chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Myocardial infarction, Stent placement
Clinical narrative: My mother is extremely healthy and active. She had labs completed in October and all values were normal. She has never been on medication.   She experienced a heart attack and under more scrutiny found a blockage which required a stent.   Her doctor refused to report the adverse event.  This goes against everything I know about medicine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Glomerular filtration rate, Lupus nephritis, Protein urine, Urine analysis
Clinical narrative: I just had my acupuncturist clear signs of the return of my long-dormant Systemic Lupus nephritis (in my kidneys) in February. After every Moderna shot, including the half-dose booster (received at a different pharmacy), there have been multiple signs of it re-flaring again. I refuse to go on stronger immunosuppressants during the pandemic and these flares have costed me in health and acupuncturist/TCM herbal bills not covered by my insurance.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Ocular hyperaemia, Vision blurred
Clinical narrative: Eyes became swollen, red and burning. Vision became blurry. Symptoms resolved about an hour after taking Benadryl. Mild redness and swelling continued for 2 days after vaccine and improved with Benadryl every 8 hours.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event. pt was suppose to receive adult pfizer and they received pediatric pfizer instead
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: SHE FELT ITCHING SENSATION IN HER LEFT ARM AFTER GETTING THE VACCINE. IT DID GO AWAY AFTER 15 MINUTES.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given 30 micrograms dose of Pfizer who was suppose to receive  10 micrograms dose of Pfizer. Patient waited 15 minutes with no adverse effects noted. Patient family was called and notified who was okay with the dose; "Okay. Thanks for letting me know."
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives thru out my arms, legs, back, chest, severe itching.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hypoaesthesia
Clinical narrative: ABOUT 20 MINUTES AFTER ADMINISTRATION OF VACCINE, PATIENT LEFT ARM AND LEG SIZED AND WENT NUMB.  SHE ALSO EXPERIENCE SHORTNESS OF BREATH AND CHEST TIGHTNESS/PAIN, AND REQUIRED OXYGE BEFORE PARAMEDICA ARRIVED ON SCENE. PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Full blood count normal, Urticaria, White blood cell count increased
Clinical narrative: Hives began on December 11th at night. 10 days after receiving Moderna booster shot, after 2 previous Moderna vaccines in March and April 2021. Changed body wash, soap, locations, diet, animal, laundry detergent, and have no progress except for benadryl.
Age: 39.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Temps went out of range overnight. was still used to administer in the morning. The Facility was closed 1/17 unable to report at the time
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Temps went out of range overnight, was still used to adminster in the morning. The Facility was closed 1/17 unable to report at the time
Age: 28.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Condition aggravated, Syncope
Clinical narrative: fainting vitals checked Patient reported history of fainting after recovery, Patient also reported history of low HR after recovery lie flat feet elevated, candy, Gatorade
Age: 1.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, VARCEL
Symptoms: Erythema, Injection site bruising, Injection site reaction, Swelling, Urticaria
Clinical narrative: 1/16/22 Mom noted a "right thigh welt" and tiny spot above it. Photo by mom showed an area of redness + 2 red bumps that faded over 2 days.  by 1/19/22 the area looked bruised. area is 1 1/2 in x 1 1/2 in
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: 1) Erratic Blood Pressure high as 201/104  Hospital, unknown outcome, on BP Pill now 2) Dizzy & Falling down (Hospital) MRI Xrais Blood CAT Scan EKG EHO 3) Headaches - Treating with Tylenol 4) Tiredness - C Blood tests - All Normal 5) Rapid Heart Palpitations
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Headache, Heart rate increased, Hypertension
Clinical narrative: 1) Erratic Blood Pressure high as 201/104  Hospital, unknown outcome, on BP Pill now 2) Dizzy & Falling down (Hospital) MRI Xrais Blood CAT Scan EKG EHO 3) Headaches - Treating with Tylenol 4) Tiredness - C Blood tests - All Normal 5) Rapid Heart Palpitations
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Palpitations, X-ray
Clinical narrative: 1) Erratic Blood Pressure high as 201/104  Hospital, unknown outcome, on BP Pill now 2) Dizzy & Falling down (Hospital) MRI Xrais Blood CAT Scan EKG EHO 3) Headaches - Treating with Tylenol 4) Tiredness - C Blood tests - All Normal 5) Rapid Heart Palpitations
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Hypoaesthesia, Tinnitus
Clinical narrative: patient experience blurred vision, difficulty breathing, light-head, ringing in the ear, arm is numb, anxiety.  Called 911, EMT came and checked him out, vital signs are normal.  pt refused to go to ER.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: patient experience blurred vision, difficulty breathing, light-head, ringing in the ear, arm is numb, anxiety.  Called 911, EMT came and checked him out, vital signs are normal.  pt refused to go to ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid 19 PCR positive on 12/24/2021. Covid 19 1st and 2nd pfizer doses given on 12/16/2020 and 1/7/21 outside this facility visit. Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Lethargy, Nausea
Clinical narrative: Headache, Arthralgia, Fever, NauseaVomiting, chest pain, right arm soreness, lethargic Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Headache, Arthralgia, Fever, NauseaVomiting, chest pain, right arm soreness, lethargic Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity, Pyrexia
Clinical narrative: Fever ARM PAIN, BONE PAIN Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: PRURITIC RASH Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: ARM PAIN, BODY ACHES, FATIGUE Narrative:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Temps went out of range overnight, was still used to adminster in the morning. DOH was closed 1/17 unable to report at the time
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram thorax, Echocardiogram, Pericardial effusion, Pericarditis
Clinical narrative: I developed pericardial effusion on or about January 13, 2022, about 5 weeks after developing pericarditis.  The pericarditis occurred 3 days post-booster on 12/6/21. I was hospitalized on 1/15/22 and discharged on 1/17/22. I am taking .6 mg of colchicine as treatment.  I have followup appointments scheduled with my cardiologist.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cardioversion, Chest X-ray abnormal, Cough
Clinical narrative: pt diagnosed positive for COVID on 7/16/21; 7/23/21 pt brought to ED via EMS; c/o increasing SOB, cough; O2 sats 60% on RA; placed on NRB mask (15L); chest xray showed COVID pneumonia; transferred to ICU; required intubation; developed worsening renal function; started dialysis; few hours into dialysis, pt sustained pulseless Ventricular tachycardia requiring CPR, shocking and med; after 20 mins of CPR, pt passed away in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dialysis, Dyspnoea, Endotracheal intubation, Intensive care
Clinical narrative: pt diagnosed positive for COVID on 7/16/21; 7/23/21 pt brought to ED via EMS; c/o increasing SOB, cough; O2 sats 60% on RA; placed on NRB mask (15L); chest xray showed COVID pneumonia; transferred to ICU; required intubation; developed worsening renal function; started dialysis; few hours into dialysis, pt sustained pulseless Ventricular tachycardia requiring CPR, shocking and med; after 20 mins of CPR, pt passed away in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Renal impairment, Resuscitation, SARS-CoV-2 test positive, Ventricular tachycardia
Clinical narrative: pt diagnosed positive for COVID on 7/16/21; 7/23/21 pt brought to ED via EMS; c/o increasing SOB, cough; O2 sats 60% on RA; placed on NRB mask (15L); chest xray showed COVID pneumonia; transferred to ICU; required intubation; developed worsening renal function; started dialysis; few hours into dialysis, pt sustained pulseless Ventricular tachycardia requiring CPR, shocking and med; after 20 mins of CPR, pt passed away in the hospital
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer, Magnetic resonance imaging breast, Mammogram, Ultrasound scan
Clinical narrative: BREAST CANCER OF THE LEFT BREAST; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) 1 total, dose was not reported, administered on 12-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 09-JUL-2021, Patient had laboratory tests performed of ultrasound which showed a circular diagram with the blood vessel that was feeding, which was suspicious for cancer and mammogram showed something that did not look right that needed to be looked into further. On 14-JUL-2021, biopsy was performed which showed confirmed cancer (breast cancer of the left breast). Patient was asked by V-safe that how she felt and she stated that she was feeling like crap because she had cancer. Patient stated that she was doing okay for now and had 16 consecutive days of radiation, and was currently taking medication which she will be on for 5 years. On 28-JUL-2021, she was underwent to Magnetic resonance imaging both breast which showed that cancer was limited to the left breast. On 03-Aug-2021, Patient had a day surgery (lumpectomy) for the treatment for breast cancer and had removal of 5 sentinel lymph nodes. The lymph nodes were clear but the actual lump showed cancer in it.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from breast cancer of the left breast. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220134438 -Covid-19 vaccine ad26.cov2.s- Breast cancer of the left breast. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: pt said developed cellulitis a few days after receiving vaccine.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives from head to toe for several days with no pervious history of allergies and was given Benadryl which didnt completely clear up
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Tinnitus, Vertigo
Clinical narrative: unilateral left sudden sensorineural hearing loss, tinnitus, and vertigo.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Condition aggravated, Erythema, Feeling hot
Clinical narrative: Itching, all over redness, flushing .severe itching, feeling hot, hives..given 25mg Benadryl by EMT..felt better..but had some chest tightness after and needed to use my rescue inhaler.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Urticaria
Clinical narrative: Itching, all over redness, flushing .severe itching, feeling hot, hives..given 25mg Benadryl by EMT..felt better..but had some chest tightness after and needed to use my rescue inhaler.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Arthralgia, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: Massive bilateral pulmonary emboli/Vaccine Induced Thrombotic Thrombocytopenia
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heparin-induced thrombocytopenia, Impaired work ability, Pain in extremity, Pulmonary thrombosis
Clinical narrative: Massive bilateral pulmonary emboli/Vaccine Induced Thrombotic Thrombocytopenia
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal
Clinical narrative: Massive bilateral pulmonary emboli/Vaccine Induced Thrombotic Thrombocytopenia
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Full blood count, Pulmonary embolism, Thrombotic thrombocytopenic purpura, Ultrasound Doppler
Clinical narrative: Massive bilateral pulmonary emboli/Vaccine Induced Thrombotic Thrombocytopenia
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bowel movement irregularity, Faeces soft, Frequent bowel movements
Clinical narrative: Change in her bowel habit after first shot/Going to the bathroom more often; Stools are small and soft; Achy; Tired for a few days.; This spontaneous case was reported by a consumer and describes the occurrence of CHANGE OF BOWEL HABIT (Change in her bowel habit after first shot/Going to the bathroom more often), FAECES SOFT (Stools are small and soft), PAIN (Achy) and FATIGUE (Tired for a few days.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHANGE OF BOWEL HABIT (Change in her bowel habit after first shot/Going to the bathroom more often), FAECES SOFT (Stools are small and soft), PAIN (Achy) and FATIGUE (Tired for a few days.). On 08-Mar-2021, PAIN (Achy) and FATIGUE (Tired for a few days.) had resolved. At the time of the report, CHANGE OF BOWEL HABIT (Change in her bowel habit after first shot/Going to the bathroom more often) and FAECES SOFT (Stools are small and soft) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment information was provided. The patient Stools was small and soft and did not have diarrhea also her bowel habit never went back to normal.   This case was linked to MOD-2022-455337, MOD-2022-455338, MOD-2022-455152 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Change of bowel habit, Faeces soft, Fatigue, Pain
Clinical narrative: Change in her bowel habit after first shot/Going to the bathroom more often; Stools are small and soft; Achy; Tired for a few days.; This spontaneous case was reported by a consumer and describes the occurrence of CHANGE OF BOWEL HABIT (Change in her bowel habit after first shot/Going to the bathroom more often), FAECES SOFT (Stools are small and soft), PAIN (Achy) and FATIGUE (Tired for a few days.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHANGE OF BOWEL HABIT (Change in her bowel habit after first shot/Going to the bathroom more often), FAECES SOFT (Stools are small and soft), PAIN (Achy) and FATIGUE (Tired for a few days.). On 08-Mar-2021, PAIN (Achy) and FATIGUE (Tired for a few days.) had resolved. At the time of the report, CHANGE OF BOWEL HABIT (Change in her bowel habit after first shot/Going to the bathroom more often) and FAECES SOFT (Stools are small and soft) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment information was provided. The patient Stools was small and soft and did not have diarrhea also her bowel habit never went back to normal.   This case was linked to MOD-2022-455337, MOD-2022-455338, MOD-2022-455152 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dyspnoea, Gait disturbance, Peripheral swelling, Thrombosis
Clinical narrative: short of breath, blod clots
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Thrombosis
Clinical narrative: short of breath, blod clots
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Loss of consciousness, Malaise
Clinical narrative: On 01/18/2022 about 10 or 15 minutes after the vaccine, I just got my shot and fainted after my shot. I had never fainted before. I was sitting on the chair,  mandatory waiting  10 or 15 minutes.  I was not feeling good.  I asked the pharmacist there was something wrong with my BP,  they checked my BP it was   30/60 after that,  I do not remember for 10 to 15 seconds, I woke up on the floor. The pharmacist did something, I do not remember the period of time. When I was in a horizontal position I was feeling a little bit better, I could see what was happening, in 5 or 10 minutes the EMT arrived, the raised my legs, and check my BP. I was almost okay after this manipulation. It was done by an emergency. The took me to the Hospital and they took one more measurement of  my BP it  was 120/80   in the car and pulse was around 67, it was around normal.. When I was in the hospital, they were checking my insurance, so for 2 or 3 hours nobody did anything. I left the hospital, I was feeling uncomfortable because of all the COVID cases, and it was uncomfortable for me.  Today, 01/21/2022- I can still see my temperature 37.1 or 37.2 Celsius in  the evening,  and I could see my BP jumping sometimes, especially after I drink some coffee. and I am feeling some weakness, it is much better than it was on Tuesday.  Note: I received my vaccination because it was mandatory by my employer.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Discomfort, Malaise, Syncope
Clinical narrative: On 01/18/2022 about 10 or 15 minutes after the vaccine, I just got my shot and fainted after my shot. I had never fainted before. I was sitting on the chair,  mandatory waiting  10 or 15 minutes.  I was not feeling good.  I asked the pharmacist there was something wrong with my BP,  they checked my BP it was   30/60 after that,  I do not remember for 10 to 15 seconds, I woke up on the floor. The pharmacist did something, I do not remember the period of time. When I was in a horizontal position I was feeling a little bit better, I could see what was happening, in 5 or 10 minutes the EMT arrived, the raised my legs, and check my BP. I was almost okay after this manipulation. It was done by an emergency. The took me to the Hospital and they took one more measurement of  my BP it  was 120/80   in the car and pulse was around 67, it was around normal.. When I was in the hospital, they were checking my insurance, so for 2 or 3 hours nobody did anything. I left the hospital, I was feeling uncomfortable because of all the COVID cases, and it was uncomfortable for me.  Today, 01/21/2022- I can still see my temperature 37.1 or 37.2 Celsius in  the evening,  and I could see my BP jumping sometimes, especially after I drink some coffee. and I am feeling some weakness, it is much better than it was on Tuesday.  Note: I received my vaccination because it was mandatory by my employer.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin lesion, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She started getting very itchy, started on the base of my scalp, spread to my neck), URTICARIA (Hives type of rash on my scalp and neck) and RASH (Rash on neck and scalp, later spread to torso, waistline, bikini line, and down her arms, also on face, chin, and eyelids. Rash starting to appear on the top of her feet) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 025L20A and 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced PRURITUS (She started getting very itchy, started on the base of my scalp, spread to my neck), URTICARIA (Hives type of rash on my scalp and neck) and RASH (Rash on neck and scalp, later spread to torso, waistline, bikini line, and down her arms, also on face, chin, and eyelids. Rash starting to appear on the top of her feet). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (She started getting very itchy, started on the base of my scalp, spread to my neck) and URTICARIA (Hives type of rash on my scalp and neck) outcome was unknown and RASH (Rash on neck and scalp, later spread to torso, waistline, bikini line, and down her arms, also on face, chin, and eyelids. Rash starting to appear on the top of her feet) had not resolved. Concomitant medication list was not provided. It was reported that Zyrtec helped the best but it did not make it go away. It was reported that the patient did not have any reactions to the first two doses in the primary series. Initially the only place the rash had not spread to were the patients legs, but in the last 24 hours it started appearing on the feet. Patient stated that patient may be having an adverse reaction to the Moderna COVID-19 vaccine. Within the last 24 hours, patient  noticed the rash starting to appear on the top of her feet.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She started getting very itchy, started on the base of my scalp, spread to my neck), URTICARIA (Hives type of rash on my scalp and neck) and RASH (Rash on neck and scalp, later spread to torso, waistline, bikini line, and down her arms, also on face, chin, and eyelids. Rash starting to appear on the top of her feet) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 025L20A and 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced PRURITUS (She started getting very itchy, started on the base of my scalp, spread to my neck), URTICARIA (Hives type of rash on my scalp and neck) and RASH (Rash on neck and scalp, later spread to torso, waistline, bikini line, and down her arms, also on face, chin, and eyelids. Rash starting to appear on the top of her feet). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (She started getting very itchy, started on the base of my scalp, spread to my neck) and URTICARIA (Hives type of rash on my scalp and neck) outcome was unknown and RASH (Rash on neck and scalp, later spread to torso, waistline, bikini line, and down her arms, also on face, chin, and eyelids. Rash starting to appear on the top of her feet) had not resolved. Concomitant medication list was not provided. It was reported that Zyrtec helped the best but it did not make it go away. It was reported that the patient did not have any reactions to the first two doses in the primary series. Initially the only place the rash had not spread to were the patients legs, but in the last 24 hours it started appearing on the feet. Patient stated that patient may be having an adverse reaction to the Moderna COVID-19 vaccine. Within the last 24 hours, patient  noticed the rash starting to appear on the top of her feet.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electroencephalogram, Magnetic resonance imaging, Tic
Clinical narrative: Full body muscle twitching-can be pain-ful to patient ibuprofen offers some relief. Twitching throughout day and night for past 48 hours (since vaccine given).
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Pain
Clinical narrative: Full body muscle twitching-can be pain-ful to patient ibuprofen offers some relief. Twitching throughout day and night for past 48 hours (since vaccine given).
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Fall, Tremor
Clinical narrative: Mother reports that he received the COVID-19 vaccine on 1/20/22 and reported that about 3 minutes after, he reported feeling dizzy/light-headed.  He then looked like he fell asleep on his chair.  He then slid off the chair to the floor (did not hit his head) had a brief episode of full body shaking that lasted <1 minute.  She said that the nurse/doctor took a BP and it was stated to be low.  Mother reports that when he woke up he was tired, but was responding and acting at his baseline.  He returned to baseline and had no other symptoms.  He was taken to the ED for further evaluation because he felt dizzy again and his head and stomach hurt.  ED did an EKG that was read as normal.  His physical exam at that time had no remarkable findings per chart review.  He was given cookies and drink and he felt better.  His BP improved.  He was discharged to home.  This is the first time he has had a reaction.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Electrocardiogram normal, Fall, Fatigue
Clinical narrative: Mother reports that he received the COVID-19 vaccine on 1/20/22 and reported that about 3 minutes after, he reported feeling dizzy/light-headed.  He then looked like he fell asleep on his chair.  He then slid off the chair to the floor (did not hit his head) had a brief episode of full body shaking that lasted <1 minute.  She said that the nurse/doctor took a BP and it was stated to be low.  Mother reports that when he woke up he was tired, but was responding and acting at his baseline.  He returned to baseline and had no other symptoms.  He was taken to the ED for further evaluation because he felt dizzy again and his head and stomach hurt.  ED did an EKG that was read as normal.  His physical exam at that time had no remarkable findings per chart review.  He was given cookies and drink and he felt better.  His BP improved.  He was discharged to home.  This is the first time he has had a reaction.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypotension, Tremor
Clinical narrative: Mother reports that he received the COVID-19 vaccine on 1/20/22 and reported that about 3 minutes after, he reported feeling dizzy/light-headed.  He then looked like he fell asleep on his chair.  He then slid off the chair to the floor (did not hit his head) had a brief episode of full body shaking that lasted <1 minute.  She said that the nurse/doctor took a BP and it was stated to be low.  Mother reports that when he woke up he was tired, but was responding and acting at his baseline.  He returned to baseline and had no other symptoms.  He was taken to the ED for further evaluation because he felt dizzy again and his head and stomach hurt.  ED did an EKG that was read as normal.  His physical exam at that time had no remarkable findings per chart review.  He was given cookies and drink and he felt better.  His BP improved.  He was discharged to home.  This is the first time he has had a reaction.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Booster (0.25ml) given to 15 yo female.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Aphasia, Blood test, Electroencephalogram
Clinical narrative: Expressive aphasias
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Injection site pain, Myalgia, Vascular pain
Clinical narrative: Injection site pain on left arm, Pain near the left armpit, Muscle pain, Joint pain, Feeling like pain inside veins
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Injection site pain, Myalgia, Nasal congestion
Clinical narrative: Injection site pain Nausea headache vomiting fever muscle aches weakness stuffiness all at 9 AM January 13, 2022 Took nighttime cold and flu medicine over the counter and sleep Most of the symptoms were gone by January 14, 2022 injection site pain remained for over a week
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Injection site pain Nausea headache vomiting fever muscle aches weakness stuffiness all at 9 AM January 13, 2022 Took nighttime cold and flu medicine over the counter and sleep Most of the symptoms were gone by January 14, 2022 injection site pain remained for over a week
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia, Sleep disorder
Clinical narrative: Could not sleep on back as shoulder would go to sleep and tingling would creep down my arm to the elbow. Had to sleep on my side. Shoulder would also go to sleep when doing things such as driving. 2 months later shoulder became sore. 4 months later shoulder and arm still goes to sleep, but is much better. Soreness has gone away. I was a perfectly healthy and sports active individual prior to taking the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Skin irritation, Urticaria
Clinical narrative: My skin started to get itchy a few days ago (about the 18th of January) and I initially thought it was winter dry skin,  but lotion wasn?t helping. It began to get worse and pop up in new places with bumps. I thought perhaps it was dust mites or bug bites. I checked all our upholstery and double-washed all the bedding but that didn?t stop new itchy spots from surfacing. By day 2 (January 19th) the spots were redder and more bumpy [possibly from scratching]. I happened to talk to a friend who was having the same thing; but we have not been any of the same places for months - partially because my family is so isolated for Covid prevention. She was prescribed steroids and told to take allergy medicine. Due to my childcare situation I was not free to go see a doctor but tried taking an over the counter allergy medicine which helped somewhat. She and I continued to text and found we both had our boosters the same day; which made me think this would be appropriate to report to vaers. My hives/rash does not seem to be as severe and irritating as hers so far. It seems like a few itchy spots will pop up and be irritating for a while, then they subside and a new place gets irritated and itchy. But it is still very irritating. At one point my scalp was so itchy I could not think about anything else.  OTC generic Zyrtec and wearing loose clothing seems to help.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Chest X-ray, Computerised tomogram neck, Computerised tomogram normal, Dysmenorrhoea
Clinical narrative: Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hyperhidrosis, Influenza like illness, Laboratory test, Lymph node pain
Clinical narrative: Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphoedema, Menstruation irregular, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw, Paraesthesia, Poor quality sleep, Pyrexia
Clinical narrative: Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, Scan with contrast, Swelling, Toothache, Weight increased
Clinical narrative: Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Urticaria chronic
Clinical narrative: Chronic spontaneous urticaria all over body.  Have never had an allergic reaction to anything, now am covered in itchy wheals and hives.  Have been on steroids and antihistamines
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Gait disturbance, Injection site inflammation, Pain, Peripheral swelling
Clinical narrative: Started with inflammation at the dose site, then itchiness in sensitive areas around the body. Started developing into hives over the next few days, then inflammation with feet and hands to the point where shoes couldn't fit and it was painful to walk due to sensitive inflammation areas. Red hives began to form and burn. Went away the next day after this episode.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Started with inflammation at the dose site, then itchiness in sensitive areas around the body. Started developing into hives over the next few days, then inflammation with feet and hands to the point where shoes couldn't fit and it was painful to walk due to sensitive inflammation areas. Red hives began to form and burn. Went away the next day after this episode.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: A couple of hours following the vaccination I felt general myalgias, headache, nausea, sinus pressure, and general malaise. These flu-like symptoms persisted all the following day. On 16Jan2022 many of the myalgias went away but the headache persisted, and most of all I experienced a sharp pain in my eyes and forehead/brow area any time I moved my eyes. This continues the next several days and at the time I?m writing this continues to be uncomfortable. A week after my vaccine my complaints are fatigue, random onset of nausea intermittent throughout day, headache, and eye pain.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: A couple of hours following the vaccination I felt general myalgias, headache, nausea, sinus pressure, and general malaise. These flu-like symptoms persisted all the following day. On 16Jan2022 many of the myalgias went away but the headache persisted, and most of all I experienced a sharp pain in my eyes and forehead/brow area any time I moved my eyes. This continues the next several days and at the time I?m writing this continues to be uncomfortable. A week after my vaccine my complaints are fatigue, random onset of nausea intermittent throughout day, headache, and eye pain.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast mass, Diagnostic procedure, Mammogram abnormal, Plasma cell mastitis
Clinical narrative: right breast lump that has now been diagnosed as idiopathic granulomatous mastitis
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast abnormal
Clinical narrative: right breast lump that has now been diagnosed as idiopathic granulomatous mastitis
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensitive skin, Urticaria
Clinical narrative: Hives, itching, sensitive skin, ~12 days after booster. Used topical anti-itch cream
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delivery, Exposure during pregnancy, Pain, Pyrexia
Clinical narrative: At 34 weeks pregnant, I received my second Moderna vaccination.  I was hesitant to get vaccinated due to not having enough research on vaccine during pregnancy.  I finally decided to vaccinate out of fear from doctor and  variant spread.  My pregnancy was otherwise healthy.  I had a previous pregnancy that resulted in a healthy full term baby with no complications.  I was diagnosed with gestational diabetes about a month prior to second vaccination.  I was managing my blood sugar with diet and I did not require any additional medications.  I exercised daily and maintained a healthy pregnancy weight. This baby was my only viable embryo conceived through two long years of IVF.  Before she was transferred, she had PGT testing done, and she did not have any chromosomal abnormalities.  My scheduled due date from this IVF pregnancy was 11/27/2021.  On 10/15/21, I received my second Moderna vaccination at 6pm.  On 10/16/21, I began to experience a low grade fever around 2pm. I took one regular strength Tylenol for fever along with chills and body aches.  I went to sleep at 8pm. I woke up at 10:30pm.  I was experiencing contractions.  My baby was born 10/17/21 at 6:23am through vaginal birth.  She was 5lbs 1oz at birth, and she was taken to and stayed in the ICU for 15 days before coming home.  Her and I were otherwise healthy, besides her needing oxygen for first 24hrs and having feeding issues due to gestational age.  Thank Goodness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine contractions during pregnancy
Clinical narrative: At 34 weeks pregnant, I received my second Moderna vaccination.  I was hesitant to get vaccinated due to not having enough research on vaccine during pregnancy.  I finally decided to vaccinate out of fear from doctor and  variant spread.  My pregnancy was otherwise healthy.  I had a previous pregnancy that resulted in a healthy full term baby with no complications.  I was diagnosed with gestational diabetes about a month prior to second vaccination.  I was managing my blood sugar with diet and I did not require any additional medications.  I exercised daily and maintained a healthy pregnancy weight. This baby was my only viable embryo conceived through two long years of IVF.  Before she was transferred, she had PGT testing done, and she did not have any chromosomal abnormalities.  My scheduled due date from this IVF pregnancy was 11/27/2021.  On 10/15/21, I received my second Moderna vaccination at 6pm.  On 10/16/21, I began to experience a low grade fever around 2pm. I took one regular strength Tylenol for fever along with chills and body aches.  I went to sleep at 8pm. I woke up at 10:30pm.  I was experiencing contractions.  My baby was born 10/17/21 at 6:23am through vaginal birth.  She was 5lbs 1oz at birth, and she was taken to and stayed in the ICU for 15 days before coming home.  Her and I were otherwise healthy, besides her needing oxygen for first 24hrs and having feeding issues due to gestational age.  Thank Goodness.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Thrombosis
Clinical narrative: Nothing serious but I noticed black patches on my right arm. It was probably a subcutaneous clot which went away in about 4 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Scratch, Urticaria
Clinical narrative: Dermatographic urticaria symptoms. Previously no allergies, now everyday I have flair ups of itchy skin. More in the upper body but can be throughout my whole body. Any contact of a foreign object like a purse strap will leave a bright red mark for at least 30-60 minutes. If I scratch myself then it becomes a hive and will remain for 1-2hours on my skin.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; Aches for 2 days; chills for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (Aches for 2 days) and CHILLS (chills for 2 days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic. Concomitant products included METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]), MONTELUKAST, SERTRALINE, LORAZEPAM (ATIVAN) and ZOLPIDEM TARTRATE (ZOLPIDEM [ZOLPIDEM TARTRATE]) for an unknown indication.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (Aches for 2 days) and CHILLS (chills for 2 days). In April 2021, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (Aches for 2 days) and CHILLS (chills for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.   This case was linked to MOD-2022-455481, MOD-2022-455496 (Patient Link).