chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Throat tightness
Clinical narrative: Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs.  April 27- manifestation of rash behind both knees and upper calves.  April 30 swelling and edema in both calves.   May 1- Swelling to left foot. Symmetrical pain in pressure points.  May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2,   May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves.  Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities.  Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Oropharyngeal pain, Rash
Clinical narrative: First symptoms were various lumps on my face and neck, which have not dissipated. The first were by my lips and on my chin, followed by my neck and jawline. As of 2:30 am on 5-8-21, I have a severe sore throat which has not been eased by my usual methods of taking Advil cold & sinus and gargling with hot salt water. As I am reporting the severe sore throat at 3:47 am on 5-8-21, I do not know yet if I will be required to see a doctor. I consulted with my doctor about the skin effects, but she said that there was nothing that could be done for them.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Nausea, Photophobia, Pyrexia, Tremor
Clinical narrative: 2000 Light sensitivity 2200 cold/shakes 2430 nausea  0300 vomiting, fever 102.3
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 2000 Light sensitivity 2200 cold/shakes 2430 nausea  0300 vomiting, fever 102.3
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Migraine, Pain
Clinical narrative: Migraine, chills, body aches, very tired feel, strong body pain all over
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: SWEATING; BODY ACHES; STOMACH ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAY-2021, the subject experienced stomach aches. On 04-MAY-2021 23:00:00, the subject experienced sweating. On 04-MAY-2021 23:00:00, the subject experienced body aches. On 04-MAY-2021 23:00:00, the subject experienced chills. On 04-MAY-2021 23:00:00, the subject experienced headache. On 04-MAY-2021 23:00:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, sweating, fever, body aches, and stomach aches. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SWEATING; BODY ACHES; STOMACH ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAY-2021, the subject experienced stomach aches. On 04-MAY-2021 23:00:00, the subject experienced sweating. On 04-MAY-2021 23:00:00, the subject experienced body aches. On 04-MAY-2021 23:00:00, the subject experienced chills. On 04-MAY-2021 23:00:00, the subject experienced headache. On 04-MAY-2021 23:00:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, sweating, fever, body aches, and stomach aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: SHOULDER BARELY MOVE; SHOULDER PAIN; 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: Unknown) dose, start therapy date were not reported 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 shoulder barely move, and shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and shoulder barely move. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: MILD BACK PAIN; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse or illicit drug usage were found.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced mild back pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild back pain. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 4 decade 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 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced incorrect storage of drug. On 05-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509090.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient concerned multiple patients. 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. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Drug delivery system malfunction, Medication error
Clinical narrative: NEEDLE & SYRINGE MALFUNCTIONED FELL APART AND THE DOSE WAS NOT ADMINISTERED; BUMP ON HER ARM; MEDICATION ERROR; This spontaneous report received from a pharmacist 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: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced needle & syringe malfunctioned fell apart and the dose was not administered. On 05-MAY-2021, the subject experienced bump on her arm. On MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump on her arm, medication error and needle & syringe malfunctioned fell apart and the dose was not administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Vomiting
Clinical narrative: THREW UP 2 TIMES; COULD NOT SIT STRAIGHT DUE TO HORRIBLE BODY PAIN; HORRIBLE HEAD PAIN; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced threw up 2 times, could not sit straight due to horrible body pain, and horrible head pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not sit straight due to horrible body pain, horrible head pain and threw up 2 times was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: TINGLING ON LEFT ARM CHEST; NAUSEA; This spontaneous report received from a patient via a company representative 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tingling on left arm chest, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of tingling on left arm chest was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Injection site pain, Nasopharyngitis
Clinical narrative: BODY WAS REALLY REALLY WARM BUT NOT A FEVER; FELT YUKKY LIKE WAS GETTING A COLD; ARM HURT LIKE CRAP; CHILLS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart condition, chronic obstructive pulmonary disease (copd), pleurisy, osteoporosis, cat dander allergy, and pollen / seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 1-JULY-2021) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced body was really really warm but not a fever. On 05-MAY-2021, the subject experienced felt yukky like was getting a cold. On 05-MAY-2021, the subject experienced arm hurt like crap. On 05-MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body was really really warm but not a fever, felt yukky like was getting a cold, and chills on 06-MAY-2021, and arm hurt like crap on 05-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LIKE TRASH FOR 6 DAYS; This spontaneous report received from a patient via a company representative 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 APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced felt like trash for 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like trash for 6 days on 2021. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Therapeutic response unexpected, Vomiting
Clinical narrative: BODY ACHE; VOMITING 2 1/2 DAYS; UNEXPECTED THERAPEUTIC BENEFIT; HEADACHE; This spontaneous report received from a consumer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included appetite lost, weight lost, and exhausted, and concurrent conditions included anxiety, bad mood, and bad cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced body ache. On 2021, the subject experienced vomiting 2 1/2 days. On 2021, the subject experienced unexpected therapeutic benefit. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, and vomiting 2 1/2 days, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: UNDER AGE PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced under age subject. On 06-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the under age patient and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Feeling abnormal, Weight decreased
Clinical narrative: NO APPETITE; LOOSING WEIGHT; ABDOMINAL PAIN FELT LIKE STARVING; FELT MISERABLE; 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 MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced no appetite. On 2021, the subject experienced loosing weight. On 2021, the subject experienced abdominal pain felt like starving. On 2021, the subject experienced felt miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the no appetite, loosing weight, abdominal pain felt like starving and felt miserable was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: CHILLS; OVERALL WEAKNESS; FEVER; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, overall weakness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and overall weakness was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Renal function test
Clinical narrative: SWELLING ON BOTH  LEGS; RASH ON  INTERIOR LOWER LEGS ALL OVER THE BOTTOM PART; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, renal failure, non alcohol user, non smoker, fish allergy, and sulpha allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, Laboratory data included: Renal function test (NR: not provided) Abnormal. On 06-MAY-2021, the subject experienced swelling on both legs. On 06-MAY-2021, the subject experienced rash on interior lower legs all over the bottom part. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on interior lower legs all over the bottom part, and swelling on both legs. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE DOSE ADMINISTERED AFTER VIAL PUNCTURED FOR MORE THAN 6 HOURS; This spontaneous report received from a pharmacist concerned a 56 year old 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: 042A21A, and expiry: 21/JUN/2021) dose was not reported, administered on 06-MAY-2021 17:40 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vaccine dose administered after vial punctured for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine dose administered after vial punctured for more than 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: DIZZY; BAD FEVER; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy, bad fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad fever, headache and dizzy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Product administration error
Clinical narrative: BLOOD POOLING AT INJECTION SITE; ADMINISTRATIVE ERROR; 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 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAY-2021, the subject experienced blood pooling at injection site. On 06-MAY-2021, the subject experienced administrative error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pooling at injection site, and the outcome of administrative error was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Injection site pain
Clinical narrative: DIZZINESS; PAIN AT THE INJECTION SITE; STOMACH ACHES; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain cancer, and concurrent conditions included seizures, dementia/Alzheimer, and vertigo. 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 29-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included levetiracetam for seizures. On 29-APR-2021, the subject experienced stomach aches. On 29-APR-2021, the subject experienced pain at the injection site. On 06-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches on 29-APR-2021, and pain at the injection site on 30-APR-2021, and had not recovered from dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Laboratory test, Pain in extremity, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: COVID SYMPTOMS/SICK/RUNNY NOSE/BREATHING ISSUE/SORE THROAT; LEG PAIN; CHEST PAIN; CHEST CONGESTION; 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced chest congestion. Laboratory data included: X-ray (NR: not provided) X-ray was good. On 12-APR-2021, the subject experienced leg pain. On 20-APR-2021, the subject experienced covid symptoms/sick/runny nose/breathing issue/sore throat. On 05-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Tested negative for covid test, Lab test (NR: not provided) Tested negative for bronchitis, Tested negative for flu, Tested negative for pneumonia, and Streptococcus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pain, covid symptoms/sick/runny nose/breathing issue/sore throat, chest pain and chest congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test, Suspected COVID-19, X-ray
Clinical narrative: COVID SYMPTOMS/SICK/RUNNY NOSE/BREATHING ISSUE/SORE THROAT; LEG PAIN; CHEST PAIN; CHEST CONGESTION; 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced chest congestion. Laboratory data included: X-ray (NR: not provided) X-ray was good. On 12-APR-2021, the subject experienced leg pain. On 20-APR-2021, the subject experienced covid symptoms/sick/runny nose/breathing issue/sore throat. On 05-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Tested negative for covid test, Lab test (NR: not provided) Tested negative for bronchitis, Tested negative for flu, Tested negative for pneumonia, and Streptococcus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pain, covid symptoms/sick/runny nose/breathing issue/sore throat, chest pain and chest congestion was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Myalgia
Clinical narrative: BLOOD PRESSURE STARTED INCREASING; MUSCLE ACHES IN SHOULDERS, NECK AND LEGS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin, and codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Blood pressure (NR: not provided) 146/87 mmHg. On 01-APR-2021, the subject experienced muscle aches in shoulders, neck and legs. On 15-APR-2021, the subject experienced blood pressure started increasing. On 30-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 165/96 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/80 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches in shoulders, neck and legs on 22-APR-2021, and had not recovered from blood pressure started increasing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED AN OPENED VIAL 6 HRS PAST ITS INITIAL PUNCTURE; MULTIDOSE WAS ADMINISTERED; OPENED VIAL WAS LEFT IN THE FRIDGE AT 41F FOR OVER 6 HRS; This spontaneous report received from a pharmacist concerned a 21 year old 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: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced administered an opened vial 6 hrs past its initial puncture. On 06-MAY-2021, the subject experienced multidose was administered. On 06-MAY-2021, the subject experienced opened vial was left in the fridge at 41f for over 6 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered an opened vial 6 hrs past its initial puncture, multidose was administered and opened vial was left in the fridge at 41f for over 6 hrs was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: palpitations; irregular heartbeat; light headed; Upon receiving at first I felt weird; felt like my heart was skipping beats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy and Drug allergy. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ROPINIROLE, ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN CALCIUM (ATORVASTIN), FAMOTIDINE, LORATADINE and PANTOPRAZOLE MAGNESIUM (PANTOPRAX) for an unknown indication.    On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization), DIZZINESS (light headed), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats). On 13-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat). The patient was hospitalized on 19-Feb-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (palpitations), HEART RATE IRREGULAR (irregular heartbeat), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats) outcome was unknown and DIZZINESS (light headed) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 13-Feb-2021, Heart rate: irregular (abnormal) Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 9 days later she experienced irregular heartbeat. She was seen by a physician and treated with Metoprolol. Upon receiving at first she felt weird, light headed and that night she starting heart palpitations. It felt like her heart was skipping beats. She called doctor and had an electrocardiogram (EKG), and then she went home. The heart palpitations continued to get worse and she went back to doctor and was admitted in the hospital on 19-Feb-2021. She was continually working with her doctor.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: added patient contact details (address, email ID, phone number), patient demographics (height, weight, race), added patient's allergies, concomitant drugs and events (palpitation, weird feeling, dizziness, heartbeats skipped); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Pyrexia, Rash
Clinical narrative: not being able to walk; joint pain; fever, fever getting worse; rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT INABILITY (not being able to walk), ARTHRALGIA (joint pain) and PYREXIA (fever, fever getting worse) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced GAIT INABILITY (not being able to walk) (seriousness criterion hospitalization), ARTHRALGIA (joint pain) (seriousness criterion hospitalization) and PYREXIA (fever, fever getting worse) (seriousness criterion hospitalization). 21-Apr-2021, the patient experienced RASH (rash). The patient was hospitalized on 26-Apr-2021 due to ARTHRALGIA, GAIT INABILITY and PYREXIA. At the time of the report, GAIT INABILITY (not being able to walk), ARTHRALGIA (joint pain), PYREXIA (fever, fever getting worse) and RASH (rash) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-097707 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Feel achy; Have headache; Really really tired; Sweating; Got dizzy; Passed out; Fever in middle of night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048821A and 047821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIZZINESS (Got dizzy) and PYREXIA (Fever in middle of night). On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating) and FATIGUE (Really really tired). On 29-Apr-2021, the patient experienced PAIN (Feel achy) and HEADACHE (Have headache). On 29-Apr-2021, PYREXIA (Fever in middle of night) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Sweating), DIZZINESS (Got dizzy), PAIN (Feel achy), HEADACHE (Have headache) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided. The patient did not experience any side effects after first dose.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Feel achy; Have headache; Really really tired; Sweating; Got dizzy; Passed out; Fever in middle of night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048821A and 047821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIZZINESS (Got dizzy) and PYREXIA (Fever in middle of night). On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating) and FATIGUE (Really really tired). On 29-Apr-2021, the patient experienced PAIN (Feel achy) and HEADACHE (Have headache). On 29-Apr-2021, PYREXIA (Fever in middle of night) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Sweating), DIZZINESS (Got dizzy), PAIN (Feel achy), HEADACHE (Have headache) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided. The patient did not experience any side effects after first dose.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Wheezing
Clinical narrative: COPD exacerbation; wheeze; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) and WHEEZING (wheeze) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included COPD and Lung scarring. Concomitant products included DOXEPIN HYDROCHLORIDE (ADAPIN), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FAMOTIDINE (PEPCID AC) and EZETIMIBE (ZETIA) for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) (seriousness criterion hospitalization) and WHEEZING (wheeze) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) outcome was unknown and WHEEZING (wheeze) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included an Inhaler. Treatment information included steroids, nebulizer treatments and oxygen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: very sick; 2nd dose it is putside of the 42 day  window; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (very sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose it is putside of the 42 day  window) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced COVID-19 (very sick). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose it is putside of the 42 day  window). At the time of the report, COVID-19 (very sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose it is putside of the 42 day  window) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   As a treatment for the SARS-CoV-2 test positive patient was intubated during his hospitalized time. No concomitant medication was reported.  This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, unknown Lot # with no associated AEs and the event of positive SARS-COV-2 infection is assessed as not applicable.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, unknown Lot # with no associated AEs and the event of positive SARS-COV-2 infection is assessed as not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eyelid ptosis, Fatigue, Hallucination, Mydriasis
Clinical narrative: feeling hallucinogenic; dilated pupils; eyelids were hanging; both eyes were red; felt light headed; nausea; feels very tired; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (feeling hallucinogenic) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Concussion (In 2010, she had a head injury (concussion), and has had two other concussions since then as well.) in 2010. Concurrent medical conditions included Hypersensitivity NOS (sensitive to medications and vaccines).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced HALLUCINATION (feeling hallucinogenic) (seriousness criterion medically significant), MYDRIASIS (dilated pupils), EYELID PTOSIS (eyelids were hanging), OCULAR HYPERAEMIA (both eyes were red), DIZZINESS (felt light headed), NAUSEA (nausea) and FATIGUE (feels very tired). At the time of the report, HALLUCINATION (feeling hallucinogenic), MYDRIASIS (dilated pupils), EYELID PTOSIS (eyelids were hanging), OCULAR HYPERAEMIA (both eyes were red), DIZZINESS (felt light headed), NAUSEA (nausea) and FATIGUE (feels very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia
Clinical narrative: feeling hallucinogenic; dilated pupils; eyelids were hanging; both eyes were red; felt light headed; nausea; feels very tired; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (feeling hallucinogenic) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Concussion (In 2010, she had a head injury (concussion), and has had two other concussions since then as well.) in 2010. Concurrent medical conditions included Hypersensitivity NOS (sensitive to medications and vaccines).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced HALLUCINATION (feeling hallucinogenic) (seriousness criterion medically significant), MYDRIASIS (dilated pupils), EYELID PTOSIS (eyelids were hanging), OCULAR HYPERAEMIA (both eyes were red), DIZZINESS (felt light headed), NAUSEA (nausea) and FATIGUE (feels very tired). At the time of the report, HALLUCINATION (feeling hallucinogenic), MYDRIASIS (dilated pupils), EYELID PTOSIS (eyelids were hanging), OCULAR HYPERAEMIA (both eyes were red), DIZZINESS (felt light headed), NAUSEA (nausea) and FATIGUE (feels very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.