chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Throat tightness
Clinical narrative: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Burning sensation, Cardiac monitoring, Chest discomfort
Clinical narrative: About 5 minutes after injection:  fast growing wave  of internal burning sensation throughout body,  feeling that I would pass out, lightheafdedness,  increased heart rate and blood pressure,  mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness,  very slight throat soft tissue sensation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Heart rate increased, Peripheral coldness, Presyncope
Clinical narrative: About 5 minutes after injection:  fast growing wave  of internal burning sensation throughout body,  feeling that I would pass out, lightheafdedness,  increased heart rate and blood pressure,  mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness,  very slight throat soft tissue sensation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Thinking abnormal, Throat irritation
Clinical narrative: About 5 minutes after injection:  fast growing wave  of internal burning sensation throughout body,  feeling that I would pass out, lightheafdedness,  increased heart rate and blood pressure,  mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness,  very slight throat soft tissue sensation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Blood pressure increased, Burning sensation, Disturbance in attention
Clinical narrative: About 5 minutes after injection:  fast growing wave  of internal burning sensation throughout body,  feeling that I would pass out, lightheafdedness,  increased heart rate and blood pressure,  mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness,  very slight throat soft tissue sensation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Mental impairment, Peripheral coldness, Speech disorder
Clinical narrative: About 5 minutes after injection:  fast growing wave  of internal burning sensation throughout body,  feeling that I would pass out, lightheafdedness,  increased heart rate and blood pressure,  mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness,  very slight throat soft tissue sensation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: About 5 minutes after injection:  fast growing wave  of internal burning sensation throughout body,  feeling that I would pass out, lightheafdedness,  increased heart rate and blood pressure,  mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness,  very slight throat soft tissue sensation
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue, sore muscle
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: extreme body aches, fever of 101 degrees F, pain at injection site, severe headache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful lymph node left clavicle
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Redness and swelling an inch away from the injection site, hives on face
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Aura, Dizziness, Injected limb mobility decreased, Migraine
Clinical narrative: Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nasal pruritus, Rhinorrhoea, Wheezing
Clinical narrative: about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes because of hx), I had the sudden onset of  itchy runny nose and  chest tightness and wheezing of significant intensity that I  needed to use inhaler then and again later in the day. Noteworthy, I had  as a precaution taken prednisone 20mg p.o  about 2 hours before the injection.  I had to take more  later that afternoon because of symptoms. I then seem better but several times since the vaccine I have needed to uses the inhaler  and take prednisone  more than I have except after an infection about 6 years ago that precipitated similar symptoms to now. Today I had a flare significant enough that except for covid I might have gone to the ER or urgent care.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Swelling face
Clinical narrative: Resident noted with right sided facial swelling and lip droop. diagnosed as bells Palsy
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Slight headache a few ours later after vaccination.  The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following  morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight headache a few ours later after vaccination.  The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following  morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Muscular weakness
Clinical narrative: 4 hours after vaccine, sore arm, fatigue, headache, blurred vision 12 hours after vaccine, full body tremors, fever of 102, extreme muscle weakness, fatigue, deep chest cough, shortness of breath. fatigue, weakness and cough continued for three days after  vaccine before subsiding
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor, Vision blurred
Clinical narrative: 4 hours after vaccine, sore arm, fatigue, headache, blurred vision 12 hours after vaccine, full body tremors, fever of 102, extreme muscle weakness, fatigue, deep chest cough, shortness of breath. fatigue, weakness and cough continued for three days after  vaccine before subsiding
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: on the following day after the vaccination, I developed chills, awful headache, body aches, extreme fatigue, malaise, no fever
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Rash
Clinical narrative: Fatigue, headache, body aches, chills, localized rash
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Ear discomfort, Haematology test normal, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: I received the shot around 0730 on 12/30/2020. Went home and got ready for work. Around 12am 12/31/2020 my arm started to radiate at the injection site and was very tense. I placed a heat pack on the right harm but the pain did not dissipate.  My arm continued to be in pain for the rest of the night. Around 0240 I ate dinner, had water and still had some arm pain. Around 0345 my arm started to flare up and sent pain sensations throughout my body. My right arm was increasingly discomforting, I could barely move it. The sensations spread to my legs, numbing them and my throat had felt as if it were closing up. I got up to get the attention of the nurse and was able to flag her down. She said I was pale as a ghost. My vision was very blurry, I could not hear anything because my ears had filled up and everything was muffled. My head had begun to ring and I was on the brink of fainting when a chair was given to me. My eyes had become extremely sensitive to the light, I was given water and spoken to about what had happened leading up to the event. I was greeted by the paramedics who drew my blood, placed an IV and transferred me to the Acute Care portion of the Emergency Department. My vitals were 76/49, 80/50, 90/56, 100/60 before being brought to the ER.  On 1/1/2021 My thighs have been sore/tense, my knees and ankles have been stiff and just feeling sickly. On 1/2/2021 much of the same symptoms are present. The soreness in the muscles isn't as prevalent, however joints still are stiff On 1/3/2021, congestion and runny nose are still present, stiffness in ankles and now shins are prevalent.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Joint stiffness, Laboratory test normal, Malaise
Clinical narrative: I received the shot around 0730 on 12/30/2020. Went home and got ready for work. Around 12am 12/31/2020 my arm started to radiate at the injection site and was very tense. I placed a heat pack on the right harm but the pain did not dissipate.  My arm continued to be in pain for the rest of the night. Around 0240 I ate dinner, had water and still had some arm pain. Around 0345 my arm started to flare up and sent pain sensations throughout my body. My right arm was increasingly discomforting, I could barely move it. The sensations spread to my legs, numbing them and my throat had felt as if it were closing up. I got up to get the attention of the nurse and was able to flag her down. She said I was pale as a ghost. My vision was very blurry, I could not hear anything because my ears had filled up and everything was muffled. My head had begun to ring and I was on the brink of fainting when a chair was given to me. My eyes had become extremely sensitive to the light, I was given water and spoken to about what had happened leading up to the event. I was greeted by the paramedics who drew my blood, placed an IV and transferred me to the Acute Care portion of the Emergency Department. My vitals were 76/49, 80/50, 90/56, 100/60 before being brought to the ER.  On 1/1/2021 My thighs have been sore/tense, my knees and ankles have been stiff and just feeling sickly. On 1/2/2021 much of the same symptoms are present. The soreness in the muscles isn't as prevalent, however joints still are stiff On 1/3/2021, congestion and runny nose are still present, stiffness in ankles and now shins are prevalent.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Pallor, Photophobia
Clinical narrative: I received the shot around 0730 on 12/30/2020. Went home and got ready for work. Around 12am 12/31/2020 my arm started to radiate at the injection site and was very tense. I placed a heat pack on the right harm but the pain did not dissipate.  My arm continued to be in pain for the rest of the night. Around 0240 I ate dinner, had water and still had some arm pain. Around 0345 my arm started to flare up and sent pain sensations throughout my body. My right arm was increasingly discomforting, I could barely move it. The sensations spread to my legs, numbing them and my throat had felt as if it were closing up. I got up to get the attention of the nurse and was able to flag her down. She said I was pale as a ghost. My vision was very blurry, I could not hear anything because my ears had filled up and everything was muffled. My head had begun to ring and I was on the brink of fainting when a chair was given to me. My eyes had become extremely sensitive to the light, I was given water and spoken to about what had happened leading up to the event. I was greeted by the paramedics who drew my blood, placed an IV and transferred me to the Acute Care portion of the Emergency Department. My vitals were 76/49, 80/50, 90/56, 100/60 before being brought to the ER.  On 1/1/2021 My thighs have been sore/tense, my knees and ankles have been stiff and just feeling sickly. On 1/2/2021 much of the same symptoms are present. The soreness in the muscles isn't as prevalent, however joints still are stiff On 1/3/2021, congestion and runny nose are still present, stiffness in ankles and now shins are prevalent.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Throat tightness, Tinnitus, Vision blurred
Clinical narrative: I received the shot around 0730 on 12/30/2020. Went home and got ready for work. Around 12am 12/31/2020 my arm started to radiate at the injection site and was very tense. I placed a heat pack on the right harm but the pain did not dissipate.  My arm continued to be in pain for the rest of the night. Around 0240 I ate dinner, had water and still had some arm pain. Around 0345 my arm started to flare up and sent pain sensations throughout my body. My right arm was increasingly discomforting, I could barely move it. The sensations spread to my legs, numbing them and my throat had felt as if it were closing up. I got up to get the attention of the nurse and was able to flag her down. She said I was pale as a ghost. My vision was very blurry, I could not hear anything because my ears had filled up and everything was muffled. My head had begun to ring and I was on the brink of fainting when a chair was given to me. My eyes had become extremely sensitive to the light, I was given water and spoken to about what had happened leading up to the event. I was greeted by the paramedics who drew my blood, placed an IV and transferred me to the Acute Care portion of the Emergency Department. My vitals were 76/49, 80/50, 90/56, 100/60 before being brought to the ER.  On 1/1/2021 My thighs have been sore/tense, my knees and ankles have been stiff and just feeling sickly. On 1/2/2021 much of the same symptoms are present. The soreness in the muscles isn't as prevalent, however joints still are stiff On 1/3/2021, congestion and runny nose are still present, stiffness in ankles and now shins are prevalent.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Mass
Clinical narrative: On 12-22-2020, approx. 2 days after vaccine, I noticed several non-tender lumps under my chin/adjacent to left jaw line ~ small gum drop size lumps seemed to congeal together over next 9 days into a single half-dollar dollar sized lump - not completely round.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pain of skin
Clinical narrative: Headache  Chills Temp  (101.6) Body aches Skin hurts to touch Soreness in arm  (injection site)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache  Chills Temp  (101.6) Body aches Skin hurts to touch Soreness in arm  (injection site)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray abnormal, Exposure to SARS-CoV-2, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with COVID-related pneumonia on 03 Jan 2021.   Close contact exposure on 25 Dec, with positive COVID PCR test on 29 Dec... managed as outpatient until respiratory sxms prompted hospitalization on 03 Jan.  Care team anticipates at least 4 inpatient days... but patient remains hospitalized at date of this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever Blister
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Intensive care, Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood phosphorus decreased, Blood potassium decreased
Clinical narrative: Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Echocardiogram normal, Intensive care
Clinical narrative: Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Palpitations, Protein total normal, Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Echocardiogram, Hypertension, Supraventricular tachycardia, Tachycardia
Clinical narrative: Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Intensive care, Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: Patient is a 28 yo male with history of SVT following flu vaccine in 2016 who was in his usual state of health when, this morning 15 minutes after receiving the Moderna COVID vaccine, he developed palpitations. He reports that while he was being monitored for adverse reaction, at exactly 15 minutes of waiting, he started to feel ill and his heart was racing. He was thus brought to the emergency room via WC. EKG demonstrated sinus tachycardia, and serial EKGs showed SVT with a rate of 150-160. These were responsive to vagal maneuvers, but shortly returned to SVT. Cardiology was consulted and adenosine 6mg and 12mg did not break the rhythm. He was bloused with 20mg IV diltiazem and started on a diltiazem infusion.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Patient is a 28 yo male with history of SVT following flu vaccine in 2016 who was in his usual state of health when, this morning 15 minutes after receiving the Moderna COVID vaccine, he developed palpitations. He reports that while he was being monitored for adverse reaction, at exactly 15 minutes of waiting, he started to feel ill and his heart was racing. He was thus brought to the emergency room via WC. EKG demonstrated sinus tachycardia, and serial EKGs showed SVT with a rate of 150-160. These were responsive to vagal maneuvers, but shortly returned to SVT. Cardiology was consulted and adenosine 6mg and 12mg did not break the rhythm. He was bloused with 20mg IV diltiazem and started on a diltiazem infusion.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood phosphorus decreased, Blood potassium decreased
Clinical narrative: Patient is a 28 yo male with history of SVT following flu vaccine in 2016 who was in his usual state of health when, this morning 15 minutes after receiving the Moderna COVID vaccine, he developed palpitations. He reports that while he was being monitored for adverse reaction, at exactly 15 minutes of waiting, he started to feel ill and his heart was racing. He was thus brought to the emergency room via WC. EKG demonstrated sinus tachycardia, and serial EKGs showed SVT with a rate of 150-160. These were responsive to vagal maneuvers, but shortly returned to SVT. Cardiology was consulted and adenosine 6mg and 12mg did not break the rhythm. He was bloused with 20mg IV diltiazem and started on a diltiazem infusion.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Echocardiogram normal, Intensive care
Clinical narrative: Patient is a 28 yo male with history of SVT following flu vaccine in 2016 who was in his usual state of health when, this morning 15 minutes after receiving the Moderna COVID vaccine, he developed palpitations. He reports that while he was being monitored for adverse reaction, at exactly 15 minutes of waiting, he started to feel ill and his heart was racing. He was thus brought to the emergency room via WC. EKG demonstrated sinus tachycardia, and serial EKGs showed SVT with a rate of 150-160. These were responsive to vagal maneuvers, but shortly returned to SVT. Cardiology was consulted and adenosine 6mg and 12mg did not break the rhythm. He was bloused with 20mg IV diltiazem and started on a diltiazem infusion.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Palpitations, Protein total normal, Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: Patient is a 28 yo male with history of SVT following flu vaccine in 2016 who was in his usual state of health when, this morning 15 minutes after receiving the Moderna COVID vaccine, he developed palpitations. He reports that while he was being monitored for adverse reaction, at exactly 15 minutes of waiting, he started to feel ill and his heart was racing. He was thus brought to the emergency room via WC. EKG demonstrated sinus tachycardia, and serial EKGs showed SVT with a rate of 150-160. These were responsive to vagal maneuvers, but shortly returned to SVT. Cardiology was consulted and adenosine 6mg and 12mg did not break the rhythm. He was bloused with 20mg IV diltiazem and started on a diltiazem infusion.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Echocardiogram, Hypertension, Supraventricular tachycardia, Tachycardia
Clinical narrative: Patient is a 28 yo male with history of SVT following flu vaccine in 2016 who was in his usual state of health when, this morning 15 minutes after receiving the Moderna COVID vaccine, he developed palpitations. He reports that while he was being monitored for adverse reaction, at exactly 15 minutes of waiting, he started to feel ill and his heart was racing. He was thus brought to the emergency room via WC. EKG demonstrated sinus tachycardia, and serial EKGs showed SVT with a rate of 150-160. These were responsive to vagal maneuvers, but shortly returned to SVT. Cardiology was consulted and adenosine 6mg and 12mg did not break the rhythm. He was bloused with 20mg IV diltiazem and started on a diltiazem infusion.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat, cold symptoms 3 days after, bone pain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: The vaccine was given in the deltoid tendon/shoulder bursa area NOT in the deltoid muscle.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Injection site pain
Clinical narrative: Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 Jan 4, 2021 significant arm pain at injection site (awakened by it at 3 am) with chills, temp 99.6. Took One tablet ALEVE followed by temp 98.6
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on sides started Thursday. Woke up Friday and rash is all over body itching red and hurts. Taken Benadryl, pepsid and hydrocortisone cream. Called tele doc they gave prednisone nothing is working getting worse
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Rash on sides started Thursday. Woke up Friday and rash is all over body itching red and hurts. Taken Benadryl, pepsid and hydrocortisone cream. Called tele doc they gave prednisone nothing is working getting worse
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Hypoaesthesia, Metabolic function test
Clinical narrative: Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm at injection site for about 1 day
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Glassy eyes, Injection site pain, Injection site swelling, Laboratory test, Lymph node pain
Clinical narrative: Pain and swelling in arm where injection was received. Lymph nodes in axilla and in neck were also swollen and painful. Eyes were described as "glassy",  Two medications prescribed Lidocaine Patch and Naproxen
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Pain and swelling in arm where injection was received. Lymph nodes in axilla and in neck were also swollen and painful. Eyes were described as "glassy",  Two medications prescribed Lidocaine Patch and Naproxen
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: Her arm hurts at the injection site; During this time it is painful to pick up small objects.; In the morning it hurts to raise her arm and lift it from her body for about an hour.; This spontaneous report was received from a a  72 year old female patient, reporting on herself. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 05-NOV-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23))(strength, dose, frequency, lot # and expiration date were not provided) in the right arm for prophylaxis. The patient began experiencing symptoms the evening of the shot. Her arm hurt at the injection site when she went to sleep, it was so painful that it woke her up. In the morning it hurt to raise her arm and lift it from her body for about an hour. During this time it was painful to pick up small objects.    At the reporting time, the outcome of the  events was unknown.        Causality was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQCs reported; Administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on 16-SEP-2020, the patients was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (dose number, route, dose, and anatomical location of administration was not provided; witch lot number T015598 has been verified to be a valid lot number, expiration date reported and validated as 02-NOV-2021) for prophylaxis.   The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to a temperature excursion of 20.5 degrees Fahrenheit for a time frame of 1 hour 54 minutes, which was detected by the Digital Data Logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 degrees Fahrenheit) for 23 minutes. No adverse effects or product quality complaints were reported.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Allergy to vaccine, Intracranial pressure increased, Platelet count decreased
Clinical narrative: Allergy to vaccines; Had ICP; platelets dropped to 2; Almost died from MMR vaccine; This spontaneous report has been received from a registered nurse concerning a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (strength, dose, vaccination schedule, route and anatomical site of administration, lot number, and expiration date were not reported).    On an unknown date, the patient almost died from measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine (vaccination complication). In addition, the patient experienced allergy to vaccines, for which he was two weeks hospitalized. On an unknown date, the patient had intracranial pressure increased (ICP) and his platelets dropped to 2 (units not provided) (platelet count decreased). The patient was advised by the pediatrician to never take another vaccine, and at the reporting time, the patient had 24-year-old and still had a significant allergy to vaccines (not recovered). The outcome of vaccination complication, platelet count decreased, and intracranial pressure increased were not reported.   The reporter considered allergy to vaccine and vaccination complication to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). The causality assessment between the suspect therapy administration and the events of platelet count decreased, and intracranial pressure increased was not reported.   The event vaccination complication was considered to be a life-threatening event by the reporter. Furthermore, upon internal review the event of intracranial pressure increased was considerer to be medically significant.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Duplicate therapy error, Wrong product administered
Clinical narrative: No additional AE reported; Pt supposed to get MMRII and Varivax and she was administered Proquad instead of MMR II; Duplicate therapy with same active substance; This spontaneous report as received from a physician refers to a 12 month old female patient. Patient's medical history, concomitant medications, drug allergies or reactions were not reported.   On 28-DEC-2020,the patient was supposes to received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and  varicella virus vaccine live (oka/merck)(VARIVAX) in her wellness visit; however she  was administered  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency, administration route, lot number and expiration date were not reported) for prophylaxis instead of rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered and duplicate therapy error). No adverse events were reported.
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant  male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP reported an improperly stored administered VARIVAX.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 28-DEC-2020, it was administered to the patient an improperly stored of (product storage error) varicella virus vaccine live (oka/merck)(VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, anatomical site of vaccination and route of administration were not provided, lot number reported as S010296, which has been verified to be valid, expiration date reported and validated as 03-APR-2021). The vaccine administered experienced a temperature excursion of -13.3 degrees Celsius (C), for a time of 15 minutes. There was no previous temperature excursion reported and no data logger was involved.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other AE reported.; Medical Assistant calls and reports an expired MMR II vaccine was inadvertently given to a patient.; This spontaneous report was received from a medical assistant, referring to a 12-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 28-DEC-2020, the patient received an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), as prophylaxis (formulation, strength, dose, vaccination scheme, anatomical site of vaccination and route of administration were not provided, lot number reported as R035700, which has been verified to be valid, expiration date reported and validated as 09-DEC-2020). There was no previous temperature excursion reported. No additional adverse event were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (already had shingles when patient was younger). Previously administered products included FLU VACCINE.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported no more vaccines for him/her as no matter what anyone says dosen't matter what GlaxoSmithKline have (flu, cold, allergies, pneumonia,etc.) they probably would say it's the Covid virus The patient haven't lived all this time with no common sense.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR231589:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: The site of my shot is still red; The site of my shot / sore.; The site of my shot is still / itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult as per the vaccine indication. The patient received the vaccine. The patient experienced site of shot was still red, itchy and sore.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: A little ache in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient said that never got sick from shots, may be a little ache in my arm for 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: i have fever today; This case was reported by a other health professional via other manufacturer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included gastrointestinal symptom nos and rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On 19th November 2020, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age group was not reported, but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient reported that he/she had gastrointestinal symptoms before starting Xeljanz and was unchanged since previous contact (10th August 2020). The patient received 2nd dose of Shingrix and next day experienced fever. Physician awareness was not stated.
Sex: U
Vaccine: FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tiredness; ache in upper left arm; This case was reported by a consumer and described the occurrence of tiredness in a 65-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included chickenpox (mild case chickenpox when 12 or 13 years of age). Concurrent medical conditions included drug allergy (allergy to sulfa drugs).   On 1st September 2020, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On 1st September 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient had no allergic reactions, only known drug allergy was to sulfa drugs. The age at vaccination was not reported but it could be 64 to 65. As the patient was aged his or her temperature ranges from 97 plus to 98.4 degree F. The patient received the Flu shot in left arm and experienced tiredness with ache in upper left arm lasted 3 days, beginning in the evening of the day of shot.  The patient received Prevnar 13 vaccine on 6th October 2020 in left arm and experienced same events. The patient received 1st dose of Shingrix on 16th November 2020 and had allergic reaction. On 19th November 2020, the patient confirmed that he or she never had shingles.  This case has been linked with US2020AMR234476 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234476:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were recovered/resolved.   It was unknown if the reporter considered the vomiting and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix 10 weeks ago.  The patient experienced extreme reaction nausea and vomiting for 6 hours. The patient asked expect the same reaction with the 2nd dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: chills; headache; fever / low grade temp; sore arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date. please refer the case US2020240919).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced chills, headache and fever. In December 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, headache, fever and pain in arm were unknown.   It was unknown if the reporter considered the chills, headache, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix. The patient reported headache, chills, fever, and a sore arm. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240919:same patient