chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Feeling of body temperature change, Nausea, Pain
Clinical narrative: HOT CHILLS; EVERYTHING HURT JUST LIKE FLU; FREEZING COLD; NAUSEOUS; VERY 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hot chills, everything hurt just like flu, freezing cold, nauseous, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot chills, everything hurt just like flu, freezing cold, nauseous, and very tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON TORSO AND ABDOMEN AREA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 22-APR-2021, the subject experienced rash on torso and abdomen area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on torso and abdomen area. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: SMELL DISTURBANCES/SMELLS EGG WHEN EATING OR COOKING OR WITH  THE TAKE OUT; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced weird smell on nose/smeled like egg when eating, cooking, take out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird smell on nose/smeled like egg when eating, cooking, take out. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: PAIN FROM FIBROMYALGIA IS GONE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included liver disease, and liver surgery, and concurrent conditions included fibromyalgia, immunocompromised, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included magnesium sulfate for cramping due to liver disease, oxycodone hydrochloride for fibromyalgia, spironolactone for high blood pressure, and prednisone for liver pain, and cramp.  On 09-APR-2021, the subject experienced pain from fibromyalgia is gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain from fibromyalgia is gone was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: SORE THROAT; INTENSE COUGH; FELT SICK; HEADACHES; SOME FORM OF NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. In this scenario follow-up is not required to obtain batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced intense cough. On APR-2021, the subject experienced felt sick. On APR-2021, the subject experienced headaches. On APR-2021, the subject experienced some form of nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt sick, some form of nausea, headaches, sore throat, and intense cough. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-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 APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: TENDERNESS AROUND SITE OF  INJECTION; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, kidney disease, high blood pressure, high cholesterol, bipolar, and glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced tenderness around site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tenderness around site of injection. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Fall, Fatigue, Injection site pain
Clinical narrative: LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP; FELL OVER A BOX; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included shoulder surgery, and concurrent conditions included type ii diabetes, lupus, and cholesterol issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise on hip. On APR-2021, the subject experienced fell over a box. On 05-APR-2021, the subject experienced pain in both of legs and calf. On 05-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced left shoulder pain. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 06-APR-2021, and felt tired on 07-APR-2021, had not recovered from left shoulder pain, pain in both of legs and calf, and bruise on hip, and the outcome of fell over a box was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP; FELL OVER A BOX; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included shoulder surgery, and concurrent conditions included type ii diabetes, lupus, and cholesterol issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise on hip. On APR-2021, the subject experienced fell over a box. On 05-APR-2021, the subject experienced pain in both of legs and calf. On 05-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced left shoulder pain. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 06-APR-2021, and felt tired on 07-APR-2021, had not recovered from left shoulder pain, pain in both of legs and calf, and bruise on hip, and the outcome of fell over a box was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Influenza like illness, Oropharyngeal pain
Clinical narrative: FLU-LIKE SYMPTOMS; SICK; FEVER; SORE THROAT; HEADACHE; BODY ACHES; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included felt sick, and covid-19. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The batch number was not reported. On APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced sore throat. On 24-APR-2021, the subject experienced flu-like symptoms. On 24-APR-2021, the subject experienced sick. On 24-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, flu-like symptoms, sore throat, and fever, and the outcome of sick was not reported. This report was non serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: FLU-LIKE SYMPTOMS; SICK; FEVER; SORE THROAT; HEADACHE; BODY ACHES; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included felt sick, and covid-19. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The batch number was not reported. On APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced sore throat. On 24-APR-2021, the subject experienced flu-like symptoms. On 24-APR-2021, the subject experienced sick. On 24-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, flu-like symptoms, sore throat, and fever, and the outcome of sick was not reported. This report was non serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: ACHINESS; CHILLS; MILD FEVER; HEADACHE; 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: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced achiness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced mild fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, chills, mild fever, and headache on 09-APR-2021. This report was non-serious. This case, from the same reporter is linked to.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHE; CHILLS; FEVER; EXHAUSTION; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced exhaustion. On 2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 100 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, exhaustion, body ache, severe headache and chills was not reported. This report was non-serious. This case, from the same reporter is linked to
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; EXHAUSTION; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced exhaustion. On 2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 100 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, exhaustion, body ache, severe headache and chills was not reported. This report was non-serious. This case, from the same reporter is linked to
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Paraesthesia, Rhinorrhoea
Clinical narrative: BURNING PAIN GOING DOWN IN BOTH ARMS FROM ELBOWS, TO FOREARMS, TO WRISTS, TO PALM OF HANDS; PINS AND NEEDLES FEELING IN FINGERS; CONSISTENT RUNNY NOSE; BOTH WRISTS SORE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced burning pain going down in both arms from elbows, to forearms, to wrists, to palm of hands. On 2021, the subject experienced pins and needles feeling in fingers. On 2021, the subject experienced consistent runny nose. On 2021, the subject experienced both wrists sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning pain going down in both arms from elbows, to forearms, to wrists, to palm of hands, both wrists sore, pins and needles feeling in fingers, and consistent runny nose. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Limb discomfort, Pain in extremity
Clinical narrative: INCREASED BACK TO BACK HEAVY NOSE BLEEDS FROM BOTH NOSTRILS; ARM SORENESS; HEAVINESS IN ARM; This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed and concurrent conditions included seasonal allergy to pollen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in arm. On 12-APR-2021, the subject experienced arm soreness. On 16-APR-2021, the subject experienced increased back to back heavy nose bleeds from both nostrils. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 14-APR-2021, had not recovered from increased back to back heavy nose bleeds from both nostrils, and the outcome of heaviness in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Contusion, Dizziness, Muscle spasms, Neck pain
Clinical narrative: BACK BRUISES; NECK SPASM; NECK PAIN; SWELLING OF THE TONGUE; BODY ACHES; DIZZINESS; CHILLS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient have no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced dizziness. On 26-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced swelling of the tongue. On 01-APR-2021, the subject experienced neck spasm. On 01-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced back bruises. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, and chills on 27-MAR-2021, and swelling of the tongue on 29-MAR-2021, was recovering from back bruises, and had not recovered from neck spasm, and neck pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative, Swollen tongue
Clinical narrative: BACK BRUISES; NECK SPASM; NECK PAIN; SWELLING OF THE TONGUE; BODY ACHES; DIZZINESS; CHILLS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient have no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced dizziness. On 26-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced swelling of the tongue. On 01-APR-2021, the subject experienced neck spasm. On 01-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced back bruises. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, and chills on 27-MAR-2021, and swelling of the tongue on 29-MAR-2021, was recovering from back bruises, and had not recovered from neck spasm, and neck pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: EARLIER MENSTRUEL CYCLE; HEAVIER BLEEDING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced earlier menstrual cycle. On APR-2021, the subject experienced heavier bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the earlier menstrual cycle and heavier bleeding was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: EXPERIENCED SOME ADVERSE EVENTS; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced experienced some adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experienced some adverse events was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; EVERYTHING TASTED METALLIC FOR 48 HOURS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced body ache, everything tasted metallic for 48 hours, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, everything tasted metallic for 48 hours, chills, fever, and headache. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: VOMITING; FEET AND LEG PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included aspirin allergy, and concurrent conditions included history of blood clot, and chronic inflammatory demyelinating polyneuropathy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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. Concomitant medications included immunoglobulin human normal for chronic inflammatory demyelinating polyneuropathy. On 28-MAR-2021, the subject experienced vomiting. On 28-MAR-2021, the subject experienced feet and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and feet and leg pain was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Face and mouth X-ray, Headache, Hordeolum
Clinical narrative: STY IN RIGHT EYE; LITTLE LIQUID IN THE EAR; CHILLS; HEADACHE; DID NOT FEEL GOOD; ARM PAIN; SWELLING OF THE NECK; SWELLING OF THE LEFT SHOULDER; ENLARGED LYMPH NODES ON THE LEFT SIDE; NECK PAIN; TENDON TIGHTNESS; POPPING NOISE WHEN SWALLOWING; SUSPECTED COVID-19; SINUS ISSUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hives, allergic to sulfa medications (welts all over the body), non-smoker, allergy to percocet (increased heart rate), latex allergy (skin burns), and sleep disorder. 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 15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for chronic hives, and diphenhydramine hydrochloride for sleep disturbance.  On APR-2021, the subject experienced popping noise when swallowing. On APR-2021, the subject experienced suspected covid-19. On APR-2021, the subject experienced sinus issue. On 10-APR-2021, the subject experienced swelling of the neck. On 10-APR-2021, the subject experienced swelling of the left shoulder. On 10-APR-2021, the subject experienced enlarged lymph nodes on the left side. On 10-APR-2021, the subject experienced neck pain. On 10-APR-2021, the subject experienced tendon tightness. On 10-APR-2021, the subject experienced did not feel good. On 10-APR-2021, the subject experienced arm pain. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced chills. On 15-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 21-APR-2021, the subject experienced sty in right eye. On 21-APR-2021, the subject experienced little liquid in the ear. Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and X-ray of nasal sinuses (NR: not provided) Normal sinuses. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, paracetamol, guaifenesin/pseudoephedrine hydrochloride, naproxen sodium, fluticasone propionate, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the neck, swelling of the left shoulder, enlarged lymph nodes on the left side, neck pain, tendon tightness, and arm pain on 13-APR-2021, and chills on 12-APR-2021, was recovering from sty in right eye, had not recovered from headache, and the outcome of popping noise when swallowing, suspected covid-19, did not feel good, sinus issue and little liquid in the ear was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy, Malaise, Neck pain, Otorrhoea
Clinical narrative: STY IN RIGHT EYE; LITTLE LIQUID IN THE EAR; CHILLS; HEADACHE; DID NOT FEEL GOOD; ARM PAIN; SWELLING OF THE NECK; SWELLING OF THE LEFT SHOULDER; ENLARGED LYMPH NODES ON THE LEFT SIDE; NECK PAIN; TENDON TIGHTNESS; POPPING NOISE WHEN SWALLOWING; SUSPECTED COVID-19; SINUS ISSUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hives, allergic to sulfa medications (welts all over the body), non-smoker, allergy to percocet (increased heart rate), latex allergy (skin burns), and sleep disorder. 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 15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for chronic hives, and diphenhydramine hydrochloride for sleep disturbance.  On APR-2021, the subject experienced popping noise when swallowing. On APR-2021, the subject experienced suspected covid-19. On APR-2021, the subject experienced sinus issue. On 10-APR-2021, the subject experienced swelling of the neck. On 10-APR-2021, the subject experienced swelling of the left shoulder. On 10-APR-2021, the subject experienced enlarged lymph nodes on the left side. On 10-APR-2021, the subject experienced neck pain. On 10-APR-2021, the subject experienced tendon tightness. On 10-APR-2021, the subject experienced did not feel good. On 10-APR-2021, the subject experienced arm pain. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced chills. On 15-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 21-APR-2021, the subject experienced sty in right eye. On 21-APR-2021, the subject experienced little liquid in the ear. Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and X-ray of nasal sinuses (NR: not provided) Normal sinuses. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, paracetamol, guaifenesin/pseudoephedrine hydrochloride, naproxen sodium, fluticasone propionate, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the neck, swelling of the left shoulder, enlarged lymph nodes on the left side, neck pain, tendon tightness, and arm pain on 13-APR-2021, and chills on 12-APR-2021, was recovering from sty in right eye, had not recovered from headache, and the outcome of popping noise when swallowing, suspected covid-19, did not feel good, sinus issue and little liquid in the ear was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test negative, Sinusitis, Suspected COVID-19, Swelling
Clinical narrative: STY IN RIGHT EYE; LITTLE LIQUID IN THE EAR; CHILLS; HEADACHE; DID NOT FEEL GOOD; ARM PAIN; SWELLING OF THE NECK; SWELLING OF THE LEFT SHOULDER; ENLARGED LYMPH NODES ON THE LEFT SIDE; NECK PAIN; TENDON TIGHTNESS; POPPING NOISE WHEN SWALLOWING; SUSPECTED COVID-19; SINUS ISSUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hives, allergic to sulfa medications (welts all over the body), non-smoker, allergy to percocet (increased heart rate), latex allergy (skin burns), and sleep disorder. 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 15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for chronic hives, and diphenhydramine hydrochloride for sleep disturbance.  On APR-2021, the subject experienced popping noise when swallowing. On APR-2021, the subject experienced suspected covid-19. On APR-2021, the subject experienced sinus issue. On 10-APR-2021, the subject experienced swelling of the neck. On 10-APR-2021, the subject experienced swelling of the left shoulder. On 10-APR-2021, the subject experienced enlarged lymph nodes on the left side. On 10-APR-2021, the subject experienced neck pain. On 10-APR-2021, the subject experienced tendon tightness. On 10-APR-2021, the subject experienced did not feel good. On 10-APR-2021, the subject experienced arm pain. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced chills. On 15-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 21-APR-2021, the subject experienced sty in right eye. On 21-APR-2021, the subject experienced little liquid in the ear. Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and X-ray of nasal sinuses (NR: not provided) Normal sinuses. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, paracetamol, guaifenesin/pseudoephedrine hydrochloride, naproxen sodium, fluticasone propionate, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the neck, swelling of the left shoulder, enlarged lymph nodes on the left side, neck pain, tendon tightness, and arm pain on 13-APR-2021, and chills on 12-APR-2021, was recovering from sty in right eye, had not recovered from headache, and the outcome of popping noise when swallowing, suspected covid-19, did not feel good, sinus issue and little liquid in the ear was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon disorder
Clinical narrative: STY IN RIGHT EYE; LITTLE LIQUID IN THE EAR; CHILLS; HEADACHE; DID NOT FEEL GOOD; ARM PAIN; SWELLING OF THE NECK; SWELLING OF THE LEFT SHOULDER; ENLARGED LYMPH NODES ON THE LEFT SIDE; NECK PAIN; TENDON TIGHTNESS; POPPING NOISE WHEN SWALLOWING; SUSPECTED COVID-19; SINUS ISSUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hives, allergic to sulfa medications (welts all over the body), non-smoker, allergy to percocet (increased heart rate), latex allergy (skin burns), and sleep disorder. 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 15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for chronic hives, and diphenhydramine hydrochloride for sleep disturbance.  On APR-2021, the subject experienced popping noise when swallowing. On APR-2021, the subject experienced suspected covid-19. On APR-2021, the subject experienced sinus issue. On 10-APR-2021, the subject experienced swelling of the neck. On 10-APR-2021, the subject experienced swelling of the left shoulder. On 10-APR-2021, the subject experienced enlarged lymph nodes on the left side. On 10-APR-2021, the subject experienced neck pain. On 10-APR-2021, the subject experienced tendon tightness. On 10-APR-2021, the subject experienced did not feel good. On 10-APR-2021, the subject experienced arm pain. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced chills. On 15-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 21-APR-2021, the subject experienced sty in right eye. On 21-APR-2021, the subject experienced little liquid in the ear. Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and X-ray of nasal sinuses (NR: not provided) Normal sinuses. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, paracetamol, guaifenesin/pseudoephedrine hydrochloride, naproxen sodium, fluticasone propionate, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the neck, swelling of the left shoulder, enlarged lymph nodes on the left side, neck pain, tendon tightness, and arm pain on 13-APR-2021, and chills on 12-APR-2021, was recovering from sty in right eye, had not recovered from headache, and the outcome of popping noise when swallowing, suspected covid-19, did not feel good, sinus issue and little liquid in the ear was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: LEFT ARM SWOLLEN; PAIN AT LEFT ARM/ HURT ON MOVEMENT; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart attack, and concurrent conditions included breast cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced left arm swollen. On 23-MAR-2021, the subject experienced pain at left arm/ hurt on movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at left arm/ hurt on movement, and left arm swollen. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Herpes zoster
Clinical narrative: Diagnosed with shingles; passed away suddenly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away suddenly) and HERPES ZOSTER (Diagnosed with shingles) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 28-Dec-2020 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion hospitalization). The patient died on 13-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HERPES ZOSTER (Diagnosed with shingles) outcome was unknown.            Treatment included antiviral medication valtrex 1 mg.  The action taken with mRNA-1273 with events was not applicable.  Cause of death was unknown. Plans for an autopsy were not provided.  This case concerns a 75-year-old, male patient, who experienced herpes zoster 5 days after and died 1 month 15 days after receiving the first dose of mRNA-1273. 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. The cause of death was not reported. It is unknown if an autopsy was performed.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: Follow-up included fatal event.; Sender's Comments: This case concerns a 75-year-old, male patient, who experienced herpes zoster 5 days after and died 1 month 15 days after receiving the first dose of mRNA-1273. 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. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis perforated, Arthralgia, Gastrointestinal pain
Clinical narrative: ruptured appendix; Cramps in his lower intestine; Shoulder started getting a little sore; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (ruptured appendix) in an 80-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 was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, ALLOPURINOL and TOPIRAMATE for an unknown indication.   On 12-Jan-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 12-Jan-2021, the patient experienced ARTHRALGIA (Shoulder started getting a little sore). On 13-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Cramps in his lower intestine). On an unknown date, the patient experienced APPENDICITIS PERFORATED (ruptured appendix) (seriousness criterion hospitalization). At the time of the report, APPENDICITIS PERFORATED (ruptured appendix) had resolved and GASTROINTESTINAL PAIN (Cramps in his lower intestine) and ARTHRALGIA (Shoulder started getting a little sore) outcome was unknown.            The patient took Tums antacids which helped for a little while and he took milk on 14-Jan-2021. For ruptured appendix, patient  had surgery in the hospital.  Although a temporal association exists, based on the current available information,  the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The  event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated.  The causality of the event of arthralgia is assessed as possibly related.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: An event  ruptured appendix was added with treatment information.; Sender's Comments: Although a temporal association exists, based on the current available information,  the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The  event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated.  The causality of the event of arthralgia is assessed as possibly related.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: could not take the second shot scheduled on 10 Mar 2021 due to his bad physical health.; COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (could not take the second shot scheduled on 10 Mar 2021 due to his bad physical health.). At the time of the report, COVID-19 (COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms) and INCOMPLETE COURSE OF VACCINATION (could not take the second shot scheduled on 10 Mar 2021 due to his bad physical health.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Based on the current available information, the event COVID-19 positive is assessed as unlikely related to mRNA-1273. This report also refers to a case of incomplete course of vaccination for mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: The patient was COVID-19 positive on 15-Feb-2021 after 5 days of getting the first shot of  vaccine (10-Feb-2021). All the reported reactions were turned out to be COVID symptoms. He was hospitalized for around 10 days and could not take the second shot scheduled on 10-Mar-2021 due to his bad physical health.; Sender's Comments: Based on the current available information, the event COVID-19 positive is assessed as unlikely related to mRNA-1273. This report also refers to a case of incomplete course of vaccination for mRNA-1273, lot
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FACIAL PARALYSIS (Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  As of 12-Apr-2021, the patient cannot move the left side of face.  Treatment for the event included acyclovir and prednisone.  Company Comment - 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.; 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.