chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt c/o redness and itchiness along the injection site. The area was hot to the touch. HR ranges from 110-120 bpm. Denies any lumps or bumbs near her axilla. She does have burning at the injection site as well.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt c/o redness and itchiness along the injection site. The area was hot to the touch. HR ranges from 110-120 bpm. Denies any lumps or bumbs near her axilla. She does have burning at the injection site as well.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Gastrointestinal pain, Nausea, Pain in extremity
Clinical narrative: Sore arm. Evening of 3/20 felt mild stomach discomfort. By 4am 3/21, bad stomach and intestinal cramping, nausea. Back pain. Vomited repeatedly. Dry heaving because there was nothing left to expel. Couldn?t keep water or crackers down. Had to take zofran. Threw it up. Waited awhile and took another. Vomiting subsided around 12:30pm. Cramping continued mildly into the night but has fully subsided today, 3/22.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vomiting
Clinical narrative: Sore arm. Evening of 3/20 felt mild stomach discomfort. By 4am 3/21, bad stomach and intestinal cramping, nausea. Back pain. Vomited repeatedly. Dry heaving because there was nothing left to expel. Couldn?t keep water or crackers down. Had to take zofran. Threw it up. Waited awhile and took another. Vomiting subsided around 12:30pm. Cramping continued mildly into the night but has fully subsided today, 3/22.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain lower, Diarrhoea, Flatulence, Head discomfort, Headache
Clinical narrative: Severe pain in lower abdomen.  Much gas.  Diarrhea with odd odor.  As of today it is still there but less painful. Also headache that felt like pressure on top of my head.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: High fever and severe chills/shaking. Terrible headache and nausea. Sensitive skin - discomfort when touched. Lower back pain. This lasted about 12 hours with headache lasting another 12 hours.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Skin discomfort, Tremor
Clinical narrative: High fever and severe chills/shaking. Terrible headache and nausea. Sensitive skin - discomfort when touched. Lower back pain. This lasted about 12 hours with headache lasting another 12 hours.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncopal episode shortly after receiving vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Ultrasound joint
Clinical narrative: Progressively worsening pain in my shoulder and neck leading to an emergency room visit on 3/18 because pain was unbearable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Slight itching the day of the shot. As the days went on, the injection site got redder, itched more and felt hard. It reached the size of 3 inches across and about 2.5 inches tall. In addition, I'm feeling slight itching at different times at random places on my body. I refer to them as twitch itching. They itch briefly, and then another one starts somewhere on my body. The redness is still visible on my arm, but not to the degree it was. I am unclear if I should get another shot.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Friday:  Very sore arm.  Saturday: arm was better but had aching body, chills, & headache.  Chills lasted about 2 hours, headache and aching body lasted until next morning.  Slept all day, very little appetite.  Sunday:  no more aching body or headache but little appetite continued and arm at the injection area was swollen and warm to touch.  That evening the arm started to itch.  Monday morning  (today):  arm still swollen, warm, and itchy.  Took 8 total tylenol capsules, 2 at a time, from Friday night until Saturday night.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus
Clinical narrative: Friday:  Very sore arm.  Saturday: arm was better but had aching body, chills, & headache.  Chills lasted about 2 hours, headache and aching body lasted until next morning.  Slept all day, very little appetite.  Sunday:  no more aching body or headache but little appetite continued and arm at the injection area was swollen and warm to touch.  That evening the arm started to itch.  Monday morning  (today):  arm still swollen, warm, and itchy.  Took 8 total tylenol capsules, 2 at a time, from Friday night until Saturday night.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Muscle tightness, Neck pain
Clinical narrative: was chilling; short headache; neck pain; back muscles tights; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Coivd-19 vaccine (1st dsoe received on an unknwon date) and Shingrix (1st dsoe received on an unknwon date). Concurrent medical conditions included autoimmune disorder. Concomitant products included COVID-19 VACCINE.   On 23rd February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced chills, headache, neck pain and tightness of back muscles. On an unknown date, the outcome of the chills, headache, neck pain and tightness of back muscles were unknown.   It was unknown if the reporter considered the chills, headache, neck pain and tightness of back muscles to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. On 2nd February 2021, the patient received the 2nd dose of Covid vaccine. The patient received 2nd dose of Shingrix and on the same night, the patient experienced chills, neck pain, short headache and back muscle tightness. The patient asked if tylenol or ibuprofen could be received as treatment and if their medication would alter the immune response.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles about a week after second shot.  ER physician thought it might be related.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Upon checking out status post sitting in the observation area for about 15 minutes, the patient reported dizziness when asked about their current health state. Declined to continue sitting in monitoring or to drink fluids.  Declined feeling faint.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Blood creatine phosphokinase, Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Myalgia
Clinical narrative: Patient was seen By PCP on  03/12/2021 for muscle pain
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Thyroxine
Clinical narrative: Patient was seen By PCP on  03/12/2021 for muscle pain
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood glucose increased, Body temperature increased, Feeling abnormal, Pallor
Clinical narrative: Patient started to feel aware of tingling and racing heart. She states she then felt "out of it." Vital signs obtained= BP 114/86; heart rate 100; temperature 100; pulse oximeter 98% on room air. Repeat vital signs BP 116/84; heart rate 92; pulse oximeter 98% on room air.  On initial exam patient was unable to verbalize. She was near syncopal. She denied respiratory symptoms. O2 sat normal. Skin dry with pallor noted. No respiratory symptoms. Pulse is weak but regular. Blood glucose by finger stick is 130. Patient was hydrated with oral fluids, Gatorade.  After observation for 20 minutes the patient was much improved with complete resolution of her symptoms. Patient was released home with her husband who was driving. She was advised to hydrate with at least two bottles of sports drink prior to her next vaccination. Note: patient has twins and two young children to care for.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Pulse abnormal
Clinical narrative: Patient started to feel aware of tingling and racing heart. She states she then felt "out of it." Vital signs obtained= BP 114/86; heart rate 100; temperature 100; pulse oximeter 98% on room air. Repeat vital signs BP 116/84; heart rate 92; pulse oximeter 98% on room air.  On initial exam patient was unable to verbalize. She was near syncopal. She denied respiratory symptoms. O2 sat normal. Skin dry with pallor noted. No respiratory symptoms. Pulse is weak but regular. Blood glucose by finger stick is 130. Patient was hydrated with oral fluids, Gatorade.  After observation for 20 minutes the patient was much improved with complete resolution of her symptoms. Patient was released home with her husband who was driving. She was advised to hydrate with at least two bottles of sports drink prior to her next vaccination. Note: patient has twins and two young children to care for.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Fear, Heart rate increased, Intrusive thoughts, Limb discomfort, Schizophrenia
Clinical narrative: 12 hours post-vaccine my heart rate was 115-125 beats per minute for over 5 hours and it was uncontrollable. No sleep, vomiting. The rapid heart rate that was so strong and persistent that it caused my brain to think my body was going to die. I had uncontrollable, racing and intrusive thoughts about the fact that I was about to die and I became incredibly scared and paranoid. I had minor "sleep" paralysis at times where I couldn't move my limbs and they felt incredibly heavy when I attempted to move (sleep in quotation marks because I did not sleep that night).   The intrusive, racing thoughts were spiraling incredibly rapidly - roughly 3 thoughts per second for the entire 5 or so hours that my heart rate was uncontrollable. When attempting to re-direct my thoughts, I was unsuccessful. Scenes/moments from my life flashed before my eyes in shuffle mode (i.e., memories from different parts of my life in no particular order) and at some points there were dark figures/shadows in my imagination that made it seem like I was about to die. My extremities became icy cold as if blood was drained from the areas during this time. I couldn't decide if I would be found dead in my bed or if I should go to the ER. I ultimately stayed home and tried to overcome the side effects (which I did).  Once my heart rate normalized the following morning, the racing and spiraling thoughts lessened, though there is an underlying fear of having these uncontrollable, intrusive, and racing thoughts return at any time.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Sleep paralysis, Tachyphrenia, Vomiting
Clinical narrative: 12 hours post-vaccine my heart rate was 115-125 beats per minute for over 5 hours and it was uncontrollable. No sleep, vomiting. The rapid heart rate that was so strong and persistent that it caused my brain to think my body was going to die. I had uncontrollable, racing and intrusive thoughts about the fact that I was about to die and I became incredibly scared and paranoid. I had minor "sleep" paralysis at times where I couldn't move my limbs and they felt incredibly heavy when I attempted to move (sleep in quotation marks because I did not sleep that night).   The intrusive, racing thoughts were spiraling incredibly rapidly - roughly 3 thoughts per second for the entire 5 or so hours that my heart rate was uncontrollable. When attempting to re-direct my thoughts, I was unsuccessful. Scenes/moments from my life flashed before my eyes in shuffle mode (i.e., memories from different parts of my life in no particular order) and at some points there were dark figures/shadows in my imagination that made it seem like I was about to die. My extremities became icy cold as if blood was drained from the areas during this time. I couldn't decide if I would be found dead in my bed or if I should go to the ER. I ultimately stayed home and tried to overcome the side effects (which I did).  Once my heart rate normalized the following morning, the racing and spiraling thoughts lessened, though there is an underlying fear of having these uncontrollable, intrusive, and racing thoughts return at any time.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: wife is experiencing severe nerve pain / the pain started on 3/2/2021; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2021, unknown after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's husband. The age at vaccination was not reported, but it could be 56 or 57 years. The reporter reported that patient received first dose of Shingrix on an unknown date. After texting with patient, sheet clarify that the pain started on 2nd March 2021. The reporter consented to follow up.  For tolerance of 2nd dose, refer case US2021062031.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062031:same patient, same reporter - 2nd dose
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: 03/20/2021  upper left arm swollen,  arm sore to move. a slight headache. 03/21/2021 Woke up with sever sore left arm . Bad pain when rasing left arm .Had a hard time getting dressed. Still had a headache but it  was a little worse 03/22/2021 Headache gone, Left arm still a little sore , but much improved.
Age: 47.0
Sex: F
Vaccine: DF
Symptoms: Asthenia, Chest discomfort, Discomfort, Erythema, Hypoaesthesia
Clinical narrative: Patient starts complaining of heaviness and numbness to left side of face at 1317.  Patient taken to private tent to evaluate symptoms.  Patient has 2 red raised areas to left side of nose and cheek.  Benadryl 25 mg IM administered at 1320 in right upper arm.  Pulse rate of 100 in with oxygen saturation of 98% on room air.  As observation continues, patient complains of heaviness and discomfort to left arm, leg, and chest.  Patient?s oxygen saturation at 1325 is 100% on room air with pulse of 80.  Neuro examination at this time.  Equal facial movements and equal strength bilaterally. Patient with no deficits, but still complaints of weak and numb feeling, traveling down her left side.  1330 pulse of 84, oxygen saturation of 100% on room air and emergency services called at this time to further evaluate patient.  Continued patient monitoring until EMT arrival.  1335 patient?s oxygen saturation is 100% with pulse of 84 at this time.  Patient able to ambulated steadily without assistance with paramedics to truck.
Age: 47.0
Sex: F
Vaccine: DF
Symptoms: Limb discomfort, Neurological examination, Swelling, Vital signs measurement
Clinical narrative: Patient starts complaining of heaviness and numbness to left side of face at 1317.  Patient taken to private tent to evaluate symptoms.  Patient has 2 red raised areas to left side of nose and cheek.  Benadryl 25 mg IM administered at 1320 in right upper arm.  Pulse rate of 100 in with oxygen saturation of 98% on room air.  As observation continues, patient complains of heaviness and discomfort to left arm, leg, and chest.  Patient?s oxygen saturation at 1325 is 100% on room air with pulse of 80.  Neuro examination at this time.  Equal facial movements and equal strength bilaterally. Patient with no deficits, but still complaints of weak and numb feeling, traveling down her left side.  1330 pulse of 84, oxygen saturation of 100% on room air and emergency services called at this time to further evaluate patient.  Continued patient monitoring until EMT arrival.  1335 patient?s oxygen saturation is 100% with pulse of 84 at this time.  Patient able to ambulated steadily without assistance with paramedics to truck.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Delusion, Migraine, Pyrexia
Clinical narrative: 2nd dosage - 102 fever, delusional, migraines.  Migraines have continued since 2nd shot , since 2/5/21.  Dr. has now prescribed blood pressure medicine as well as preventative migraine meds.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Herpes zoster, Lip blister, Oral discomfort, Oral mucosal blistering
Clinical narrative: I started getting chapped lips and the 13th and I applied Chapstick - within two days, they became water blisters (like what you get with a sunburn) on both top and bottom of lips. On inside of lips there were more blisters. It started affected eating. My mouth was on fire. I realized it was another shingles outbreak - I have a standing prescription for shingles since I've had shingles before  - Valacyclovir  HCL - 1 gram tablet  - I took two pills a day - 12 hours apart. Taking these: inflammation went down first and then blisters started going away - it took about two weeks. The herpes stays in my system but the outbreak is gone.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 3/7 developed fever of 103.7 at around 11:30 PM. Right arm was swollen, red painful, hot. applied heating pad & herbal salve specific 4 trauma to skin  took a 500 mg Tylenol at around 12:30 AM. first time ever experienced chattering teeth. 3/8Woke next morning with 103.7 temp continued T/O the day & night. took 500 mg Tylenol 2x's. arm more red and swollen. Didn't feel ill. 3/9 fever of 101.5 , arm still swollen, red, painful.  3/10  fever of 101.1 took one Tylenol 3/11 no fever during day fever of 101.2 evening. More ice on swollen red painful and itchy arm 3/12 no fever during day up to 101.2 in the evening. 3/13 no fever. slept all day. 3/14 rested arm fine. No redness or swelling.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: 3/7 developed fever of 103.7 at around 11:30 PM. Right arm was swollen, red painful, hot. applied heating pad & herbal salve specific 4 trauma to skin  took a 500 mg Tylenol at around 12:30 AM. first time ever experienced chattering teeth. 3/8Woke next morning with 103.7 temp continued T/O the day & night. took 500 mg Tylenol 2x's. arm more red and swollen. Didn't feel ill. 3/9 fever of 101.5 , arm still swollen, red, painful.  3/10  fever of 101.1 took one Tylenol 3/11 no fever during day fever of 101.2 evening. More ice on swollen red painful and itchy arm 3/12 no fever during day up to 101.2 in the evening. 3/13 no fever. slept all day. 3/14 rested arm fine. No redness or swelling.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Large rash at injection site
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Cardiac monitoring normal, Chest X-ray normal, Chest pain
Clinical narrative: Elevated blood pressure, dizziness, chest pain
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Elevated blood pressure, dizziness, chest pain
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Illness, Pain, Pyrexia
Clinical narrative: very sick from 1st shingles shot; 102.4 fever; aches; chills; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, pain and chills. On an unknown date, the outcome of the sickness, fever, pain and chills were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, pain and chills to be related to Shingles vaccine.   Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had received first dose of Shingles vaccine and experienced sickness, fever, chills and pain. The patient's body temperature was found to be 102.4 degree Celsius. The patient had also received second dose of shingles vaccine and it was fine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only side effects was a sore arm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever ~ 101F, started about 18 hours after injection, lasted about 8 hours Headache, started with fever, lasted about 12 hours
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Redness, Swelling, Heat at sight. Hives on face
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Swelling, Throat irritation, Tongue pruritus
Clinical narrative: RASH, HIVES, SCRATCHY THROAT,  SWELLING , ITCHY TONGUE, ITCHING SENSTAION
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: RASH, HIVES, SCRATCHY THROAT,  SWELLING , ITCHY TONGUE, ITCHING SENSTAION
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient reported feeling light-headed and dizzy immediately following vaccine, then fainted in a sitting position in chair. Pharmacist and customer assisted unconscious patient into lying down position on floor and patient promptly awoke. Patient remained lying down for 10 minutes while pharmacist directly observed with emergency kit nearby. Patient reported feeling better and then was able to sit upright. She was given a bottle of water and sat for observation for a remaining 20 minutes, then felt comfortable exiting the pharmacy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Pain, Palpitations, Pyrexia, Vomiting
Clinical narrative: fever (spiking at 101.7), vomiting, body ache, heart racing and blood pressure raised
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, C-reactive protein increased, Cardiovascular evaluation, Cardioversion, Chest pain
Clinical narrative: Second COVID vaccine received 01/06/21.  Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea.  Duration 8 hours, clinical dehydration, missed one night ED shift(HCP).   5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21.  Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional.  02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo.  03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis.   Continue high dose aspirin, colchicine, metoprolol, flecanide.  Have not returned to work.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Echocardiogram abnormal, Malaise
Clinical narrative: Second COVID vaccine received 01/06/21.  Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea.  Duration 8 hours, clinical dehydration, missed one night ED shift(HCP).   5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21.  Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional.  02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo.  03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis.   Continue high dose aspirin, colchicine, metoprolol, flecanide.  Have not returned to work.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pericardial drainage, Pericardial effusion
Clinical narrative: Second COVID vaccine received 01/06/21.  Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea.  Duration 8 hours, clinical dehydration, missed one night ED shift(HCP).   5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21.  Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional.  02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo.  03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis.   Continue high dose aspirin, colchicine, metoprolol, flecanide.  Have not returned to work.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Stress echocardiogram normal, Vomiting
Clinical narrative: Second COVID vaccine received 01/06/21.  Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea.  Duration 8 hours, clinical dehydration, missed one night ED shift(HCP).   5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21.  Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional.  02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo.  03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis.   Continue high dose aspirin, colchicine, metoprolol, flecanide.  Have not returned to work.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pruritus, Fatigue, Paraesthesia, Pruritus
Clinical narrative: a rash on her right face, behind her ear and on her scalp; her scalp itching was very severe / itchy scalp / itchiness has spread to other areas; itchiness is a tingling sensation; itchiness has spread to other areas including / ears; This case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (and chills, fatigue after receiving 1st dose in September 2020, for tolerance refer case US2021062019).   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced rash, itchy scalp, tingling sensation and ear pruritus. The patient was treated with cosmetics (Shampoo), selenium sulfide (Selenium Sulfide Lotion), salicylic acid, sulfur (Exoderm), valaciclovir (Valacyclovir), fluocinolone acetonide and acetic acid (Vinegar). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, itchy scalp, tingling sensation and ear pruritus were not recovered/not resolved.   It was unknown if the reporter considered the rash, itchy scalp, tingling sensation and ear pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 83 or 84 years. After the second dose, the patient experienced rash on her right face, behind her ear and on her scalp, her scalp itching was very severe.  Her HCP (health care provider) gave her shampoo, selenium sulfide lotion 2.5 percent, exoderm cream, valacyclovir and fluticasone acetonide scalp oil.  The rash was not improved and actually gotten worse and spread to her left neck.  No hospitalization required. The patient experienced a itchy scalp. She reported that this itchiness had spread to other areas including her right and left jawbone, her back, as well as her ears. She reported that the itchiness was a tingling sensation and was still present and not resolved.  The physician recommended various shampoos and lotions, which had no effect.  She reported that, she had used witch hazel and clear vinegar, which had helped take away some of the itchiness. No further information reported. She also reported speaking with someone from GSK in who recommended a biopsy.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062019:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: a rash on her right face, behind her ear and on her scalp; her scalp itching was very severe / itchy scalp / itchiness has spread to other areas; itchiness is a tingling sensation; itchiness has spread to other areas including / ears; This case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (and chills, fatigue after receiving 1st dose in September 2020, for tolerance refer case US2021062019).   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced rash, itchy scalp, tingling sensation and ear pruritus. The patient was treated with cosmetics (Shampoo), selenium sulfide (Selenium Sulfide Lotion), salicylic acid, sulfur (Exoderm), valaciclovir (Valacyclovir), fluocinolone acetonide and acetic acid (Vinegar). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, itchy scalp, tingling sensation and ear pruritus were not recovered/not resolved.   It was unknown if the reporter considered the rash, itchy scalp, tingling sensation and ear pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 83 or 84 years. After the second dose, the patient experienced rash on her right face, behind her ear and on her scalp, her scalp itching was very severe.  Her HCP (health care provider) gave her shampoo, selenium sulfide lotion 2.5 percent, exoderm cream, valacyclovir and fluticasone acetonide scalp oil.  The rash was not improved and actually gotten worse and spread to her left neck.  No hospitalization required. The patient experienced a itchy scalp. She reported that this itchiness had spread to other areas including her right and left jawbone, her back, as well as her ears. She reported that the itchiness was a tingling sensation and was still present and not resolved.  The physician recommended various shampoos and lotions, which had no effect.  She reported that, she had used witch hazel and clear vinegar, which had helped take away some of the itchiness. No further information reported. She also reported speaking with someone from GSK in who recommended a biopsy.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062019:same reporter
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump in left armpit found 2 days after 2nd shot
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pink rash below injection site that is painful and slightly swollen
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Progress Notes: APRN (Nurse Practitioner)  Cosign Needed  COVID VACCINE CLINIC 3/18/2021    Patient:                                                                             Date:  3/18/2021                                                                                              Subjective Pt is a 34 y.o. male who was seen at COVID Vaccine Clinic today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the left deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience difficulty breathing and throat tightness.  He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.   Pt was given a water to drink and he reported the SOB was very mild and the water helped.  He does have a history of childhood asthma but does not use an inhaler for years.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of frequent throat clearing and shortness of breath   CONT negative Eyes negative Skin negative GI negative Musculo negative Neuro negative     Previous Reactions: None    Objective    Vitals Vitals:   03/18/21 1052 03/18/21 1107 03/18/21 1114 BP: 133/86 119/80 129/82 Pulse: 50 53 (!) 49 SpO2: 100% 99% 99%      Pt is a runner and states he runs a lower pulse     Physical Exam Constitutional:      Appearance: He is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal:        General: Normal range of motion.     Cervical back: Normal range of motion and neck supple.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt was dismissed at 11:15 to return to work.  No symptoms at time of discharge.  He was told to take an antihistamine before his next appointment.     APRN Electronically Signed 3/18/2021 11:18 AM
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: reports SOB and difficulty breathing  Pt observed for 45 mins no signs of acute distress 02; 97% on room air RR:18 Bilateral lungs clear upon auscultation with equal chest expansion Pt able to speak in full sentences without complication  denies itching. no swelling in throat no palpitation  Educated on vaccine and side effect ER precaution
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Flushing, Oropharyngeal discomfort, Pharyngeal paraesthesia
Clinical narrative: Patient reported her throat was scratchy, back of throat tingling, had a little cough. Skin flushed per patient. HCP on site assessed, lungs clear, vital signs stable. 10mg Zyrtec given sublingually. Patient tolerated it well. After 15 minutes, symptoms improved per patient. Vital signs stable. HCP on site reassessed. Lungs clear, airway patent. Heart rate regular rate and rhythm. Patient discharged from clinic.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Impaired work ability
Clinical narrative: Report chest pain that pain on day 1 post vaccination and progressively got worst. Treatment: Seen in the emergency room. Outcome:  Need to follow-up with primary care doctor and off 3 days of work before returning.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient feels a buzzing or ringing in her ears that intensifies in the morning.  She is planning to schedule a follow with primary care doctor, but as of now no treatment.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive Covid test on 3/18. Note: have a request to repeat mammogram, with a Diagnostic Mammogram
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Receipt of invalid dose of vaccine. Pt did not meet age criteria for EUA product. It is anticipated that patient will receive second dose of Moderna to complete the series.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac function test, Chest discomfort, Erythema, Flushing
Clinical narrative: 20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK.  A FLUSHED FEELING ALL OVER AND TIGHTING OF MY CHEST.  I TOOK ORAL BENEDRYL 10 MINUTES AFTER THE SHOT BUT UNFORTUNETLY IT DID NOT HELP.  I WAS GIVE IV BENEDRYL IMMEDIATELY AFTER THAT AND WAS MONITORED FOR 4 HOURS AT THE HOSPITAL.  ALSO GIVEN TYLENOL FOR A HEADHACHE DURING MY HSPTALIZATION.  IT TOOK APPROX. 30 MINUTES FOR THE SYMPTOMS TO SUBSIDE.  I WAS RELEASED 4 HOURS LATER.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Oxygen saturation
Clinical narrative: 20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK.  A FLUSHED FEELING ALL OVER AND TIGHTING OF MY CHEST.  I TOOK ORAL BENEDRYL 10 MINUTES AFTER THE SHOT BUT UNFORTUNETLY IT DID NOT HELP.  I WAS GIVE IV BENEDRYL IMMEDIATELY AFTER THAT AND WAS MONITORED FOR 4 HOURS AT THE HOSPITAL.  ALSO GIVEN TYLENOL FOR A HEADHACHE DURING MY HSPTALIZATION.  IT TOOK APPROX. 30 MINUTES FOR THE SYMPTOMS TO SUBSIDE.  I WAS RELEASED 4 HOURS LATER.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Malaise, Pain in extremity, Paraesthesia
Clinical narrative: felt sick; sore arm; dose 1 of Shingrix about 6 months ago / dose 2 about 4 months ago / March 12, 2021 / diagnosed with shingles; shingles; headache; felt tingling on her cheek; had a lesion; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine and shingles.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On 12th March 2021, between 3 and 4 months after receiving Shingrix and between 5 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, tingling and skin lesion. On an unknown date, the patient experienced feeling unwell and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, headache, tingling and skin lesion were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the feeling unwell and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, headache, tingling, skin lesion, feeling unwell and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, headache, tingling and skin lesion to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix about 6 months before the date of reporting and dose 2 about 4 months before the date of reporting. Less than 4 months after receiving 2nd dose of Shingrix, the patient experienced a sore arm and felt sick for a few days. On 12th March 2021, the patient felt tingling on her cheek. She had a lesion and was diagnosed with shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter did not consent to follow-up. For tolerance to the 1st dose of Shingrix refer linked case US2021062736 reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062736:same patient, same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: felt sick; sore arm; dose 1 of Shingrix about 6 months ago / dose 2 about 4 months ago / March 12, 2021 / diagnosed with shingles; shingles; headache; felt tingling on her cheek; had a lesion; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine and shingles.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On 12th March 2021, between 3 and 4 months after receiving Shingrix and between 5 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, tingling and skin lesion. On an unknown date, the patient experienced feeling unwell and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, headache, tingling and skin lesion were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the feeling unwell and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, headache, tingling, skin lesion, feeling unwell and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, headache, tingling and skin lesion to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix about 6 months before the date of reporting and dose 2 about 4 months before the date of reporting. Less than 4 months after receiving 2nd dose of Shingrix, the patient experienced a sore arm and felt sick for a few days. On 12th March 2021, the patient felt tingling on her cheek. She had a lesion and was diagnosed with shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter did not consent to follow-up. For tolerance to the 1st dose of Shingrix refer linked case US2021062736 reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062736:same patient, same reporter
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: I have had Tinnitus in both ears for over a year now.  A week and  a half after receiving the shot, my Tinnitus has gotten much worse.  It is a high pitch sound.  Over the last year it has subsided significantly; however, now it seems to be getting worse.  In addition, periodically the sound increases significantly.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dyspnoea, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Short of breath, body soreness, sweats, chills, fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Rheumatic disorder, Urticaria
Clinical narrative: Patient has experienced worsening generalized urticaria and arthralgias, fatigue 48 hours after her vaccination. This is a chronic longstanding issue for her already but has worsened, and patient is unsure if she should get the second dose of pfizer. She did not experience any anaphylaxis symptoms.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling and itching injection site
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Migraine, Nausea, Pain in extremity
Clinical narrative: Rash, swelling and soreness on left arm one week after vaccine. 9 days after vaccine, severe migraine, nausea, back pain, fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Rash, swelling and soreness on left arm one week after vaccine. 9 days after vaccine, severe migraine, nausea, back pain, fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles shot and several years later l still got the shingles/ Suspected vaccination failure; Shingles; Very painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient received the shingles shot and several years later developed the shingles. The patient was told that it was a light case, but to the patient they were very painful. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Fall, Loss of consciousness
Clinical narrative: Pt was 15 minutes after his first vaccine when he passed out in his chair and fell to the floor.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Loss of consciousness, Skin laceration
Clinical narrative: Patient was administered vaccine and appeared fine immediately after, even got up and walk for a second.  He then sat down (all in a matter of 1 minute)  after about 2 mins of sitting in the chair he fell to the floor.  He cut his head and also bled from his nose.  He became conscious again quickly in less than about 1 minute.  He was then aware of where he was, date and his name.  EMS responded and took over.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache, myalgias the morning following administration, lasting 6 hours
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Incapacitating dizziness. Cannot stop room from spinning for 4 days
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Heart rate increased, Pain in extremity
Clinical narrative: Rapid heartbeat for six hours beyond injection base line is 59 bpm - averaged 78-83  accompanied with extreme diarrhea during this time frame.  Beyond that six hours - Entire arm sore in the injected arm (too uncomfortable to lie on that arm overnight), fatigue, chills, fever at 93 degrees, or below  for up to 48 hours with this first injection.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Rapid heartbeat for six hours beyond injection base line is 59 bpm - averaged 78-83  accompanied with extreme diarrhea during this time frame.  Beyond that six hours - Entire arm sore in the injected arm (too uncomfortable to lie on that arm overnight), fatigue, chills, fever at 93 degrees, or below  for up to 48 hours with this first injection.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Systemic inflammatory response syndrome
Clinical narrative: Patient appeared to have had a systemic inflammatory syndrome vs anaphylactic  type reaction to the vaccine. She presented with dyspnea 12 hours after receiving the vaccine and ultimately required brief intubation and vasopressor support. She was extubated and weaned off pressors within 2 days and discharged at her baseline functional status.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose, about an hour from the time of vaccination.