chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Within 12 hours of receiving the booster, I developed a fever of 100.4-101.0, severe body aches, night sweats, chills, exhaustion, nausea and bad headache. These acute symptoms lasted for 72 hours and then resolved. Approximately on 12/13, I developed a chronic headache/migraine at times (with some nausea) that has yet to resolve. It has been minimally responsive to OTC meds, chronic, and varying in degree from mild to severe. On 12/21, I went to my primary care doctor complaining of this same headache and nausea. He did a neurological workup and suggested bloodwork, prescribed antibiotics, offered RX pain meds (which I declined that day) and a return visit if it worsens. Two days later, 12/24, my headache began waking me up at night and increased in severity. I went to the ER where they performed a CT scan, bloodwork and prescribed migraine medication. On 12/26, symptoms exacerbated and in addition to the intense headache, the symptoms from my booster shot returned: body aches, chills, elevated temperature (99.7), nausea, and some additional pains including more muscle soreness, especially in my legs at night. I took an at home Covid-19 test and it was negative. I went to my primary care doctor again on 12/28 and he prescribed prednisone and urged I get bloodwork the following day. Today, 12/29, I met with a naturopathic doctor to discuss supplements to support my immune system and detox from the vaccine side effects.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Lethargy, Myalgia, Pyrexia
Clinical narrative: Injection occurred at approximately 1015am local on 12/28. Extreme lethargy began at approximately 8pm. At 2am following morning (12/29), I woke and was unable to return to sleep. I had extreme back and muscle main, as well as pain at injection site. I had a low grade fever. I took ibuprofen and/or acetaminophen every 4-6 hours. Low grade fever subsided by mid-day, however muscle pain and injection site pain continues at time of this report (12/30 at 0730). I am applying topical pain relievers to assist with muscle pain.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Injection occurred at approximately 1015am local on 12/28. Extreme lethargy began at approximately 8pm. At 2am following morning (12/29), I woke and was unable to return to sleep. I had extreme back and muscle main, as well as pain at injection site. I had a low grade fever. I took ibuprofen and/or acetaminophen every 4-6 hours. Low grade fever subsided by mid-day, however muscle pain and injection site pain continues at time of this report (12/30 at 0730). I am applying topical pain relievers to assist with muscle pain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Skin warm
Clinical narrative: The day after my 3rd dose I experienced left arm pain and a new extreme pain in all of my joints.  With my first dose I had similar left arm pain, but with the second dose the left arm pain had been minimal.  However, I don't remember ever feeling joint pain with my first two doses.  Days 3 to 5 after my 3rd dose, the arm and joint pain slowly subsided and completely went away.  However, in the weeks since on random days like today I will experience pain in my left arm at the shot location, my wrist joints, finger joints, and occasionally other random joints as well and those areas usually feel warmer than normal.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: heartache tired ness out of breath sudden fast heart beat
Age: 52.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Lymphadenopathy, Pain
Clinical narrative: swelling of lymph nodes under both arm pits.  Started 12/24/2021 and still hurts as of today 12/30/2021
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Angiogram, Arthralgia, Blood test, Computerised tomogram, Injection site hypoaesthesia
Clinical narrative: Woke up 12/8 with severe pain in right upper arm, it got progressively worse with an hour of being awake that I was in tears. Felt like my muscle in my arm was twisting and burning and it would not stop. It?s been 3 weeks. I had Toradol injection,  dilaudid injection, morphine and Valium in the ER and still felt pain. I had 2 CT scans, MRI, ultrasound, blood work and angiogram. I cannot lay down with intensifying pain so I have sleep sitting up since 12/8. Will get a cervical epidural steroid injection in my neck on 1/4. I tried a cortisone shot in shoulder with short term minor relief and I?m taking Neurontin and Flexiril 3 times daily. Prednisone once daily, started at high dose and gradually reduced every 4 days, this helped but with medicine reduced, pain returned to severe unmanageable feeling and I?m taking Percocet as needed. MRI shows bulging disc that is compressing a nerve. All my consistent pain comes from my arm where the stuff was given. It?s been numb for almost 3 weeks as well. I do have ache in my neck at times and shoulder pain a lot, pain even radiates to my forearm at times. My upper arm is the worst however and it feels like a tight band is around my bicep.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site pain, Intervertebral disc protrusion, Magnetic resonance imaging abnormal, Muscle tightness, Myalgia
Clinical narrative: Woke up 12/8 with severe pain in right upper arm, it got progressively worse with an hour of being awake that I was in tears. Felt like my muscle in my arm was twisting and burning and it would not stop. It?s been 3 weeks. I had Toradol injection,  dilaudid injection, morphine and Valium in the ER and still felt pain. I had 2 CT scans, MRI, ultrasound, blood work and angiogram. I cannot lay down with intensifying pain so I have sleep sitting up since 12/8. Will get a cervical epidural steroid injection in my neck on 1/4. I tried a cortisone shot in shoulder with short term minor relief and I?m taking Neurontin and Flexiril 3 times daily. Prednisone once daily, started at high dose and gradually reduced every 4 days, this helped but with medicine reduced, pain returned to severe unmanageable feeling and I?m taking Percocet as needed. MRI shows bulging disc that is compressing a nerve. All my consistent pain comes from my arm where the stuff was given. It?s been numb for almost 3 weeks as well. I do have ache in my neck at times and shoulder pain a lot, pain even radiates to my forearm at times. My upper arm is the worst however and it feels like a tight band is around my bicep.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Neck pain, Nerve compression, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Woke up 12/8 with severe pain in right upper arm, it got progressively worse with an hour of being awake that I was in tears. Felt like my muscle in my arm was twisting and burning and it would not stop. It?s been 3 weeks. I had Toradol injection,  dilaudid injection, morphine and Valium in the ER and still felt pain. I had 2 CT scans, MRI, ultrasound, blood work and angiogram. I cannot lay down with intensifying pain so I have sleep sitting up since 12/8. Will get a cervical epidural steroid injection in my neck on 1/4. I tried a cortisone shot in shoulder with short term minor relief and I?m taking Neurontin and Flexiril 3 times daily. Prednisone once daily, started at high dose and gradually reduced every 4 days, this helped but with medicine reduced, pain returned to severe unmanageable feeling and I?m taking Percocet as needed. MRI shows bulging disc that is compressing a nerve. All my consistent pain comes from my arm where the stuff was given. It?s been numb for almost 3 weeks as well. I do have ache in my neck at times and shoulder pain a lot, pain even radiates to my forearm at times. My upper arm is the worst however and it feels like a tight band is around my bicep.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Tearfulness, Ultrasound scan
Clinical narrative: Woke up 12/8 with severe pain in right upper arm, it got progressively worse with an hour of being awake that I was in tears. Felt like my muscle in my arm was twisting and burning and it would not stop. It?s been 3 weeks. I had Toradol injection,  dilaudid injection, morphine and Valium in the ER and still felt pain. I had 2 CT scans, MRI, ultrasound, blood work and angiogram. I cannot lay down with intensifying pain so I have sleep sitting up since 12/8. Will get a cervical epidural steroid injection in my neck on 1/4. I tried a cortisone shot in shoulder with short term minor relief and I?m taking Neurontin and Flexiril 3 times daily. Prednisone once daily, started at high dose and gradually reduced every 4 days, this helped but with medicine reduced, pain returned to severe unmanageable feeling and I?m taking Percocet as needed. MRI shows bulging disc that is compressing a nerve. All my consistent pain comes from my arm where the stuff was given. It?s been numb for almost 3 weeks as well. I do have ache in my neck at times and shoulder pain a lot, pain even radiates to my forearm at times. My upper arm is the worst however and it feels like a tight band is around my bicep.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain
Clinical narrative: Headache, slight chills. Slight body ache.  Sleeplessness.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Fall, Malaise, Nausea
Clinical narrative: Was getting ready for bed, I believe it was a seizure; I  Lost all blood pressure, fell to floor. Had convulsions for awhile, couldn't speak out for help. nausea, couldn't hold bowels. After that episode of about 45 min. Felt sick and week for a few days. Did not call a doctor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Was getting ready for bed, I believe it was a seizure; I  Lost all blood pressure, fell to floor. Had convulsions for awhile, couldn't speak out for help. nausea, couldn't hold bowels. After that episode of about 45 min. Felt sick and week for a few days. Did not call a doctor.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: metallic taste ,  arm  swelling, itchy arm, 50cent size raised swelling, red, painful hot to touch.  24 hours later 3x2 inch swelling raised area, hot to touch arm swelling
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: metallic taste ,  arm  swelling, itchy arm, 50cent size raised swelling, red, painful hot to touch.  24 hours later 3x2 inch swelling raised area, hot to touch arm swelling
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: First dose Pfizer had no reaction other than sore arm. At that time, injection given in left arm. Second dose in June had injection same arm but severe chills that started around 8:30pm. Simultaneously, I also experienced numbness in my face but subtle and I chaulked it up to chills I had. Two days ago I got Pfizer Booster around 10:30am injected in right arm this time. I got slight chills around 6:30pm. They subsided but I had severe facial numbness on my left side and no signs of stroke. It feels like the numbness wearing off from a dental procedure. Yet, two days later I am still having facial numbness on my left side. No chills or other issues other than standard sore arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash and welts all over the body
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Lymphadenopathy
Clinical narrative: Arm pain, injection site redness, itchiness, and tenderness, swelling in armpit area, lymph node swelling and tenderness in the left arm and neck, itchy red bumps on left side of neck and on left arm near injection site. These symptoms lasted for 4-5 days.   On Saturday December 18th around 6pm shivers, aches, and chills happened until after taking ibuprofen.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: Arm pain, injection site redness, itchiness, and tenderness, swelling in armpit area, lymph node swelling and tenderness in the left arm and neck, itchy red bumps on left side of neck and on left arm near injection site. These symptoms lasted for 4-5 days.   On Saturday December 18th around 6pm shivers, aches, and chills happened until after taking ibuprofen.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Headache, Injection site swelling, Pyrexia
Clinical narrative: Fever reached 102.4 F. 12 hours after the injection and stayed elevated for 48 hrs. despite administration of ibuprofen (400 mg at 6 hour intervals) and fluids. Fatigue and headache for 72 hours. Swelling of upper left arm from shoulder to elbow. This was a repeat of events after dose two, except fever was a full degree higher and lasted on 36 hours.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Pain, Pain in extremity
Clinical narrative: she feels hot and cold; The sole of the left foot is hurting/ Her calves hurt; Intermittent pain throughout her body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (she feels hot and cold), PAIN IN EXTREMITY (The sole of the left foot is hurting/ Her calves hurt) and PAIN (Intermittent pain throughout her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (she feels hot and cold), PAIN IN EXTREMITY (The sole of the left foot is hurting/ Her calves hurt) and PAIN (Intermittent pain throughout her body). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (she feels hot and cold), PAIN IN EXTREMITY (The sole of the left foot is hurting/ Her calves hurt) and PAIN (Intermittent pain throughout her body) had not resolved.            No concomitant medications was reported. No treatment drug details was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm, swollen lymph nodes, chest pains
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Biopsy bone marrow, Biopsy lymph gland, Blood lactate dehydrogenase, Blood urine present
Clinical narrative: 11/9-11/12 chills/shivering - no fever 11/9 - started noticing blood in urine,  11/13 - started on 500mg Cipro 2xday, Hemoglobin at 11.5 showing some anemia 11/17 - stopped Cipro, Hemoglobin at 7.4, admitted to hospital 11/17, 11/18, 11/22 - Received blood transfusions, 3 total units 12/2 - Platelet counts dropped from 170 to 44 12/13 - Platelet counts rebounded to 154 12/26 - Platelet counts dropped to critical level of 2, received 2 units of platelet transfusion, platelet levels rose to 6 12/28 - Platelet counts dropped to 1. Started on Nplate 2mcg/kg
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Coombs direct test, Flow cytometry, Full blood count, Haemoglobin decreased
Clinical narrative: 11/9-11/12 chills/shivering - no fever 11/9 - started noticing blood in urine,  11/13 - started on 500mg Cipro 2xday, Hemoglobin at 11.5 showing some anemia 11/17 - stopped Cipro, Hemoglobin at 7.4, admitted to hospital 11/17, 11/18, 11/22 - Received blood transfusions, 3 total units 12/2 - Platelet counts dropped from 170 to 44 12/13 - Platelet counts rebounded to 154 12/26 - Platelet counts dropped to critical level of 2, received 2 units of platelet transfusion, platelet levels rose to 6 12/28 - Platelet counts dropped to 1. Started on Nplate 2mcg/kg
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Haptoglobin, Liver function test, Lymphadenectomy, Lymphadenopathy, Metabolic function test
Clinical narrative: 11/9-11/12 chills/shivering - no fever 11/9 - started noticing blood in urine,  11/13 - started on 500mg Cipro 2xday, Hemoglobin at 11.5 showing some anemia 11/17 - stopped Cipro, Hemoglobin at 7.4, admitted to hospital 11/17, 11/18, 11/22 - Received blood transfusions, 3 total units 12/2 - Platelet counts dropped from 170 to 44 12/13 - Platelet counts rebounded to 154 12/26 - Platelet counts dropped to critical level of 2, received 2 units of platelet transfusion, platelet levels rose to 6 12/28 - Platelet counts dropped to 1. Started on Nplate 2mcg/kg
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Red blood cell count decreased, Reticulocyte count, Transfusion
Clinical narrative: 11/9-11/12 chills/shivering - no fever 11/9 - started noticing blood in urine,  11/13 - started on 500mg Cipro 2xday, Hemoglobin at 11.5 showing some anemia 11/17 - stopped Cipro, Hemoglobin at 7.4, admitted to hospital 11/17, 11/18, 11/22 - Received blood transfusions, 3 total units 12/2 - Platelet counts dropped from 170 to 44 12/13 - Platelet counts rebounded to 154 12/26 - Platelet counts dropped to critical level of 2, received 2 units of platelet transfusion, platelet levels rose to 6 12/28 - Platelet counts dropped to 1. Started on Nplate 2mcg/kg
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis, White blood cell count decreased
Clinical narrative: 11/9-11/12 chills/shivering - no fever 11/9 - started noticing blood in urine,  11/13 - started on 500mg Cipro 2xday, Hemoglobin at 11.5 showing some anemia 11/17 - stopped Cipro, Hemoglobin at 7.4, admitted to hospital 11/17, 11/18, 11/22 - Received blood transfusions, 3 total units 12/2 - Platelet counts dropped from 170 to 44 12/13 - Platelet counts rebounded to 154 12/26 - Platelet counts dropped to critical level of 2, received 2 units of platelet transfusion, platelet levels rose to 6 12/28 - Platelet counts dropped to 1. Started on Nplate 2mcg/kg
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Wrong dose administered for 12 year old. Patient received Pfizer COVID vaccine 0.2mL instead of 30mcg/0.3mL on 12/1/21 1553. No adverse effects reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute pulmonary oedema, Arteriogram coronary abnormal, Condition aggravated, Coronary artery bypass, Coronary artery disease
Clinical narrative: Presented in Ventricular tachycardia with acute cardiac ischemia and further reduced EF to 15% from previous baseline of 30%.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Myocardial ischaemia, Ventricular tachycardia
Clinical narrative: Presented in Ventricular tachycardia with acute cardiac ischemia and further reduced EF to 15% from previous baseline of 30%.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISING IN VARIOUS PARTS OF THE BODY; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (very unusual maybe a glass of wine), and non smoker. The patient had no known allergy. The patient previously received covid-19 vaccine ad26. cov2.s (Janssen, Dose number in series 1)(suspension for injection, route of admin not reported, batch number:1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The patient had no issues with series 1. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-DEC-2021 (Post 4 weeks of vaccination), the patient experienced bruising in various parts of the body. The reporter saw 2 on right arm and patient stated she had bruising in various part of body covered by clothing. The reporter stated that bruising appeared after booster dose. The reporter stated that bruising was noticed after doing exercise. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising in various parts of the body. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Feeling cold, Pyrexia, Sleep disorder
Clinical narrative: He was sleeping and had a nightmare and he woke up; Felt an immense cold; His body was shaking so strongly that he could not control it/his body was shaking so much; He was almost convulsing; Fever/mild fever/ body temperature of 40.1°C; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (He was sleeping and had a nightmare and he woke up), FEELING COLD (Felt an immense cold), TREMOR (His body was shaking so strongly that he could not control it/his body was shaking so much), FEELING ABNORMAL (He was almost convulsing) and PYREXIA (Fever/mild fever/ body temperature of 40.1°C) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035H21B) for COVID-19 vaccination.     The patient's past medical history included Bone operation (he does not have any underlying condition.).    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced SLEEP DISORDER (He was sleeping and had a nightmare and he woke up), FEELING COLD (Felt an immense cold), TREMOR (His body was shaking so strongly that he could not control it/his body was shaking so much), FEELING ABNORMAL (He was almost convulsing) and PYREXIA (Fever/mild fever/ body temperature of 40.1°C). The patient was treated with ACETAMINOPHEN on 24-Dec-2021 at a dose of two 350mg pills and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 24-Dec-2021 at a dose of 1 tablet. At the time of the report, SLEEP DISORDER (He was sleeping and had a nightmare and he woke up), FEELING COLD (Felt an immense cold), TREMOR (His body was shaking so strongly that he could not control it/his body was shaking so much) and FEELING ABNORMAL (He was almost convulsing) outcome was unknown and PYREXIA (Fever/mild fever/ body temperature of 40.1°C) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, Body temperature: 40.1°c (High) 40.1°C.         Concomitant product use was not provider by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow up received include no new information.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: He was sleeping and had a nightmare and he woke up; Felt an immense cold; His body was shaking so strongly that he could not control it/his body was shaking so much; He was almost convulsing; Fever/mild fever/ body temperature of 40.1°C; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (He was sleeping and had a nightmare and he woke up), FEELING COLD (Felt an immense cold), TREMOR (His body was shaking so strongly that he could not control it/his body was shaking so much), FEELING ABNORMAL (He was almost convulsing) and PYREXIA (Fever/mild fever/ body temperature of 40.1°C) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035H21B) for COVID-19 vaccination.     The patient's past medical history included Bone operation (he does not have any underlying condition.).    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced SLEEP DISORDER (He was sleeping and had a nightmare and he woke up), FEELING COLD (Felt an immense cold), TREMOR (His body was shaking so strongly that he could not control it/his body was shaking so much), FEELING ABNORMAL (He was almost convulsing) and PYREXIA (Fever/mild fever/ body temperature of 40.1°C). The patient was treated with ACETAMINOPHEN on 24-Dec-2021 at a dose of two 350mg pills and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 24-Dec-2021 at a dose of 1 tablet. At the time of the report, SLEEP DISORDER (He was sleeping and had a nightmare and he woke up), FEELING COLD (Felt an immense cold), TREMOR (His body was shaking so strongly that he could not control it/his body was shaking so much) and FEELING ABNORMAL (He was almost convulsing) outcome was unknown and PYREXIA (Fever/mild fever/ body temperature of 40.1°C) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, Body temperature: 40.1°c (High) 40.1°C.         Concomitant product use was not provider by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow up received include no new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Electrocardiogram normal, Feeling hot, Flushing, Palpitations
Clinical narrative: Woke up from sleep with Flushing/hot feeling with no fever, feeling of doom, racing heart up to 180 at rest
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Woke up from sleep with Flushing/hot feeling with no fever, feeling of doom, racing heart up to 180 at rest
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Testicular pain
Clinical narrative: Body aches especially in testicles
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmalgia, Dysphagia, Erythema, Oropharyngeal discomfort, Pruritus
Clinical narrative: Ten days after receiving the Moderna booster, I woke up feeling very itchy all over my body. When I itched, the area would immediately turn red. Sometimes it would become raised. The rash would usually disappear within 30 minutes. Two days later my throat felt as it if something was lodged in my throat and I could not swallow it. I also experienced pain in my diagraphm. The rash continues to pop up in different parts of my body, but subsides when I take an antihistamine. The skin is very sensitive and reacts to heat, jewelry, itching and other substances. While I thought it was an allergic reaction to something in my environment, I have tested lotions, detergent, foods etc. and have been unable to find a solution, even though the rash persists.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Sensitive skin
Clinical narrative: Ten days after receiving the Moderna booster, I woke up feeling very itchy all over my body. When I itched, the area would immediately turn red. Sometimes it would become raised. The rash would usually disappear within 30 minutes. Two days later my throat felt as it if something was lodged in my throat and I could not swallow it. I also experienced pain in my diagraphm. The rash continues to pop up in different parts of my body, but subsides when I take an antihistamine. The skin is very sensitive and reacts to heat, jewelry, itching and other substances. While I thought it was an allergic reaction to something in my environment, I have tested lotions, detergent, foods etc. and have been unable to find a solution, even though the rash persists.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Condition aggravated, Dizziness, Hypotension
Clinical narrative: Radiating injection site pain to back, neck, chest.  Itching, pain, swelling at site. Itching radiates up neck.  Feeling faint Palpitations  Feeling like blood pressure is extremely low. (Same as in morning from prazosin before hydrating) Neuropathy symptoms   ***** I have peripheral neuropathy in legs *****
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Neck pain, Neuropathy peripheral
Clinical narrative: Radiating injection site pain to back, neck, chest.  Itching, pain, swelling at site. Itching radiates up neck.  Feeling faint Palpitations  Feeling like blood pressure is extremely low. (Same as in morning from prazosin before hydrating) Neuropathy symptoms   ***** I have peripheral neuropathy in legs *****
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pruritus
Clinical narrative: Radiating injection site pain to back, neck, chest.  Itching, pain, swelling at site. Itching radiates up neck.  Feeling faint Palpitations  Feeling like blood pressure is extremely low. (Same as in morning from prazosin before hydrating) Neuropathy symptoms   ***** I have peripheral neuropathy in legs *****
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: has experienced chest tightness; has experienced chest pain; inability to take deep breaths since receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "has experienced chest tightness"; CHEST PAIN (non-serious), outcome "unknown", described as "has experienced chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "inability to take deep breaths since receiving the vaccine". The events "has experienced chest tightness", "has experienced chest pain" and "inability to take deep breaths since receiving the vaccine" were evaluated at the physician office visit.  Additional information: She had been evaluated by multiple physicians who have not been able to identify reasons for these symptoms. After reviewing VAERS, and other creditable sources this seems to be a potential trend after receiving the vaccine and requesting a review of this information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from nurse prescriber, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-DEC-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 1 milliliter, (lot #T017179, which was confirmed to be valid, and expiration date: 26-OCT-2021), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided) (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 08-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, dose:0.5  milliliter, lot # T001213, expiration date: 12-JAN-2022, intramuscular instead of subcutaneous route for prophylaxis (dose number unspecified) (Incorrect route of product administration). No additional adverse reported. No product quality complaint was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare business professional and refers to a patient of unknown age and gender. No details regarding concurrent conditions, medical history or concomitant therapies were reported in regard to the patient. On 03-DEC-2021, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T033510, expiration date 28-DEC-2021, dose 2 milliliter, administered orally and with haemophilus B conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot# T037650, expiration date 21-JUL-2023, dose 0.5 milliliter, administered intramuscularly to left thigh. Both vaccinations were first doses of respective vaccines. Administered vaccines experienced temperature excursion of 47.29 degrees Fahrenheit (F) for 3 hours and 22 minutes (Product storage error). Previous temperature excursions were reported as not applicable. Digital data logger was involved. No additional adverse events were reported.
Age: 29.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE reported; a consumer received their 1st dose of VARIVAX on 10-MAR-2021 / they are receiving their 2nd dose of VARIVAX today, 10-DEC-2021; This spontaneous report was received from a pharmacist and refers to a 30 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2021, the patient was vaccinated with the first dose od varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # T006347, expiration date 20-FEB-2022 (formulation, concentration, site and route of administration not provided) for prophylaxis. The pharmacist reported that the patient was receiving their second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)(dose, route and site of administration, lot # and expiration date not provided) on 10-DEC-2021 (reported also as "today") (inappropriate schedule of vaccine administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. The patient's concurrent conditions, concomitant medications and medical history were unknown. On or about 15-JAN-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider (HCP) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation (unspecified date), the patient was treated by a physician for shingles and other zoster-related conditions(ill-defined disorder). As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and other zoster-related conditions was not recovered. The lawyer considered shingles and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient was administered a dose of PROQUAD intramuscularly instead of subcutaneously; No additional AE reported; This spontaneous report has been received from a pharmacist concerning to a 4-years-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose number, dose, frequency, lot# and expiration date were not reported) intramuscularly instead of subcutaneously (incorrect route of product administration). No additional adverse event (AE) reported.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: I was in bed for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shots a few years ago and he/she was in bed for a few days from the side effects.
Sex: U
Vaccine: FLU3, MENB, MNQ
Symptoms: Extra dose administered, Headache, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a Other Health Professional via sales rep and described the occurrence of headache in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis and Flu Seasonal TIV Quebec (Flulaval) for prophylaxis. Concomitant products included Men ACWY-CRM NVS (Menveo), Men B NVS (Bexsero) and Flu Seasonal TIV Quebec (Flulaval). On an unknown date, the patient received the 2nd dose of Menveo, the 2nd dose of Bexsero, Meningococcal B Vaccine Pre-Filled Syringe Device and the 2nd dose of Flulaval. On an unknown date, unknown after receiving Menveo, Bexsero, Meningococcal B Vaccine Pre-Filled Syringe Device and Flulaval, the patient experienced headache, drug dose administration interval too short and extra dose administered. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the drug dose administration interval too short and extra dose administered were unknown. It was unknown if the reporter considered the headache to be related to Menveo, Bexsero, Meningococcal B Vaccine Pre-Filled Syringe Device and Flulaval. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was not reported. The patient was given 1st dose of Menveo, Bexsero and Flulaval then 6 weeks later was administered another dose of each Menveo, Bexsero and Flulaval. The patient received 2nd dose of Menveo early than recommended which led to shortening of vaccination schedule. The patient received 2nd dose of Flulaval, which led to extra dose administration. The patient had ongoing headaches for weeks after 2nd administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles 2 times years ago). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The patient got the shingle 2 times years ago. She had both shots a couple years ago and has the shingles again now. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 2 years prior to the reporting date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never got the 2nd dose, which led to incomplete course of vaccination. The patient asked to start over. The reporter wanted to know what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose. The reporter reported her pharmacy thought she should start over since first dose was about two years ago.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got them the next week; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 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 reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shot and thought that he/she would not get shingles sure enough and got them the next week. The patient stated that it was horrible stuff and he/she did not trust any of these shots now. The follow-up would not possible as no contact details were available.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th September 2021, the patient received the 1st dose of Shingrix. On 7th September 2021, 6 hrs after receiving Shingrix, the patient experienced general body pain and influenza-like symptoms. On 8th September 2021 22:00, the outcome of the general body pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the general body pain and influenza-like symptoms to be related to Shingrix. The patient self-reported this case. The patient stated that after 1st Shingrix dose given in his right arm and experienced flu like symptoms, body aches and pain on the same day and were resolved by the end of the next day at 10 pm. The reporter could not provide the lot number or expiration date of Shingrix vaccine he was administered. The reporter did not want to provide his address or email when collecting demographics. The reporter consented to be contacted however did not want to provide his physician's demographics. For tolerance of 2nd dose refer case US2021263854, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021263854:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (first bout of shingles was over 5 years ago). Concurrent medical conditions included post herpetic neuralgia. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got first bout of shingles over 5 years ago and still had post herpatic neuralgia. The patient had received all the Shingles shots and had three lesser flare ups of shingles in the 5 years. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain in extremity, Sneezing, Upper-airway cough syndrome
Clinical narrative: Sore arm; Head cold; Sneeze; Postnasal drip; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 21st October 2022) for prophylaxis.   On 21st October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, head cold, sneezing and postnasal drip. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the head cold, sneezing and postnasal drip were recovering/resolving.   It was unknown if the reporter considered the pain in arm, head cold, sneezing and postnasal drip to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient experienced sore arm after getting the Shingrix dose in left arm.  The reporter mentioned that he was recovering from head cold, sneeze, and postnasal drip about 10 days ago from the day of reporting.  The reporter did not think the events (head cold, sneeze, and postnasal drip) were from Shingrix. The reporter did not have lot number for the first dose but, did provide the expiration date. The reporter did not consent to follow up with the Healthcare professional.