chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Genital pain, Genital swelling, Peripheral swelling, Secretion discharge
Clinical narrative: WATER LEAKING FROM SWOLLEN ARM; SWOLLEN ARM; ACHEY OF PRIVATE PARTS; SWELLING OF PRIVATE PARTS; This spontaneous report received from a consumer concerned a 77 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced achey of private parts. On 31-MAR-2021, the subject experienced swelling of private parts. On 11-APR-2021, the subject experienced water leaking from swollen arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm, achey of private parts, swelling of private parts, and water leaking from swollen arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: INJECTION SITE IRRITATION; INJECTION SITE SWELLING; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 145 pounds, and height was not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced injection site irritation, injection site swelling, and injection site redness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, injection site redness, and injection site irritation. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: WHOLE BODY SHAKES; DIZZINESS; TROUBLE WALKING AND HAND TO WALK REAL SLOW; FEELING SICK; CHILLS/SHIVERS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included pace maker, and concurrent conditions included arthritis, herniating disk in the lower back, and dyslexia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:00, the subject experienced whole body shakes. On 08-APR-2021 15:00, the subject experienced dizziness. On 08-APR-2021 15:00, the subject experienced trouble walking and hand to walk real slow. On 08-APR-2021 15:00, the subject experienced feeling sick. On 08-APR-2021 15:00, the subject experienced chills/shivers. On 08-APR-2021 15:00, the subject experienced tiredness. On 08-APR-2021 15:00, the subject experienced headache. Treatment medications (dates unspecified) included: lorazepam, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body shakes, feeling sick, and headache, recovered with sequelae from chills/shivers, had not recovered from dizziness, and tiredness, and the outcome of trouble walking and hand to walk real slow was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Tremor
Clinical narrative: WHOLE BODY SHAKES; DIZZINESS; TROUBLE WALKING AND HAND TO WALK REAL SLOW; FEELING SICK; CHILLS/SHIVERS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included pace maker, and concurrent conditions included arthritis, herniating disk in the lower back, and dyslexia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:00, the subject experienced whole body shakes. On 08-APR-2021 15:00, the subject experienced dizziness. On 08-APR-2021 15:00, the subject experienced trouble walking and hand to walk real slow. On 08-APR-2021 15:00, the subject experienced feeling sick. On 08-APR-2021 15:00, the subject experienced chills/shivers. On 08-APR-2021 15:00, the subject experienced tiredness. On 08-APR-2021 15:00, the subject experienced headache. Treatment medications (dates unspecified) included: lorazepam, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body shakes, feeling sick, and headache, recovered with sequelae from chills/shivers, had not recovered from dizziness, and tiredness, and the outcome of trouble walking and hand to walk real slow was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Back pain, Confusional state, Dizziness
Clinical narrative: VOMITING/THROWN UP; ANXIETY; CONFUSION; TROUBLE WITH SPEECH ISNT THE  SAME; UNABLE TO SLEEP; "SULFA TASTE" IN HER MOUTH; FELT A LITTLE DIZZY; COULD BARELY WALK; BACK ACHE; KIDNEY SWOLLEN; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt a little dizzy. On APR-2021, the subject experienced could barely walk. On APR-2021, the subject experienced back ache. On APR-2021, the subject experienced kidney swollen. On APR-2021, the subject experienced anxiety. On APR-2021, the subject experienced confusion. On APR-2021, the subject experienced trouble with speech isnt the same. On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced "sulfa taste" in her mouth. On 11-APR-2021, the subject experienced vomiting/thrown up. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/thrown up on 12-APR-2021, and the outcome of felt a little dizzy, could barely walk, back ache, anxiety, confusion, trouble with speech isnt the same, unable to sleep, kidney swollen and "sulfa taste" in her mouth was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Gait disturbance, Insomnia, Speech disorder, Vomiting
Clinical narrative: VOMITING/THROWN UP; ANXIETY; CONFUSION; TROUBLE WITH SPEECH ISNT THE  SAME; UNABLE TO SLEEP; "SULFA TASTE" IN HER MOUTH; FELT A LITTLE DIZZY; COULD BARELY WALK; BACK ACHE; KIDNEY SWOLLEN; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt a little dizzy. On APR-2021, the subject experienced could barely walk. On APR-2021, the subject experienced back ache. On APR-2021, the subject experienced kidney swollen. On APR-2021, the subject experienced anxiety. On APR-2021, the subject experienced confusion. On APR-2021, the subject experienced trouble with speech isnt the same. On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced "sulfa taste" in her mouth. On 11-APR-2021, the subject experienced vomiting/thrown up. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/thrown up on 12-APR-2021, and the outcome of felt a little dizzy, could barely walk, back ache, anxiety, confusion, trouble with speech isnt the same, unable to sleep, kidney swollen and "sulfa taste" in her mouth was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain
Clinical narrative: BODY ACHES AND BODY SORENESS; DIFFICULTY IN BREATHING; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker, colitis, seizures, diabetes, and cholesterol, and other pre-existing medical conditions included the patient had no known drug allergies, not allergic to any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included azathioprine for colitis, lamotrigine for seizures, zolpidem for sleeping, meclozine for vertigo, amoxicillin, atorvastatin, hydrochlorothiazide, infliximab, olmesartan, ondansetron, potassium, potassium chloride, propranolol, and venlafaxine. On APR-2021, the subject experienced body aches and body soreness. On APR-2021, the subject experienced difficulty in breathing. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and body soreness, difficulty in breathing and tired was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Insomnia, Muscle tightness, Musculoskeletal discomfort
Clinical narrative: HEART RACING FEELING; PRESSURE IN THE BACK; TIGHTNESS IN THE BACK; SEVERE HEADACHE LOCALIZED TO TOP OF HEAD; COULD NOT SLEEP OVER NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included hypertension, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced could not sleep over night. On 11-APR-2021 21:00, the subject experienced pressure in the back. On 11-APR-2021 21:00, the subject experienced tightness in the back. On 11-APR-2021 21:00, the subject experienced severe headache localized to top of head. On 12-APR-2021, treatment medications included: paracetamol. On 12-APR-2021 10:00, the subject experienced heart racing feeling. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep over night, had not recovered from severe headache localized to top of head, and heart racing feeling, and the outcome of pressure in the back and tightness in the back was not reported. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART RACING FEELING; PRESSURE IN THE BACK; TIGHTNESS IN THE BACK; SEVERE HEADACHE LOCALIZED TO TOP OF HEAD; COULD NOT SLEEP OVER NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included hypertension, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced could not sleep over night. On 11-APR-2021 21:00, the subject experienced pressure in the back. On 11-APR-2021 21:00, the subject experienced tightness in the back. On 11-APR-2021 21:00, the subject experienced severe headache localized to top of head. On 12-APR-2021, treatment medications included: paracetamol. On 12-APR-2021 10:00, the subject experienced heart racing feeling. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep over night, had not recovered from severe headache localized to top of head, and heart racing feeling, and the outcome of pressure in the back and tightness in the back was not reported. 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: Poor venous access
Clinical narrative: DIFFICULTY IN DRAWING BLOOD FROM FINGER; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced difficulty in drawing blood from finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty in drawing blood from finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Muscle tightness, Platelet aggregation test
Clinical narrative: MUSCLE TIGHTNESS IN THE ARM; SWELLING OF THE LYMPH NODES; FELT TIRED; HEADACHE; 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 past medical history included neck injury, and car accident, and concurrent conditions included hashimoto's disease, overweight, sinus infection, and blood clot. The patient was previously treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. Concomitant medications included acetylsalicylic acid for blood clot, curcuma longa rhizome for drug use for unknown indication, zingiber officinale rhizome for drug use for unknown indication, amoxicillin trihydrate/clavulanate potassium for sinus infection, ergocalciferol, magnesium, and . On 2018, Laboratory data included: Platelet aggregation test (NR: not provided) negative.  On 09-APR-2021, the subject experienced felt tired. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced muscle tightness in the arm. On 10-APR-2021, the subject experienced swelling of the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt tired, headache, muscle tightness in the arm, and swelling of the lymph nodes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HORRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-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 05-APR-2021, the subject experienced horrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible headache on 05-APR-2021. This report was non-serious.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included ischemic stroke, and ischemic stroke. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Tremor
Clinical narrative: SHAKING; WEAKNESS; CHILLS; HEAD PAIN; TIREDNESS; This spontaneous report received from a patient concerned a 68 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication. On 07-APR-2021, the subject experienced shaking. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced head pain. On 07-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: moringa oleifera, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and head pain on 07-APR-2021, and had not recovered from tiredness, and weakness. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Injection site pain, Lethargy
Clinical narrative: SHORTNESS OF BREATH; EARLY MENSTRUAL PERIOD; DIARRHEA; LETHARGY; WEAKNESS; NAUSEA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included low iron, egg allergy, and pork allergy. 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 10-APR-2021 for prophylactic vaccination. Concomitant medications included iron for low iron. On an unspecified date, the subject experienced shortness of breath, early menstrual period, diarrhea, lethargy, weakness, nausea, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, diarrhea, weakness, lethargy, shortness of breath, early menstrual period and injection site pain was not reported. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedures.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Polymenorrhoea
Clinical narrative: SHORTNESS OF BREATH; EARLY MENSTRUAL PERIOD; DIARRHEA; LETHARGY; WEAKNESS; NAUSEA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included low iron, egg allergy, and pork allergy. 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 10-APR-2021 for prophylactic vaccination. Concomitant medications included iron for low iron. On an unspecified date, the subject experienced shortness of breath, early menstrual period, diarrhea, lethargy, weakness, nausea, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, diarrhea, weakness, lethargy, shortness of breath, early menstrual period and injection site pain was not reported. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedures.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: PAIN IN DOWN RIGHT SIDE; SEVERE SHOULDER PAIN; PAIN ALL OVER THE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in down right side, severe shoulder pain, and pain all over the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, pain all over the arm and pain in down right side was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Diarrhoea, Dizziness
Clinical narrative: DIARRHEA; VOMITTING; CHEST TIGHTNESS; EXTREME DIZZINESS; ACHEY KNEES; CHILLS; NAUSEA; HEADACHE; FATIGUED; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced extreme dizziness. On 11-APR-2021, the subject experienced achey knees. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fatigued. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced vomitting. On 12-APR-2021, the subject experienced chest tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 13-APR-2021, and vomitting, and achey knees on 12-APR-2021, was recovering from nausea, headache, chills, and extreme dizziness, and had not recovered from chest tightness, and fatigued. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: DIARRHEA; VOMITTING; CHEST TIGHTNESS; EXTREME DIZZINESS; ACHEY KNEES; CHILLS; NAUSEA; HEADACHE; FATIGUED; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced extreme dizziness. On 11-APR-2021, the subject experienced achey knees. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fatigued. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced vomitting. On 12-APR-2021, the subject experienced chest tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 13-APR-2021, and vomitting, and achey knees on 12-APR-2021, was recovering from nausea, headache, chills, and extreme dizziness, and had not recovered from chest tightness, and fatigued. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: LEFT FOOT  SWELLING COMES AND GOES; LEFT FOOT SORENESS; LEFT FOOT FEELING HOT; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced left foot feeling hot. On 30-MAR-2021, the subject experienced left foot swelling comes and goes. On 30-MAR-2021, the subject experienced left foot soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot swelling comes and goes, and left foot soreness, and the outcome of left foot feeling hot was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: FELT LIKE HEAVINESS / WEIGHTS IN OBLIQUES; SORENESS IN ARM; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced soreness in arm. On 14-APR-2021, the subject experienced felt like heaviness / weights in obliques. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm on 21-MAR-2021, and had not recovered from felt like heaviness / weights in obliques. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: LETHARGIC; FEVER; MUSCLE ACHES; BAD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced lethargic. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, fever, muscle aches, and bad headache on 12-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: INJECTION SITE SWELLING; 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site swelling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Influenza like illness, Nausea
Clinical narrative: FLU LIKE SYMPTOMS; LOSS OF APPETITE; NAUSEA; This spontaneous report received from a consumer concerned a 48 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A22A expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 07:20 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021 18:00, the subject experienced flu like symptoms. On 13-APR-2021 18:00, the subject experienced loss of appetite. On 13-APR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, loss of appetite and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Lacrimation increased, Pyrexia
Clinical narrative: FOGGINESS; RUNNY NOSE; WATERY EYES; DROWSINESS; CHILLS; FEVER; FATIGUE; 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 pre-existing medical conditions included never had allergies before. 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 31-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 fatigue. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced watery eyes. On APR-2021, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fogginess, runny nose, and watery eyes on APR-2021, and chills, and fever on 2021, and the outcome of fatigue and drowsiness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: FOGGINESS; RUNNY NOSE; WATERY EYES; DROWSINESS; CHILLS; FEVER; FATIGUE; 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 pre-existing medical conditions included never had allergies before. 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 31-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 fatigue. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced watery eyes. On APR-2021, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fogginess, runny nose, and watery eyes on APR-2021, and chills, and fever on 2021, and the outcome of fatigue and drowsiness was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Dyspnoea, Fatigue, Headache
Clinical narrative: HEADACHE; DOUBLE VISION; SHORT OF BREATH; PAIN IN LEGS; UNUSUALLY TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 101 kilograms, and height was 60 inches. The patient's concurrent conditions included psoriasis, dry eyes, seasonal allergies-non serious, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and not asked drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ciclosporin for dry eyes, and etanercept for treatment of psoriasis.  On 11-APR-2021, the subject experienced double vision. On 11-APR-2021, the subject experienced short of breath. On 11-APR-2021, the subject experienced pain in legs. On 11-APR-2021, the subject experienced unusually tired. On 12-APR-2021, the subject experienced headache. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and pain in legs on 11-APR-2021, and headache on 13-APR-2021, and was recovering from unusually tired, and short of breath. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HEADACHE; DOUBLE VISION; SHORT OF BREATH; PAIN IN LEGS; UNUSUALLY TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 101 kilograms, and height was 60 inches. The patient's concurrent conditions included psoriasis, dry eyes, seasonal allergies-non serious, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and not asked drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ciclosporin for dry eyes, and etanercept for treatment of psoriasis.  On 11-APR-2021, the subject experienced double vision. On 11-APR-2021, the subject experienced short of breath. On 11-APR-2021, the subject experienced pain in legs. On 11-APR-2021, the subject experienced unusually tired. On 12-APR-2021, the subject experienced headache. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and pain in legs on 11-APR-2021, and headache on 13-APR-2021, and was recovering from unusually tired, and short of breath. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Renal pain
Clinical narrative: SEVERE ABDOMINAL PAIN; LEFT KIDNEY PAIN / KIDNEY STILL HURTS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included kidney stones.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A210 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced severe abdominal pain, and left kidney pain / kidney still hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, and was recovering from left kidney pain / kidney still hurts. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: CHILLS; FREEZING; 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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-MAR-2021, and the outcome of freezing was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: SORE ARM/ CAN HARDLY MOVE IT; FLU SYMPTOMS/ NAUSEA/ NO APPETITE; This spontaneous report received from a patient concerned a 45 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: 206A22A expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 07:20 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021 18:00, the subject experienced flu symptoms/ nausea/ no appetite. On 14-APR-2021 08:00, the subject experienced sore arm/ can hardly move it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms/ nausea/ no appetite on 14-APR-2021, and had not recovered from sore arm/ can hardly move it. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Pyrexia, Restlessness
Clinical narrative: BODY ACHES; MIGRAINE; RESTLESS IN BED; SHAKING CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 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 body aches, migraine, restless in bed, shaking chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and the outcome of shaking chills, body aches, fever and restless in bed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436881.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: LITTLE RED MARK AT INJECTION SITE; DIARRHEA; BODY ACHES; STOMACH ACHE; NAUSEA; TIREDNESS; HEADACHE; LIGHT HEADED; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's 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: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  Non-company suspect drugs included: paracetamol (caplet, oral, batch number: 2GE1525C expiry: 31-JAN-2015) 500 mg, 2 times every 1 day, from 13-APR-2021 for headache; and ibuprofen (caplet, oral, batch number: 9DE2742A expiry: 31-JAN-2021) 200 mg, 2 times every 1 day, from 13-APR-2021 for body ache, and headache. No concomitant medications were reported.  On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced burning during injection. On 13-APR-2021 07:00, the subject experienced headache. On 13-APR-2021 07:00, the subject experienced tiredness. On 13-APR-2021 13:00, the subject experienced stomach ache. On 13-APR-2021 13:00, the subject experienced nausea. On 13-APR-2021 17:00, the subject experienced diarrhea. On 13-APR-2021 17:00, the subject experienced body aches. On 14-APR-2021, the subject experienced little red mark at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and burning during injection on APR-2021, and had not recovered from light headed, headache, nausea, stomach ache, little red mark at injection site, body aches, and tiredness. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: LITTLE RED MARK AT INJECTION SITE; DIARRHEA; BODY ACHES; STOMACH ACHE; NAUSEA; TIREDNESS; HEADACHE; LIGHT HEADED; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's 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: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  Non-company suspect drugs included: paracetamol (caplet, oral, batch number: 2GE1525C expiry: 31-JAN-2015) 500 mg, 2 times every 1 day, from 13-APR-2021 for headache; and ibuprofen (caplet, oral, batch number: 9DE2742A expiry: 31-JAN-2021) 200 mg, 2 times every 1 day, from 13-APR-2021 for body ache, and headache. No concomitant medications were reported.  On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced burning during injection. On 13-APR-2021 07:00, the subject experienced headache. On 13-APR-2021 07:00, the subject experienced tiredness. On 13-APR-2021 13:00, the subject experienced stomach ache. On 13-APR-2021 13:00, the subject experienced nausea. On 13-APR-2021 17:00, the subject experienced diarrhea. On 13-APR-2021 17:00, the subject experienced body aches. On 14-APR-2021, the subject experienced little red mark at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and burning during injection on APR-2021, and had not recovered from light headed, headache, nausea, stomach ache, little red mark at injection site, body aches, and tiredness. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: RASH TO BOTH ARMS AND REST OF THE  BODY; BUMPS TO BODY AND HIVES; This spontaneous report received from a patient concerned a 41 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 and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced rash to both arms and rest of the body. On 05-APR-2021, the subject experienced bumps to body and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash to both arms and rest of the body, and bumps to body and hives. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: DIZZY; HEADACHES ON RIGHT SIDE BY EARS; GROGGY; FELT OUT OF IT; SOARED AROUND ARM; TIREDNESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 380 pounds, and height was 71 inches. The patient's concurrent conditions included pre-diabetes, high blood pressure, pollen allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced groggy. On 02-APR-2021, the subject experienced felt out of it. On 02-APR-2021, the subject experienced soared around arm. On 02-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced headaches on right side by ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soared around arm, and tiredness, and had not recovered from groggy, headaches on right side by ears, dizzy, and felt out of it. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: DIZZY; HEADACHES ON RIGHT SIDE BY EARS; GROGGY; FELT OUT OF IT; SOARED AROUND ARM; TIREDNESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 380 pounds, and height was 71 inches. The patient's concurrent conditions included pre-diabetes, high blood pressure, pollen allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced groggy. On 02-APR-2021, the subject experienced felt out of it. On 02-APR-2021, the subject experienced soared around arm. On 02-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced headaches on right side by ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soared around arm, and tiredness, and had not recovered from groggy, headaches on right side by ears, dizzy, and felt out of it. This report was non-serious.