chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Injection site discomfort, Pain
Clinical narrative: ACHY; FEELING WEAK; CHILLS; HEADACHE; DISCOMFORT AT SITE OF INJECTION; RAPID HEART BEAT OF 120; This spontaneous report received from a consumer 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 (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced discomfort at site of injection. On 10-MAR-2021, the subject experienced rapid heart beat of 120. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 120 (units unspecified). On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort at site of injection, rapid heart beat of 120, chills, and headache on 11-MAR-2021, and achy, and feeling weak on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Sluggishness
Clinical narrative: LITTLE SLUGGISH TODAY, BUT NOTHING MAJOR; COLD CHILLS; BODY ACHES; 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, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021 20:00, the subject experienced cold chills. On 13-MAR-2021 20:00, the subject experienced body aches. On 14-MAR-2021, the subject experienced little sluggish today, but nothing major. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills, and body aches on 14-MAR-2021 01:00, and the outcome of little sluggish today, but nothing major was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FEELS SORE; 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 feels sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels sore was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations
Clinical narrative: POUNDING HEART; GENERAL MALAISE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 pounding heart, and general malaise. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding heart and general malaise was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: LIGHT HEAD; SORE ARM; 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, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm, and light head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and light head. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: BODY ACHE; COLD CHILLS; QUEASY; HEADACHE; DIZZY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizzy. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced cold chills. On 12-MAR-2021, the subject experienced queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the queasy, dizzy, cold chills, body ache and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS IN LEG; 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced numbness in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in leg. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, and the outcome of chills was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hypersensitivity, Malaise, Pyrexia
Clinical narrative: HYPERSENSITIVITY WITH SKIN; SKIN ON FIRE AND BURNING; EXTREMELY COLD; NIGHTTIME CHILLS; MALAISE; FEVER; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced hypersensitivity with skin. On 14-MAR-2021, the subject experienced skin on fire and burning. On 14-MAR-2021, the subject experienced extremely cold. On 14-MAR-2021, the subject experienced nighttime chills. On 14-MAR-2021, the subject experienced malaise. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hypersensitivity with skin, extremely cold, nighttime chills, malaise, fever, and skin on fire and burning. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: HYPERSENSITIVITY WITH SKIN; SKIN ON FIRE AND BURNING; EXTREMELY COLD; NIGHTTIME CHILLS; MALAISE; FEVER; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced hypersensitivity with skin. On 14-MAR-2021, the subject experienced skin on fire and burning. On 14-MAR-2021, the subject experienced extremely cold. On 14-MAR-2021, the subject experienced nighttime chills. On 14-MAR-2021, the subject experienced malaise. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hypersensitivity with skin, extremely cold, nighttime chills, malaise, fever, and skin on fire and burning. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Mental disorder, Pain in extremity, Pyrexia
Clinical narrative: PSYCHOLOGICAL PROBLEMS HAVE WORSENED; SORENESS IN ARM; FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included depression.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced flu-like symptoms. On 11-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced soreness in arm. On an unspecified date, the subject experienced psychological problems have worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, and the outcome of flu-like symptoms, soreness in arm and psychological problems have worsened was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Feeling hot
Clinical narrative: FEELING WARM; STIFF BODY; WEAKNESS; HEADACHE; ACHY BODY; DIZZINESS AND LIGHT HEADEDNESS; NO APPETITE; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included iud mirena and orilissa, and gall bladder removal, and concurrent conditions included endometriosis, 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to the left arm for prophylactic vaccination. Concomitant medications included elagolix sodium, and levonorgestrel. On MAR-2020, the subject experienced achy body. On MAR-2021, the subject experienced dizziness and light headedness. On MAR-2021, the subject experienced no appetite. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced stiff body. On 14-MAR-2021, the subject experienced weakness. On 15-MAR-2021, the subject experienced feeling warm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and light headedness, and had not recovered from feeling warm, headache, stiff body, weakness, no appetite, tiredness, and achy body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle rigidity, Myalgia
Clinical narrative: FEELING WARM; STIFF BODY; WEAKNESS; HEADACHE; ACHY BODY; DIZZINESS AND LIGHT HEADEDNESS; NO APPETITE; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included iud mirena and orilissa, and gall bladder removal, and concurrent conditions included endometriosis, 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to the left arm for prophylactic vaccination. Concomitant medications included elagolix sodium, and levonorgestrel. On MAR-2020, the subject experienced achy body. On MAR-2021, the subject experienced dizziness and light headedness. On MAR-2021, the subject experienced no appetite. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced stiff body. On 14-MAR-2021, the subject experienced weakness. On 15-MAR-2021, the subject experienced feeling warm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and light headedness, and had not recovered from feeling warm, headache, stiff body, weakness, no appetite, tiredness, and achy body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: HAD A FEW SIDE EFFECTS; This spontaneous report received from a patient via a company representative . 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 not reported and is requested) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced had a few side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had a few side effects was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY ACHE; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included doesn't take any medication, alcoholic, and nonsmoker, and other pre-existing medical conditions included patient had no known allergies. patient was alcoholic consume alcohol occasionally, about once monthly patient was non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 001B21A expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 14-MAR-2021 23:00, the subject experienced body ache. On 14-MAR-2021 23:00, the subject experienced headache. On 14-MAR-2021 23:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and was recovering from headache, and body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHINESS; This spontaneous report received from a parent 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness on 14-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210329147.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; DIZZINESS; ACHE; LOW GRADE FEVER; 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. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms, dizziness, ache, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, ache, dizziness and low grade fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Hypersensitivity
Clinical narrative: YEAST INFECTION; ALLERGIC REACTION - ITCHING ALL OVER THE BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced itching all over the body (mostly in hands and feet). On 09-MAR-2021, the subject experienced yeast infection. On 09-MAR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching all over the body (mostly in hands and feet), yeast infection and allergic reaction was not reported. The batch number was not reported and has been requested. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Productive cough, Rash
Clinical narrative: PRODUCTIVE COUGH; RASH ON ARM, LEGS, BETWEEN BREASTS AND ANKLES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included ex smoker, and poison ivy rash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced productive cough, rash on arm, legs, between breasts and ankles and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on arm, legs, between breasts and ankles, injection site pain and productive cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated blood pressure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue/tiredeness. On 13-MAR-2021, the subject experienced fast heart beats.consumer got the vaccine week ago, suffering from fatigue and tiredeness that did not go away and fast heart beats The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart beats, and had not recovered from fatigue/tiredeness. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and  fast heart beats and fatigue/tiredness..Company causality between covid-19 vaccine ad26.cov2.s and fast heart beats, fatigue/ tiredeness was possible. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 32.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal
Clinical narrative: FEELING OFF; This spontaneous report received from a patient via a company representative concerned a 32 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received tylenol unspecified (form of admin and route of admin were not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. 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 is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced feeling off. The action taken with covid-19 vaccine ad26.cov2.s, and tylenol unspecified was not applicable. The outcome of feeling off was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Flank pain, Pain, Peripheral swelling
Clinical narrative: SEVERE BODY PAIN; SWOLLEN ARM; RIGHT SIDE HURTS; FREAKED OUT; 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 and batch number: 1805020 expiry: UNKNNOWN) dose was not reported, administered on 13-MAR-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced severe body pain. On 15-MAR-2021, the subject experienced swollen arm. On 15-MAR-2021, the subject experienced right side hurts. On 15-MAR-2021, the subject experienced freaked out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe body pain, and swollen arm, and the outcome of right side hurts and freaked out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Erythema, Headache, Injection site reaction, Injection site swelling
Clinical narrative: IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Fatigue, Impaired work ability
Clinical narrative: IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Loss of personal independence in daily activities, Magnetic resonance imaging, Malaise
Clinical narrative: IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Rash, Rotator cuff syndrome
Clinical narrative: IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tendonitis, X-ray limb
Clinical narrative: IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain
Clinical narrative: 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, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced dizziness. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, dizziness, chills, and headache on 15-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: LIGHTHEADEDNESS; HEADACHE; SORE LEGS; NAUSEA; TIREDNESS; LOW-GRADE FEVER; CHILLS; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 around15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride. On MAR-2021 around 9:30-10:00 pm, the subject experienced chills. On 12-MAR-2021 around 9:30-10:00 pm, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) Approximately 99 F. On 13-MAR-2021, the subject experienced sore legs. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced tiredness. On 15-MAR-2021, the subject experienced lightheadedness. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAR-2021, and the outcome of lightheadedness, sore legs, tiredness, headache, low-grade fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: LIGHTHEADEDNESS; HEADACHE; SORE LEGS; NAUSEA; TIREDNESS; LOW-GRADE FEVER; CHILLS; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 around15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride. On MAR-2021 around 9:30-10:00 pm, the subject experienced chills. On 12-MAR-2021 around 9:30-10:00 pm, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) Approximately 99 F. On 13-MAR-2021, the subject experienced sore legs. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced tiredness. On 15-MAR-2021, the subject experienced lightheadedness. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAR-2021, and the outcome of lightheadedness, sore legs, tiredness, headache, low-grade fever and chills was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Somnolence
Clinical narrative: Severe headaches, joint pain 9 out of 10, fatigue, sleepiness.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities, Pruritus, Rhinorrhoea
Clinical narrative: At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to help that much except to dry out my nasal passage. Then, I started feeling lightheaded in the same evening and somewhat disconnected from my body. Then, the next morning, and all day, I've been clumsy and uncoordinated.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Headache, Nausea, Pain
Clinical narrative: BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGRAVATED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous neck injury, recent knee surgery, and shoulder injury, and concurrent conditions included penicillin allergy, use reading glasses, and headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced blurry vision. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced head to toe soreness. On 13-MAR-2021, the subject experienced weakness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache aggravated. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021, was recovering from weakness, nausea, blurry vision, headache aggravated, vomiting, and stomach upset, and had not recovered from head to toe soreness. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred, Vomiting
Clinical narrative: BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGRAVATED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous neck injury, recent knee surgery, and shoulder injury, and concurrent conditions included penicillin allergy, use reading glasses, and headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced blurry vision. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced head to toe soreness. On 13-MAR-2021, the subject experienced weakness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache aggravated. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021, was recovering from weakness, nausea, blurry vision, headache aggravated, vomiting, and stomach upset, and had not recovered from head to toe soreness. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Ear discomfort, Ear pain, Erythema
Clinical narrative: One week after the shot, my left ear filled up, extreme pain, was completely clogged, low grade fever began (100.2) around that time and I did experience a little dizziness on one day. I had my ear cleaned out at an urgent care, he said my ear was only a little red so it was not an infection but gave me an amoxicillin to take just in case. My tinnitus also increased. It has been a little over 3 weeks since the event began and my fever did break, the ear pain is much less, no more dizziness currently but the Tinnitus is louder than what I had pre-shot. It seems a little better but not back to where it was pre-shot.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: One week after the shot, my left ear filled up, extreme pain, was completely clogged, low grade fever began (100.2) around that time and I did experience a little dizziness on one day. I had my ear cleaned out at an urgent care, he said my ear was only a little red so it was not an infection but gave me an amoxicillin to take just in case. My tinnitus also increased. It has been a little over 3 weeks since the event began and my fever did break, the ear pain is much less, no more dizziness currently but the Tinnitus is louder than what I had pre-shot. It seems a little better but not back to where it was pre-shot.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Ear discomfort, Ear pain, Hypoacusis, Pain assessment
Clinical narrative: One week after the shot, my left ear filled up, extreme pain, was completely clogged, low grade fever began (100.2) around that time and I did experience a little dizziness on one day. I had my ear cleaned out at an urgent care, he said my ear was only a little red so it was not an infection but gave me an amoxicillin to take just in case. My tinnitus also increased. It has been a little over 3 weeks since the event began and my fever did break, the ear pain is much less, no more dizziness currently but the Tinnitus is louder than what I had pre-shot. It seems a little better but not back to where it was pre-shot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A tinnitus started in my ears - a hissing or sound of static - constant and loud. Never experienced this before.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: 1 week after vaccine developed swelling at the site and it itches.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Lethargy, Pain
Clinical narrative: At 9 pm the day of my shot- I got a fever of 101, and was  lethargic. I went to bed. At midnight I woke up with a bad headache, fever, chills, lightheaded and dizzy. For the entire next day, I had all of these symptoms, along with body ache and lethargic.  I went to bed around 9 pm, and when I woke up the next day- I felt much better, other than a slight headache and body ache
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: At 9 pm the day of my shot- I got a fever of 101, and was  lethargic. I went to bed. At midnight I woke up with a bad headache, fever, chills, lightheaded and dizzy. For the entire next day, I had all of these symptoms, along with body ache and lethargic.  I went to bed around 9 pm, and when I woke up the next day- I felt much better, other than a slight headache and body ache
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE LEAKED BETWEEN THE NEEDLE AND SYRINGE, PATIENT GOT PARTIAL DOSE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced vaccine leaked between the needle and syringe, subject got partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine leaked between the needle and syringe, patient got partial dose was not reported. This report was non-serious. This case is associated with product quality complaint-90000173093.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Tinnitus
Clinical narrative: constant tinnitus in left ear, headaches, ear pressure.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Epistaxis, Pain, Polymenorrhoea
Clinical narrative: One or more nosebleeds per day for 4-5 days (started about 4 days after vaccine).  I rarely get nosebleeds. Lower back pain. At first it was more intense and painful to even walk. This started 3-4 days after my vaccine. After about a week it lessened, but it's still present 3.5 weeks later. My period is very regular since I'm on birth control, but my period started a couple days early after getting the vaccine. It started about 6 days after my vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Rash
Clinical narrative: Rash in hair on base if neck. Substantial hair loss in same area.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Head discomfort, Headache, Muscle spasms, Nasal discomfort
Clinical narrative: Mild headache and mild leg pain started on 4/12/2021 at around 23:00. Leg pain can best be described as cramping, shooting pain in the back of the calf and thigh, at times radiating through the rest of the leg. Headache was a dull throbbing on right side of the head. Pain increased to moderate in both areas in the following days. Headache and Leg pain persisted through 4/23/2021. The leg pain continued to be sharp/shooting/cramping, but the headache transformed from a dull throbbing on the side of the head to a moderate sharp, burning feeling in the temples. This was also accompanied by a burning feeling in the nasal cavity and a "pins and needles"/heaviness feeling around the ears. Pain was not severe enough to be debilitating but required frequent pain medication to manage. The headache and leg pain appear to have ceased as of 4/24/2021.