chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Insomnia, Pain
Clinical narrative: MILD BODY ACHES- BACK; LOW GRADE FEVER; HEADACHE; FATIGUE; TROUBLE SLEEPING; FEELING VERY UNCOMFORTABLE; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: Physical examination (NR: not provided) Cleared. On 11-MAR-2021, the subject experienced trouble sleeping. On 11-MAR-2021, the subject experienced feeling very uncomfortable. Laboratory data included: Low grade fever (NR: not provided) 99.2-99.9 F. On 11-MAR-2021 08:00, the subject experienced mild body aches- back. On 11-MAR-2021 08:00, the subject experienced low grade fever. On 11-MAR-2021 08:00, the subject experienced headache. On 11-MAR-2021 08:00, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, mild body aches- back, headache, fatigue, trouble sleeping, and feeling very uncomfortable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Pyrexia
Clinical narrative: MILD BODY ACHES- BACK; LOW GRADE FEVER; HEADACHE; FATIGUE; TROUBLE SLEEPING; FEELING VERY UNCOMFORTABLE; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: Physical examination (NR: not provided) Cleared. On 11-MAR-2021, the subject experienced trouble sleeping. On 11-MAR-2021, the subject experienced feeling very uncomfortable. Laboratory data included: Low grade fever (NR: not provided) 99.2-99.9 F. On 11-MAR-2021 08:00, the subject experienced mild body aches- back. On 11-MAR-2021 08:00, the subject experienced low grade fever. On 11-MAR-2021 08:00, the subject experienced headache. On 11-MAR-2021 08:00, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, mild body aches- back, headache, fatigue, trouble sleeping, and feeling very uncomfortable. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 14:15, the subject experienced tingling legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling legs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: FEVER; ACHY; RUNNY NOSE; This spontaneous report received from a patient concerned a patient of unspecified age and 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: Unk) dose was not reported, administered on 08-MAR-2021 04:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced runny nose. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of achy and runny nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PARTIAL DOSE; 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 10-MAR-2021 for prophylactic vaccination Batch number was not reported has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. The batch number was not reported and has been requested.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN IN ELBOWS; PAIN IN KNEES; This spontaneous report received from a patient 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 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 hand pain, and knee pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hand pain, and knee pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Flushing, Headache
Clinical narrative: FAST HEART BEAT; FEVER; NAUSEA; CHILLS; HEADACHE; RIGHT SIDED CHEST PAIN; FLUSHED FACE; This spontaneous report received from a patient concerned a male. 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: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flushed face. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg, and Heart rate increased (NR: not provided) 100 bpm. On 11-MAR-2021 01:30:00, the subject experienced right sided chest pain. On 11-MAR-2021 01:30:00, the subject experienced chills. On 11-MAR-2021 01:30:00, the subject experienced headache. On 11-MAR-2021 02:00:00, the subject experienced nausea. On 11-MAR-2021 05:00:00, the subject experienced fever. On 11-MAR-2021 05:30:00, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face on 10-MAR-2021, chills on 11-MAR-2021 02:00:00, nausea on 11-MAR-2021, and fever on 11-MAR-2021 05:30:00, had not recovered from headache, and the outcome of right sided chest pain and fast heart beat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pyrexia
Clinical narrative: FAST HEART BEAT; FEVER; NAUSEA; CHILLS; HEADACHE; RIGHT SIDED CHEST PAIN; FLUSHED FACE; This spontaneous report received from a patient concerned a male. 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: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flushed face. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg, and Heart rate increased (NR: not provided) 100 bpm. On 11-MAR-2021 01:30:00, the subject experienced right sided chest pain. On 11-MAR-2021 01:30:00, the subject experienced chills. On 11-MAR-2021 01:30:00, the subject experienced headache. On 11-MAR-2021 02:00:00, the subject experienced nausea. On 11-MAR-2021 05:00:00, the subject experienced fever. On 11-MAR-2021 05:30:00, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face on 10-MAR-2021, chills on 11-MAR-2021 02:00:00, nausea on 11-MAR-2021, and fever on 11-MAR-2021 05:30:00, had not recovered from headache, and the outcome of right sided chest pain and fast heart beat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: 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, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 11-MAR-2021, the subject experienced migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine headache. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and migraine headache as not related. This report was non-serious.  Version created to amend previously reported information on 11-MAR-2021. Upon review, following information was amended: The reporter causality has been updated from possible to non related and updated same in narrative.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Palpitations
Clinical narrative: HEART POUNDING; CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pre-diabetic, and hbp, and concurrent conditions included seasonal allergy, and other pre-existing medical conditions included high blood pressure under control, medicated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced heart pounding. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding, and chills on 11-MAR-2021, and was recovering from pain in arm. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE VERY SORE; This spontaneous report received from a patient concerned a 43 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: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site very sore.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site very sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: FATIGUE; PAIN IN INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-hypertension, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018) dose was not reported, 1 total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced pain in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and pain in injection site. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: The next day after the shot, I started to feel light headed, dizzy and I also started getting a headache too. This happened around 10:00 AM.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: DAY AFTER, RED, HOT, PAIN, SWELLING. A FEW DAYS LATER PAIN WENT AWAY THEN BECAME ITCHY. THE FOLLOW DAY THE REDDNESS GOT LARGER. IT IS NOW LARGER THAN IT WAS EVER BEFORE.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Heart rate, Nausea, Palpitations
Clinical narrative: HEART RACING; FEVER; NAUSEA; HEADACHE; UNCONTROLLABLE SHAKING; UNABLE TO EAT ALL DAY; This spontaneous report received from a patient concerned female of unspecified age.. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805012, and batch number: 1805012 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:40 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced unable to eat all day. On 10-MAR-2021, the subject experienced uncontrollable shaking. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 100 laying down and sitting down in the 90s, normally in the 50s. On 10-MAR-2021 23:00, the subject experienced heart racing. On 10-MAR-2021 23:00, the subject experienced fever. On 10-MAR-2021 23:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking on 11-MAR-2021, and fever on MAR-2021, was recovering from headache, and nausea, had not recovered from heart racing, and the outcome of unable to eat all day was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review the following information was amended: Latest received date (ICH) was corrected.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed as Non-serious. .
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: HEART RACING; FEVER; NAUSEA; HEADACHE; UNCONTROLLABLE SHAKING; UNABLE TO EAT ALL DAY; This spontaneous report received from a patient concerned female of unspecified age.. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805012, and batch number: 1805012 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:40 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced unable to eat all day. On 10-MAR-2021, the subject experienced uncontrollable shaking. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 100 laying down and sitting down in the 90s, normally in the 50s. On 10-MAR-2021 23:00, the subject experienced heart racing. On 10-MAR-2021 23:00, the subject experienced fever. On 10-MAR-2021 23:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking on 11-MAR-2021, and fever on MAR-2021, was recovering from headache, and nausea, had not recovered from heart racing, and the outcome of unable to eat all day was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review the following information was amended: Latest received date (ICH) was corrected.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed as Non-serious. .
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Colonoscopy, Culture stool, Diarrhoea haemorrhagic
Clinical narrative: Severe abdominal pain with bloody diarrhea, vomiting, chills for 14 hours
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Intestinal ischaemia, Vomiting
Clinical narrative: Severe abdominal pain with bloody diarrhea, vomiting, chills for 14 hours
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Myalgia, Suicidal ideation
Clinical narrative: About 24 hours after vaccination, I began feeling very fatigued and over time began having severe upper back muscle aching and pain. The next day the pain was gone but felt an overwhelming feeling of severe depression, hopelessness, thoughts of not wanting to live and crying that lasted 48 hours. It resolved on its own but was terrifying and was something I have never felt before.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Laboratory test, Pain, Pyrexia
Clinical narrative: Chills and body pain started evening of 30th with fever up to 102.5 and headaches. Body pain went away afterctwo days and only chills down to 89 (min.) deg. F and fevers up to 104 (max.)  for next 17 days. Average low temp 95 DEG. F, average high 103 deg. F. Minor fevers and chills followed for 5 more days.  Fevers always had headache. Dr. prescribed steroids and ZPak on 15th of April. Took Tylenol and ibuprofen alternate with naproxin.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Chills and body pain started evening of 30th with fever up to 102.5 and headaches. Body pain went away afterctwo days and only chills down to 89 (min.) deg. F and fevers up to 104 (max.)  for next 17 days. Average low temp 95 DEG. F, average high 103 deg. F. Minor fevers and chills followed for 5 more days.  Fevers always had headache. Dr. prescribed steroids and ZPak on 15th of April. Took Tylenol and ibuprofen alternate with naproxin.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt lightheaded/dizzy and fainted after receiving first vaccine dose. Paramedics were called and all vitals were stable. Patient stated she did not eat prior to receiving her vaccine and has a needle phobia, where she tends to pass out after recieving an injection. Patient was given fluids and a snack to eat. She was further monitored for another half hour before leaving the store.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mother was found deceased in her home two days after receiving the first dose of Pfizer vaccine of unknown causes.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: DIARRHOEA; SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and 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: unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhoea. On MAR-2021, the subject experienced soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhoea and soreness at the injection site was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Epinephrine, Pharyngeal paraesthesia
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient said about 5 minutes into the shot that her throat was tingling and soon after that she said that her tongue was swelling up in her throat. I noticed that she had trouble speaking. She took some benadryl and said he was feeling worse and asked me to give her the Epi-Pen and her speaking was getting worse. After the Epi-Pen her speaking got better and I called for emergency personnal.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient said about 5 minutes into the shot that her throat was tingling and soon after that she said that her tongue was swelling up in her throat. I noticed that she had trouble speaking. She took some benadryl and said he was feeling worse and asked me to give her the Epi-Pen and her speaking was getting worse. After the Epi-Pen her speaking got better and I called for emergency personnal.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: Tinnitus bilateral
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia, Wrong technique in product usage process
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Peripheral coldness, Pyrexia
Clinical narrative: Chills, low grade fever, legs felt like Jell-O, and ties were very cold.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia, Nausea, Tremor, Visual impairment
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Balance disorder, Cardiac function test, Chest X-ray, Computerised tomogram head
Clinical narrative: On 4/17/2021 I got extreme dizziness and could not walk because I was so unsteady and the room was spinning.  Also tinnitus, nausea tired.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Differential white blood cell count, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: On 4/17/2021 I got extreme dizziness and could not walk because I was so unsteady and the room was spinning.  Also tinnitus, nausea tired.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Metabolic function test, Tinnitus, Ultrasound Doppler
Clinical narrative: On 4/17/2021 I got extreme dizziness and could not walk because I was so unsteady and the room was spinning.  Also tinnitus, nausea tired.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vertigo
Clinical narrative: On 4/17/2021 I got extreme dizziness and could not walk because I was so unsteady and the room was spinning.  Also tinnitus, nausea tired.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Pain, Vision blurred
Clinical narrative: Migraine headache started at 8PM  on 04/22/2021. Intensity increased over next 26 hours. Took 2 Tylenol at 10PM on 04/23/2021.  Headache resolved by 6AM on 4/24/2021. Body aches started at 10PM on 4/22/2021 and continued through 6 AM on 04/24/2021. Blurred vision started at 1PM on 4/23/2021 and resolved by 6AM on 04/24/2021. Mild nausea started at 8PM on 4/22/2021 and resolved by 6AM on 4/24/2021.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Mild, Additional Details: numbess and tingling of the right arm
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Nausea, Paraesthesia, Syncope
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Mild, Additional Details: numbess and tingling of the right arm
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Mild, Additional Details: numbess and tingling of the right arm
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Hypoaesthesia, Magnetic resonance imaging neck, Magnetic resonance imaging thoracic, Neuropathy peripheral
Clinical narrative: neuropathy; tingling, pins and needles below waist and in right hand.;numbness in right foot. Appeared to re-activate long-dormant condition.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: neuropathy; tingling, pins and needles below waist and in right hand.;numbness in right foot. Appeared to re-activate long-dormant condition.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flushing, Hypoaesthesia oral, Injection site nodule
Clinical narrative: SEVERE STOMACH CRAMPS/SHARP PAIN; SEVERE FLUSHING ON EAR, FACE AND CHEST; HIVES; SCRATCHY THROAT; SWELLING ON GROIN AREA; NODULES ON INJECTION SITE; NUMB TONGUE; BUMPS AND RASH ALL OVER HER BODY; DIARRHEA; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast-cell activation syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 10-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAR-2021 30 min after vaccination the patient experienced severe stomach cramps/sharp pain. On 10-MAR-2021, 4 hours after vaccination the subject experienced multiple symptoms like severe flushing on ear, face, and chest. hives, bumps, and rash all over her body, scratchy throat, diarrhea, swelling on groin area, nodules on injection site and numb tongue. The patient was expecting to have these side effects since she has mast-cell activation syndrome an took Benadryl which seemed to help, and she did not go to emergency room (ER). The patient would follow up with her PCP.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps/sharp pain, severe flushing on ear, face and chest, hives, scratchy throat, swelling on groin area, nodules on injection site, bumps and rash all over her body, and diarrhea on 10-MAR-2021, and the outcome of numb tongue was not reported. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Throat irritation, Urticaria
Clinical narrative: SEVERE STOMACH CRAMPS/SHARP PAIN; SEVERE FLUSHING ON EAR, FACE AND CHEST; HIVES; SCRATCHY THROAT; SWELLING ON GROIN AREA; NODULES ON INJECTION SITE; NUMB TONGUE; BUMPS AND RASH ALL OVER HER BODY; DIARRHEA; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast-cell activation syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 10-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAR-2021 30 min after vaccination the patient experienced severe stomach cramps/sharp pain. On 10-MAR-2021, 4 hours after vaccination the subject experienced multiple symptoms like severe flushing on ear, face, and chest. hives, bumps, and rash all over her body, scratchy throat, diarrhea, swelling on groin area, nodules on injection site and numb tongue. The patient was expecting to have these side effects since she has mast-cell activation syndrome an took Benadryl which seemed to help, and she did not go to emergency room (ER). The patient would follow up with her PCP.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps/sharp pain, severe flushing on ear, face and chest, hives, scratchy throat, swelling on groin area, nodules on injection site, bumps and rash all over her body, and diarrhea on 10-MAR-2021, and the outcome of numb tongue was not reported. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea around 1 PM Thursday, April 22 headache 8 AM Friday, April 23.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Tinnitus, Vomiting
Clinical narrative: Fatigue, headache, vomiting, roaring tinnitus. Lasted approximately 24 hours, then all symptoms dissipated.  No after effects have been noticed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: I?m a woman weighing under 120lbs and the entire needle was injected into my arm causing extreme pain.  I told the person giving the injection that it really hurt and the entire needle shouldn?t have been injected.  He replied that two other people said it hurt as well but that?s how the injection needs to be given and that I?m skinny.  According to the CDC then entire needle length should not have been injected given my weight and size.  I also reported this complete to the company directly.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Fibrin D dimer increased, Hyponatraemia, Pain in extremity, Pyrexia
Clinical narrative: acute fever of 102.0 F,  shortness of breath, arm pain and local swelling, required emergency room visit.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: acute fever of 102.0 F,  shortness of breath, arm pain and local swelling, required emergency room visit.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Dizziness, Miosis, Vital signs measurement
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: All vitals were stable; eyes were responsive to light; blood sugar also when checked was stable; we called EMT and they aslo checked her vitals and still everything was within normal limits. She was taken to hospital by ambulance for more observation.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Severe headache, shoulder neck pain, nausea, fatigue  24 hours
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: SIGNIFICANT REACTIONS; This spontaneous report received from a physician concerned a patient of unspecified age and 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced significant reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of significant reactions was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Delayed anaphylaxis
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling and numbness to all four limbs began within 5 minutes of vaccination, after 30 minutes of being monitored of most of the tingling went away except for her feet which she felt warmer then usual.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase normal, Computerised tomogram head, Computerised tomogram normal, Dehydration, Differential white blood cell count
Clinical narrative: Extreme vomiting leading to dehydration requiring 3 L of IV saline; headache; nausea; chills; woozy feeling; all beginning 11 days after shot, leading  to ER visit 14 days after shot.  Still ill 15 days after shot but now have meds for symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Erythrocyte osmotic fragility test, Feeling cold, Full blood count
Clinical narrative: Extreme vomiting leading to dehydration requiring 3 L of IV saline; headache; nausea; chills; woozy feeling; all beginning 11 days after shot, leading  to ER visit 14 days after shot.  Still ill 15 days after shot but now have meds for symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lipase normal, Metabolic function test, Nausea, SARS-CoV-2 test negative
Clinical narrative: Extreme vomiting leading to dehydration requiring 3 L of IV saline; headache; nausea; chills; woozy feeling; all beginning 11 days after shot, leading  to ER visit 14 days after shot.  Still ill 15 days after shot but now have meds for symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal, Venogram normal, Vomiting
Clinical narrative: Extreme vomiting leading to dehydration requiring 3 L of IV saline; headache; nausea; chills; woozy feeling; all beginning 11 days after shot, leading  to ER visit 14 days after shot.  Still ill 15 days after shot but now have meds for symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Motion sickness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Patient reported dizziness and motion like sicknes after 15 minutes of vaccination, patient also reported taking Clonazepam 15 minutes after vaccination. Patient remained monitored at the pharmacy for an additional 15-20 minutes and drank orange juice and felt much better.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Onset of sudden hearing loss left ear
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: Extreme tiredness, headache & loss of appetite
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Noticeable weakness on Thursday 4/22/21 during Pilates workout also pain in the left armpit. Saturday 4/24/21 woke up around 4am with an overall ache in the whole left arm as well as swelling and pain in the upper arm immediately around the injection site.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Glandular swelling and discomfort near right armpit
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Myalgia, Pain of skin
Clinical narrative: FLU SYMPTOMS; SKIN HURT; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072) dose was not reported, administered on 09-MAR-2021 18:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced muscle aches. On an unspecified date, the subject experienced flu symptoms, and skin hurt. The patient recovered from fatigue, and muscle aches, and the outcome of flu symptoms and skin hurt was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Intense itching and arm very red Prior to this from time of shot for 48 hours arm was very painful
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Piloerection, Pruritus, Rash, Rash macular, Throat irritation
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt received IM pfizer 1520 vaccine onset of slight itching to throat without noted swelling 1550 pt turned around in car drove back to cvs received 25 mg benadryl po at 1602 pt monitored in observation area back and neck blotching with goose bumps noted. pt speech remained clear speaking full sentences. Pt blotching to neck and anterior neck improved pt itching improved with second dose of benadryl given at 1620. Pt parents arrived has epipen at home sent with benadryl education done. pcp to cal
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Fatigue, Heart rate increased
Clinical narrative: Day of vaccine arm was extremely sore and felt overall tired as if I was coming down with something. After that was fine until day 10, woke up feeling short of breath and over all not well.  On day 16, began a racing heart. This has continued to current day. 3 ekgs normal, blood work done 4 times all normal, CBC, thyroid, metabolic panel, heart, etc. 3 chest X-rays normal, echocardiogram normal. But still short of breath and occasional racing heart that often wakes me from a deep sleep.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Laboratory test normal, Malaise, Sleep disorder
Clinical narrative: Day of vaccine arm was extremely sore and felt overall tired as if I was coming down with something. After that was fine until day 10, woke up feeling short of breath and over all not well.  On day 16, began a racing heart. This has continued to current day. 3 ekgs normal, blood work done 4 times all normal, CBC, thyroid, metabolic panel, heart, etc. 3 chest X-rays normal, echocardiogram normal. But still short of breath and occasional racing heart that often wakes me from a deep sleep.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram thorax, Dyspnoea, Echocardiogram
Clinical narrative: Day of vaccine arm was extremely sore and felt overall tired as if I was coming down with something. After that was fine until day 10, woke up feeling short of breath and over all not well.  On day 16, began a racing heart. This has continued to current day. 3 ekgs normal, blood work done 4 times all normal, CBC, thyroid, metabolic panel, heart, etc. 3 chest X-rays normal, echocardiogram normal. But still short of breath and occasional racing heart that often wakes me from a deep sleep.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Heart rate, Palpitations, Tachycardia
Clinical narrative: Day of vaccine arm was extremely sore and felt overall tired as if I was coming down with something. After that was fine until day 10, woke up feeling short of breath and over all not well.  On day 16, began a racing heart. This has continued to current day. 3 ekgs normal, blood work done 4 times all normal, CBC, thyroid, metabolic panel, heart, etc. 3 chest X-rays normal, echocardiogram normal. But still short of breath and occasional racing heart that often wakes me from a deep sleep.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Injection site pain, Pyrexia
Clinical narrative: thirst dry mouth fever tired injection site pain
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product dispensing error, Product preparation error
Clinical narrative: Error: Incorrect Reconstitution
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy period started a day after receiving the second covid-19 vaccination shot. I have an IUD and have not had a period other than light spotting for almost 5 years.  This lasted ~48 hours. It was an unexpected side effect. Reporting this after reading some articles on the subject that recommended reporting to VAERS to support in aggregating women?s experiences in case there is more that can be learned about why this happens.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: during post vaccination observation period, patient fell to floor, never lost consciousness, immunizing tech alerted pharmacist on duty, patient was alert but lightheaded while laying on back, we elevated feet using her chair, provided ice pack for head and water bottle for hydration.  Patient remained lying down with feet elevated for about 15 minutes then returned to seated position with ice pack on top of head.  Patient was observed by staff and parent/friend 30 minutes before leaving.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: during post vaccination observation period, patient fell to floor, never lost consciousness, immunizing tech alerted pharmacist on duty, patient was alert but lightheaded while laying on back, we elevated feet using her chair, provided ice pack for head and water bottle for hydration.  Patient remained lying down with feet elevated for about 15 minutes then returned to seated position with ice pack on top of head.  Patient was observed by staff and parent/friend 30 minutes before leaving.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Within  3 days was feeling super tired and then the next day I woke up with the whole left side of my face numb