chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON HER ANTERIOR LEFT THIGH; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced rash on her anterior left thigh. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from rash on her anterior left thigh. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: MILD PAIN IN LEFT LEG; RIGHT ARM WAS SORE WHERE HE GOT THE VACCINE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies, had no bad medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm was sore where he got the vaccine. On 02-APR-2021, the subject experienced mild pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild pain in left leg, and right arm was sore where he got the vaccine. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS ON THE LEFT ARM; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced soreness on the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness on the left arm. This report was non-serious.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation, Injection site haemorrhage
Clinical narrative: PARTIAL ADMINISTRATION OF VACCINE; LOT OF VACCINE LIQUID CAME OUT RIGHT AFTER ADMINISTRATION; LOT OF BLOOD CAME OUT; This spontaneous report received from a pharmacist concerned a 23 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced partial administration of vaccine. On 04-APR-2021, the subject experienced lot of vaccine liquid came out right after administration. On 04-APR-2021, the subject experienced lot of blood came out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial administration of vaccine, lot of vaccine liquid came out right after administration and lot of blood came out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: VOMITING; DIZZINESS; NAUSEA; TIREDNESS; This spontaneous report received from a consumer 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness, tiredness and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: ACHINESS; CHILLS; HEADACHES; 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. 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 achiness, chills, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, achiness and chills was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left deltoid for prophylactic vaccination. 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.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDERDOSED; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced underdosed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of underdosed was not reported. This report was non-serious. This case is a duplicate of 20210406991.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Headache, Renal pain
Clinical narrative: SLEEPINESS; KIDNEY HURT; LOSS OF APPETITE; COUGH; CHILLS; HEADACHE; 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: 042421A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced sleepiness. On 02-APR-2021, the subject experienced kidney hurt. On 02-APR-2021, the subject experienced loss of appetite. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, cough, and chills on 02-APR-2021, and had not recovered from headache, sleepiness, and kidney hurt. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SLEEPINESS; KIDNEY HURT; LOSS OF APPETITE; COUGH; CHILLS; HEADACHE; 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: 042421A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced sleepiness. On 02-APR-2021, the subject experienced kidney hurt. On 02-APR-2021, the subject experienced loss of appetite. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, cough, and chills on 02-APR-2021, and had not recovered from headache, sleepiness, and kidney hurt. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Acne, Decreased activity
Clinical narrative: SMALL PIMPLE ON FACE; RESTED ABNORMALLY; This spontaneous report received from a patient of an unspecified age and sex (reporting on self). 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) dose was not reported, administered on APR-2021 on an unspecified site for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced pimple on face. On APR-2021, the patient experienced rested abnormally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rested abnormally, and the outcome of pimple on face was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210407212.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blepharospasm, Fatigue, Nasal congestion, Tension headache
Clinical narrative: BACK PAIN; FATIGUE; TENSION HEADACHE; NASAL CONGESTION; SPASMS NEAR EYES; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced nasal congestion. On 02-APR-2021, the subject experienced spasms near eyes. On 02-APR-2021, the subject experienced tension headache. On 03-APR-2021, the subject experienced back pain. On 03-APR-2021, the subject experienced fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, and tension headache on 04-APR-2021, and had not recovered from nasal congestion, fatigue, and spasms near eyes. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Viral test negative
Clinical narrative: TERRIBLE SHARP LOWER RIGHT SIDE BACK PAIN; SPASM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain cyst surgery, and concurrent conditions included anaplastic astrocytoma, kidney stones, fell and broke tibia, herpes simplex virus 2, and nonsmoker, and other pre-existing medical conditions included the patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced terrible sharp lower right side back pain. On 03-APR-2021, the subject experienced spasm. Laboratory data (dates unspecified) included: Viral test negative (NR: not provided) Negative. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible sharp lower right side back pain, and the outcome of spasm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHE; BONE ACHE; JOINT ACHES; FEVER; FEELING TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced feeling tired. Treatment medications included: paracetamol. On 02-APR-2021, the subject experienced severe body ache. On 02-APR-2021, the subject experienced bone ache. On 02-APR-2021, the subject experienced joint aches. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe body ache, fever, joint aches, feeling tired, and bone ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: SHAKES; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to follow-up batch number/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced shakes, and chills. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and shakes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a 24 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-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 03-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea
Clinical narrative: FLU LIKE SYMPTOMS; CHILLS; SHIVERING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced shivering. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, shivering, nausea, and headache on 22-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWOLLEN RIGHT BIG TOE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.   On 23-MAR-2021 patient got a swollen right big toe.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen right big toe. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210409422- Covid-19 vaccine ad26.cov2.s  covid-19 vaccine ad26.cov2.s -SWOLLEN RIGHT BIG TOE. 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: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous report as received from a currently 70 year old male patient  consumer via company concernign himself.  There was no information about the patient's medical history, concurrent conditions or concomitant medication. In November 2020 the patient was vaccinated witha  dose of pneumococcal vaccine, polyvalent (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  Other suspect vaccine included a dose of influenza virus vaccine (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED)) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced sore arms. The outcome of sore arms was unknown. The causal relationship between the aforementioned event and with pneumococcal vaccine, polyvalent (manufacturer unknown) and  influenza virus vaccine (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED))  was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dysphonia, Lymphadenopathy, Nausea, Pain
Clinical narrative: swelling voice; swelling neck; swelling gland; nausea; Abdominal pain radiating to left side of body; Abdominal pain radiating to left side of body; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Abdominal pain radiating to left side of body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Abdominal pain radiating to left side of body) (seriousness criterion disability), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain) and NAUSEA (nausea). On 07-Jan-2021, the patient experienced SWELLING (swelling neck) and LYMPHADENOPATHY (swelling gland). On 08-Jan-2021, the patient experienced DYSPHONIA (swelling voice). At the time of the report, PAIN (Abdominal pain radiating to left side of body), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain), DYSPHONIA (swelling voice), SWELLING (swelling neck), LYMPHADENOPATHY (swelling gland) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include prednisone, Benadryl and oxycontin.  Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: swelling voice; swelling neck; swelling gland; nausea; Abdominal pain radiating to left side of body; Abdominal pain radiating to left side of body; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Abdominal pain radiating to left side of body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Abdominal pain radiating to left side of body) (seriousness criterion disability), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain) and NAUSEA (nausea). On 07-Jan-2021, the patient experienced SWELLING (swelling neck) and LYMPHADENOPATHY (swelling gland). On 08-Jan-2021, the patient experienced DYSPHONIA (swelling voice). At the time of the report, PAIN (Abdominal pain radiating to left side of body), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain), DYSPHONIA (swelling voice), SWELLING (swelling neck), LYMPHADENOPATHY (swelling gland) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include prednisone, Benadryl and oxycontin.  Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: Enlarged lymph nodes; Itching in her scalp and wrist; Hives in neck, forehead and wrist; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in her scalp and wrist), URTICARIA (Hives in neck, forehead and wrist) and LYMPHADENOPATHY (Enlarged lymph nodes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMINS [VITAMINS NOS], RALOXIFENE and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ) for an unknown indication.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (Itching in her scalp and wrist) (seriousness criterion medically significant) and URTICARIA (Hives in neck, forehead and wrist) (seriousness criterion medically significant). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itching in her scalp and wrist), URTICARIA (Hives in neck, forehead and wrist) and LYMPHADENOPATHY (Enlarged lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received.; 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: Chills, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Soreness/aching; Not feeling quite right; Extreme tiredness; Chill; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/aching), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Jan-2021, the patient experienced PAIN (Soreness/aching) (seriousness criterion medically significant), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache). At the time of the report, PAIN (Soreness/aching), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dyspnoea, Headache, Oropharyngeal discomfort
Clinical narrative: high blood pressure; fever; chills; severe headache; rash all over in the arm where got the vaccine; rash trunk and leg; burned; trouble breathing; throat problem; rapid heartbeat; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure) and TACHYCARDIA (rapid heartbeat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure (Taking meds to control blood pressure.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure) (seriousness criterion hospitalization) and TACHYCARDIA (rapid heartbeat) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache), VACCINATION SITE RASH (rash all over in the arm where got the vaccine), RASH (rash trunk and leg), THERMAL BURN (burned), DYSPNOEA (trouble breathing ) and OROPHARYNGEAL DISCOMFORT (throat problem). The patient was hospitalized from 12-Feb-2021 to 18-Feb-2021 due to BLOOD PRESSURE INCREASED and TACHYCARDIA. At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure), TACHYCARDIA (rapid heartbeat), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache), VACCINATION SITE RASH (rash all over in the arm where got the vaccine), RASH (rash trunk and leg), THERMAL BURN (burned), DYSPNOEA (trouble breathing ) and OROPHARYNGEAL DISCOMFORT (throat problem) 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 known to have been used by the patient, within two weeks prior to the event, included thyroid medication and blood pressure medication.   Treatment of these events included prednisone and Benadryl.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tachycardia, Thermal burn, Vaccination site rash
Clinical narrative: high blood pressure; fever; chills; severe headache; rash all over in the arm where got the vaccine; rash trunk and leg; burned; trouble breathing; throat problem; rapid heartbeat; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure) and TACHYCARDIA (rapid heartbeat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure (Taking meds to control blood pressure.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure) (seriousness criterion hospitalization) and TACHYCARDIA (rapid heartbeat) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache), VACCINATION SITE RASH (rash all over in the arm where got the vaccine), RASH (rash trunk and leg), THERMAL BURN (burned), DYSPNOEA (trouble breathing ) and OROPHARYNGEAL DISCOMFORT (throat problem). The patient was hospitalized from 12-Feb-2021 to 18-Feb-2021 due to BLOOD PRESSURE INCREASED and TACHYCARDIA. At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure), TACHYCARDIA (rapid heartbeat), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache), VACCINATION SITE RASH (rash all over in the arm where got the vaccine), RASH (rash trunk and leg), THERMAL BURN (burned), DYSPNOEA (trouble breathing ) and OROPHARYNGEAL DISCOMFORT (throat problem) 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 known to have been used by the patient, within two weeks prior to the event, included thyroid medication and blood pressure medication.   Treatment of these events included prednisone and Benadryl.; 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Eye swelling, Heart rate increased, Hypersensitivity
Clinical narrative: serious allergic reaction; breathing was labored; red scratch marks all over her upper body; heart beat was getting very rapid; vision was wonky; right eye was swollen; face was beet red; nauseous; A spontaneous report was received from a consumer's mother who state's a 21 year female experienced a serious allergic reaction(hypersensitivity) to the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 03-MAR-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03-MAR-2021around 15:00, she received the Moderna COVID-19 vaccine in her left deltoid muscle at Shop Rite Pharmacy. 6 hours later she noticed red scratch marks all over her upper body, her heart beat was getting very rapid, her breathing was labored, her vision was wonky, her right eye was swollen and her face was beat red. 911 was called, upon arrival the EMT administered IV diphenhydramine (Benadryl) 50 mg and at the emergency room they gave her famotidine (Pepcid) and a steroid drip (methylprednisolone). After receiving treatment, the reporter states the patient felt great and was discharged. The doctor prescribed her methylprednisolone. Additionally she states the patient was also nauseous last night which went away around 2:00am. They told her to consult her primary care provider about the second Moderna COVID-19 vaccination  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event, serious allergic reaction is unknown.; Reporter's Comments: This case concerns a 21 Y/O F with serious unexpected events of hypersensitivity, dyspnea, and nonserious unexpected heart rate increased, vision blurred, eye swelling, erythema, scratches and expected nausea. Event onset on Day 1 after first dose mRNA-1273. Treated with diphenhydramine and methylprednisolone. Hypersensitivity resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Scratch, Vision blurred
Clinical narrative: serious allergic reaction; breathing was labored; red scratch marks all over her upper body; heart beat was getting very rapid; vision was wonky; right eye was swollen; face was beet red; nauseous; A spontaneous report was received from a consumer's mother who state's a 21 year female experienced a serious allergic reaction(hypersensitivity) to the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 03-MAR-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03-MAR-2021around 15:00, she received the Moderna COVID-19 vaccine in her left deltoid muscle at Shop Rite Pharmacy. 6 hours later she noticed red scratch marks all over her upper body, her heart beat was getting very rapid, her breathing was labored, her vision was wonky, her right eye was swollen and her face was beat red. 911 was called, upon arrival the EMT administered IV diphenhydramine (Benadryl) 50 mg and at the emergency room they gave her famotidine (Pepcid) and a steroid drip (methylprednisolone). After receiving treatment, the reporter states the patient felt great and was discharged. The doctor prescribed her methylprednisolone. Additionally she states the patient was also nauseous last night which went away around 2:00am. They told her to consult her primary care provider about the second Moderna COVID-19 vaccination  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event, serious allergic reaction is unknown.; Reporter's Comments: This case concerns a 21 Y/O F with serious unexpected events of hypersensitivity, dyspnea, and nonserious unexpected heart rate increased, vision blurred, eye swelling, erythema, scratches and expected nausea. Event onset on Day 1 after first dose mRNA-1273. Treated with diphenhydramine and methylprednisolone. Hypersensitivity resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Neuropathy peripheral, Pruritus, Skin burning sensation
Clinical narrative: Felt weak; Neuropathy; hot skin all over; skin burning; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak) and NEUROPATHY PERIPHERAL (Neuropathy) in a 91-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.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Felt weak) (seriousness criterion hospitalization), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Felt weak), NEUROPATHY PERIPHERAL (Neuropathy), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness) had not resolved.            Treatment Medication was cortisone cream, cerave, and Citalopram.  This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus.  Event onset Day 2 after second dose mRNA-1273. Events ongoing. 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 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus.  Event onset Day 2 after second dose mRNA-1273. Events ongoing. 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: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, Chest pain, Dizziness, Headache
Clinical narrative: Chest pain; Dizzy; Spasm; Memory loss; Ringing ears; Off balance; Headache; Sleepy; A spontaneous report was received from a consumer who was also a 63-years-old, patient of unknown gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and who felt dizzy/dizziness, off balance/balance disorder, sleepy/somnolence, memory loss/amnesia, chest pain/non-cardiac chest pain, headache, ears ringing/tinnitus and spasm/muscle spasms.   The patient's medical history included reflux, spasm and erosion gastritis. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient had chest pain, dizzy and spasm for which the patient had to take an ambulance to the hospital. No further details regarding hospitalization provided at time of report. The patient also had memory loss, ringing ears, sleepy, off balance and headache.  Treatment for the event included pepsid, doxycycline at 100 milligram 2 dose a day and baby aspirin.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. The events were consistent with increased risk of complications associated with history of comorbidities and confounded by age of patient. Company assessed the events to be unlikely related to company product.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Somnolence, Tinnitus
Clinical narrative: Chest pain; Dizzy; Spasm; Memory loss; Ringing ears; Off balance; Headache; Sleepy; A spontaneous report was received from a consumer who was also a 63-years-old, patient of unknown gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and who felt dizzy/dizziness, off balance/balance disorder, sleepy/somnolence, memory loss/amnesia, chest pain/non-cardiac chest pain, headache, ears ringing/tinnitus and spasm/muscle spasms.   The patient's medical history included reflux, spasm and erosion gastritis. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient had chest pain, dizzy and spasm for which the patient had to take an ambulance to the hospital. No further details regarding hospitalization provided at time of report. The patient also had memory loss, ringing ears, sleepy, off balance and headache.  Treatment for the event included pepsid, doxycycline at 100 milligram 2 dose a day and baby aspirin.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. The events were consistent with increased risk of complications associated with history of comorbidities and confounded by age of patient. Company assessed the events to be unlikely related to company product.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: mild anaphylactic shock; nauseated; about to pass out; bolt of tightness in her chest and across from her shoulder; pain in her chest; shortness of breath; dizzy/lightheadness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (mild anaphylactic shock) and LOSS OF CONSCIOUSNESS (about to pass out) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 medical history reported ).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (about to pass out) (seriousness criterion medically significant), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness). On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (mild anaphylactic shock) (seriousness criterion medically significant) and NAUSEA (nauseated). On 13-Feb-2021, LOSS OF CONSCIOUSNESS (about to pass out), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (mild anaphylactic shock) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other relevant medication was reported. No treatment information was reported.  This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. 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 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. 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.