chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fluid intake reduced, Lethargy
Clinical narrative: APPETITE LOST; LETHARGIC; DIDN'T DRINK; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 appetite lost, lethargic, and didn't drink. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from appetite lost, lethargic, and didn't drink. This report was non-serious. This case, from the same reporter is linked to 20210642553.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210662182.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: MILD NAUSEA FOR 3 DAYS; MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 mild nausea for 3 days, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild nausea for 3 days, and mild headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Sciatica
Clinical narrative: CAN'T SLEEP; SCIATICA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced sciatica. On JUN-2021, the subject experienced can't sleep. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sciatica, and can't sleep. This report was non-serious.; Sender's Comments:   Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-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 26-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 26-JUN-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 26-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: PALE; BLURRY VISION; DIZZINESS; TIGHT CHEST; SHORTNESS OF BREATH; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced pale. On 28-JUN-2021, the subject experienced blurry vision. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced tight chest. On 28-JUN-2021, the subject experienced shortness of breath. On 28-JUN-2021, the subject experienced nausea. On 28-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pale, blurry vision, nausea, dizziness, tight chest, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment not required as per standard operating procedure as the case is assessed as Non-serious
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Vision blurred
Clinical narrative: PALE; BLURRY VISION; DIZZINESS; TIGHT CHEST; SHORTNESS OF BREATH; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced pale. On 28-JUN-2021, the subject experienced blurry vision. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced tight chest. On 28-JUN-2021, the subject experienced shortness of breath. On 28-JUN-2021, the subject experienced nausea. On 28-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pale, blurry vision, nausea, dizziness, tight chest, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment not required as per standard operating procedure as the case is assessed as Non-serious
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Thyroid function test, Tremor
Clinical narrative: FATIGUE; SHAKINESS IN ARMS AND LEGS; WEAKNESS IN ARMS AND LEGS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-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 shakiness in arms and legs. On APR-2021, the subject experienced weakness in arms and legs. On an unspecified date, the subject experienced fatigue. Laboratory data (dates unspecified) included: Thyroid function test (NR: not provided) ELEVATED. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shakiness in arms and legs, and weakness in arms and legs, and the outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Coagulation test, Headache, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: NECK STIFFNESS; RED BLOTCHES ON FACE AND YOUR NECK; LOW FEVER TEMP 99 DEGREES; PERSISTENT HEADACHE; PAIN IN NECK AND BACK; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient received blood thinned in emergency room. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced pain in neck and back. On an unspecified date, the subject experienced neck stiffness, red blotches on face and your neck, low fever temp 99 degrees, and persistent headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F, and Coagulation test (NR: not provided) no evidence of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in neck and back, and the outcome of neck stiffness, persistent headache, red blotches on face and your neck and low fever temp 99 degrees was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: NECK STIFFNESS; RED BLOTCHES ON FACE AND YOUR NECK; LOW FEVER TEMP 99 DEGREES; PERSISTENT HEADACHE; PAIN IN NECK AND BACK; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient received blood thinned in emergency room. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced pain in neck and back. On an unspecified date, the subject experienced neck stiffness, red blotches on face and your neck, low fever temp 99 degrees, and persistent headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F, and Coagulation test (NR: not provided) no evidence of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in neck and back, and the outcome of neck stiffness, persistent headache, red blotches on face and your neck and low fever temp 99 degrees was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Headache, Tinnitus, Visual impairment
Clinical narrative: HEARING LOSS; TINNITUS; DECREASED VISION; HEADACHE; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included tinnitus (increase in intensity and had to increase the strength of reading glasses), and concurrent conditions included diabetes type 2, non-smoker, and non alcohol user. The patient did not have 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: 1805020 and expiry: 09-JUL-2021) dose was not reported, 1 total administered on 09-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced hearing loss, decreased vision, headache and tinnitus.  On 10-MAR-2021 Hearing test (NR: not provided) hearing loss 70 dB on a auditory exam which was different from two years ago, Laboratory data (dates unspecified) included: Hearing test (NR: not provided) 20 dB. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from tinnitus, hearing loss, and decreased vision. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210664144-COVID-19 VACCINE AD26.COV2.S-HEARING LOSS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Bell's palsy, Oropharyngeal pain, Toothache
Clinical narrative: BELLS PALSY; SORE THROAT PAIN; DENTAL PAIN; CANKER SORE; This spontaneous report received from a patient concerned a 56 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperlipidemia, and penicillin allergy, and patient was allergic to wycampin. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, isoniazid, and atorvastatin calcium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: 05-AUG-2021) dose was not reported, 1 total administered on left arm on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the patient experienced sharp ear pain, sore throat pain, dental pain, canker sore, taste issue, drooping left eye, and left side of head pain for which patient visited physician office and emergency room. On 21-JUN-2021, the patient was diagnosed with Bells palsy. Patient had been in contact with the health care professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bells palsy, sore throat pain, dental pain and canker sore was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664608-covid-19 vaccine ad26.cov2.s -Bell's palsy . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Device issue, Dizziness, Ear pain, Headache, Inappropriate schedule of product administration
Clinical narrative: RINGING IN EARS; PAIN IN EARS; DIZZINESS; INAPPROPRIATE DOSE OF DRUG ADMINISTERED; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION; PSORIASIS FACIAL; INJECTION SITE BRUISING; DEVICE ISSUE; HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 ringing in ears, pain in ears, dizziness, inappropriate dose of drug administered, inappropriate schedule of drug administration, psoriasis facial, injection site bruising, device issue, headache, and injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in ears, pain in ears, headache, dizziness, inappropriate dose of drug administered, inappropriate schedule of drug administration, psoriasis facial, injection site swelling, injection site bruising and device issue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site bruising, Injection site swelling, Psoriasis, Tinnitus
Clinical narrative: RINGING IN EARS; PAIN IN EARS; DIZZINESS; INAPPROPRIATE DOSE OF DRUG ADMINISTERED; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION; PSORIASIS FACIAL; INJECTION SITE BRUISING; DEVICE ISSUE; HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 ringing in ears, pain in ears, dizziness, inappropriate dose of drug administered, inappropriate schedule of drug administration, psoriasis facial, injection site bruising, device issue, headache, and injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in ears, pain in ears, headache, dizziness, inappropriate dose of drug administered, inappropriate schedule of drug administration, psoriasis facial, injection site swelling, injection site bruising and device issue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via other company Pfizer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) one total 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 patient was died. The cause of death was not reported. It was unknown whether the autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210666298-Covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: TIRED; MUSCLE SORENESS; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and muscle soreness on 11-APR-2021. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Pyrexia
Clinical narrative: SHARP PAIN IN STOMACH; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, high blood pressure, and testosterone replacement, and other pre-existing medical conditions included patient had no known allergies any allergies and no 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: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced sharp pain in stomach. On 29-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, and had not recovered from sharp pain in stomach. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: COUGH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-2021 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 25-JUN-2021, the subject experienced cough. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever and headache was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Erythema, Joint swelling, Pain, Peripheral swelling
Clinical narrative: RED MARKS ON ANKLE, FEET AND CALVES OF LEGS; SWOLLEN WRIST; SWOLLEN  RIGHT FOREARM; SWELLING OF LEFT LEG CALF; PAIN; REACTION ON LEFT LEG WORSENED AND SPREAD TO RIGHT LEG AND INNER THIGHS; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user (occasionally on weekend), and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no complaints of medical issues. The patient was previously treated with fexofenadine hydrochloride for seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, 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 swollen wrist. On APR-2021, the subject experienced swollen right forearm. On APR-2021, the subject experienced swelling of left leg calf. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced reaction on left leg worsened and spread to right leg and inner thighs. On 20-APR-2021, the subject experienced red marks on ankle, feet and calves of legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen wrist, swollen right forearm, swelling of left leg calf, and pain on APR-2021, had not recovered from reaction on left leg worsened and spread to right leg and inner thighs, and the outcome of red marks on ankle, feet and calves of legs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Contusion, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red circle around injection site; swollen; hot; itchy; Cellulitis; small bluish bruise; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a female patient of an unknown age 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 10-Jan-2021 at 3:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 11-Jan-2021, the patient experienced CONTUSION (small bluish bruise). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy) and CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 milligram four times per day; LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 25-Jan-2021, VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy) and CELLULITIS (Cellulitis) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), CONTUSION (small bluish bruise) and VACCINATION SITE ERYTHEMA (red circle around injection site) 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 were not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon internal review on 25 Jun 2021, the patient age was corrected and narrative updated accordingly.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: red circle around injection site; swollen; hot; itchy; Cellulitis; small bluish bruise; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a female patient of an unknown age 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 10-Jan-2021 at 3:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 11-Jan-2021, the patient experienced CONTUSION (small bluish bruise). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy) and CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 milligram four times per day; LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 25-Jan-2021, VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy) and CELLULITIS (Cellulitis) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), CONTUSION (small bluish bruise) and VACCINATION SITE ERYTHEMA (red circle around injection site) 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 were not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon internal review on 25 Jun 2021, the patient age was corrected and narrative updated accordingly.; Sender'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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Mass, Rash erythematous
Clinical narrative: lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist); lumpy red rash on her left armpit; cellulitis; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit). In May 2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis), MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit) had not resolved.            Concomitant medications were not provided.  Patient consulted a dermatologist who initially  thought it was cellulitis for which a blood test and puncture biopsy was done and also given a unspecified medicine but it did not resolve. She was then referred to neurologist and MRI was done and awaiting results. The lumps were still present at the time of the call.  Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration
Clinical narrative: Stroke; Received the first dose at least two months ago, second dose due in Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 71-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.     The patient's past medical history included Stroke in February 2021.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose at least two months ago, second dose due in Apr2021). The patient was hospitalized on 30-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose at least two months ago, second dose due in Apr2021) 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.   No relevant concomitant medication were provided.  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 event, a causal relationship cannot be excluded. However, the patient's medical history of stroke is a possible confounding factor.; Sender'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. However, the patient's medical history of stroke is a possible confounding factor.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Diagnosed with breast cancer; Flu like symptoms; Body Ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, METFORMIN, EZETIMIBE (ZETIA), CALCITRIOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Surgery (Double Mastectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with breast cancer), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information in response to events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded.  Although a temporal association exists, based on the current available information ,  the mechanism of action of mRNA-1237 vaccine,  and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.   This case was linked to MOD-2021-227876 (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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information ,  the mechanism of action of mRNA-1237 vaccine,  and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diagnosed with breast cancer; Flu like symptoms; Body Ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, METFORMIN, EZETIMIBE (ZETIA), CALCITRIOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Surgery (Double Mastectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with breast cancer), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information in response to events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded.  Although a temporal association exists, based on the current available information ,  the mechanism of action of mRNA-1237 vaccine,  and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.   This case was linked to MOD-2021-227876 (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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information ,  the mechanism of action of mRNA-1237 vaccine,  and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Neuromyopathy, Pyrexia, Vaccination complication
Clinical narrative: neuromuscular syndrome; adverse side effect; numbness in the fingers; Low grade fever; Body aches; specific pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROMYOPATHY (neuromuscular syndrome) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B212A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROMYOPATHY (neuromuscular syndrome) (seriousness criterion medically significant), VACCINATION COMPLICATION (adverse side effect), HYPOAESTHESIA (numbness in the fingers), PYREXIA (Low grade fever), MYALGIA (Body aches) and VACCINATION SITE PAIN (specific pain at injection site). The patient was treated with IBUPROFEN (IBUPROFEN IB) (oral) at a dose of UNK dosage form. At the time of the report, NEUROMYOPATHY (neuromuscular syndrome), HYPOAESTHESIA (numbness in the fingers), PYREXIA (Low grade fever), MYALGIA (Body aches) and VACCINATION SITE PAIN (specific pain at injection site) had not resolved and VACCINATION COMPLICATION (adverse side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient reported that he got the second dose seven weeks ago and still had significant pain at injection site in the bicep muscle and right shoulder region. The patient didn't have reactions with the 1st dose.  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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Additional information received on 21-Jun-2021 contain no new information.; Sender'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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: neuromuscular syndrome; adverse side effect; numbness in the fingers; Low grade fever; Body aches; specific pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROMYOPATHY (neuromuscular syndrome) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B212A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROMYOPATHY (neuromuscular syndrome) (seriousness criterion medically significant), VACCINATION COMPLICATION (adverse side effect), HYPOAESTHESIA (numbness in the fingers), PYREXIA (Low grade fever), MYALGIA (Body aches) and VACCINATION SITE PAIN (specific pain at injection site). The patient was treated with IBUPROFEN (IBUPROFEN IB) (oral) at a dose of UNK dosage form. At the time of the report, NEUROMYOPATHY (neuromuscular syndrome), HYPOAESTHESIA (numbness in the fingers), PYREXIA (Low grade fever), MYALGIA (Body aches) and VACCINATION SITE PAIN (specific pain at injection site) had not resolved and VACCINATION COMPLICATION (adverse side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient reported that he got the second dose seven weeks ago and still had significant pain at injection site in the bicep muscle and right shoulder region. The patient didn't have reactions with the 1st dose.  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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Additional information received on 21-Jun-2021 contain no new information.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Narcolepsy
Clinical narrative: A bit of narcolepsy; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of NARCOLEPSY (A bit of narcolepsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced NARCOLEPSY (A bit of narcolepsy) (seriousness criterion medically significant) and FATIGUE (Extremely tired). At the time of the report, NARCOLEPSY (A bit of narcolepsy) and FATIGUE (Extremely tired) outcome was unknown.            The concomitant medications were not reported.  The treatment information was not 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.   Reporter did not allow further contact; 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cytokine storm, Head titubation, Retching
Clinical narrative: weakness; chills; shaking; vomiting; wretching; shaking with head bobbing; cytokine storm reaction; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), TREMOR (shaking), VOMITING (vomiting), RETCHING (wretching), HEAD TITUBATION (shaking with head bobbing) and CYTOKINE STORM (cytokine storm reaction) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (weakness) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), RETCHING (wretching) (seriousness criterion hospitalization), HEAD TITUBATION (shaking with head bobbing) (seriousness criterion hospitalization) and CYTOKINE STORM (cytokine storm reaction) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHENIA (weakness), CHILLS (chills), TREMOR (shaking), VOMITING (vomiting), RETCHING (wretching), HEAD TITUBATION (shaking with head bobbing) and CYTOKINE STORM (cytokine storm reaction) 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.   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.