chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at the injection site / only symptom that persisted; Fatigue / taking a nap at the 4 hour; Chills; Headache; This case was reported by a consumer and described the occurrence of injection site pain in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB27AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) (batch number U68788BB ?, expiry date unknown) for prophylaxis.   On 3rd February 2021, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo). On 3rd February 2021, 3 hrs 30 min after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced injection site pain, fatigue, chills and headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fatigue, chills and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, chills and headache to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo).   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the patient's parent. The reporter reported an adverse reaction, the patient experienced after receiving the 1st dose of Bexsero and MCV4 shot on the day of reporting. Approximately 3.5 hours after the receiving the vaccine, the patient started to experience the symptoms of fatigue, pain at the injection site and headache. The patient took 2 Advil (200mg ea) right before taking the nap at the 4 hours. The patient woke up 45 minutes later feeling better. The only symptoms that persisted was the pain at the injection site. The reporter plead to let her/ him know if there was any further action that they need to take. The information regarding consent to follow up was not reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix and experienced sore arm. The patient had done blood work for a rheumatology consult and would visit an orthopedic surgeon. The reporter called back and updated the correct date for the 1st dose as 10th September 2020. For the tolerance of 2nd dose of Shingrix, refer case US2021AMR002842. The case is linked with the case number US2021002013, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002013:Same reporter US-GLAXOSMITHKLINE-US2021AMR002842:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: Mild rash / slept it off; So tired they slept; This case was reported by a nurse and described the occurrence of rash in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and tiredness. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the rash and tiredness to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not applicable for this report. It was reported that the patients had experienced a mild rash following Shingrix and then slept it off.  The reporter believed it occurred after the second dose. These patients were so tired they slept and by the next day the rash was gone. The reporter didn't think it was of any severity because they didn't report it. They just mentioned it. No information was available regarding patients or product (lot/expiry dates). The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Rash, Throat tightness
Clinical narrative: Rash throughout her upper body / ER Visit Required / still have not resolved; Throat tightening / ER Visit Required / still have not resolved; Trouble breathing / ER Visit Required / still have not resolved; Coughing / ER Visit Required / still have not resolved; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th December 2020, several hours after receiving Shingrix, the patient experienced rash, throat tightness, difficulty breathing and cough. The patient was treated with steroids nos (Steroids) and antihistamine. On an unknown date, the outcome of the rash, throat tightness, difficulty breathing and cough were not recovered/not resolved.   It was unknown if the reporter considered the rash, throat tightness, difficulty breathing and cough to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient had her 2nd dose of Shingrix and a few hours later, she began to experience a rash throughout her upper body, throat tightening, trouble breathing and coughing. She had to go to the Emergency Room on 28th December 2020 for these symptoms and again on 31st December 2020 for these same symptoms. She was being treated with steroids and antihistamines. These symptoms still had not resolved. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: One patient 14 years old received their first dose of the Moderna vaccine; A spontaneous report  was received from a pharmacist concerning a 14-year-old patient who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273) at the age of 14.  The patient's medical history was not provided. Concomitant product use was not provided.  Between 11 Jan 2021 and 21 Jan 2021 (date not specified), the patient received their first of two planned doses of mRNA-1273 (No Specific Batch numbers provided: 011L20A - 013L20A - 039K20A)  intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date in Jan-2021 (between 11/Jan/2021 and 21/Jan/2021), at the age of 14, the patient received their first dose of vaccine.  Action taken with mRNA-1273 in response to the event was not provided.  The event, one patient 14 years old received their first dose of the Moderna vaccine was considered resolved on an unspecified date in Jan-2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011617: US-MODERNATX, INC.-MOD-2021-011581:
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Extra dose administered, Underdose
Clinical narrative: received the second dose of the vaccine yesterday and a lot of it leaked out; The facility realized this and administered a third dose; Syringe Connection Issue; A spontaneous report was received from a healthcare provider, HCP concerning an unknown age female patient who was administered Moderna Covid-19 Vaccine, the patient was administered second dose of mRNA-1273 Vaccine, but a lot of it leaked out. The facility realized this and administered a third dose.  On an unknown date, the patient received first dose of two doses of the Moderna mRNA-1273 vaccine, for prophylaxis of COVID-19 infectious, batch number unknown, date first dose administered unknown. Route unknown. The nurse called on behalf of her friend which in this case was the patient. The patient received the second dose of the vaccine yesterday and a lot of it leaked out. The facility realized this and administered a third dose. The nurse would not disclose the patient's information and shared that she would inform her friend the patient to reported the adverse event.   The patient medical history was not provided, no concomitant medications were reported.  On 04 Feb 2021, the patient was administered the second dose of mRNA-1273 no batch number unknown for prophylaxis of COVID-19 infectious.  Action Taken was to administer a third dose.  The event was considered resolved after the third dose was administered.; Reporter's Comments: This report refers to a case of underdose, extra dose administered and device connection issue for mRNA-1273 (lot# not provided) with no associated AEs.  Causality of these events is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: A nurse was administering the vaccine when it leaked between the needle and the piston; A nurse was administering the vaccine when it leaked between the needle and the piston; A spontaneous report was received from a healthcare facility staff member concerning a 19 year old, male patient who experienced the vaccine  syringe connection issue and vaccine under dose as it leaked between the needle and the piston.  The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.  The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 06-FEB-2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 6FEB2021, he took his son "Jr." who has the same first and last name to an  vaccination location. He is a dental assistant in the office and a first responder. A nurse was administering the vaccine when it leaked between the needle and the piston. He is unsure how much of the vaccine was administered and how much was lost.  The injection was attempted by intramuscular injection to the left deltoid. He has had no symptoms following vaccination and has not taken any treatments.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event vaccine under dose and syringe connection issues were considered resolved.; Reporter's Comments: This report refers to a case of syringe connection issue and underdose for mRNA-1273 (lot number: not provided) with no associated AEs reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Unknown amount of vaccine ran down the back of his arm; A spontaneous report was received from a consumer concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had an unknown amount of vaccine drip down his arm.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter   On an unknown date, the patient received their first of two planned doses of mRNA-1273.   On 01 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Feb 2021, during administration, some of the vaccine dripped down the back of the patient's arm and onto his pants. The amount of vaccine administered was unknown. Treatment information was not provided/unknown.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event vaccine dripped down arm was considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 030L20A  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Incorrect route of product administration, Vaccination site swelling
Clinical narrative: Swelling on injection site; Fatigue; Joint pain; Vaccinated subcutaneous instead of intramuscular; A spontaneous report received from a Consumer concerning, unknown age, female patient who received first dose of the Moderna COVID-19 vaccine subcutaneous instead of intramuscular. /MedDRA PT: [Incorrect route of product administration] and experienced swelling on injection site, fatigue, and joint pain.   The patient's medical history was not included. Patient's concomitant was not included.   On 13 JAN 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated she received the Moderna COVID-19 vaccine subcutaneous instead of intramuscular on 13 JAN 2021. Patient stated she experienced swelling on injection site, fatigue, joint pain. Patient stated that the swelling came back in her arm on 21 JAN 2021.    c dx Patient stated she was put on antibiotics for treatment.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a patient of unknown gender and age  who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Incorrect route of product administration associated with vaccination site swelling, fatigue and arthralgia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: very sick; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case was linked to case 2020SA292550 (same report).  This case involved an adult patient (age and gender were not reported) who was very sick (malaise), after he/she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor but he/she had not been sick for a number of years and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination as the patient was a volunteer at a hospital.  Since the comment received from a public post on the internet, they are assuming that the consumer was referring to the Sanofi flu vaccine.  On an unknown date, the patient became very sick (malaise) (non-serious event and unknown latency), following the administration of INFLUENZA VACCINE.  Hence reportedly the patient decided to not get flu shot this year (at the time of reporting).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the event was unknown.   There will be no information available on the batch number for this case.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation decreased
Clinical narrative: Short of Breath, Spo2 74%
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Pt received vaccine on 2/11/21.  She reported onset of redness (approx. 5-6" diameter) and itching at the site on 2/17/21.  She was seen by a dermatologist on 2/19/21 and was diagnosed with cellulitis and started on a five day course of cephalexin.  Pt reports redness and itching is resolving and that no further follow up is necessary.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: T. 99.8
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: When family members came to receive the second dose of their COVID vaccine, they informed us that the above patient had passed away.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash ,itching , 5 days after dose prednisone 5 days, Pepcid 5 days, antihistamine shot ,mostly cleared up. received 2nd dose 2-2-21, 7 days later itching restarted, no rash , doctor prescribed same treatment, have some minor itching.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Malaise, Pruritus
Clinical narrative: Patient did not feel well and reports general malaise day 2 and day 3 post vaccination.  She noticed itching of Right Breast  on Day 3 and later that evening, noticed a rash with blisters.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, aches and fatigue.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Nausea
Clinical narrative: Chilly Nausea weak
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness, nausea; took antivert without noticeable effect, recovered in 12 hrs
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash/small bumps at the site of the injection.   Appeared approximately 1 week after initial vaccine injection.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Rash
Clinical narrative: Rash, Fatigue, & Body aches
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching at injection site, continued for one day
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Age under the requirement for EUA (<18 years of age).  No other adverse symptoms noted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: papular rash bilateral arms chest and back
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Syncope
Clinical narrative: I have had every effect listed on the paper of side affect including, difficulty of breathing, fainted, dizzy, nauseous, I have spent days in bed
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itching, red rash on upper left arm 37 hours after vaccine and still present
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vein rupture
Clinical narrative: bursting blood vessels on hand x 2 now. One is R hand finger and now in L hand palm. No reason of injury.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Pain
Clinical narrative: Symptoms onset occurred approx 10 min post administration. Case reports shortness of breath and midsternal chest pain that radiates around her back. She has a history of a cardiac stent one year ago.  BP 110/80 HR 80 SpOx 00% room air LS-CTAB Patient evaluated, she presents anxious and admits to anxiety upon arrival. Highly recommended transfer to a higher level of care. Patient refused EMS transport multiple times, she was accompanied by a passenger in the vehicle. She agreed to stay an additional  30 minutes for continued monitoring and then felt well enough to drive home. She was advised to follow up with her PCP and cardiologist.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site rash, Pruritus, Rash
Clinical narrative: started out with a rash around injection site and is now full blown on left arm from top to wrist and under to arm pit area of arm.  rash is a burning sensation and very itchy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pruritus
Clinical narrative: Day of shot 2/19/21: fatigue, sluggish tired, low grade fever 99.8, nausea, headache. Day #1 after shot 2/20/21: tired, sore, body aches, low grade fever 99.6, nausea, headache. Day #2 after shot 2/21/21: nausea, vomiting, woke up with rash on pelvis, hips and thighs. Severe itching with rash. Day #3 after shot 2/22/21: Hives/rash on lower abdomen, more severe below umbilical area and suprapubic area; rash on bilateral upper anterior thighs, and rash on bilateral hips; severe itching; raised red nodules with circular white base.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling, Vomiting
Clinical narrative: Day of shot 2/19/21: fatigue, sluggish tired, low grade fever 99.8, nausea, headache. Day #1 after shot 2/20/21: tired, sore, body aches, low grade fever 99.6, nausea, headache. Day #2 after shot 2/21/21: nausea, vomiting, woke up with rash on pelvis, hips and thighs. Severe itching with rash. Day #3 after shot 2/22/21: Hives/rash on lower abdomen, more severe below umbilical area and suprapubic area; rash on bilateral upper anterior thighs, and rash on bilateral hips; severe itching; raised red nodules with circular white base.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, Headache, & Fever
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: About a week later I experienced a large red circular raised itchy rash around the injection site.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Pruritus
Clinical narrative: Started out as very mild itching just above both ankles but below the  knees.   Starting on Friday, six days after receiving the shot, the itching  was a little more aggressive. I started to use  over the counter Hydrocortisone .5% level, which helped.  The inching is not severe just agitating .
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm with redness and swelling
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site pruritus
Clinical narrative: Moderna Covid Vaccine, 1st dose.  I experienced "covid arm" 6-7 days after  I received the vaccine.  I had itching and developed a 3" x 2" oval shaped red area near the site of the vaccine (upper left arm).  It is not too bothersome physically, but it does worry me mentally.  I also had some left armpit tenderness a couple days after the vaccine, which lasted about 3 days, but that has subsided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Muscular weakness, Skin warm
Clinical narrative: Severe headache, upset stomach, body felt very hot and weakness in legs
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dysgeusia, Limb discomfort, Vision blurred
Clinical narrative: AFTER RECEIVING THE SHOT, SHE COMPLAINED OF TASTING THE METALIC TASTE, HER VISION WAS BLURRY, HER FEET WERE HEAVY. ON SITE EMS RESPONDED. SHE SAID SHE FORGOT  TO TAKE HER METOPROLOL THIS MORNING (PART OF HER NUMBERS TODAY). SINCE IT HAD BEEN AT LEAST AN HOUR SINCE SHE RECEIVED THE VACCINE AND HER VISION WAS STILL BLURRY, IT WAS RECOMMENDED TO GO TO E.R. FOR FURTHER EVALUATION AND SHE AGREED. EMS TRANSPORTED HER TO THE E.R.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, fatigue, body ache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Injection site reaction, Injection site swelling, Injection site warmth, Skin irritation
Clinical narrative: Redness and swelling radiating from old vaccine scar (either smallpox or TB) located about 2 inches below injection site.  First noticed about 26 hours after injection.  Redness, swelling, and warmth expanded to about 1.5 inch radius about 62 hours after injection.  Second old vaccine scar (either smallpox or TB) located about 2 mm above injection site also turned red but did not radiate.  Skin irritation from bandaid adhesive also became red and inflamed. 72 hours after injection and redness, swelling, and warmth improving.  No treatment was applied or felt necessary.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast swelling, Dizziness, Immediate post-injection reaction, Lymphadenopathy, Nausea
Clinical narrative: Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size  larger than a golf ball. Pain radiates down my inner arm to my forearm.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size  larger than a golf ball. Pain radiates down my inner arm to my forearm.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At ten days after receiving my vaccine my left upper arm reddened and swelled around the site of injection.  There is some pain and the site is very hot to the touch.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: According to medical information I have Covid 19 Arm.  The  injection site is red, swollen and very itchy.  I also have a few other whelps on other body areas.  Same arm higher and lower, midback.  It started on Sunday, February 21 upon my waking up.  It is still red and whelped up and itchy.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Tachycardia and palpitations. Currently on holter monitor for SVT. Followed up with PCP and did receive 2nd dose without issue.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Left arm red, swollen, and itching.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site erythema, Injection site pruritus
Clinical narrative: Itchy red area measuring approximately 5inches long by 4 inches wide with darker red area in the center approximately 2 inches below injection site. Started 9 days after vaccine. 1st day area was approx 3 inches long by2 inches wide. By evening it had gotten larger, next day more red and itchy and larger. 3rd morning same size but red color is not as bright and no itch.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to age < EUA (vaccine given to < 18 year old).  No other adverse effects noted.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Throat irritation
Clinical narrative: Body aches, Chills & itchy throat
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient has general malaise  unknown cause . Onsite EMS was called vitals BP 118/64  100% O2 room air HR 72 Patient efused evaluation/care went home against medical advice.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth 3 inches below injection site. Began 2/20/21 and has not gone away yet 2/22/2021
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Developed spreading erythematous nonvesicular macular rash starting on L shoulder and axilla 1 week later; spread to rest of body
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Right -side neck pain (injection was given in right arm).  Unresolved as of today.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: pt  went home 15 min after immunization and then went to drive home and developed throat tightening, she and soa, this happened twice , pt went to the hospital ER for treatment
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Nausea
Clinical narrative: Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen  and some anti -nausea drugs I had on hand.  Fever left, but returned next night.  Weakness, no appetite stayed for two days.  Thought it was the flu, but no upper respiratory symptoms.  Thought it might be Covid-19 but tested negative.  Finally decided it was a reaction to the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen  and some anti -nausea drugs I had on hand.  Fever left, but returned next night.  Weakness, no appetite stayed for two days.  Thought it was the flu, but no upper respiratory symptoms.  Thought it might be Covid-19 but tested negative.  Finally decided it was a reaction to the vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza virus test negative, Laboratory test, Nausea
Clinical narrative: That night I started feeling bad, I woke up with a fever of 103 and I took some tylenol. The next day I had fever, chills, nausea and it just continued. Yesterday morning I had my husband take me to ER and I had lost 15 pounds since Wednesday. I couldn't keep down fluids. They tested me for Corona and the flu but both were negative. They also gave me fluids. Everything and smells and tastes terrible. They gave me Zofran but it didn't help. I haven't been able to take my medicine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia, SARS-CoV-2 test negative, Taste disorder, Vomiting
Clinical narrative: That night I started feeling bad, I woke up with a fever of 103 and I took some tylenol. The next day I had fever, chills, nausea and it just continued. Yesterday morning I had my husband take me to ER and I had lost 15 pounds since Wednesday. I couldn't keep down fluids. They tested me for Corona and the flu but both were negative. They also gave me fluids. Everything and smells and tastes terrible. They gave me Zofran but it didn't help. I haven't been able to take my medicine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: That night I started feeling bad, I woke up with a fever of 103 and I took some tylenol. The next day I had fever, chills, nausea and it just continued. Yesterday morning I had my husband take me to ER and I had lost 15 pounds since Wednesday. I couldn't keep down fluids. They tested me for Corona and the flu but both were negative. They also gave me fluids. Everything and smells and tastes terrible. They gave me Zofran but it didn't help. I haven't been able to take my medicine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Patient reported feeling that her throat felt swollen after receiving dose. Assisted by onsite EMS. Felt better and was released to home from the POD.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Vertigo
Clinical narrative: Staff member had hot flash and vertigo upon standing. BP 138/101, P 76, O2 SAT 98%.  5 Minutes later BP 132/87, P 77, O2 SAT 99% Symptoms lasted about 5 minutes and he was able to get up and leave without any further symptoms post 15 minutes after injection per staff member's verbal statement. He was leaving his shift to go home.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Slight erythema and pruritus slightly distal to injection site
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: 8 days after the vaccine was given, a rash began to form around the injection site. At the time of the injection, a bandaid was not placed over the injection site. due to concern for infection, medical treatment was recommended with hydrocortisone and benadryl creams. As of today, rash is stabilizing, slightly worse
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, Rhonchi, SARS-CoV-2 test positive, Somnolence
Clinical narrative: 2/18/2021 fever 100.5 and scratchy throat 2/20/21-Covid test positive. No contact with covid positive, patient is still admitted in the hospital from December. 2/20/21 patient was drowsy, lung sounds rhonchi, Respirations 36, O2-78 % on room air. 4L per NC applied.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 2/18/2021 fever 100.5 and scratchy throat 2/20/21-Covid test positive. No contact with covid positive, patient is still admitted in the hospital from December. 2/20/21 patient was drowsy, lung sounds rhonchi, Respirations 36, O2-78 % on room air. 4L per NC applied.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: With the 1st dose I experienced like a really bad mosquito bite at the injection site. It git red, swollen and very very itchy. About 4 inches round. My PCP recommended me to take Benadryl and it worked. About 24 hours later the symptoms started subsiding.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide, Full blood count, Laboratory test, Metabolic function test, Transient global amnesia
Clinical narrative: transient global amnesia
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was given IV and steroids. The symptoms lasted for 6 weeks.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Intestinal perforation
Clinical narrative: ABDOMINAL PAIN, PERFORATED BOWEL.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Fever, chills, shaking,body aches, headache, dizziness, fatigue
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, chills, shaking,body aches, headache, dizziness, fatigue
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Received 1st dose of Pfizer vaccine on Thursday.  Started experiencing left-sided facial droop (eye and mouth) Friday morning.  No improvement on Monday morning.  Difficulty closing left eye and severe left-sided mouth asymmetry.  Patient denies any extremity weakness. Presented to Emergency Department Monday morning for evaluation on 2/22/21.  Discharged to home.  (Assessment:  Bell's Palsy).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site induration, Injection site swelling, Nausea
Clinical narrative: Was feeling great after the vaccine, felt some tightening in the arm, soreness.  Later in the afternoon felt tightness and felt like food poisoning.  Significant swelling and harness to the area, chills, nausea and vomiting x2, with fever of 102.   Later that evening did take an Aleve.  Things settled down and was Saturday before he felt like doing anything and comfortable.   He is fine today, just feeling weak, hard swelling at the injection site, but otherwise well.  He does occasional gets chills as well.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Skin tightness, Vomiting
Clinical narrative: Was feeling great after the vaccine, felt some tightening in the arm, soreness.  Later in the afternoon felt tightness and felt like food poisoning.  Significant swelling and harness to the area, chills, nausea and vomiting x2, with fever of 102.   Later that evening did take an Aleve.  Things settled down and was Saturday before he felt like doing anything and comfortable.   He is fine today, just feeling weak, hard swelling at the injection site, but otherwise well.  He does occasional gets chills as well.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: My injection site was large and red afterward, but now that I am 12 days out from receiving the vaccine, the injection site looks horrible. It is a large red circle with a dark red rash around the circle.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: 1/4/21 given Pfizer; 2/19/21 given Moderna. Still attempting to contact patient for follow up (his voicemail is full).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site pruritus, Injection site rash, Laboratory test
Clinical narrative: Moderna COVID-19 Vaccine EUA. Rash and itching around injection site (left arm) - went to ED and was diagnosed with cellulitis. She was given a course of antibiotics (IV cefazolin 1 gm x 1 followed by a script for cephalexin 500 mg po QID x 7 days)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: arm looked like cellulitus, bright red, white circle close tot he injection site. puffy and swollen the size of an orange. I iced it and it went away after 4-5 days. it was painful. I took ibuprofen. never spread, just got lighter in color each day and by day 5 it was gone.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 16 days round rash, slight sore but no itch
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Blood culture, Cerebellar stroke, Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery disease, Echocardiogram, Electrocardiogram, Glycosylated haemoglobin, Lipids
Clinical narrative: Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging brain, Scan with contrast, Type 2 diabetes mellitus, Type V hyperlipidaemia
Clinical narrative: Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Moderna COVID-19 Vaccine EUA On the eighth day post vaccination, I developed an itchy rash and lump at the vaccination site (left arm).  Two days later,  the rash is still there but barely visible. Benadryl (topical) stopped the itchiness. The lump is still there. I have no other symptoms.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient complained of difficulty breathing after receiving dose. Onsite EMS assisted the patient and transported them to the hospital.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient felt syncope / fainting unknown cause . Onsite EMS was called vitals BP 100/54  100% O2 room air HR 88  BG 130  Patient refused evaluation/care went home against medical advice.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose #1 and Dose #2 administered 23 days apart.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, C-reactive protein normal, Computerised tomogram head normal, Red blood cell sedimentation rate normal
Clinical narrative: TIA 10 days after injection
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA 10 days after injection
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, Chills, Body aches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Impaired work ability, Pain
Clinical narrative: back pain on 02/13, body aches which intensified at work. symptoms persisted over night with addition of chills/shaking and missed work on 02/14
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Neck pain, Pain in extremity
Clinical narrative: After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better.  7 day ok.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better.  7 day ok.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Diagnosed Bell's Palsy. Facial paralysis.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Fatigue, Headache
Clinical narrative: all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Throat tightness
Clinical narrative: all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: Hive reaction on injection arm approximately 10-12 cm; very red with itching and stinging
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hot flush
Clinical narrative: flushed, feels hot 169/89 80 98.8 F temp  96% SAT   #21 Home follow up with pcp
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Facial pain, Headache, Herpes zoster, Neuralgia
Clinical narrative: Painful site of vaccine area for 3-4 days.  Headache and body aches beginning the evening of the vaccine (Friday 2/12/2021) and still continues.  Itching around the mouth the next day(Saturday).  Red spots on chin started appearing on (Sunday) the third day. Red painful spots continued to come up on scalp, eyelid, eyebrow, and forehead all on the left side of my head.  Finally went to a Clinic (Saturday 2/20/21)and was diagnosed with Shingles.  Prescribed Valacyclovir Hcl 1 gram tablet.  Was told to contact eye doctor since most of the red areas were around left eye.  Also scheduled with family doctor to get something prescribed for nerve pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Pain, Vaccination site pain
Clinical narrative: Painful site of vaccine area for 3-4 days.  Headache and body aches beginning the evening of the vaccine (Friday 2/12/2021) and still continues.  Itching around the mouth the next day(Saturday).  Red spots on chin started appearing on (Sunday) the third day. Red painful spots continued to come up on scalp, eyelid, eyebrow, and forehead all on the left side of my head.  Finally went to a Clinic (Saturday 2/20/21)and was diagnosed with Shingles.  Prescribed Valacyclovir Hcl 1 gram tablet.  Was told to contact eye doctor since most of the red areas were around left eye.  Also scheduled with family doctor to get something prescribed for nerve pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower back ache that began the day after the injection. My backache lasted 5 days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I developed a swollen warm lump on my right arm about an inch below the injection site. This occurred two days after I received my second Moderna injection. The pain radiated through the top of arm and in my upper back. It is quite itchy. And the area is very red, in a large oval shape.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient given Pfizer instead of Moderna for her 2nd vaccination
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine haemorrhage
Clinical narrative: My period stopped in December 2019, I got covid19 vaccine on 2/19/2021 in the morning and I got my period at night. Not sure it is side effect of vaccine or not.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: site pain  headache, nausea, vomiting
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: gradual onset of mild itching sensation in bilateral ear canals and posterior pharynx along with a tingling tongue sensation after administration of vaccine. No signs of urticaria or respiratory distress (or wheezing). Patient had no other known allergy triggers today, but did have post-nasal drip PTA. Chose to self-administer 0.3mg of epi at 1530 via her own epi-pen which she always carries with her. Post-administration all symptoms resolved, signed a release and left independently
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Night sweats
Clinical narrative: same symptoms I had with covid approx 11/4/20: extreme fatigue, night sweats, muscle aches
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Starting 12 hours after injection fatigue, overall body aches and headache. Starting 12 hours after injection red hot painful welt over the arm. Increased to 3inches by 4 inches after 48 hours. At 48 hours began to itch.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Pain
Clinical narrative: Starting 12 hours after injection fatigue, overall body aches and headache. Starting 12 hours after injection red hot painful welt over the arm. Increased to 3inches by 4 inches after 48 hours. At 48 hours began to itch.