chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Muscle weakness, low grade fever, joint pain, headache, mild nausea
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncopal episode during 15 minute waiting period. Was sitting in a chair and was syncopal and fell out of chair onto the floor. Woke up immediately. Monitoring period extended. Recovered and went home.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: about an hour have receiving the injection i experienced a mild rash from armpit to armpit. I do have sensitive skin and was doing yard work earlier in the day so that may be the cause. It only last a few hours.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient received Moderna Vaccine at 6:44pm in left deltoid.  Patient c/o rash under chin and SOB while in monitoring area.  Patient given Diphenhydramine HCL  25 mg  1 tab orally.  Ambulance called and O2 applied at 7:09pm.  Patient alert and speaking with staff. Patient transported to Hospital.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye swelling, Headache, Injection site pruritus
Clinical narrative: Within 10 min, mild headache. Around 2 hrs, eyes slightly swollen, dizzy. Next morning, noticed 2 itchy hives 1.5" from injection site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site irritation, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: I have what appears to swollen lymph nodes in the collarbone, IT appeared on 03/08/2021, the day after the first shot/injection, and has been swollen to the touch, a sore and irritated sensation at times.  It is the size of an almond, and has not gotten any better.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pain, Sneezing
Clinical narrative: Stiff joints, body aches, sneezing
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear swelling, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: She got the vaccine, she went home, had no reaction.  The next day she woke up and her arms was sore, and swollen (huge).  Later on she started to have fever, cough, and then headache.  She then went to bed and slept 7-8 hours, all day long.  The swelling stayed for almost a week in her arm.  Then approximately 4-5 days later on 3/21/21 the right side of her face, the lower part of her ear to the lower part of her face started swelling, and her lip was numb.  Fearing she had Bell's palsy which she had about 10 years ago she went to see her doctor and the doctor said that it was a reaction from the vaccine.  The right side of her face and the swelling is almost gone, but her face is still feeling numb.   Her doctor did not give her anything, and since her swelling was almost gone and was improving he didn't want to give her anything for it.  He told her to watch it and if it worsens to get back to him, and to report to VAERS.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: She got the vaccine, she went home, had no reaction.  The next day she woke up and her arms was sore, and swollen (huge).  Later on she started to have fever, cough, and then headache.  She then went to bed and slept 7-8 hours, all day long.  The swelling stayed for almost a week in her arm.  Then approximately 4-5 days later on 3/21/21 the right side of her face, the lower part of her ear to the lower part of her face started swelling, and her lip was numb.  Fearing she had Bell's palsy which she had about 10 years ago she went to see her doctor and the doctor said that it was a reaction from the vaccine.  The right side of her face and the swelling is almost gone, but her face is still feeling numb.   Her doctor did not give her anything, and since her swelling was almost gone and was improving he didn't want to give her anything for it.  He told her to watch it and if it worsens to get back to him, and to report to VAERS.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Second Moderna dose received to soon. Spoke with patient and he reports mild fatigue and chills evening of receiving vaccine and improved by the next day
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Throbbing pain at injection site still remains a month later.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus, Rash, Rash erythematous
Clinical narrative: Red rash all over my body with hives that were itching uncontrollably. Anytime I was touch my body or a red rash/whelp would appear. I felt nauseated, had chest pain and felt fatigued. This occurred at all times of the day and night  and was worse when I wore loose clothing.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Red rash all over my body with hives that were itching uncontrollably. Anytime I was touch my body or a red rash/whelp would appear. I felt nauseated, had chest pain and felt fatigued. This occurred at all times of the day and night  and was worse when I wore loose clothing.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PT RECEIVED MODERNA #1 ON 3/26 AND PASSED AWAY ON 3/28 AT HOME.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: I got the injection on 3/23 The day after the injection (3/24), the injection site felt like a bug bit and has every day. I woke up today (3/31) with red swelling at the injection site. It looks and feels like a bug bite.   I have looked it up and I guess this is what the world is calling ?Covid Arm?
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated individual who subsequently became symptomatic and tested positive for COVID-19 on 03/28/2021
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Injection site reaction, Paraesthesia
Clinical narrative: 8 days after Moderna 1: Arm welt, arm and fingers itching amd tingling 6 hours after Moderna 2: fatigue, headache, flu-like symptoms without fever, chills sweats. Full Symptoms  for 30 hours; 10 more hours of fatigue. Most symptoms gone by 54 hours after 2nd shot )injected 845am 3/27)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 8 days after Moderna 1: Arm welt, arm and fingers itching amd tingling 6 hours after Moderna 2: fatigue, headache, flu-like symptoms without fever, chills sweats. Full Symptoms  for 30 hours; 10 more hours of fatigue. Most symptoms gone by 54 hours after 2nd shot )injected 845am 3/27)
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient booked and arrived at vaccine pod, for 2nd dose Moderna COVID-19 vaccine. Patient was checked in through clerical checkpoint and 2nd dose of the vaccine was administered by RN. 1st dose was administered on 3/18/21 at health department and 2nd dose was administered only 12 days later on 3/30/21. No adverse reaction has been reported by patient thus far.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hypotension
Clinical narrative: Shortly after vaccine administration, the pt  honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi.  Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well.  While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved.  She had a significant period of hypotension for appx. 20 minutes however (prior to improvement).  Unclear if she had a prolonged vasovagal response  or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis.  She was transported to local ER by EMS in improved condition.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Feeling hot, Heart rate increased, Hyperhidrosis, Visual impairment
Clinical narrative: Shortly after vaccine administration, the pt  honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi.  Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well.  While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved.  She had a significant period of hypotension for appx. 20 minutes however (prior to improvement).  Unclear if she had a prolonged vasovagal response  or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis.  She was transported to local ER by EMS in improved condition.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram
Clinical narrative: Patient stating she was feeling short of breath and some chest tightness.  Patient does have a history of asthma.  Paramedics onsite performed an 12 lead EKG and patient was transported to Hospital due to chest tightness.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: Patient reported extreme lethargy and body soreness the day after vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Dehydration
Clinical narrative: 03/31/2021, 0929. 53 YO F. Syncopal episode. PT was waiting with her father who had received his vaccine today in the observation area. PT received her vaccine yesterday, time unknown. EMS Evaluation, 12-lead. 0939 BP 104/64, HR 80.  Suspected dehydration. IV established L Hand Dorsal. Care transferred to EMS @ 0948. PT transported to hospital.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: Reported substantial swelling where she has filler in her lips, cheeks, under eye, chin.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: COVID ARM - THE SITE OF THE SHOT IS RED, ITCHING, HOT AND PAINFUL
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheaded (slight);  reported feeling slightly/ mild lightheadedness .   5 mins. post vaccination.   Relates symptoms to minimal fluid intake (only coffee) & very small breakfast.  Symptom resolved with mask removal, fresh air, entire bottle of water, reclining. of car seat.  Able to return to upright position without adverse effects.  Drove off lot independently after another 15 mins.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dizziness, Dyspnoea, Fatigue, Resuscitation
Clinical narrative: Patient took the Pfizer Corona Virus shot does 1 on march 1, 2021.  He passed away on march 20, 2021.  Reported being fatigued and exhausted after taking does 1. Was sleeping up 10 hours a day.  On the day he passed, he reported being light-headed and struggling to breath.  The paramedics worked on him for 40 minutes to try and revive him.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Patient took the Pfizer Corona Virus shot does 1 on march 1, 2021.  He passed away on march 20, 2021.  Reported being fatigued and exhausted after taking does 1. Was sleeping up 10 hours a day.  On the day he passed, he reported being light-headed and struggling to breath.  The paramedics worked on him for 40 minutes to try and revive him.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: I have dermal fillers in my lips and chin. I received my lip filler 3 weeks prior to vaccination and they did not swell the next day. My chin filler that I received in beginning of December 2020 did swell the next day and is slightly painful to touch.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Received Moderna Vaccine #1 on March 19. About 8 days later, noticed a large (2" diameter) red welt around the injection site. The welt was hot to the touch, raised, and itchy. On Day 9 the welt had reduced in size, but the redness and itchiness remained. By Day 11 all symptoms were gone.  The only treatment was an ice pack on the affected area with the onset of symptoms for the first day.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, body aches, head ache, fatigue
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Rash, Rash pruritic, Urticaria
Clinical narrative: rash on the left side of the torso that looks like shingles or hives, very itchy with a burning sensation sometimes.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: Sore throat, post-nasal drip. Non-severe.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 years old at the time the vaccine was administered. Moderna is currently only authorized for individuals 18 years of age and older.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: pt. reports feeling like his heart rate is elevated.  radial pulse in 70s.  pt. reports  a hx of valovagal syncope.  Medics present.  Symptom beginning to resolve with comfort / calming measures.  Will cont. to monitor for an additional 15 mins.  pt. denies any difficulty swallowing / breathing &/or other S/S.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Death, Injection site pain
Clinical narrative: Patient received her first Moderna COVID-19 vaccination on 03/11/2021. She did not have any ill effects directly afterwards. However, starting on 03/27/2021, she began complaining of left arm pain in the area of the injection. She continued to complain of pain in the injection site on 03/28/2021. On 03/29/2021, her roommate found her deceased on her bed due to a probable cardiac event.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, No adverse event
Clinical narrative: Just began overnight last night ~ 1 week after vaccination. Injection site is sore, worse to the touch and itches.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Sore and stiff arm at injection site about 3 hours after injection. 23 hours later diarrhea started and low grade fever of 99 coming and going.  The diarrhea has lasted for the last 17 hours and still occurring.  The fever is up and down as well.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthma, Dizziness, Hypersensitivity, Migraine
Clinical narrative: Anaphylaxis  40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope.   Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned.  She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved.  She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered.  She was also given 1 IM dose of epinephrine.  Her symptoms resolved she is at her baseline.  Medically stable for discharge.  Discharge home with short course of steroid, H2 blocker and Benadryl as needed.  Advised patient to follow-up with PCP post discharge.  Resume other home medicationS as listed.   Of note, the patient had a similar reaction with influenza vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Reaction to previous exposure to any vaccine, Sleep apnoea syndrome, Syncope, Unresponsive to stimuli
Clinical narrative: Anaphylaxis  40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope.   Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned.  She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved.  She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered.  She was also given 1 IM dose of epinephrine.  Her symptoms resolved she is at her baseline.  Medically stable for discharge.  Discharge home with short course of steroid, H2 blocker and Benadryl as needed.  Advised patient to follow-up with PCP post discharge.  Resume other home medicationS as listed.   Of note, the patient had a similar reaction with influenza vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Impaired work ability, Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: On the evening of 3/21 I started to feel like I had a sore throat.  Morning of 3/22 it felt like a full blow cold with soar throat, swollen glands.  Symptoms became worse throughout the day.  Reported sick at work on 3/23 because symptoms were worse.  (measured temperature 98.9 to 99.9 throughout the say, normal temperature for me is 97.5)  Had covid test that came back negative.  Started taking cold relief medications.  Conditions slowly improved over next few days but still don't feel 100% as of this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: On the evening of 3/21 I started to feel like I had a sore throat.  Morning of 3/22 it felt like a full blow cold with soar throat, swollen glands.  Symptoms became worse throughout the day.  Reported sick at work on 3/23 because symptoms were worse.  (measured temperature 98.9 to 99.9 throughout the say, normal temperature for me is 97.5)  Had covid test that came back negative.  Started taking cold relief medications.  Conditions slowly improved over next few days but still don't feel 100% as of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: Report fever of 101, HA and stomach pain.  Treatment: Nothing, Outcome: Does not interfere with ADLs
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Paraesthesia
Clinical narrative: pt. c/o headache, sweating, tingling.  pt. went home after symptoms was resolved.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Red welt appeared on his arm; Itching at the site of injection; A spontaneous report  was received from a 76-year-old male patient, who received Moderna's COVID-19 vaccine and experienced itching at the site of injection/vaccination site pruritus and red welt appeared on his arm/vaccination site urticaria.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number 013M20A) via intramuscular route for COVID-19 infection prophylaxis.  On an unspecified date, the patient thought the nurse did a poor job administering the vaccine. The patient experienced itching at the site of injection and red welt appeared on his arm. It was not painful . No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, itching at the site of injection was resolved on an unspecified date and outcome of red welt on his arm was unknown at the time of this report.; Reporter's Comments: 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Body temperature increased, Chest X-ray, Decreased appetite
Clinical narrative: mild case of pneumonia; no appetite; body temperature was 4-5F above baseline; lost 10 pounds in 10 days; xray were similar to someone to had covid; Vomiting; Forgetfulness; uncoherent and unresponsive episode; body tremors; weakness; A spontaneous report  was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased.   The patient's medical history included leukemia/AML since an unknown date in SEP-2017 and Stem cell transplant since an unknown date in JAN-2018.  No relevant concomitant medications were reported.   On 18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced the events weakness, no energy, no appetite, body temperature were 4-5F above baseline. On 21-JAN-2021, the patient started experiencing body tremors and incontrollable shaking, both are worse at night. On 24-JAN-2021, he had an episode being uncoherent and unresponsive. On 25-JAN-2021, his resting heart rate was increased at 93BPM and his respiratory rate was also increased at 21 RPM. On 26-JAN-2021, he started vomiting and was forgetful. On an unknown date during a follow-up visit with PCP he was prescribed with antibiotics due to a mild case of pneumonia and suspected COVID-19.   Laboratory details included a negative COVID test performed on 22JAN2021 and some blood tests showing elevated WBC on 26JAN2021. He also had done a neuroscan and chest X-rays with unknown results.    Treatment information included antibiotics for the indication pneumonia.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events , memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Incoherent, Memory impairment, Pneumonia, Respiratory rate
Clinical narrative: mild case of pneumonia; no appetite; body temperature was 4-5F above baseline; lost 10 pounds in 10 days; xray were similar to someone to had covid; Vomiting; Forgetfulness; uncoherent and unresponsive episode; body tremors; weakness; A spontaneous report  was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased.   The patient's medical history included leukemia/AML since an unknown date in SEP-2017 and Stem cell transplant since an unknown date in JAN-2018.  No relevant concomitant medications were reported.   On 18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced the events weakness, no energy, no appetite, body temperature were 4-5F above baseline. On 21-JAN-2021, the patient started experiencing body tremors and incontrollable shaking, both are worse at night. On 24-JAN-2021, he had an episode being uncoherent and unresponsive. On 25-JAN-2021, his resting heart rate was increased at 93BPM and his respiratory rate was also increased at 21 RPM. On 26-JAN-2021, he started vomiting and was forgetful. On an unknown date during a follow-up visit with PCP he was prescribed with antibiotics due to a mild case of pneumonia and suspected COVID-19.   Laboratory details included a negative COVID test performed on 22JAN2021 and some blood tests showing elevated WBC on 26JAN2021. He also had done a neuroscan and chest X-rays with unknown results.    Treatment information included antibiotics for the indication pneumonia.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events , memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Tremor, Vomiting, Weight decreased
Clinical narrative: mild case of pneumonia; no appetite; body temperature was 4-5F above baseline; lost 10 pounds in 10 days; xray were similar to someone to had covid; Vomiting; Forgetfulness; uncoherent and unresponsive episode; body tremors; weakness; A spontaneous report  was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased.   The patient's medical history included leukemia/AML since an unknown date in SEP-2017 and Stem cell transplant since an unknown date in JAN-2018.  No relevant concomitant medications were reported.   On 18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced the events weakness, no energy, no appetite, body temperature were 4-5F above baseline. On 21-JAN-2021, the patient started experiencing body tremors and incontrollable shaking, both are worse at night. On 24-JAN-2021, he had an episode being uncoherent and unresponsive. On 25-JAN-2021, his resting heart rate was increased at 93BPM and his respiratory rate was also increased at 21 RPM. On 26-JAN-2021, he started vomiting and was forgetful. On an unknown date during a follow-up visit with PCP he was prescribed with antibiotics due to a mild case of pneumonia and suspected COVID-19.   Laboratory details included a negative COVID test performed on 22JAN2021 and some blood tests showing elevated WBC on 26JAN2021. He also had done a neuroscan and chest X-rays with unknown results.    Treatment information included antibiotics for the indication pneumonia.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events , memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events. Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Eye haemorrhage, Pain
Clinical narrative: Broken of the right eye vein that led to bleeding; excruciating pain (like a labor pain; Diarrhea; vaginal bleeding; Dizziness; Stomach Cramping; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced:  excruciating pain - like a labor pain (pain), stomach cramping (abdominal pain upper), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage).   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included: methotrexate.   On 22Jan2021, the patient received their first of two planned doses of Moderna's COVD-19 Vaccine (mRNA-1273, lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  Later on 22Jan2021, the patient began to develop: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage).  She reports these events lasted for 1 day and then stopped. The patient states she still experiences stomach cramping (abdominal pain upper), The patient confirmed she consulted with her physician and blood work was done. The results of the blood work were not provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported. Patient is wondering if these events are normal and if she should receive her second dose.   The outcome of the events: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorthage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage) is considered to be resolved based on patient reported duration of 1 day. The outcome of event: stomaching cramping (abdominal pain upper) is considered not recovered/not resolved per patient report.; Reporter's Comments: This case concerns a 82-years-old, female patient who experienced:  excruciating pain- like a labor pain, abdominal pain upper, diarrhea, vaginal bleeding, dizziness and eye haemorrhage.  Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Broken of the right eye vein that led to bleeding; excruciating pain (like a labor pain; Diarrhea; vaginal bleeding; Dizziness; Stomach Cramping; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced:  excruciating pain - like a labor pain (pain), stomach cramping (abdominal pain upper), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage).   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included: methotrexate.   On 22Jan2021, the patient received their first of two planned doses of Moderna's COVD-19 Vaccine (mRNA-1273, lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  Later on 22Jan2021, the patient began to develop: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage).  She reports these events lasted for 1 day and then stopped. The patient states she still experiences stomach cramping (abdominal pain upper), The patient confirmed she consulted with her physician and blood work was done. The results of the blood work were not provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported. Patient is wondering if these events are normal and if she should receive her second dose.   The outcome of the events: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorthage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage) is considered to be resolved based on patient reported duration of 1 day. The outcome of event: stomaching cramping (abdominal pain upper) is considered not recovered/not resolved per patient report.; Reporter's Comments: This case concerns a 82-years-old, female patient who experienced:  excruciating pain- like a labor pain, abdominal pain upper, diarrhea, vaginal bleeding, dizziness and eye haemorrhage.  Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Cellulitis, Erythema, Lymphadenopathy, Pain in extremity
Clinical narrative: scabs on my forearm; itching really badly; extreme swelling; redness from the shoulder down to my fingers; hot to the touch; cellulitis; it tingled; blisters on my forearm; blotches of about 6 inches x 4 inches, purplish blotches on my forearm of 1 inch x 5 inches; lymph node about the size of a Ping-Pong formed in my armpit; pain in my left bicep; redness in my left bicep; A spontaneous report was received from a consumer concerning a 67-years-old, male patient who experienced cellulitis, lymph node about the size of a ping pong formed in my armpit, it tingled, extreme swelling, blisters on my forearm, blotches of about 6 inches in to 4 inches, purplish blotches on my forearm of 1 inch in to 5 inches, hot to the touch, scabs on my forearm, redness in my left bicep, itching really badly, pain in my left bicep and redness from the shoulder down to my fingers.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 25 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient started getting redness and pain in his left bicep. He had a lymph node about the size of a ping pong formed in his armpit. He reported that the swelling was getting worse daily.  On 06 Mar 2021, the patient had redness from the shoulder down to his fingers of his left arm. There was extreme swelling, blisters on his forearm and blotches of about six inches by four inches. The site was hot to the touch and it tingled. He went to urgent care where he was diagnosed with cellulitis (Medically significant).  On 15 Mar 2021, the patient reported his forearm started itching really badly. There were multiple cabbed over blisters to that forearm. He also reported that he had purplish blotches on his forearm of one inch by five inches.  Treatment for the event included cephalexin and allegra.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events were unknown.; Reporter's Comments: 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash macular, Scab, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: scabs on my forearm; itching really badly; extreme swelling; redness from the shoulder down to my fingers; hot to the touch; cellulitis; it tingled; blisters on my forearm; blotches of about 6 inches x 4 inches, purplish blotches on my forearm of 1 inch x 5 inches; lymph node about the size of a Ping-Pong formed in my armpit; pain in my left bicep; redness in my left bicep; A spontaneous report was received from a consumer concerning a 67-years-old, male patient who experienced cellulitis, lymph node about the size of a ping pong formed in my armpit, it tingled, extreme swelling, blisters on my forearm, blotches of about 6 inches in to 4 inches, purplish blotches on my forearm of 1 inch in to 5 inches, hot to the touch, scabs on my forearm, redness in my left bicep, itching really badly, pain in my left bicep and redness from the shoulder down to my fingers.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 25 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient started getting redness and pain in his left bicep. He had a lymph node about the size of a ping pong formed in his armpit. He reported that the swelling was getting worse daily.  On 06 Mar 2021, the patient had redness from the shoulder down to his fingers of his left arm. There was extreme swelling, blisters on his forearm and blotches of about six inches by four inches. The site was hot to the touch and it tingled. He went to urgent care where he was diagnosed with cellulitis (Medically significant).  On 15 Mar 2021, the patient reported his forearm started itching really badly. There were multiple cabbed over blisters to that forearm. He also reported that he had purplish blotches on his forearm of one inch by five inches.  Treatment for the event included cephalexin and allegra.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events were unknown.; Reporter's Comments: 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: scabs on my forearm; itching really badly; extreme swelling; redness from the shoulder down to my fingers; hot to the touch; cellulitis; it tingled; blisters on my forearm; blotches of about 6 inches x 4 inches, purplish blotches on my forearm of 1 inch x 5 inches; lymph node about the size of a Ping-Pong formed in my armpit; pain in my left bicep; redness in my left bicep; A spontaneous report was received from a consumer concerning a 67-years-old, male patient who experienced cellulitis, lymph node about the size of a ping pong formed in my armpit, it tingled, extreme swelling, blisters on my forearm, blotches of about 6 inches in to 4 inches, purplish blotches on my forearm of 1 inch in to 5 inches, hot to the touch, scabs on my forearm, redness in my left bicep, itching really badly, pain in my left bicep and redness from the shoulder down to my fingers.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 25 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient started getting redness and pain in his left bicep. He had a lymph node about the size of a ping pong formed in his armpit. He reported that the swelling was getting worse daily.  On 06 Mar 2021, the patient had redness from the shoulder down to his fingers of his left arm. There was extreme swelling, blisters on his forearm and blotches of about six inches by four inches. The site was hot to the touch and it tingled. He went to urgent care where he was diagnosed with cellulitis (Medically significant).  On 15 Mar 2021, the patient reported his forearm started itching really badly. There were multiple cabbed over blisters to that forearm. He also reported that he had purplish blotches on his forearm of one inch by five inches.  Treatment for the event included cephalexin and allegra.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events were unknown.; Reporter's Comments: 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Diarrhoea, Dizziness, Eye swelling, Haemorrhage
Clinical narrative: Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tumeric, multivitamin, vitamin d, lexapro and adderall.          On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection.   On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock.   Treatment for the event included was given steroids, benadryl, and prescription antihistamine.    Action taken with mrna-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Pharyngitis, Pruritus
Clinical narrative: Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tumeric, multivitamin, vitamin d, lexapro and adderall.          On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection.   On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock.   Treatment for the event included was given steroids, benadryl, and prescription antihistamine.    Action taken with mrna-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.