke up 1/4/21 feeling better but had headache and was very weak. 1/5/21 still very weak but headache gone
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: woke up at 3 am 1/3/21 with flu like symptoms: chills, fever, body aches, weakness and headache which lasted all day. woke up 1/4/21 feeling better but had headache and was very weak. 1/5/21 still very weak but headache gone
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: moderate redness, itching and mild swelling about 3 inches in diameter around left deltoid that appeared 8 days after vaccine injection. Took Tylenol and left alone. Gradually improved and slowly resolved over next few days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash at injection site
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effects noted
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Drooling, Dyspnoea, Fatigue
Clinical narrative: After an hour of receiving my vaccine, I started feeling  a little jittery, my heart rate went up to 113. I felt very short of breath. worst when walking and talking that improved with me sitting. Nausea with lots of drool. Around 4:30 I started feeling body aches . Then at 5 on my way home, i started feeling extreme pain in my joints, to where i couldnt hold the steering wheel tight. Around 7:30 I started having shaking and aching. Around 9:30 I ate potatoes, and took motrin and it helped a little. I felt weak and washed out like I ran a marathon.  I was still feeling fatigue and wiped out, I had no energy.  I took my pulse ox and it was 95-96.  I am now having muscle pain at the injection site, and injection site is very sore.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Impaired driving ability, Injection site pain, Nausea, Pain
Clinical narrative: After an hour of receiving my vaccine, I started feeling  a little jittery, my heart rate went up to 113. I felt very short of breath. worst when walking and talking that improved with me sitting. Nausea with lots of drool. Around 4:30 I started feeling body aches . Then at 5 on my way home, i started feeling extreme pain in my joints, to where i couldnt hold the steering wheel tight. Around 7:30 I started having shaking and aching. Around 9:30 I ate potatoes, and took motrin and it helped a little. I felt weak and washed out like I ran a marathon.  I was still feeling fatigue and wiped out, I had no energy.  I took my pulse ox and it was 95-96.  I am now having muscle pain at the injection site, and injection site is very sore.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: After an hour of receiving my vaccine, I started feeling  a little jittery, my heart rate went up to 113. I felt very short of breath. worst when walking and talking that improved with me sitting. Nausea with lots of drool. Around 4:30 I started feeling body aches . Then at 5 on my way home, i started feeling extreme pain in my joints, to where i couldnt hold the steering wheel tight. Around 7:30 I started having shaking and aching. Around 9:30 I ate potatoes, and took motrin and it helped a little. I felt weak and washed out like I ran a marathon.  I was still feeling fatigue and wiped out, I had no energy.  I took my pulse ox and it was 95-96.  I am now having muscle pain at the injection site, and injection site is very sore.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Feeling of body temperature change, Flushing, Headache, Hypertension
Clinical narrative: 0.5 ml Moderna covid vaccine administered in right deltoid at 0630. Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by Dr. Husband called to transport home. Instructed when to return to ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Rash macular, Tachycardia, Tremor
Clinical narrative: 0.5 ml Moderna covid vaccine administered in right deltoid at 0630. Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by Dr. Husband called to transport home. Instructed when to return to ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Headache, Hypertension, Nausea
Clinical narrative: 0.5 ml Moderna covid vaccine administered in right deltoid at 0630. Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by Dr. Husband called to transport home. Instructed when to return to ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Tachycardia, Tremor
Clinical narrative: 0.5 ml Moderna covid vaccine administered in right deltoid at 0630. Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by Dr. Husband called to transport home. Instructed when to return to ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Feeling of body temperature change, Flushing, Headache, Hypertension
Clinical narrative: Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by physician on site and spouse was called to transport patient home. She was given instructions on when to return to the ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Rash macular, Tachycardia, Tremor
Clinical narrative: Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by physician on site and spouse was called to transport patient home. She was given instructions on when to return to the ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Headache, Hypertension, Nausea
Clinical narrative: Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by physician on site and spouse was called to transport patient home. She was given instructions on when to return to the ED
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Tachycardia, Tremor
Clinical narrative: Several minutes following vaccine c/o feeling flushed and "really hot." She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by physician on site and spouse was called to transport patient home. She was given instructions on when to return to the ED
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort
Clinical narrative: Recipient reported chest tightness on one side then the other. Blood pressure was checked- 162/103. The recipient was escorted to our facility's outpatient clinic. He reports receiving medication for the blood pressure and being monitor for a few hours but his blood pressure did not decrease. He was encouraged to visit his PCP.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Rhonchi, Sputum abnormal
Clinical narrative: Rhonchi, frothy sputum, low grade temp, elevated HR,   12/30 MD assessed 1:00PM and increased prednisone and added Cefdinir.  Sent to hospital 12/30 at approximately 6:30PM with worsening symptoms
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effected reported
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Painful axilar Lymphadenopathy same side of injection arm
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills, slight fever, body aches
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Besides the arm pain, exhaustion exactly like when I had Covid. I had a headache when I was sleeping last night, unable to sleep last night, very achy, congested, chills but afebrile. The exhaustion and achiness is the worst part of it. I don't know if it is related to my RA. I am off my RA meds (Mycophenalate 3000 mg and Methotrexate 20 mg subQ because I had surgery on November 16 and then got Covid so they haven't restarted them.  I am a nurse and just thought this my be helpful.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sleep disorder
Clinical narrative: Besides the arm pain, exhaustion exactly like when I had Covid. I had a headache when I was sleeping last night, unable to sleep last night, very achy, congested, chills but afebrile. The exhaustion and achiness is the worst part of it. I don't know if it is related to my RA. I am off my RA meds (Mycophenalate 3000 mg and Methotrexate 20 mg subQ because I had surgery on November 16 and then got Covid so they haven't restarted them.  I am a nurse and just thought this my be helpful.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Facial paralysis, Laboratory test
Clinical narrative: Developed left sided Bell's Palsy two days after receiving COVID vaccine
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Cardiac monitoring, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Swollen tongue, Tongue discomfort
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dysphonia, Heart rate, Heart rate increased
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Palpitations, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cheilitis, Cough, Dizziness, Dysphonia, Glossodynia
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia oral, Injection site paraesthesia, Lip swelling, Oropharyngeal pain
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Tachycardia
Clinical narrative: Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Erythema, Hospice care, Localised oedema, Skin warm
Clinical narrative: Redness and warmth with edema to right side of  neck and under chin. Resident was on Hospice services  and expired on 1.1.21
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Local reaction
Clinical narrative: 12/30/2020 am started with local reaction of  swelling and pain in right arm along with heaviness of right arm.   Also extreme fatigue.  All of these sx subsided 01/02/2021.    12/30/2020 pm started with chills, assumed fever, achiness of arms and legs, nightmares, waking up in the middle of the night right sided headache.  All of these sx have subsided (12/31/2020) except for headache and waking up at night.  These two sx continue.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: 12/30/2020 am started with local reaction of  swelling and pain in right arm along with heaviness of right arm.   Also extreme fatigue.  All of these sx subsided 01/02/2021.    12/30/2020 pm started with chills, assumed fever, achiness of arms and legs, nightmares, waking up in the middle of the night right sided headache.  All of these sx have subsided (12/31/2020) except for headache and waking up at night.  These two sx continue.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Patient complained of metallic taste in mouth and tingling in top lip immediately after the vaccine. Resolved after 5 minutes.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: A week after receiving the vaccine I noticed a  bright red warm 2" x2" circle on my arm. (possible cellulitis?) I called my PCP but they wanted me to notify you to see what I should do about it.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypertension, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling.    Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol.   Disposition: Patient declined ED visit
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling.    Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol.   Disposition: Patient declined ED visit
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect reported
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: the injection site (upper left arm) was warm and tender; the injection site (upper left arm) was warm and tender; her left arm was very sore; her left arm was so swollen; list the product as an allergy; severe local reaction; arm was red down both side; discomfort; This spontaneous report was received from a 73-year-old female patient, who was referring to herself. The patient's concurrent conditions included diabetes mellitus, coronary artery disease and allergy to tetracycline. Her medical history included stent placement in 2008. Concomitant therapies included metformin, carvedilol, lisinopril (manufacturer unknown), simvastatin (manufacturer unknown), aspirin and vitamin D (unspecified). Her historical vaccines included regular straight pneumonia shot (manufacturer unknown) in October 2008 and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in August 2015 and in approximately August 2016 (reported as year after). The patient reported no adverse events with any of the previously mentioned vaccinations.  On 23-JUN-2020, the patient was vaccinated with a one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered in the left arm (lot #, expiration date, strength, dose and route of administration were not provided) for precautionary because of age and medical problems.      On the same date, upon initial injection, the injection site became warm and tender. On 23-JUN-2020 in the evening, her left arm was very sore and by bedtime, her left arm was so swollen that it could be seen where the band aid was. She stated her arm was twice the size of right arm. The patient put an ice pack on arm and was taking acetaminophen (TYLENOL). She reported her left arm was continuously aching and sore and she had swelling from her elbow to her shoulder, and her arm was red down both side. On 23-JUN-2020 at night, she went to emergency room (ER), but she was not admitted to the hospital. In the ER, she was told she had a local reaction and to "keep an eye on it." On 24-JUN-2020, the patient went to see a pharmacist, who advised her to continue using ice and acetaminophen (TYLENOL) for discomfort. On 25-JUN-2020, she visited her physician who advised her that she had a severe local reaction and advised her not to get pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again and to list the product as an allergy. The patient stated that at this time the swelling had "drained down" to her lower left arm. No lab diagnostics/ studies were performed. On 28-JUN-2020, the patient recovered from the events.  The reporter considered allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to be related to the suspect vaccine. The relatedness between other events and the suspect vaccine was not reported.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: the injection site (upper left arm) was warm and tender; the injection site (upper left arm) was warm and tender; her left arm was very sore; her left arm was so swollen; list the product as an allergy; severe local reaction; arm was red down both side; discomfort; This spontaneous report was received from a 73-year-old female patient, who was referring to herself. The patient's concurrent conditions included diabetes mellitus, coronary artery disease and allergy to tetracycline. Her medical history included stent placement in 2008. Concomitant therapies included metformin, carvedilol, lisinopril (manufacturer unknown), simvastatin (manufacturer unknown), aspirin and vitamin D (unspecified). Her historical vaccines included regular straight pneumonia shot (manufacturer unknown) in October 2008 and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in August 2015 and in approximately August 2016 (reported as year after). The patient reported no adverse events with any of the previously mentioned vaccinations.  On 23-JUN-2020, the patient was vaccinated with a one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered in the left arm (lot #, expiration date, strength, dose and route of administration were not provided) for precautionary because of age and medical problems.      On the same date, upon initial injection, the injection site became warm and tender. On 23-JUN-2020 in the evening, her left arm was very sore and by bedtime, her left arm was so swollen that it could be seen where the band aid was. She stated her arm was twice the size of right arm. The patient put an ice pack on arm and was taking acetaminophen (TYLENOL). She reported her left arm was continuously aching and sore and she had swelling from her elbow to her shoulder, and her arm was red down both side. On 23-JUN-2020 at night, she went to emergency room (ER), but she was not admitted to the hospital. In the ER, she was told she had a local reaction and to "keep an eye on it." On 24-JUN-2020, the patient went to see a pharmacist, who advised her to continue using ice and acetaminophen (TYLENOL) for discomfort. On 25-JUN-2020, she visited her physician who advised her that she had a severe local reaction and advised her not to get pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again and to list the product as an allergy. The patient stated that at this time the swelling had "drained down" to her lower left arm. No lab diagnostics/ studies were performed. On 28-JUN-2020, the patient recovered from the events.  The reporter considered allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to be related to the suspect vaccine. The relatedness between other events and the suspect vaccine was not reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: a temperature excursion MMR II had been administered; no further adverse event (AE); This spontaneous report as received from a registered nurse referring to a currently would be 4-year-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S020160, expiration date was 30-JUN-2021, dose was 1 injection, route was not reported) for prophylaxis. The temperature excursion of this vaccine was above 8 degree Celsius (C) (9.0 C) for 26 minutes without any previous temperature excursion. The digital data logger was involved. No further adverse event (AE).
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: No additional AE,; temperature excursion, caller disclosed that multiple doses of MMRlI were administered to multiple patients; This spontaneous report as received from an office administrator refers to a 11-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.    On 08-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 ml injection,"once", lot # S012944 was confirmed to be valid, expiration date 28-APR-2021 (route and site of administration were not reported) for prophylaxis. There were previous excursions reported. The digital data logger was involved. No additional adverse events were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2101USA000852:Same Reporter Link US-009507513-2101USA000853:Same Reporter Link US-009507513-2101USA000854:Same Reporter Link
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No other AE reported; it was given past its expiration date; We read the date incorrectly as it is printed on the bottle as 2020 Sept 22; This spontaneous report was received from a registered nurse referring to an 11-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 29-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, lot # N032284, expiration date 22-SEP-2020) for prophylaxis, the registered nurse read the expiration date incorrectly as it was printed on the bottle as 2020 Sept 22, so thought the year was 2022, which past its expiration date (expired product administered and product expiration date issue). No other adverse event was reported.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE,; temperature excursion, caller disclosed that multiple doses of MMRlI were administered to multiple patients; This spontaneous report as received from an office administrator refers to a 13-month-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.    On 08-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 ml injection,"once", lot # S012944 was confirmed to be valid, expiration date 28-APR-2021 (route and site of administration were not reported) for prophylaxis. There were previous excursions reported. The digital data logger was involved. No additional adverse events were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2012USA012763:Same Reporter Link US-009507513-2101USA000854:Same Reporter Link US-009507513-2101USA000853:Same Reporter Link