chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Pain in extremity
Clinical narrative: INJECTION SITE DISCOMFORT; SHARP SHOOTING PAIN IN LEFT ARM; This spontaneous report received from a consumer concerned a 59 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced injection site discomfort. On APR-2021, the subject experienced sharp shooting pain in left arm. Treatment medications included: diphenhydramine hydrochloride/naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp shooting pain in left arm, and the outcome of injection site discomfort was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: CARDIO FITNESS HAD TRIPLED (UNEXPECTED THERAPEUTIC BENEFIT); 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 APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced cardio fitness had tripled (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cardio fitness had tripled (unexpected therapeutic benefit). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: SORE THROAT; FATIGUE; HEADACHE; PAIN IN ARM; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, ulcerative colitis, insulin resistance, latex allergy, dust allergy, seasonal allergies, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with naproxen sodium, acetylsalicylic acid, ibuprofen, and levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced pain in arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 13-MAR-2021, pain in arm on 01-APR-2021, headache on 11-MAR-2021, and fatigue on 12-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210328999.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Cold sweat, Illness, Pain in extremity, Pyrexia
Clinical narrative: SICK IN BED; ACHY BONES; COLD SWEAT; SORE ARM; FEVER; 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, 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 sick in bed, achy bones, cold sweat, sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick in bed, fever, achy bones, sore arm and cold sweat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral discomfort, Vision blurred
Clinical narrative: BLURRED VISION; SWOLLEN LIPS; BURNING LIPS; This spontaneous report received from a patient concerned a 91 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: Unk) dose was not reported, administered on 11-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 blurred vision. On 11-MAR-2021, the subject experienced swollen lips. On 11-MAR-2021, the subject experienced burning lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, swollen lips, and burning lips. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Illness
Clinical narrative: FEELS WORSE; SICK; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feels worse, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feels worse and sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hot flush, Pain in extremity
Clinical narrative: HOT FLASHES; EXTREME ARM PAIN; MINOR CHILLS; FATIGUE; RAN A TEMPERATURE OF 99.8; 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: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced extreme arm pain. On APR-2021, the subject experienced minor chills. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced ran a temperature of 99.8. Laboratory data included: Body temperature (NR: not provided) 99.8 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ran a temperature of 99.8 on APR-2021, and the outcome of extreme arm pain, minor chills, hot flashes and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210458832.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HOT FLASHES; EXTREME ARM PAIN; MINOR CHILLS; FATIGUE; RAN A TEMPERATURE OF 99.8; 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: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced extreme arm pain. On APR-2021, the subject experienced minor chills. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced ran a temperature of 99.8. Laboratory data included: Body temperature (NR: not provided) 99.8 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ran a temperature of 99.8 on APR-2021, and the outcome of extreme arm pain, minor chills, hot flashes and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210458832.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: CAN'T SLEEP; BODY ACHE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 27-APR-2021, the subject experienced can't sleep. On 27-APR-2021, the subject experienced body ache. On 27-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, fever and can't sleep was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Injection site pain, Injection site swelling
Clinical narrative: UNABLE TO RISE UP ARM; KNOB LEFT ARM; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included vitiligo, and pruritus, and concurrent conditions included diabetes mellitus, hypertension, severed leg cramps, osteoarthritis, venous reflux, sulfonamide allergy, iodine allergy, shellfish / lobster allergy, shrimp/ lemon/ pepper allergy, no alcoholic user, and non smoker, and other pre-existing medical conditions included 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced unable to rise up arm. On 27-APR-2021, the subject experienced knob left arm. On 27-APR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left shoulder pain on 28-APR-2021, and had not recovered from knob left arm, and unable to rise up arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sunburn
Clinical narrative: POSSIBLE SUNBURN; RASH ON FACE; This spontaneous report received from a patient concerned a 42 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: 206A21A, and  expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 14:40 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced possible sunburn. On 29-APR-2021, the subject experienced rash on face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on face, and possible sunburn. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dyspnoea, Headache, Heart rate increased, Myalgia
Clinical narrative: BLOOD PRESSURE DROPPED; ELEVATED HEART RATE; TROUBLE BREATHING; FEVER; HEADACHE; MUSCLE SORE; This spontaneous report received from a consumer concerned a 53 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle sore. On an unspecified date, the subject experienced blood pressure dropped, elevated heart rate, and trouble breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and muscle sore on 07-MAR-2021, and had not recovered from blood pressure dropped, elevated heart rate, and trouble breathing. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BLOOD PRESSURE DROPPED; ELEVATED HEART RATE; TROUBLE BREATHING; FEVER; HEADACHE; MUSCLE SORE; This spontaneous report received from a consumer concerned a 53 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle sore. On an unspecified date, the subject experienced blood pressure dropped, elevated heart rate, and trouble breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and muscle sore on 07-MAR-2021, and had not recovered from blood pressure dropped, elevated heart rate, and trouble breathing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE 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 was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Injection site pain
Clinical narrative: COLD; CHILLS; FATIGUE; SORENESS AT THE SITE OF INJECTION; DIZZINESS; UNABLE TO STAND UP; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and problems in ear, and concurrent conditions included acid reflux, motion sickness, and dizziness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included meclozine for motion sickness. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced unable to stand up. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at the site of injection. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, soreness at the site of injection, fatigue, chills, cold and unable to stand up was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: COLD; CHILLS; FATIGUE; SORENESS AT THE SITE OF INJECTION; DIZZINESS; UNABLE TO STAND UP; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and problems in ear, and concurrent conditions included acid reflux, motion sickness, and dizziness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included meclozine for motion sickness. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced unable to stand up. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at the site of injection. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, soreness at the site of injection, fatigue, chills, cold and unable to stand up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Nausea, Rash pruritic, Sleep disorder, Tachycardia
Clinical narrative: INTERFERED WITH ABILITY TO SLEEP; ITCHY RASH ON LEFT SIDE OF NECK, SPREAD UPWARDS TOWARD SCALP AND TOWARD LOWER ABDOMEN ABOVE PUBIC AREA AND ITCHED WHICH LOOK LIKE PINK SPLOTCHES; NAUSEA; TACHYCARDIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stress-related lupus, and concurrent conditions included non-alcohol user, non-smoker, penicillin allergy, sulfa allergy, crohn's disease, and arthritis, and other pre-existing medical conditions included the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis. On 26-APR-2021, the subject experienced tachycardia. Laboratory data included: Heart rate (NR: not provided) usually 60 bpm increased as119bpm. On 27-APR-2021, the subject experienced nausea. On 28-APR-2021, the subject experienced interfered with ability to sleep. On 28-APR-2021, the subject experienced itchy rash on left side of neck, spread upwards toward scalp and toward lower abdomen above pubic area and itched which look like pink splotches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia on 27-APR-2021, and nausea on 28-APR-2021, had not recovered from itchy rash on left side of neck, spread upwards toward scalp and toward lower abdomen above pubic area and itched which look like pink splotches, and the outcome of interfered with ability to sleep was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: PAIN; BODY ACHES; SORE ARM; FEVER; TIREDNESS; SHINGLES; RASH; SWOLLEN LYMPH NODES AT HIP; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-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 shingles. On MAR-2021, the subject experienced swollen lymph nodes at hip. On MAR-2021, the subject experienced rash. On 26-MAR-2021, the subject experienced pain. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced sore arm. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain, body aches, sore arm, fever, and tiredness on 27-MAR-2021, had not recovered from shingles, and the outcome of swollen lymph nodes at hip and rash was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: PAIN; BODY ACHES; SORE ARM; FEVER; TIREDNESS; SHINGLES; RASH; SWOLLEN LYMPH NODES AT HIP; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-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 shingles. On MAR-2021, the subject experienced swollen lymph nodes at hip. On MAR-2021, the subject experienced rash. On 26-MAR-2021, the subject experienced pain. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced sore arm. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain, body aches, sore arm, fever, and tiredness on 27-MAR-2021, had not recovered from shingles, and the outcome of swollen lymph nodes at hip and rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Medication error, Product storage error
Clinical narrative: POTENTIAL MEDICATION ERROR (3 SHOTS GIVEN FROM AN EXPIRED PUNCTURED VIAL THAT WAS LEFT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS); INCORRECT STORAGE OF DRUG/ VIAL WAS STORED AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced potential medication error (3 shots given from an expired punctured vial that was left at room temperature for more than 2 hours), incorrect storage of drug/ vial was stored at room temperature for more than 2 hours, and expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential medication error (3 shots given from an expired punctured vial that was left at room temperature for more than 2 hours), incorrect storage of drug/ vial was stored at room temperature for more than 2 hours and expired vaccine administered was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache
Clinical narrative: BONE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 34 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 and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and bone pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459729 and 20210459703.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: TREMBLING OF RIGHT ARM; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021 22:00, the subject experienced trembling of right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trembling of right arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: SORE ARM; WEAKNESS; 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 concurrent conditions included pain in sciatica. 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 and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and weakness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia oral, Oropharyngeal discomfort, Paraesthesia oral, Pruritus
Clinical narrative: Lips began to tingle; Lips numb; Face itchy; Throat scratchy; Face became warm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Lips began to tingle) and HYPOAESTHESIA ORAL (Lips numb) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy (Allergy to Dilaudid). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PARAESTHESIA ORAL (Lips began to tingle) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion medically significant), PRURITUS (Face itchy), OROPHARYNGEAL DISCOMFORT (Throat scratchy) and FEELING HOT (Face became warm). On 05-Jan-2021, PARAESTHESIA ORAL (Lips began to tingle), HYPOAESTHESIA ORAL (Lips numb), PRURITUS (Face itchy), OROPHARYNGEAL DISCOMFORT (Throat scratchy) and FEELING HOT (Face became warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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 30-Mar-2021: No specific follow-up information recorded.; 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Paraesthesia, Peripheral swelling
Clinical narrative: Cellulitis; Arm started swelling; Arm was red; Arm was tingling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling). On 22-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16 Jan 2021, the patient's arm started swelling, and it was red and tingling. The redness started traveling down her arm.  On 22 Jan 2021, the patient went to urgent care and was told she had cellulitis. She was told it was bacteria getting into the skin from the way it was administered. She stated the physician who gave her the injection, cleaned the area before the shot was given. She reported that she was to pick-up antibiotics that day (22-Jan-2021). The patient states she definitely has an infection in the arm.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Gait disturbance, Joint swelling, Pain in extremity
Clinical narrative: Blood Clot; left knee had red marks above it; pain in thigh; swelling from the knee up to the thigh; left knee was in pain tremendously; difficulaty walking; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT DISTURBANCE (difficulaty walking) and ARTHRALGIA (left knee was in pain tremendously). On 16-Jan-2021, the patient experienced ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh) and JOINT SWELLING (swelling from the knee up to the thigh). On an unknown date, the patient experienced THROMBOSIS (Blood Clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood Clot), GAIT DISTURBANCE (difficulaty walking), ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh), JOINT SWELLING (swelling from the knee up to the thigh) and ARTHRALGIA (left knee was in pain tremendously) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications like high blood pressure medication, cholesterol medication and medication for irregular heartbeat were reported.  On 15 Jan2021, the patient said that his left knee was in pain tremendously and had difficulty walking. On 16 JAN 2021, the left knee had Red marks above it. He also had swelling from the knee up to the thigh. He also experienced pain in the thigh and knee. He went to the doctor on 20 JAN 2021 and was sent for an ultrasound. The doctor thought it could be related blood clot. No laboratory details were provided.  On 20-Jan-2021, the patient was sent for an ultra sound, results unknown.  Treatment included ibuprofen and paracetamol.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clot; left knee had red marks above it; pain in thigh; swelling from the knee up to the thigh; left knee was in pain tremendously; difficulaty walking; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT DISTURBANCE (difficulaty walking) and ARTHRALGIA (left knee was in pain tremendously). On 16-Jan-2021, the patient experienced ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh) and JOINT SWELLING (swelling from the knee up to the thigh). On an unknown date, the patient experienced THROMBOSIS (Blood Clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood Clot), GAIT DISTURBANCE (difficulaty walking), ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh), JOINT SWELLING (swelling from the knee up to the thigh) and ARTHRALGIA (left knee was in pain tremendously) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications like high blood pressure medication, cholesterol medication and medication for irregular heartbeat were reported.  On 15 Jan2021, the patient said that his left knee was in pain tremendously and had difficulty walking. On 16 JAN 2021, the left knee had Red marks above it. He also had swelling from the knee up to the thigh. He also experienced pain in the thigh and knee. He went to the doctor on 20 JAN 2021 and was sent for an ultrasound. The doctor thought it could be related blood clot. No laboratory details were provided.  On 20-Jan-2021, the patient was sent for an ultra sound, results unknown.  Treatment included ibuprofen and paracetamol.  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.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Had a reaction to the vaccine; A spontaneous report was received from a Consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction to the vaccine (PT: Anaphylactic reaction).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, Had a reaction to the vaccine (Anaphylactic reaction). Anaphylactic reaction was deemed medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date the outcome of event, Had a reaction to the vaccine was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Neuropathy peripheral, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Peripheral neuropathy on both of her legs; Soreness on the injection site; The site was more itchy; inappropriate schedule of vaccine administered; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy on both of her legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A006M20A and 006M20A029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition reported.).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Numbness). On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The site was more itchy). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy on both of her legs) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Soreness on the injection site). In February 2021, HYPOAESTHESIA (Numbness) had resolved. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy on both of her legs) had resolved and VACCINATION SITE PRURITUS (The site was more itchy) and VACCINATION SITE PAIN (Soreness on the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. 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 31-Mar-2021: Event: Numbness start date and recovered date updated.; 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Cough, Hypoxia, Oxygen saturation
Clinical narrative: COVID diagnosis; coughing; low oxygen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COUGH (coughing) (seriousness criterion hospitalization) and HYPOXIA (low oxygen) (seriousness criterion hospitalization). On 24-Feb-2021, the patient experienced COVID-19 (COVID diagnosis) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Antibody test: negative (Negative) Negative. On 19-Feb-2021, Oxygen saturation: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not given.  This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Chills, Cough, Diarrhoea
Clinical narrative: COVID Diagnoses After Vaccination; Nasal congestion; Cough; Diarrhea; Loss of taste; Chills; Nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID Diagnoses After Vaccination) in a 78-year-old female 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID Diagnoses After Vaccination) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID Diagnoses After Vaccination), NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Source of sample- Nasopharyngeal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  Treatment information included Monoclonal antibody therapy as bamlanivimab infusion for the virus start on 19 Jan 2021.  Company Comment: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information included adverse events (chills, cough, nausea, diarrhea, nasal congestion and loss of taste), hospitalization confirmation, laboratory exam performed date and treatment information as bamlanivimab infusion.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.