chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Palpitations, Tachycardia
Clinical narrative: Tachycardia, heart palpitations, clammy, chills & terrible headache
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Rash
Clinical narrative: rash all over entire body and anxiety
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache lasting 2 days, fever reaching 100.3 lasting 1 day, chills, body aches.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Peripheral swelling, Skin warm
Clinical narrative: 01/20/2021: Telephone call from patient. States that her left arm is red, swollen with a lump, and warm to the touch. States it started that evening  after her Moderna vaccination. States that the swelling, redness and warmth is getting worse.  Has tried cold packs and Tylenol with no relief.  Instructed to call her Health Care Provider.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neurological symptom, Pain in extremity, Paraesthesia
Clinical narrative: Neurological symptoms.  Stabbing pain in left foot, numbness and tingling in both legs and arms.  Pain woke me up in the middle of the night.  Took Gabapentine 300 mg. , two doses.  Pain resolved the next day.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, SARS-CoV-2 test negative
Clinical narrative: Extreme fatigue since getting shot - effecting ability to work
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Chest X-ray normal, Chest discomfort, Computerised tomogram normal, Dizziness
Clinical narrative: he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal.  Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Full blood count normal, Headache, Metabolic function test
Clinical narrative: he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal.  Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Vertigo
Clinical narrative: he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal.  Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal.  Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Presyncope
Clinical narrative: he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal.  Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Employee stated the day she received her last vaccination and acknowledged it had been 28 days. After submitting to NYSIIS we noticed that she was incorrect and it had only been 15 days since her 1st dose. (1st Dose given on 1/4/21). No adverse reactions at this time just error.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Epistaxis, Full blood count, International normalised ratio, Metabolic function test
Clinical narrative: On January 4 at 2:00 pm I suddenly started to bleed from the nose from the left nostril and then from both. The event lasted more than 35 minutes so I had to go to the ER. The diagnosis was Epistaxis. I was discharged because at the time of the medical evaluation I removed a large clot from my mouth and the bleeding stopped.  Appointment with primary physician for diagnosis and appointment with ENT was ordered. On January 5 at 4:15 am I had another episode of nasal bleeding lasting 25 min. After removing a clot through the mouth, the bleeding stopped. At 4:00 pm I presented Epistaxis again so I had to return to the Emergency Room. I was reevaluated and the instruction was to visit the ENT and Afrin prescription for three days and Claritin D q 12 hrs PRN. From January 6 to 9, I began to eliminate a serous-bloody vaginal discharge. That began with the elimination of a clot and progressively diminished day by day.  January 11, 2021, the ENT evaluated me and indicated that it did not observe polyps or anatomical problems. I had not previously prolonged nosebleeds. Previously two minor episodes happened to me, a year ago that resolved in less than 7 minutes. I didn't have a cold or any other symptoms.  I want to raise the flag because it was a strange event that occurred after the vaccination and that I had not experienced before in that way.My next dose is January 29, 2021. I am awaiting clot test results
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin level, Urine analysis, Vaginal haemorrhage
Clinical narrative: On January 4 at 2:00 pm I suddenly started to bleed from the nose from the left nostril and then from both. The event lasted more than 35 minutes so I had to go to the ER. The diagnosis was Epistaxis. I was discharged because at the time of the medical evaluation I removed a large clot from my mouth and the bleeding stopped.  Appointment with primary physician for diagnosis and appointment with ENT was ordered. On January 5 at 4:15 am I had another episode of nasal bleeding lasting 25 min. After removing a clot through the mouth, the bleeding stopped. At 4:00 pm I presented Epistaxis again so I had to return to the Emergency Room. I was reevaluated and the instruction was to visit the ENT and Afrin prescription for three days and Claritin D q 12 hrs PRN. From January 6 to 9, I began to eliminate a serous-bloody vaginal discharge. That began with the elimination of a clot and progressively diminished day by day.  January 11, 2021, the ENT evaluated me and indicated that it did not observe polyps or anatomical problems. I had not previously prolonged nosebleeds. Previously two minor episodes happened to me, a year ago that resolved in less than 7 minutes. I didn't have a cold or any other symptoms.  I want to raise the flag because it was a strange event that occurred after the vaccination and that I had not experienced before in that way.My next dose is January 29, 2021. I am awaiting clot test results
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Palpitations, Paraesthesia, Tremor
Clinical narrative: 5 minutes following injection patient complaint of dizziness, hands and feet tingling, blurry vision. Patient was flush, diaphoretic. VS 144/74 HR 61 (10:00am) 10:07 BP 144/77 HR 60- Pt reports palpitations, legs shaking (trembling). 10:09 Diphenhydramine 25mg administered to LD IM. No adverse reactions noted. 10:15 VS BP 144/77, HR 61- patient states he is "feeling better". 10:30 BP 127/72 HR 61 Patient remained in clinic until 11:00 am. He was escorted to his home by family. Instructed to seek emergency medical attention for any adverse reactions at home.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 5 minutes following injection patient complaint of dizziness, hands and feet tingling, blurry vision. Patient was flush, diaphoretic. VS 144/74 HR 61 (10:00am) 10:07 BP 144/77 HR 60- Pt reports palpitations, legs shaking (trembling). 10:09 Diphenhydramine 25mg administered to LD IM. No adverse reactions noted. 10:15 VS BP 144/77, HR 61- patient states he is "feeling better". 10:30 BP 127/72 HR 61 Patient remained in clinic until 11:00 am. He was escorted to his home by family. Instructed to seek emergency medical attention for any adverse reactions at home.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: About 20 minutes after shot  a little dizzy, arms and legs tingly. Subsided, but tingling in arms returned about an hour later, though not as severe
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Late on the 7th day after the vaccine (Sunday, Jan 17) my arm a bit below the vaccine site started to itch.  I get skin itching sometimes and put  prescription Ultravate lotion on it.  The next morning (Jan 18) it itched more and the Ultravate did not to relieve it, so I put hydrocortisone cream on it and that made the itching stop.  The area that itched was about the size of a golf ball and was red. I put hydrocortisone cream on Jan 19 once in the morning and at night.  Today, Jan 20 when I woke up the area is red and about 4" long and 3" across, mostly below the injection site. It itches some. I don't have a primary care physician.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Cluster headache, Cold sweat
Clinical narrative: 1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAIN, LOW GRADE FEVER (99.8) AND SEVERE HEADACHE. SWOLLEN FACE AND ARM PAIN. 1/8 NIGHT: HIGH GRADE FEVER (101.4). 1/10: HIGH GRADE FEVER (101.3 REACHING HIGHEST OF 102.9). SEVERE BODY ACHES, CLUSTER HEADACHE/MIGRAINE, JOINT PAIN. CILLS, COLD SEATS, LOSS OF APPETITIE, NAUSEA. SWOLLEN FACE AND ARM PAIN. 1/11 MORNING: LOW GRADE FEVER, MODERATE BODY ACHES, CHILLS AND COLD SWEATS, NAUSEA (STRONGER), LOSS OF APPETITE AND STOMACH ACHE, DIARRHEA, AND ARM PAIN. 1/11 AFTERNOON AND NIGHT: MODERATE STOMACH ACHE, NAUSEA. 1/12: STILL MILD NAUSEA AND LOSS OF APPETITE, ARM PAIN. TOOK IBUPROFEN, TYLENOL.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Migraine, Nausea
Clinical narrative: 1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAIN, LOW GRADE FEVER (99.8) AND SEVERE HEADACHE. SWOLLEN FACE AND ARM PAIN. 1/8 NIGHT: HIGH GRADE FEVER (101.4). 1/10: HIGH GRADE FEVER (101.3 REACHING HIGHEST OF 102.9). SEVERE BODY ACHES, CLUSTER HEADACHE/MIGRAINE, JOINT PAIN. CILLS, COLD SEATS, LOSS OF APPETITIE, NAUSEA. SWOLLEN FACE AND ARM PAIN. 1/11 MORNING: LOW GRADE FEVER, MODERATE BODY ACHES, CHILLS AND COLD SWEATS, NAUSEA (STRONGER), LOSS OF APPETITE AND STOMACH ACHE, DIARRHEA, AND ARM PAIN. 1/11 AFTERNOON AND NIGHT: MODERATE STOMACH ACHE, NAUSEA. 1/12: STILL MILD NAUSEA AND LOSS OF APPETITE, ARM PAIN. TOOK IBUPROFEN, TYLENOL.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: 1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAIN, LOW GRADE FEVER (99.8) AND SEVERE HEADACHE. SWOLLEN FACE AND ARM PAIN. 1/8 NIGHT: HIGH GRADE FEVER (101.4). 1/10: HIGH GRADE FEVER (101.3 REACHING HIGHEST OF 102.9). SEVERE BODY ACHES, CLUSTER HEADACHE/MIGRAINE, JOINT PAIN. CILLS, COLD SEATS, LOSS OF APPETITIE, NAUSEA. SWOLLEN FACE AND ARM PAIN. 1/11 MORNING: LOW GRADE FEVER, MODERATE BODY ACHES, CHILLS AND COLD SWEATS, NAUSEA (STRONGER), LOSS OF APPETITE AND STOMACH ACHE, DIARRHEA, AND ARM PAIN. 1/11 AFTERNOON AND NIGHT: MODERATE STOMACH ACHE, NAUSEA. 1/12: STILL MILD NAUSEA AND LOSS OF APPETITE, ARM PAIN. TOOK IBUPROFEN, TYLENOL.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient had some shortness of breath@ 10:30am , 10 minutes after receiving vaccination, pulse=88, blood pressure=118/80.  Patient rested on cot with feet elevated x 10 minutes and had 1 bottle of water, patient reports having come straight from working night shift and di not have much water while working, patient reported feeling better after 10 minutes, pulse=84, blood pressure =130/80 while sitting up at 10:45am, patient requests to go home and reported she no longer had any shortness of breath or other concerns at this time.  Patient left clinic at 10:55am.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site discolouration, Injection site induration, Injection site pain
Clinical narrative: Patient describes at the site of injection the following symptoms: tenderness, black and blue discoloration (like a bruise but no history of trauma to arm since vaccine injection), site feels hard but not warm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Injection date-1/11/21  adverse event started 1/19/2021.  left upper arm itching intensely, hot and red. itching stopped on its own. 1/20/21-left upper arm still red with small amount of swelling around injection site and pain around the site.  no treatment as I didn't have any Benadryl. Message left on primary provider at 10:22 am I have not heard back from provider yet as I fill out this form, therefore, not able to answer item 21 below
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: fever weakness
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: 01/10/2021 (2nd day after injection) - flu like fatigue, muscle and joints pain (last about one week),   01/10/2021 -  swelling and pain at the injection site last about a week 01/17/2021 - injection site swelling enlarged  with skin etching, this is still exist after 12 days
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus
Clinical narrative: 01/10/2021 (2nd day after injection) - flu like fatigue, muscle and joints pain (last about one week),   01/10/2021 -  swelling and pain at the injection site last about a week 01/17/2021 - injection site swelling enlarged  with skin etching, this is still exist after 12 days
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Began experiencing a rash about 3 inches in diameter on Left Arm below injection site about 7 days after first dose of Moderna COVID vaccine.  Rash itches and has grown in size over the last 2-3 days.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Feeling abnormal
Clinical narrative: Started with cough, mild shortness of breath and feeling terrible  in evening of 1/19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Erythema, Neck pain, Pain
Clinical narrative: fever of 101.5, chills, body aches, severe neck and back pain, local redness
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 101.5, chills, body aches, severe neck and back pain, local redness
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Haematoma
Clinical narrative: patient came to our clinic complaining of "vaccine reaction" after receiving covid vaccine at another clinic. stated "it bled and bled" and receiving shot in left deltoid. pt appeared to have small hematoma and mild localized cellulitis. patient denied any type of allergic or immune reaction to vaccine contents.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death 3 days after receiving 2nd dose of COVID vaccine, unknown if related to vaccine administration.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Heart was racing and lightheadedness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: patient reports body aches and chill on 1/20/2021 that started at 5:30 am
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain, Insomnia, Joint stiffness
Clinical narrative: Chills, stiff joints, insomnia, excessive sweating while sleeping, pain to injection site
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Moderate redness, swelling, and pain at the injection site for the first 2-3 days that resolved (along with mild fever and myalgias).  Then 1 week later, on 1/15 I woke up with a very large red, hot, itchy patch on my left biceps around my injection site.  It is not as bright now, but still very large (larger than my palm) and intermittently itchy.  It will be 2 weeks from my injection tomorrow.  I am concerned about whether or not to get the second dose as I am afraid this was some sort of allergic reaction and I read that many people experience more significant adverse reactions to the second dose.  I did check in with a health care provider at my clinic and she only suggested ice and Tylenol, which provided relief of itchiness, but no improvement.  I also notified Moderna.  No one seems to know for sure if I should receive the second dose.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Moderate redness, swelling, and pain at the injection site for the first 2-3 days that resolved (along with mild fever and myalgias).  Then 1 week later, on 1/15 I woke up with a very large red, hot, itchy patch on my left biceps around my injection site.  It is not as bright now, but still very large (larger than my palm) and intermittently itchy.  It will be 2 weeks from my injection tomorrow.  I am concerned about whether or not to get the second dose as I am afraid this was some sort of allergic reaction and I read that many people experience more significant adverse reactions to the second dose.  I did check in with a health care provider at my clinic and she only suggested ice and Tylenol, which provided relief of itchiness, but no improvement.  I also notified Moderna.  No one seems to know for sure if I should receive the second dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Injection site pain, Nausea
Clinical narrative: Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No further information provided; HCP reported an inadvertent administration of expired VAQTA.; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 14-JAN-2021, the patient was inadvertent vaccinated with  an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location and vaccine scheme were not provided lot number S032358 has been verified to be a valid lot number, expiration date was on 11-JAN-20210, as prophylaxis (expired product administered).There was no prior temperature excursions reported. No further information provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: COVID19
Symptoms: Needle issue, Product leakage
Clinical narrative: Dose went down the arm rather than in the arm; Dose went down the arm rather than in the arm; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine and the dose went down the arm, rather than in the arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient was administered the vaccine with a malfunctioning needle that caused the dose to drip down the patient's arm, rather than in the arm. The patient might not have received the full dose. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The event, dose went down the arm, rather than in the arm, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting malfunctioning needle and dose went down the arm  rather than in the arm without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old female received Moderna's COVID-19 vaccination; A spontaneous report was received from a nurse concerning a 17-years old, female patient who received Moderna's COVID-19 vaccine and experienced product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) intramuscularly in the deltoid (unspecified) for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event, product administered to patient of inappropriate age, was resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: received partial dose; Needle not attached to the hub; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine and received partial dose.   The patient's medical history was not provided. Concomitant medications have not been provided.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient received a partial dose of the vaccine, the needle was not attached and some leaked out.   Action taken with mRNA-1273 in response to the events was unknown.  The event, partial dose received, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of out of inappropriate dose administered and needle issue for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of inappropriate dose administered and needle issue.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine to someone who was less than 18 years old.; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  No side effects were reported. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, vaccine given to a patient less than 18-years-old, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Possibly given into the lower part of the deltoid muscle; Local redness; Pain and tenderness; A spontaneous report was received from a physician concerning a 50-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced local redness, pain, tenderness and was possibly given the vaccination in the wrong spot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the lower part of the deltoid muscle intramuscularly for prophylaxis of COVID-19 infection.     The date of the vaccine was not reported. However, the healthcare professional (HCP) reported the vaccine was given incorrectly and in the wrong spot. The patient, also, developed local redness, pain and tenderness. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event outcome of the vaccination being possibly given in the wrong spot was considered resolved. The outcome of the events, local redness, pain and tenderness, were not reported.    The reporter's assessment of causality for the events was not provided.; Reporter's Comments: This case concerns a 50-year old, male patient. The patient's medical history was not provided. The patient who experienced an expected  event of injection site pain, injection site erythema and an unexpected event of product administered at inappropriate site. The event occurred on an unknown date, after administration of the first dose of mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site movement impairment, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: SIRVA (Shoulder Injury Related to Vaccine Administration); It was injected where her shoulder joint is instead of the deltoid; She had zero range of motion in her arm; A spontaneous report was received from a nurse who was also a 23-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced incorrect route of product administration, injection site movement impaired, and shoulder injury related to vaccine administration.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 02 Jan 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT number 026LA20A) intramuscularly for prophylaxis of COVID-19 infection. The vaccine was injected where her shoulder joint was instead of the deltoid, and the patient experienced incorrect route of product administration.  For the first 36 hours following vaccine administration, the patient reported zero range of motion in her arm. She began to regain some function after that. She was under the care of a shoulder specialist who took x-rays, prescribed a methylprednisolone dose pack, and diagnosed her with shoulder injury related to vaccine administration (SIRVA). She was not able to work. Additional treatment for the event included ibuprofen and acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported.; Reporter's Comments: This case concerns a 23-years-old, female, who experienced a non-serious unexpected events of shoulder injury related to vaccine administration, incorrect route of product administration, and injection site movement impairment. The event of incorrect route of product administration occurred same day after the firs dose of mRNA-1273 (Lot# 026L20A) administration. There was no reported AE associated with incorrect route of product administration. The event of shoulder injury related to vaccine administration and injection site movement impairment occurred on an unspecified date after the first dose of mRNA-1273 administration. The treatment medications included Medrol Dose Pak, Ibuprofen and Tylenol. 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema
Clinical narrative: Chest Pain arm became red
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever, chills, headache, body aches
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: injection site pain, arm hurts, head-ace, throwing up, body aches, fever of 101.8
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: injection site pain, arm hurts, head-ace, throwing up, body aches, fever of 101.8
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: fever, chills, body aches, dizziness, nausea
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Injection site pain, Insomnia
Clinical narrative: I received the Moderna vaccination around 10:00am. It was confirmed that it was okay to get the vaccine being that I tested positive for Covid on 12/23/20. Around 19:00 I started to get cold and by midnight I was shivering uncontrollably, I had a fever and had a massive headache. I alternated ibuprofren and Tylenol which did not work. I was only able to sleep from midnight to about 3:00am. The entire day I was shivering with a massive headache. It hurt so bad that I wanted to cry but it hurt worse when I did cry. My highest fever was 101 degrees. My fever broke around 19:00 on 01/05/2021 but the massive headache and body aches lasted the entire week. I felt like I was "hit by a bus" and my entire top part of my arm was in pain . I was seen by a doctor  at HS on Thursday the 7th to have my medical condition documented. My arm felt better by then. She had me take off the rest of the week and to return to work on the 11th. I finally started to feel somewhat better by the 9th
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I received the Moderna vaccination around 10:00am. It was confirmed that it was okay to get the vaccine being that I tested positive for Covid on 12/23/20. Around 19:00 I started to get cold and by midnight I was shivering uncontrollably, I had a fever and had a massive headache. I alternated ibuprofren and Tylenol which did not work. I was only able to sleep from midnight to about 3:00am. The entire day I was shivering with a massive headache. It hurt so bad that I wanted to cry but it hurt worse when I did cry. My highest fever was 101 degrees. My fever broke around 19:00 on 01/05/2021 but the massive headache and body aches lasted the entire week. I felt like I was "hit by a bus" and my entire top part of my arm was in pain . I was seen by a doctor  at HS on Thursday the 7th to have my medical condition documented. My arm felt better by then. She had me take off the rest of the week and to return to work on the 11th. I finally started to feel somewhat better by the 9th
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, body aches, nausea, vomiting, injection site pain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral, Peripheral coldness
Clinical narrative: pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hyperventilation, Paraesthesia
Clinical narrative: Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic.  She returned 2 hours later with anxiety, hyperventilation and paresthesia.  Vital signs showed improvement before symptoms resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Heart rate increased, Pain, Peripheral swelling
Clinical narrative: RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received Pfizer COVID vaccine on 12/23/20. On 1/13/2021, patient was scheduled to receive 2nd dose of Pfizer vaccine, but received Moderna vaccine. location is a drive through vaccine clinic and was giving both vaccines on this date due to supply and logistics. On days when both vaccines are given, there are individuals assigned to each vaccine for check-in, vaccinator and scheduler. Color cards of green/red (Moderna) and orange/blue (Pfizer) along with face sheet are placed on the windshields to communicate which vaccine is to be administered. Unclear if incorrect color was assigned to vehicle or if vaccinator did not perform safety checks with color cards and face sheet.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of vaccine was administered to patient in the face of a known contraindication.  Patient reported having received another vaccine within the prior 14 days.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever, headache >48 hrs.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral
Clinical narrative: About 7 minutes after receiving the vaccine she starting her numbness and tingling of the mouth and lips and swelling of upper lips. NP gave her epinephrine at 3:19 and called 911 and patient was transported to ER (I think Hospital patient will know more). NP did follow  up  with patient later that 4:42 PM and patient said she was feeling better and received Benadryl and Solumedro.    **follow up with patient for missing information as reporter does not have access to it**
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: I felt fine the day of the vaccine. However, The  next day I was extremely tired. The next day I went to the Doctor and texted positive for covid with a rapied test. I also Had a PCR test which was neg. for covid.  Im currently being treated for a sinus infection.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: Nausea: I was seen at for Nausea. and abdominal pain.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Lethargy
Clinical narrative: Elevated temperature of 101.7, weakness, and lethargy on 01/15/2021 Treated with 400 mg Ibuprofen Q6 hours, temperature down to 100.1 Temperature spiked to 101.3 on morning of 01/16/2021 Treated with 500mg Tylenol  All symptoms resolved completely 01/17/2021
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain in extremity, Pyrexia, Tremor
Clinical narrative: I have a horrible headache, I had a fever last night, unsure how high, I was just shaking and freezing under blankets in bed during the middle of the night.  My arm is also very sore, which i expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient developed deep arm pain soon after vaccine that persisted for multiple days.  Days after vaccine, arm became red and warm  This has persisted to today (1/20).  Has not worsened.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever chills
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush
Clinical narrative: chills that night and slight headache, then next morning had two occurrences of hot flashes and headache till 12 noon
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disorientation, Fatigue, Headache
Clinical narrative: 2nd dose of COVID vaccine received approx 0800 on 1/19/21, felt healthy throughout the day. Began to feel flu like symptoms approx 1800 on the evening of 1/19/21. Symptoms worsened through the night rapidly, beginning with uncontrollable chills/shivering, body aches, restless, slight vertigo, weakness/fatigue. At approx 0100 the morning of 1/20/21, blacked out while in the bathroom of which awoken and found myself disoriented, weak, and on the ground (no injuries noted as i must have eased myself down).  I was able to hydrate afterwards and tolerate eating some dry cereal to help with the weakness. Symptoms began to dissipate while an intense headache continued throughout the night and even through the daytime. The time is now 1020 on the day of 1/20/21 and i still have quite the headache but all other symptoms seem to be relieved at this time.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Loss of consciousness, Pain, Restlessness, Vertigo
Clinical narrative: 2nd dose of COVID vaccine received approx 0800 on 1/19/21, felt healthy throughout the day. Began to feel flu like symptoms approx 1800 on the evening of 1/19/21. Symptoms worsened through the night rapidly, beginning with uncontrollable chills/shivering, body aches, restless, slight vertigo, weakness/fatigue. At approx 0100 the morning of 1/20/21, blacked out while in the bathroom of which awoken and found myself disoriented, weak, and on the ground (no injuries noted as i must have eased myself down).  I was able to hydrate afterwards and tolerate eating some dry cereal to help with the weakness. Symptoms began to dissipate while an intense headache continued throughout the night and even through the daytime. The time is now 1020 on the day of 1/20/21 and i still have quite the headache but all other symptoms seem to be relieved at this time.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Moderna Vaccine- first injection One week after the vaccine was injected, developed a raised, red, itchy rash on right shoulder in the area where the vaccine was given.   Rash was localized- no other symptoms symptoms improving two days later
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysgeusia, Heart rate increased, Hypopnoea, Pharyngeal swelling
Clinical narrative: Within 3 minutes, developed ametallic taste in mouth, throat and tongue swelling, maintained swallow and breathing, heart rate increased vitals were ok.  Called ambulance.  Took bendryl.  Has had symptoms off/on few days after
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Dose was given 1 week early
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Patient states that the night of her vaccine she felt feverish, and had extreme shortness of breath for about 5-6 hours, and she has been exhausted ever since.  She states there has been a few days she has not even been able to get out of bed.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Chills, Headache, Lethargy
Clinical narrative: 5AM: TEMP 101.7, HEADACHE, CHILLS, LOWER BACK PAIN, LETHARGY. SYMPTOMS PROGRESSED THROUGOUT THE DAY. SYMPTOMS STARTED ABATING 1/8 TIME 2100. 5AM TOOK 2 EXTRA STRENGTH TYLENOL. 8AM- 2 EXCEDRIN. 1300 - 2 ADVIL; 1600- EXTRA STRENGTH TYLENOL. 01/0 0700 - 2 EXTRA STRENGTH TYLENOL FOR HEADACHE.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Fever for 3 days following vaccine with max temp of 101.3, rigors, chills, body aches, fatigue, congestion, sneezing, coughing and sore throat. At 7 days post vaccine, remaining symptoms include lingering cough and fatigue.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Fever for 3 days following vaccine with max temp of 101.3, rigors, chills, body aches, fatigue, congestion, sneezing, coughing and sore throat. At 7 days post vaccine, remaining symptoms include lingering cough and fatigue.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: swollen lymph glands under right arm, breast, collar bone , neck pain lasting >11 days
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Sensation of foreign body, Urticaria
Clinical narrative: Developed hives a few hours after shot, with swollen lips that progressed into the evening on the 30th.  Worse on the 31st, went to urgent care given IV cortisone and pepcid symptoms resolved, discharged in the early afternoon, 2 hours after dc symptoms returned to cover face with lump in throat.  911 contact and taken by ambulance to Medical Center ER, admitted over night and discharged on 11/1 to home still with full body hives.  11/2 had consults with primary MD and allergist MD, given regimen of predisone taper 60 mg over 10 days along with pepcid, zyrtec .  Full body hives began to resolve of 11/3, returned to work on 11/4, intermittant hives persisted on/off for 4 weeks, currently still taking pepcid and zyrtec.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of the left arm, mainly fingertips within the first 10 min. after vaccine was given.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Dry throat, Fatigue, Feeling of body temperature change
Clinical narrative: On 1/15 around 6pm, I began to feel extremely fatigued (about 27 hours after my initial injection).  I began to feel severe flu-like symptoms (hot/cold chills, sensitive skin, headache, dry/scratchy throat, fever dreams) which persisted for several hours during the night. The next day (1/16), the fatigue, headache, and chills persisted (although the chills decreased). I took Dayquil before noon and that seemed to help with the symptoms, and Nyquil at night so I was able to sleep. By the following morning, I still had a mild headache and fatigue but continued to improve. I felt normal again on 1/18.   I also had stiffness, swelling, and soreness at the injection site for 3-4 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: On 1/15 around 6pm, I began to feel extremely fatigued (about 27 hours after my initial injection).  I began to feel severe flu-like symptoms (hot/cold chills, sensitive skin, headache, dry/scratchy throat, fever dreams) which persisted for several hours during the night. The next day (1/16), the fatigue, headache, and chills persisted (although the chills decreased). I took Dayquil before noon and that seemed to help with the symptoms, and Nyquil at night so I was able to sleep. By the following morning, I still had a mild headache and fatigue but continued to improve. I felt normal again on 1/18.   I also had stiffness, swelling, and soreness at the injection site for 3-4 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: On 1/15 around 6pm, I began to feel extremely fatigued (about 27 hours after my initial injection).  I began to feel severe flu-like symptoms (hot/cold chills, sensitive skin, headache, dry/scratchy throat, fever dreams) which persisted for several hours during the night. The next day (1/16), the fatigue, headache, and chills persisted (although the chills decreased). I took Dayquil before noon and that seemed to help with the symptoms, and Nyquil at night so I was able to sleep. By the following morning, I still had a mild headache and fatigue but continued to improve. I felt normal again on 1/18.   I also had stiffness, swelling, and soreness at the injection site for 3-4 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Urticaria
Clinical narrative: Hives around the waist, weakness/ tired at 0500 1/20
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site erythema, Pyrexia
Clinical narrative: 2" wide slightly red streak at injections reached top of shoulder and then down to humours sight.  Had slight low grade fever 99 with chills all day long
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat
Clinical narrative: cold sweats in middle at night from upper part of body. So much  that has to change in the middle of the night.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Bacterial test, Body temperature increased, Diarrhoea
Clinical narrative: Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, unrelieved with  OTC intervention. Continued for 34 hours. Temp continued thru 12/27/20. Aching, severe fatigue. Diarrhea stopped after 34 hours. Has been intermittent nearly daily since. Only occasional 24 hour periods without it. When diarrhea resumed following the 34 hour stretch, MD prescribed Lomotil. Lomotil was taken x4 days, then diarrhea stopped x2 days, then resumed again. Diarrhea continues at this time along with pain in upper stomach area, intermittent lower abdominal cramps that occur prior to episodes. Remains unable to eat normal foods r/t stomach pain and diarrhea