chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient reported being "a little itchy" at beginning of observation period.  Denied further c/o.  Reported h/o "hives" with "some antibiotics".  Evaluated by EMS staffed at on-site mass vaccine clinic.  Vitals stable - BP 124/80,P 88. 02 99%.  s/s resolved without incidence prior to 30 minute observation period completion.    EMS advised patient on further follow-up if needed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blood glucose normal, Electrocardiogram normal, Muscle twitching, Syncope
Clinical narrative: The nurse that administered the vaccine at 4:00 pm and  states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: after four days, swollen site injection with puffiness and redness. Painful, sore shoulder. looked like it had a bit of cellulitis so was advised to take advil and use hot compresses. swelling dissipated in 24-48 hrs.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Death, Diabetes mellitus, End stage renal disease, Fall
Clinical narrative: Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient.  Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD.  There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Unresponsive to stimuli
Clinical narrative: Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient.  Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD.  There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Productive cough, Secretion discharge, X-ray
Clinical narrative: Five weeks of violent coughing of phlegm from the lungs, followed by two weeks of light-to-moderate coughing of sinus mucus.  Five days of antibiotics (seemed to mitigate), daily nebulizing with saline and hydrogen peroxide solution, plus flushing sinuses with saline solution via neti pot.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Lightheadedness Bilateral arm paresthesia
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: severe headache beginning after a few hours and still occurring 26 hours after injection, minor injection site pain beginning morning after
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Gait disturbance, Headache, Injection site pain
Clinical narrative: confused, 102.7 fever, headache, chills, Charlie horses in both upper legs and couldn't walk, injection site very painful
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: confused, 102.7 fever, headache, chills, Charlie horses in both upper legs and couldn't walk, injection site very painful
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Administered 3rd dose of Pfizer vaccine in error
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Myalgia
Clinical narrative: Throbbing pain, swelling, and redness at injection site Headache Fatigue Muscle Aches Chills
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Throbbing pain, swelling, and redness at injection site Headache Fatigue Muscle Aches Chills
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Lethargy, Myalgia, Nausea
Clinical narrative: Fever, Congestion, Cough, Muscle Ache, Headache, Lethargy and Nausea
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, Congestion, Cough, Muscle Ache, Headache, Lethargy and Nausea
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: wjile monitoring pt after giving the vaccine , she fainted but after few minutes she said she is feeling berrer, refused us to call 911 she said she panics quick and had history of panic attack
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt was to receive Pfizer vaccine. Had multiple doses of Moderna available on table and a single Pfizer dose.  Proceeded to administer Moderna dose into the left arm of Pt around 1030. Pt was informed directly afterward, and was given appointment 1 week from March 2, 2021 to receive 2nd Pfizer dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Insomnia, Mobility decreased
Clinical narrative: Moderna rec'd last Thursday, the injection was pushed in deep and by the evening the pain at the injection site was unbearable, she injected pretty high in my arm and it started to sting.  After 4 hours the pain was unbearable and my range of motion was limited and the it feels very hot.  I cant sleep because of the pain and have to take Motrin to even function.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Injection site oedema, Lethargy, Pruritus
Clinical narrative: Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash.  Thursday-Saturday diarrhea and lethargy Some intermittent vertigo.  Rest, fluids, Tylenol and benedryl
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vertigo
Clinical narrative: Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash.  Thursday-Saturday diarrhea and lethargy Some intermittent vertigo.  Rest, fluids, Tylenol and benedryl
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: My arm was very sore the evening of vaccine and the next day.  Later the day after I had a headache and felt nauseous. I keep getting headaches on and off. Sometimes dizzy. The nausea is almost all the time. It has not improved.  It has been one week.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness
Clinical narrative: Experienced Dizziness after the Pfizer vaccine. I waited 15 minutes on site and experience the dizziness  the entire time. I left after the 15 minutes and still had slight disorientation.  After 30 minutes I fell normal.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Computerised tomogram, Electrocardiogram, Facial paresis
Clinical narrative: 38 year old male presented to the ED with weakness to the left side of the face beginning 45 minutes prior to arrival.  He stated that he had his COVID vaccine 2 days prior.  He states the day after he began to lose his sense of taste and he has a weird feeling in his right arm as well.   Diagnosed with Bell's Palsy.  Started on valacyclovir as well as a prednisone taper.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Specialist consultation
Clinical narrative: 38 year old male presented to the ED with weakness to the left side of the face beginning 45 minutes prior to arrival.  He stated that he had his COVID vaccine 2 days prior.  He states the day after he began to lose his sense of taste and he has a weird feeling in his right arm as well.   Diagnosed with Bell's Palsy.  Started on valacyclovir as well as a prednisone taper.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Gestational hypertension, Laboratory test normal, Oedema peripheral
Clinical narrative: Gestational hypertension developed on 1/11. Increased edema of feet, diastolic pressures 95-105. Was sent to the emergency room by the OB team for observation. Was discharged without starting any medications
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Light headedness, balance issues; nausea intermittent over 5 days  Primary care doctor not consulted  Second dose on 2/27/2021-no side effects
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The next day of vaccination I had my lymph node swollen on the axilla on my right arm. It lasted for almost 3 weeks.  Talked to a doctor where I worked & he said to massage the area.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Staphylococcal infection
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt diagnosed w/ a staph infection 2 weeks after first dose shot
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: I developed hives between my breasts and on my chest within 10 days after receiving the second dose of the COVID 19 vaccine from Pfizer. It was very itchy and red and uncomfortable. Anytime clothing touched it, it was itchy.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Pain in extremity, Rash erythematous, Rash papular, SARS-CoV-2 test negative
Clinical narrative: Sore left arm    Red raised rash about 2" by 4" inches appeared on the 11th day at site of injection for about 30 hours
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Malaise, Myalgia
Clinical narrative: symptoms on second day was tiredness, feeling unwell, chills, fever, muscle pain and diarea.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had no symptoms for 1 week after injection. Then began with swelling, redness, itching, pain and heat at the injection site. Got very swollen. Took allergy medication. It is still red, itchy and swollen today but slowly improving since then.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Erythema, Urticaria
Clinical narrative: Patient received Moderna Vaccine # 1 on 2/19/2021. On Sunday 2/21/2021 at 9am patient noted both lower extremities covered in hives, and both ears were red and swollen.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Paraesthesia
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: tingling all over. patient reported feeling better after about 20-30 minutes of watching/waiting.-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in extremities
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Vertigo
Clinical narrative: Dizziness within 24 hours, extreme vertigo needing medical treatment within 48 hours. Extreme fatigue beginning immediately after injection.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Memory impairment, Paraesthesia oral
Clinical narrative: headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Sneezing
Clinical narrative: headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Lymphadenopathy, Physical breast examination, Pyrexia
Clinical narrative: Exhaustion, insomnia, fever, swollen lymph node in right underarm. Painful to the tough and without. Grew to size of a golf ball.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Exhaustion, insomnia, fever, swollen lymph node in right underarm. Painful to the tough and without. Grew to size of a golf ball.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Joint range of motion decreased, X-ray
Clinical narrative: A few hours after injection, pain and swelling at the injection site (far upper right arm)  lasting about 1 week. On approx. day 2 post injection, began experiencing pain and limited range of motion of my left shoulder.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site pain, Pruritus
Clinical narrative: Intense, severe itching in low back by spine, more I scratched the worse it got. Came on suddenly, no warning. Lasted a good 20 minutes, very inflamed. Retired at 10:30 pm and it subsided. Back was clear in morning. Also, my right upper arm is still sore this 13th day after shot.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Had the vaccine on 2/12/21, was doing okay, had nausea and chills.  Then on Friday 2/26/21 felt like she was hit with a ton of bricks, and went to the Urgent Care to do a COVID test, and they told her they could not read it on 2/27/21.  She went to Hospital ER last night and had another COVID test and was diagnosed with the COVID virus, and told to go in the morning for an infusion.  Went this morning to Hospital Infusion center where they gave her an infusion to fight off the virus.    They told her to wait 90 days before she receives the 2nd vaccine injection.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: Chills overnight starting 6:00 pm 26 February 2021 and lasting until midday on 27 February 2021.  I put on extra blankets and slept okay in my own bed.  Appetite remained good.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient experienced lightheadedness after vaccination and fell down. He was able to get up and sit on chair after 1 minute. We offered water, checked blood pressure (92/78). Ambulance arrived and patient went to hospital. Will follow up how he's doing later today.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Arm soreness; Swelling at injection site; Whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix. On 30th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, pain in arm and injection site swelling. On an unknown date, the outcome of the general body pain, pain in arm and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient experienced whole body achiness that presented in vaccination night but it resolved by day 4. The patient had arm soreness and swelling at injection site after the first dose that resolved within 4 days. The reporter consented to follow up. For the tolerence of dose 2 refer case US2021002010, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002010:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Decreased appetite, Diarrhoea, Feeling hot, Hyperhidrosis
Clinical narrative: Felt weak specifically in her legs; Felt lethargic; Nauseous; Had episodes of diarrhea; Sweating in the day; Hot at night; Loss of appetite; Silly cough as she described it; Swelling at injection; Arm soreness; Severe whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on 30th October 2020,for further tolerance of 1st dose refer case US2021AMR002816).   On 30th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, pain in arm and general body pain. On 3rd January 2021, the patient experienced lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved and the outcome of the general body pain, lower extremities weakness of, lethargy, nausea, sweating, feeling hot, appetite lost and cough were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, pain in arm, general body pain, lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough to be related to Shingrix.  Additional details were provided as follows: The patient received  2nd dose and experienced early in the morning the following day, she felt severe whole body achiness. By the 4th day other symptoms presented,felt weak specifically in her legs,lethargic, nauseous, had episodes of diarrhea, sweating in the day and hot at night, loss of appetite and a silly cough, arm soreness and swelling at the injection which resolves by day 4.  The reporter stated that the symptoms listed in this report following the second dose have not resolved with the exception of the injection site reactions. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002816:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Muscular weakness, Nausea, Pain
Clinical narrative: Felt weak specifically in her legs; Felt lethargic; Nauseous; Had episodes of diarrhea; Sweating in the day; Hot at night; Loss of appetite; Silly cough as she described it; Swelling at injection; Arm soreness; Severe whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on 30th October 2020,for further tolerance of 1st dose refer case US2021AMR002816).   On 30th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, pain in arm and general body pain. On 3rd January 2021, the patient experienced lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved and the outcome of the general body pain, lower extremities weakness of, lethargy, nausea, sweating, feeling hot, appetite lost and cough were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, pain in arm, general body pain, lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough to be related to Shingrix.  Additional details were provided as follows: The patient received  2nd dose and experienced early in the morning the following day, she felt severe whole body achiness. By the 4th day other symptoms presented,felt weak specifically in her legs,lethargic, nauseous, had episodes of diarrhea, sweating in the day and hot at night, loss of appetite and a silly cough, arm soreness and swelling at the injection which resolves by day 4.  The reporter stated that the symptoms listed in this report following the second dose have not resolved with the exception of the injection site reactions. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002816:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Felt weak specifically in her legs; Felt lethargic; Nauseous; Had episodes of diarrhea; Sweating in the day; Hot at night; Loss of appetite; Silly cough as she described it; Swelling at injection; Arm soreness; Severe whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on 30th October 2020,for further tolerance of 1st dose refer case US2021AMR002816).   On 30th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, pain in arm and general body pain. On 3rd January 2021, the patient experienced lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved and the outcome of the general body pain, lower extremities weakness of, lethargy, nausea, sweating, feeling hot, appetite lost and cough were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, pain in arm, general body pain, lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough to be related to Shingrix.  Additional details were provided as follows: The patient received  2nd dose and experienced early in the morning the following day, she felt severe whole body achiness. By the 4th day other symptoms presented,felt weak specifically in her legs,lethargic, nauseous, had episodes of diarrhea, sweating in the day and hot at night, loss of appetite and a silly cough, arm soreness and swelling at the injection which resolves by day 4.  The reporter stated that the symptoms listed in this report following the second dose have not resolved with the exception of the injection site reactions. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002816:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: Th reporter was patient's mother. The age at vaccination was not reported. The patient received Shingrix and experienced diarrhea. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021005930:Same reporter US-GLAXOSMITHKLINE-US2021005938:Same reporter
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin, Pruritus, Swelling face, Urticaria
Clinical narrative: left arm is Sore and Tender; Jaw Swollen; in itching Hives "from head to toe".; Itching hives from head to toe; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2021, 8 hrs after receiving Shingrix, the patient experienced hives and pruritus. On 29th January 2021, the patient experienced facial swelling. On an unknown date, the patient experienced pain in arm. On 29th January 2021, the outcome of the hives and pruritus were recovered/resolved. On an unknown date, the outcome of the facial swelling was recovering/resolving and the outcome of the pain in arm was unknown.   The reporter considered the facial swelling, hives and pruritus to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient broke out in itching Hives from head to toe.  On 29th January, he woke up at 4:00 AM to find his Jaw Swollen, the swelling had decreased.  He also reported that his left arm was sore and tender.  The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Lethargy, Somnolence
Clinical narrative: two bad episodes of Atrial Fibrillation; slept for like a day and a half; Felt lethargic; A spontaneous report was received from two consumers and a healthcare professional concerning a male patient of unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced  two bad episodes of Atrial Fibrillation, Slept for like a day and a half and Felt lethargic.  The patient's medical history included Atrial Fibrillation. Products known to have been used by the patient, within two weeks prior to the event, included Multaq, at 400mg two times a day for Atrial Fibrillation.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: not provided).  On 14 FEB 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced two bad episodes of Atrial Fibrillation, slept for like a day and a half and felt lethargic. No treatment was given for the reported events.   The action taken with mRNA-1273 in response to the events was considered not applicable, as the patient received both the doses of Moderna's COVID-19 vaccine prior to the events.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a male patient, with medical history of atrial fibrillation, who experienced a serious unexpected event of atrial fibrillation, after receiving second dose mRNA- 1273 (Lot# 029K20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the patient's history of atrial fibrillation. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pneumonia
Clinical narrative: Pneumonia; A spontaneous report was received from a consumer  concerning his mother, a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.  The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter.  On 19 Jan 2021, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient developed a cough. The patient's temperature was recorded at 101 degrees Fahrenheit. The patient went to doctor. She was fatigued and coughing blood and was diagnosed with pneumonia. Treatment included azithromycin, and the patient seemed to improve.  On 05 Feb 2021, the patient developed a temperature of 101°F, coughed up blood and was very fatigued. She was diagnosed with pneumonia. Treatment for the event included levofloxacin.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, pneumonia, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pneumonia, a causal relationship cannot be excluded. Patient's elderly age and medical history of COPD are considered a risk factors.
Sex: M
Vaccine: COVID19
Symptoms: Multiple organ dysfunction syndrome
Clinical narrative: organs shut down after vaccine; A spontaneous report was received from a female consumer via social media regarding her father, unknown age, who was administered Moderna Covid-19 Vaccine and have experienced multiple organ failure.  The patient's medical history was not provided. His concomitants were not provided.   On an unspecified date, prior to onset of symptoms, the patient received their a planned doses of mRNA-1273 (Lot Number: unknown) unknown route of administration. It is not known whether patient received first dose or 2nd dose of vaccine.  On an unknown date the patient experienced shut down of multiple organs. It was noted that the doctors said, there was no concrete proof that its due to vaccine. But according to her, the patient was fine till he had the vaccine. Treatment details were not provided. Doctors talked about do not resuscitate orders with her.  Action taken with the vaccine is unknown.   The outcome of the event multiple organ failure is unknown at the time of report.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Multiorgan failure after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Due to lack of contact details, no follow-up information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Received the vaccine subcutaneously; Received vaccine a little lower in the arm than the deltoid muscle; A spontaneous report was received from Healthcare Professional concerning a 40-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle   The patient's medical history was not provided. Concomitant medications were not reported.   On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) subcutaneously in the arm for prophylaxis of COVID-19 infection  On 25 Jan 2021, the patient experienced received the vaccine subcutaneously and a little lower in the arm  than the deltoid muscle.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event received the vaccine subcutaneously and a little lower in the arm  than the deltoid muscle was resolved on 25 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration and vaccine administered at inappropriate site for mRNA-1273 (Batch Number: 039K20A) with no associated AEs.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Fatigue, Herpes simplex test, Malaise, Oropharyngeal blistering
Clinical narrative: felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown.   Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pharyngeal erythema, SARS-CoV-2 test, Streptococcus test
Clinical narrative: felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown.   Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown.   Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Cold sweat, Decreased appetite, Dyspnoea
Clinical narrative: Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally.  Night sweats that are still continuing.  Just during the day and get hot flashes.  Flushing, upper body clamminess and then goes away and then has chills.  His breathing has improved but is still not real steady on his feet.  He is about 80-85% on his balance, 95% on his breathing.  His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Night sweats, Pyrexia, Weight decreased
Clinical narrative: Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally.  Night sweats that are still continuing.  Just during the day and get hot flashes.  Flushing, upper body clamminess and then goes away and then has chills.  His breathing has improved but is still not real steady on his feet.  He is about 80-85% on his balance, 95% on his breathing.  His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Bradycardia, Dizziness, Electrocardiogram, Hyperhidrosis
Clinical narrative: lower abdominal pain, diaphoresis, pale, nauseated, lightheaded, dizzy, bradycardic
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor
Clinical narrative: lower abdominal pain, diaphoresis, pale, nauseated, lightheaded, dizzy, bradycardic
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bells Palsy on 02/21/2021. Presented to hospital 02/22/2021. Treated with Prednisone and Valacyclovir  Is improved
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash erythematous, Urticaria
Clinical narrative: I have reported to the program as well, but something else occurred after that was concluded. I had mild-moderate soreness in arm at injection site, red rash 24 hours later and welt. Treated with Cortizone and ibuprofen. Healed after day 4 of shot. Woke up day 10 after shot and it was back and much more red this time, as sore again as first time, even though had been pain/sore free. I'm hearing this happens a week or so after the Moderana shot specifically. Thought I would report. Treating with same as first treatment, at home.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nasal congestion, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: The patient presented to the Emergency Department today secondary to symptoms which she states started about 1 hour ago prior to arrival after she received her Covid vaccine first injection at 11:40 AM, states that she went back to work as a teacher and started to feel a sensation as if she had some swelling of her throat and a mild sore throat as well, she states that she developed some nasal congestion as well as lightheadedness, she denied any dyspnea, no coughing or wheezing, no chest pain, vomiting or diarrhea, she called her doctor and was told to present here for evaluation, she did not take any medication for symptoms prior to arrival and states that her symptoms are very similar to her previous allergic reactions but has never required epinephrine. Treatment required: NS1L IV bolus, Famotidine 20mg IV, Solu-medrol 125mg IV, and Diphenhydramine 50 IV all x1. The patient will be given a prescription for a short course of steroids at home and has been advised to take benadryl and pepcid at home if needed.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pain
Clinical narrative: excruciating headache front and back of head, fever 102.4, body aches, fatigue, weakness, nausea, inability to focus
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: excruciating headache front and back of head, fever 102.4, body aches, fatigue, weakness, nausea, inability to focus
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Injection site pruritus, Injection site rash, Pyrexia, Rash
Clinical narrative: Patient reports started having fever and chills at approximately 4:30 on Friday 2-26-21. Woke up on Saturday with arm itching and a rash at site(2-27-21). Rash gradually spread to all extremities by night on 2-27-21. Currently has rash on scalp and abdomen. Saw PMD today and was given a steroid shot to help dry up rash.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: He states he sit down pulled out his phone to play and he started to feel dizzy and clammy.  Pt noted to be diaphoretic and noted to be slightly pale. Report s he has not ate yet today but did take his b/p med. 1049 HR-34, R-18, B/P 70/50, 02 sat 97% RA, he is sweaty to touch.  1057 HR-42, 02 sat 97%. 1104 B/P 130/82, HR 50-60, 02 sat 96%. 1110 B/P 120/78, HR-66-68, 02 96%RA. 1117-B/P 122/87, HR-60, 02 96% RA, R-18. 1123 walked pt to care and his wife was in the car, instructed her she needed to drive him home. Wife verbalized understanding. Pt instructed to f/u with MD as needed.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Covid Arm
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Mobility decreased, Pain, Pain in extremity
Clinical narrative: I took 600  mg Ibuprofen before the vaccine. About three hours after and I felt soreness in arm but it wasn't bad. 7:00 pm - body aches and softness; chills, shivering and a fever at 2:00 am and lasted until about 6:00 am. Next day, I couldn't move because body pain was bad, and I still had chills and shivering and fever and arm rash came back - but it was less itchy and red and less painful as first dose of vaccine - used the cream from first dose and Tylenol. Saturday symptoms started going away. Sunday I woke up with no symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: I took 600  mg Ibuprofen before the vaccine. About three hours after and I felt soreness in arm but it wasn't bad. 7:00 pm - body aches and softness; chills, shivering and a fever at 2:00 am and lasted until about 6:00 am. Next day, I couldn't move because body pain was bad, and I still had chills and shivering and fever and arm rash came back - but it was less itchy and red and less painful as first dose of vaccine - used the cream from first dose and Tylenol. Saturday symptoms started going away. Sunday I woke up with no symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid rash, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: A few days after the same ecema type rash appeared again over both eyelids but was severly worse this time.  I also had itchiness, redness and soreness at the injection site which lasted about a week after and I was administed the steroid cream again which made the rash disappear after about a week
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Urticaria
Clinical narrative: 2/24/21 with hives, 2/11/21 chills , muscle aches;  2/11/21 hives all over body, chills , muscle aches for day. Rash continued; dermatologist started zyrtec