chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Cicada sounding/Hiss Noise on 4/15,4/16 then a pause and back on 4/19
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives, itching across right torso
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Moderate to severe menstrual cramps (outside of cycle)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Contracted hissing sound around same time of my wife VAERS #458377 on 4/15 4/16 but went away for now,.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Extreme upper arm pain extending into armpit and left breast areas, chills, headache, body aches
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: injection received 10:45am on Friday 4/16 and noticed red rash on upper left arm but below injection site around 7am Monday 4/19;   slightly swollen arm, warm and tender to touch.  occurred 3 days after injection.  as suggested taking tylenol for discomfort.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Vomiting
Clinical narrative: VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Feeling cold, Hypoaesthesia
Clinical narrative: VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Migraine, Productive cough
Clinical narrative: VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Large red circle at injection site. Sore to the touch and warm. Slightly itchy.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac sarcoidosis, Condition aggravated, Lymphadenopathy
Clinical narrative: I came off my immuno suppressant for two weeks after taking the shot to try to build up an immune response. After that, I had swollen lymph nodes in my left breast that lasted for one month and a major cardiac sarcoidosis flare that increased in intensity for eight weeks. I have now started prednisone In addition to Micophenolate 1000 mg twice a day to come the flare. One month prior to the shot, I had had a clean PT scan?no flare.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose normal, Dizziness, Nervousness
Clinical narrative: Anxiety, Dizziness, shaky and pale. Sugar level check 64.
Age: 67.0
Sex: M
Vaccine: ANTH
Symptoms: Herpes zoster
Clinical narrative: Shingles in right eye
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: I have had severe diarrhea the past 4 days. Starting Friday morning around 2am, by the time it was 6 am, I have already gone 6 times. I have gone 25 times from Friday am-sat night. It calmed on Sunday and picked up Monday and this morning. I have been following the BRAT diet and have been drinking fluids. It doesn?t make sense why I?m still feeling this way. I also had a fever for three days,  throwing up Friday/Saturday, and have had headaches since Friday.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills and body ache. Tool Advil and then Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FATIGUE; FEVERISH; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Q02A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced body aches, fatigue, and feverish. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fatigue, feverish and body aches was not reported. This report was non-serious.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Oedema peripheral, Pain
Clinical narrative: Patient is a forty-four year-old female with a history of cervical cancer, who presents to the Emergency Department complaining of right shoulder pain beginning after 1st dose of COVID-19 vaccination in same arm on Friday. No fever. Symptoms have been constant. Worse with movement. Feel swelling into axilla.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Eye swelling, Mouth swelling, Nausea, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Mild
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Mild
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Intermentent Stomach pain everyday the day after the 2nd injection throughout the day and sometimes with nausea and, sore arm and a fever of 102.5. All 3 started about 10am on the 16th. The fever and sore arm slowly, completely went away on the 17th in the evening.  My stomach still hurt. It feels like when you really have to have a bowel movement because you haven't had one in weeks. But I've been going to the bathroom and my last stomachache and fever was in my 20s. I've tried tylenol, pepto bismol, hot bath and drinking plenty water.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: The patient felt lightheaded before the vaccine was administered.  After the vaccine the patient continued to feel light headed and had a racing heart.  The issue resolved after 15 minute observation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Severe
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: TWITCHING ON RIGHT LEG IN CALF AREA; FEVER; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced twitching on right leg in calf area. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 09-APR-2021, and had not recovered from twitching on right leg in calf area. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue Body ache Fever 100 Headache
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chiropractic, Gait disturbance, Headache
Clinical narrative: 1-3 days headache 4-18 days painful joints, pain in chest, left side worse - rest, advil day 20 - Vitreous detachment resulting in floaters in left eye. Saw Dr to check for torn retina- none 17-present -  painful left hip/glute, unable to walk/stand without pain - advil, hot/cold, saw chiropractor, exercises, additional treatment
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: 1-3 days headache 4-18 days painful joints, pain in chest, left side worse - rest, advil day 20 - Vitreous detachment resulting in floaters in left eye. Saw Dr to check for torn retina- none 17-present -  painful left hip/glute, unable to walk/stand without pain - advil, hot/cold, saw chiropractor, exercises, additional treatment
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Fall, Magnetic resonance imaging spinal, Thoracic vertebral fracture
Clinical narrative: Pt awoke at 0615 on 4/13/21 to use bathroom and became dizzy and fell, hitting her head and suffering T2,T4 vertebral fracture.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Headache, Hypersensitivity, Hyperventilation
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Headache-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: Patient was given Moderna Covid Vaccine in Right Deltoid at 10:50. About 30 seconds later patient slid down from sitting possition and was shaking uncontrollably and reported difficulty in breathing. Patient was given Epi 0.3mg pen IM in right outer thigh and 911 was called.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Seizure, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Headache-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: Patient was given Moderna Covid Vaccine in Right Deltoid at 10:50. About 30 seconds later patient slid down from sitting possition and was shaking uncontrollably and reported difficulty in breathing. Patient was given Epi 0.3mg pen IM in right outer thigh and 911 was called.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The patient had a syncope episode 2 minutes after administration of the vaccine.  The patient recovered and was released on their own accord.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated, Myopathy, Pain in extremity
Clinical narrative: the day after vaccination, I had a recurrence of severe pain in my left knee (arthritis) and both shins and calves (myopathy).  In the past I have managed my arthritis and myopathy through stretching, exercise and weight management. I had no pain prior to the injection for many many months. I could not exercise for several weeks because of the pain. Given the severity of the pain and the fact I had not experienced it for several months prior to the injection, I strongly believe the reaction was caused by the vaccine (Pfizer).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Nausea, Tachycardia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Fatigue-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Severe
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: DIARRHEA; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, diarrhea and fatigue was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Hypoaesthesia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient stayed for 1.5 hours post vaccination. symptoms resolved well enough for her to feel confident to leave. denied receiving paramedics help
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoacusis, Nausea, Tinnitus
Clinical narrative: Mild tinnitus SEVERE vertigo (leading to a trip to Urgent Care  where they prescribed meclizine and home Epley maneuvers, diagnosis of BPPV).  Nausea  Muffled hearing in left ear  As days progressed- vertigo lessened, no just constant but slight dizziness and fogginess. Muffled hearing persists.  Some relief was found with osteopathic manipulations of the neck. Began taking vitamin D, vitamin B complex, zinc, vitamin C, and magnesium.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vertigo positional
Clinical narrative: Mild tinnitus SEVERE vertigo (leading to a trip to Urgent Care  where they prescribed meclizine and home Epley maneuvers, diagnosis of BPPV).  Nausea  Muffled hearing in left ear  As days progressed- vertigo lessened, no just constant but slight dizziness and fogginess. Muffled hearing persists.  Some relief was found with osteopathic manipulations of the neck. Began taking vitamin D, vitamin B complex, zinc, vitamin C, and magnesium.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE LUMP; INJECTION SITE WARMTH; ACHINESS; INJECTION SITE PAIN; INJECTION SITE SWELLING; INJECTION SITE REDNESS; FATIGUE; SWOLLEN LYMPH NODES; This spontaneous report received from a consumer concerned a 39 year old female. The patient's weight was 138 pounds, and height was 156 centimeters. The patient's concurrent conditions included alcohol user, non smoker, and allergy to dog and cat fur, and other pre-existing medical conditions included the patient had no history of illicit drug use/abuse. The patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced swollen lymph nodes. On 11-APR-2021, the subject experienced injection site lump. On 11-APR-2021, the subject experienced injection site warmth. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced injection site swelling. On 11-APR-2021, the subject experienced injection site redness. On 11-APR-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 3/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and fatigue on 11-APR-2021, had not recovered from injection site lump, injection site pain, injection site swelling, injection site redness, and injection site warmth, and the outcome of swollen lymph nodes was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Lymphadenopathy, Pain, Pain assessment
Clinical narrative: INJECTION SITE LUMP; INJECTION SITE WARMTH; ACHINESS; INJECTION SITE PAIN; INJECTION SITE SWELLING; INJECTION SITE REDNESS; FATIGUE; SWOLLEN LYMPH NODES; This spontaneous report received from a consumer concerned a 39 year old female. The patient's weight was 138 pounds, and height was 156 centimeters. The patient's concurrent conditions included alcohol user, non smoker, and allergy to dog and cat fur, and other pre-existing medical conditions included the patient had no history of illicit drug use/abuse. The patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced swollen lymph nodes. On 11-APR-2021, the subject experienced injection site lump. On 11-APR-2021, the subject experienced injection site warmth. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced injection site swelling. On 11-APR-2021, the subject experienced injection site redness. On 11-APR-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 3/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and fatigue on 11-APR-2021, had not recovered from injection site lump, injection site pain, injection site swelling, injection site redness, and injection site warmth, and the outcome of swollen lymph nodes was not reported. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Nervousness
Clinical narrative: SHAKY FEELING; SCARED; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, penicillin allergy, allergic to dairy products, perfume allergy, dust allergy, pollen allergy, mold allergy, allergy to cats, peanuts allergy / cashews allergy, and live vaccines allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had a history of unknown cold medicine caused her to go to the hospital and get a shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced scared. On 13-APR-2021, the subject experienced shaky feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaky feeling, and the outcome of scared was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site nodule, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: BIG KNOT LIKE BUG BITE OR A BEE STING ON ARM AROUND THE INJECTION SITE; HOT SKIN AROUND THE INJECTION SITE; SLIGHTLY ITCHY AROUND THE INJECTION SITE; HARD SKIN ON ARM/TOUGH SKIN ON ARM; SORE ARM AROUND THE INJECTION SITE; SWELLING AROUND THE INJECTION SITE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clots. The patient was previously treated with warfarin for blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced big knot like bug bite or a bee sting on arm around the injection site. On 09-APR-2021, the subject experienced hot skin around the injection site. On 09-APR-2021, the subject experienced slightly itchy around the injection site. On 09-APR-2021, the subject experienced hard skin on arm/tough skin on arm. On 09-APR-2021, the subject experienced sore arm around the injection site. On 09-APR-2021, the subject experienced swelling around the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm around the injection site on APR-2021, was recovering from big knot like bug bite or a bee sting on arm around the injection site, swelling around the injection site, hot skin around the injection site, and slightly itchy around the injection site, and the outcome of hard skin on arm/tough skin on arm was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin induration
Clinical narrative: BIG KNOT LIKE BUG BITE OR A BEE STING ON ARM AROUND THE INJECTION SITE; HOT SKIN AROUND THE INJECTION SITE; SLIGHTLY ITCHY AROUND THE INJECTION SITE; HARD SKIN ON ARM/TOUGH SKIN ON ARM; SORE ARM AROUND THE INJECTION SITE; SWELLING AROUND THE INJECTION SITE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clots. The patient was previously treated with warfarin for blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced big knot like bug bite or a bee sting on arm around the injection site. On 09-APR-2021, the subject experienced hot skin around the injection site. On 09-APR-2021, the subject experienced slightly itchy around the injection site. On 09-APR-2021, the subject experienced hard skin on arm/tough skin on arm. On 09-APR-2021, the subject experienced sore arm around the injection site. On 09-APR-2021, the subject experienced swelling around the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm around the injection site on APR-2021, was recovering from big knot like bug bite or a bee sting on arm around the injection site, swelling around the injection site, hot skin around the injection site, and slightly itchy around the injection site, and the outcome of hard skin on arm/tough skin on arm was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Injection site pain
Clinical narrative: COUGH; CHEST HEAVINESS; VACCINE HURT GOING IN; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's past medical history included allergy shots, and concurrent conditions included bronchitis in oak and cedar season, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for allergy. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced chest heaviness. On 08-APR-2021, the subject experienced vaccine hurt going in. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, had not recovered from chest heaviness, and the outcome of vaccine hurt going in was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWELLING ON BOTH LEGS AND THIGHS; This spontaneous report received from a pharmacist concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling on both legs and thighs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling on both legs and thighs. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Hyperhidrosis, Muscle spasms, Therapeutic response unexpected
Clinical narrative: MUSCLE SPASMS; UNCONTROLLABLE SHAKING; HOT FLASHES; SWEATY; DISAPPEARANCE OF PREVIOUS TINNITUS; CHILLS; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle spasms. On 10-APR-2021, the subject experienced uncontrollable shaking. On 10-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced disappearance of previous tinnitus. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms on 10-APR-2021, and uncontrollable shaking, hot flashes, and sweaty on 11-APR-2021, had not recovered from disappearance of previous tinnitus, and the outcome of chills was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: MUSCLE SPASMS; UNCONTROLLABLE SHAKING; HOT FLASHES; SWEATY; DISAPPEARANCE OF PREVIOUS TINNITUS; CHILLS; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle spasms. On 10-APR-2021, the subject experienced uncontrollable shaking. On 10-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced disappearance of previous tinnitus. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms on 10-APR-2021, and uncontrollable shaking, hot flashes, and sweaty on 11-APR-2021, had not recovered from disappearance of previous tinnitus, and the outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Peripheral swelling, Pruritus, Rash
Clinical narrative: ITCHING/ FEET ITCHING; BURNING OF THROAT; RIGHT ARM SWELLING/ FEET SWELLING; FEET BURNING; RASH; LOW GRADE HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known medications. The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced itching/ feet itching. On 09-APR-2021, the subject experienced burning of throat. On 09-APR-2021, the subject experienced right arm swelling/ feet swelling. On 09-APR-2021, the subject experienced feet burning. On 09-APR-2021, the subject experienced rash. On 09-APR-2021, the subject experienced low grade headache. Treatment medications (dates unspecified) included: paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching/ feet itching, burning of throat, right arm swelling/ feet swelling, low grade headache, and feet burning. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: ITCHING/ FEET ITCHING; BURNING OF THROAT; RIGHT ARM SWELLING/ FEET SWELLING; FEET BURNING; RASH; LOW GRADE HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known medications. The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced itching/ feet itching. On 09-APR-2021, the subject experienced burning of throat. On 09-APR-2021, the subject experienced right arm swelling/ feet swelling. On 09-APR-2021, the subject experienced feet burning. On 09-APR-2021, the subject experienced rash. On 09-APR-2021, the subject experienced low grade headache. Treatment medications (dates unspecified) included: paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching/ feet itching, burning of throat, right arm swelling/ feet swelling, low grade headache, and feet burning. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: CHILLS; SEVERE HEADACHE; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 26-MAY-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced low grade fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99 F. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low grade fever, severe headache and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ecchymosis
Clinical narrative: BLACK AND BLUE MARKS ON BOTTOM AND DOWN OF ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced black and blue marks on bottom and down of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of black and blue marks on bottom and down of arm was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dialysis, Headache, Nausea, Retching, Vomiting
Clinical narrative: VOMITING; DRY HEAVES; BAD HEADACHE; NAUSEOUS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma, raynaud's disease, osteoporosis, arthritis, and end-stage kidney failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09/JUN/2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced vomiting. On 29-MAR-2021, the subject experienced dry heaves. On 29-MAR-2021, the subject experienced bad headache. On 29-MAR-2021, the subject experienced nauseous. Laboratory data (dates unspecified) included: Dialysis (NR: not provided) Not reported. Treatment medications (dates unspecified) included: calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 01-APR-2021, and had not recovered from bad headache, nauseous, and dry heaves. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: RIGHT ARM NUMBNESS/LEFT ARM NUMBNESS/NUMBNESS IN LEFT TOES; SWEATS; PRESSURE IN HEAD; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced pressure in head. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced sweats. On 14-APR-2021, the subject experienced right arm numbness/left arm numbness/numbness in left toes.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweats, right arm numbness/left arm numbness/numbness in left toes, pressure in head, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: BRUISE AT SITE OF INJECTION; WHOLE ARM ACHES/SHARP PAIN IN ARM/ARM ACHES ALL THE TIME; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced bruise at site of injection. On 03-APR-2021, the subject experienced whole arm aches/sharp pain in arm/arm aches all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole arm aches/sharp pain in arm/arm aches all the time, and bruise at site of injection. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Diarrhoea, Epistaxis
Clinical narrative: DECREASED BLOOD PRESSURE; WATERY VOMITING; NOSE BLEED; BODY IS WEAK; SLIGHT HEADACHE; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 07-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced watery vomiting. On 12-APR-2021, the subject experienced nose bleed. On 12-APR-2021, the subject experienced body is weak. On 12-APR-2021, the subject experienced slight headache. On 12-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced decreased blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 98/89, 144/84. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, watery vomiting, and nose bleed, and decreased blood pressure on 13-APR-2021, and had not recovered from slight headache, body is weak, and tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: DECREASED BLOOD PRESSURE; WATERY VOMITING; NOSE BLEED; BODY IS WEAK; SLIGHT HEADACHE; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 07-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced watery vomiting. On 12-APR-2021, the subject experienced nose bleed. On 12-APR-2021, the subject experienced body is weak. On 12-APR-2021, the subject experienced slight headache. On 12-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced decreased blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 98/89, 144/84. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, watery vomiting, and nose bleed, and decreased blood pressure on 13-APR-2021, and had not recovered from slight headache, body is weak, and tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pain, Pyrexia
Clinical narrative: BODY ACHES; UNWELL; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch: unknown) dose was not reported, administered on 01-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 01-APR-2021, the patient experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 01-APR-2021, the patient experienced fever. On 01-APR-2021 21:00, the patient experienced body aches. On 01-APR-2021 21:00, the patient experienced unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, unwell, fever, and severe headache on 03-APR-2021. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nasopharyngitis
Clinical narrative: DIARRHEA; CHILLS; COLD; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included itp (low platelet condition), and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206421A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, diarrhea, and chills on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210427033.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: HEAVY NOSE BLEEDING; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced heavy nose bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy nose bleeding on 20-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Appetite disorder, Feeling abnormal, Feeling hot, Influenza
Clinical narrative: BAD FLU SYMPTOMS; VOMITING; FEELING STRANGE/JUST WEIRD FEELINGS IN HANDS; FEELING ANXIOUS; FEELING A LITTLE HYPER; INSOMNIA; APPETITE CHANGE; BODY FEELS LIKE ITS STARTING  TO HEAT UP AGAIN; NERVOUS FEELING; ILL FEELING/FEELING SICKER; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bad flu symptoms. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced feeling strange/just weird feelings in hands. On APR-2021, the subject experienced feeling anxious. On APR-2021, the subject experienced feeling a little hyper. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced appetite change. On APR-2021, the subject experienced body feels like its starting to heat up again. On APR-2021, the subject experienced nervous feeling. On APR-2021, the subject experienced ill feeling/feeling sicker. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad flu symptoms, vomiting, feeling strange/just weird feelings in hands, feeling anxious, feeling a little hyper, insomnia, appetite change, ill feeling/feeling sicker, nervous feeling, nausea, fever, and body feels like its starting to heat up again. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Nausea, Nervousness, Psychomotor hyperactivity
Clinical narrative: BAD FLU SYMPTOMS; VOMITING; FEELING STRANGE/JUST WEIRD FEELINGS IN HANDS; FEELING ANXIOUS; FEELING A LITTLE HYPER; INSOMNIA; APPETITE CHANGE; BODY FEELS LIKE ITS STARTING  TO HEAT UP AGAIN; NERVOUS FEELING; ILL FEELING/FEELING SICKER; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bad flu symptoms. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced feeling strange/just weird feelings in hands. On APR-2021, the subject experienced feeling anxious. On APR-2021, the subject experienced feeling a little hyper. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced appetite change. On APR-2021, the subject experienced body feels like its starting to heat up again. On APR-2021, the subject experienced nervous feeling. On APR-2021, the subject experienced ill feeling/feeling sicker. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad flu symptoms, vomiting, feeling strange/just weird feelings in hands, feeling anxious, feeling a little hyper, insomnia, appetite change, ill feeling/feeling sicker, nervous feeling, nausea, fever, and body feels like its starting to heat up again. This report was non-serious.