chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; 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 (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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case is associated with PQC no. 90000176125. The suspected product quality complaint has been confirmed to be no PQC was identified within the complaint reported.  Complaint has been approved for void, based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Asthenia, Body temperature, Chills, Confusional state
Clinical narrative: STINGING AT INJECTION SITE; CHILLS; COULD BARELY WALK TO KITCHEN; NAUSEA; HEADACHE; FEVER; FATIGUE; WEAKNESS; LITTLE SORENESS AT INJECTION SITE; MAYBE A LITTLE BIT OF MENTAL CONFUSION; NECK PAIN; FELT LETHARGIC; HUNGER; LAST NIGHT WAS OUT OF IT AND COULD NOT DO  ANYTHING; KNOCKED OUT FOR ABOUT 10 HOURS; 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 pass out when younger due to allergies, and tingling in mouth before pass out, and concurrent conditions included history of allergic reactions to many different things, and penicillin and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hunger. On APR-2021, the subject experienced last night was out of it and could not do anything. On APR-2021, the subject experienced knocked out for about 10 hours. On 12-APR-2021, the subject experienced maybe a little bit of mental confusion. On 12-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced felt lethargic. On 12-APR-2021, the subject experienced could barely walk to kitchen. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced little soreness at injection site. On 12-APR-2021 16:30, the subject experienced chills. On 13-APR-2021, the subject experienced stinging at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging at injection site, was recovering from nausea, chills, maybe a little bit of mental confusion, little soreness at injection site, felt lethargic, and could barely walk to kitchen, had not recovered from headache, fever, fatigue, weakness, and neck pain, and the outcome of hunger, last night was out of it and could not do anything and knocked out for about 10 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hunger, Injection site pain
Clinical narrative: STINGING AT INJECTION SITE; CHILLS; COULD BARELY WALK TO KITCHEN; NAUSEA; HEADACHE; FEVER; FATIGUE; WEAKNESS; LITTLE SORENESS AT INJECTION SITE; MAYBE A LITTLE BIT OF MENTAL CONFUSION; NECK PAIN; FELT LETHARGIC; HUNGER; LAST NIGHT WAS OUT OF IT AND COULD NOT DO  ANYTHING; KNOCKED OUT FOR ABOUT 10 HOURS; 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 pass out when younger due to allergies, and tingling in mouth before pass out, and concurrent conditions included history of allergic reactions to many different things, and penicillin and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hunger. On APR-2021, the subject experienced last night was out of it and could not do anything. On APR-2021, the subject experienced knocked out for about 10 hours. On 12-APR-2021, the subject experienced maybe a little bit of mental confusion. On 12-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced felt lethargic. On 12-APR-2021, the subject experienced could barely walk to kitchen. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced little soreness at injection site. On 12-APR-2021 16:30, the subject experienced chills. On 13-APR-2021, the subject experienced stinging at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging at injection site, was recovering from nausea, chills, maybe a little bit of mental confusion, little soreness at injection site, felt lethargic, and could barely walk to kitchen, had not recovered from headache, fever, fatigue, weakness, and neck pain, and the outcome of hunger, last night was out of it and could not do anything and knocked out for about 10 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Neck pain, Pyrexia, Somnolence
Clinical narrative: STINGING AT INJECTION SITE; CHILLS; COULD BARELY WALK TO KITCHEN; NAUSEA; HEADACHE; FEVER; FATIGUE; WEAKNESS; LITTLE SORENESS AT INJECTION SITE; MAYBE A LITTLE BIT OF MENTAL CONFUSION; NECK PAIN; FELT LETHARGIC; HUNGER; LAST NIGHT WAS OUT OF IT AND COULD NOT DO  ANYTHING; KNOCKED OUT FOR ABOUT 10 HOURS; 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 pass out when younger due to allergies, and tingling in mouth before pass out, and concurrent conditions included history of allergic reactions to many different things, and penicillin and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hunger. On APR-2021, the subject experienced last night was out of it and could not do anything. On APR-2021, the subject experienced knocked out for about 10 hours. On 12-APR-2021, the subject experienced maybe a little bit of mental confusion. On 12-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced felt lethargic. On 12-APR-2021, the subject experienced could barely walk to kitchen. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced little soreness at injection site. On 12-APR-2021 16:30, the subject experienced chills. On 13-APR-2021, the subject experienced stinging at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging at injection site, was recovering from nausea, chills, maybe a little bit of mental confusion, little soreness at injection site, felt lethargic, and could barely walk to kitchen, had not recovered from headache, fever, fatigue, weakness, and neck pain, and the outcome of hunger, last night was out of it and could not do anything and knocked out for about 10 hours was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Illness
Clinical narrative: ELEVATED D-DIMER; SHORTNESS OF BREATH; COLD; GOT SICK; This spontaneous report received from a parent concerned a 22 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced got sick. On 09-APR-2021, the subject experienced elevated d-dimer. Laboratory data included: Fibrin D dimer (NR: not provided) elevated levels of 0.6. On 09-APR-2021 15:30, Laboratory data included: CT scan (NR: not provided) negative for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, got sick, shortness of breath and elevated d-dimer was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: ELEVATED D-DIMER; SHORTNESS OF BREATH; COLD; GOT SICK; This spontaneous report received from a parent concerned a 22 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced got sick. On 09-APR-2021, the subject experienced elevated d-dimer. Laboratory data included: Fibrin D dimer (NR: not provided) elevated levels of 0.6. On 09-APR-2021 15:30, Laboratory data included: CT scan (NR: not provided) negative for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, got sick, shortness of breath and elevated d-dimer was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a parent concerned a 25 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 31-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210424198.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: LEFT ARM SORE; NAUSEOUS; HEADACHE; TIREDNESS; DIZZINESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iron deficient. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced left arm sore. On 12-APR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and headache, was recovering from dizziness, and had not recovered from left arm sore, and nauseous. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: NUMBNESS IN CHEEKS; TINGLING PINS AND NEEDLES; GROGGY; FELT GROSS; SWEATY; NAUSEA; VERY TIRED; HEADACHE; CHILLS AND FEVERS; This spontaneous report received from a patient concerned a 27 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: 205A264, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 22:00, the subject experienced chills and fevers. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 10:00, the subject experienced groggy. On 10-APR-2021 10:00, the subject experienced felt gross. On 11-APR-2021 22:00, the subject experienced tingling pins and needles. On 12-APR-2021, the subject experienced numbness in cheeks. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, groggy, felt gross, nausea, and headache, and chills and fevers on 10-APR-2021, had not recovered from tingling pins and needles, and very tired, and the outcome of numbness in cheeks was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia, Somnolence
Clinical narrative: NUMBNESS IN CHEEKS; TINGLING PINS AND NEEDLES; GROGGY; FELT GROSS; SWEATY; NAUSEA; VERY TIRED; HEADACHE; CHILLS AND FEVERS; This spontaneous report received from a patient concerned a 27 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: 205A264, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 22:00, the subject experienced chills and fevers. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 10:00, the subject experienced groggy. On 10-APR-2021 10:00, the subject experienced felt gross. On 11-APR-2021 22:00, the subject experienced tingling pins and needles. On 12-APR-2021, the subject experienced numbness in cheeks. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, groggy, felt gross, nausea, and headache, and chills and fevers on 10-APR-2021, had not recovered from tingling pins and needles, and very tired, and the outcome of numbness in cheeks was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: HEART RATE HIGH; CHILLS; DIFFICULTY BREATHING/SHORTNESS OF BREATH; COUGHING; FEELING ANXIOUS; HEADACHE; FEELING UNWELL; INJECTION SITE SORE; INJECTION SITE WARMTH; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 54 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site warmth. On 08-APR-2021, the subject experienced injection site sore. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced feeling unwell. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced difficulty breathing/shortness of breath. On 12-APR-2021, the subject experienced coughing. On 12-APR-2021, the subject experienced feeling anxious. On 13-APR-2021, the subject experienced heart rate high. On 13-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) unknown, and Pulse rate (NR: not provided) 105. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of injection site sore, injection site warmth, fatigue, difficulty breathing/shortness of breath, coughing, heart rate high, tiredness, feeling unwell, chills and feeling anxious 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Injection site pain, Injection site warmth
Clinical narrative: HEART RATE HIGH; CHILLS; DIFFICULTY BREATHING/SHORTNESS OF BREATH; COUGHING; FEELING ANXIOUS; HEADACHE; FEELING UNWELL; INJECTION SITE SORE; INJECTION SITE WARMTH; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 54 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site warmth. On 08-APR-2021, the subject experienced injection site sore. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced feeling unwell. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced difficulty breathing/shortness of breath. On 12-APR-2021, the subject experienced coughing. On 12-APR-2021, the subject experienced feeling anxious. On 13-APR-2021, the subject experienced heart rate high. On 13-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) unknown, and Pulse rate (NR: not provided) 105. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of injection site sore, injection site warmth, fatigue, difficulty breathing/shortness of breath, coughing, heart rate high, tiredness, feeling unwell, chills and feeling anxious 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: HEART RATE HIGH; CHILLS; DIFFICULTY BREATHING/SHORTNESS OF BREATH; COUGHING; FEELING ANXIOUS; HEADACHE; FEELING UNWELL; INJECTION SITE SORE; INJECTION SITE WARMTH; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 54 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site warmth. On 08-APR-2021, the subject experienced injection site sore. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced feeling unwell. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced difficulty breathing/shortness of breath. On 12-APR-2021, the subject experienced coughing. On 12-APR-2021, the subject experienced feeling anxious. On 13-APR-2021, the subject experienced heart rate high. On 13-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) unknown, and Pulse rate (NR: not provided) 105. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of injection site sore, injection site warmth, fatigue, difficulty breathing/shortness of breath, coughing, heart rate high, tiredness, feeling unwell, chills and feeling anxious 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
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: SWEATY AFTER FEVER BROKE; FLU FEELING; MUSCLE SORENESS; CHILLS; FRONTAL HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 173 pounds, and height was not reported. The patient's concurrent conditions included ehlers-danlos syndrome, sjogren's syndrome, and blood clotting disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced frontal headache. On 13-APR-2021, the subject experienced sweaty after fever broke. On 13-APR-2021, the subject experienced flu feeling. On 13-APR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty after fever broke, flu feeling, chills, frontal headache, and muscle soreness on 13-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Injection site nodule, Muscle spasms
Clinical narrative: SHORTNESS OF BREATH; LEG CRAMPS; KNOT AT INJECTION SITE ON RIGHT ARM; HEADACHE; 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 sulfa allergy, penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced knot at injection site on right arm. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from knot at injection site on right arm, leg cramps, and shortness of breath. 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: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, the batch number will not be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and mild headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Pain
Clinical narrative: DIZZY; "JOINTS KILLED ME"; ACHY; This spontaneous report was received from a consumer and concerned a female patient of an unspecified age with an unknown race and unknown ethnicity. 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 patient experienced achy, "joints killed me", and dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, "joints killed me" and dizzy was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Eye pruritus, Fatigue, Headache
Clinical narrative: ALLERGIC REACTION; SWOLLEN EYELID; VERTIGO; RASH ON NECK; NAUSEA; EYES PUFFY; ITCHY EYES; EAR CLOGGED; EARACHE; RINGING IN EAR; SLEEPY; TIRED; HEADACHE; This spontaneous report received from a patient via Social media concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and pneumonia, and concurrent conditions included asthma, and high cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNNOWN) dose was not reported, administered on 08-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced earache. On 21-MAR-2021, the subject experienced ringing in ear. On APR-2021, the subject experienced ear clogged. On 05-APR-2021, the subject experienced eyes puffy. On 05-APR-2021, the subject experienced itchy eyes. On 12-APR-2021, the subject experienced swollen eyelid. On 12-APR-2021, the subject experienced vertigo. On 12-APR-2021, the subject experienced rash on neck. On 12-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, ciprofloxacin/dexamethasone, azithromycin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, was recovering from earache, and nausea, had not recovered from, swollen eyelid, rash on neck, tired, and headache, and the outcome of vertigo, eyes puffy, allergic reaction, sleepy, ear clogged and itchy eyes was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nausea, Periorbital swelling, Rash, Somnolence
Clinical narrative: ALLERGIC REACTION; SWOLLEN EYELID; VERTIGO; RASH ON NECK; NAUSEA; EYES PUFFY; ITCHY EYES; EAR CLOGGED; EARACHE; RINGING IN EAR; SLEEPY; TIRED; HEADACHE; This spontaneous report received from a patient via Social media concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and pneumonia, and concurrent conditions included asthma, and high cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNNOWN) dose was not reported, administered on 08-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced earache. On 21-MAR-2021, the subject experienced ringing in ear. On APR-2021, the subject experienced ear clogged. On 05-APR-2021, the subject experienced eyes puffy. On 05-APR-2021, the subject experienced itchy eyes. On 12-APR-2021, the subject experienced swollen eyelid. On 12-APR-2021, the subject experienced vertigo. On 12-APR-2021, the subject experienced rash on neck. On 12-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, ciprofloxacin/dexamethasone, azithromycin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, was recovering from earache, and nausea, had not recovered from, swollen eyelid, rash on neck, tired, and headache, and the outcome of vertigo, eyes puffy, allergic reaction, sleepy, ear clogged and itchy eyes was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Tinnitus, Vertigo
Clinical narrative: ALLERGIC REACTION; SWOLLEN EYELID; VERTIGO; RASH ON NECK; NAUSEA; EYES PUFFY; ITCHY EYES; EAR CLOGGED; EARACHE; RINGING IN EAR; SLEEPY; TIRED; HEADACHE; This spontaneous report received from a patient via Social media concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and pneumonia, and concurrent conditions included asthma, and high cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNNOWN) dose was not reported, administered on 08-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced earache. On 21-MAR-2021, the subject experienced ringing in ear. On APR-2021, the subject experienced ear clogged. On 05-APR-2021, the subject experienced eyes puffy. On 05-APR-2021, the subject experienced itchy eyes. On 12-APR-2021, the subject experienced swollen eyelid. On 12-APR-2021, the subject experienced vertigo. On 12-APR-2021, the subject experienced rash on neck. On 12-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, ciprofloxacin/dexamethasone, azithromycin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, was recovering from earache, and nausea, had not recovered from, swollen eyelid, rash on neck, tired, and headache, and the outcome of vertigo, eyes puffy, allergic reaction, sleepy, ear clogged and itchy eyes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included hives, bariatric surgery, and diabetic, and concurrent conditions included lettuce. nuts and unspecified ingredient in indian food allergy, asthma, heart disease, cholesterol problem, ex smoker, allergy of unknown food substance, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included montelukast for asthma, atorvastatin for high cholesterol, famotidine for stomach acid, acetylsalicylic acid, biotin, and cyanocobalamin. On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and nausea. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Inflammation
Clinical narrative: TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ITCHY ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with Percocet (oxycodone hydrochloride;paracetamol), morphine ,diphenhydramine, Demerol (pethidine hydrochloride) ,Biaxin (clarithromycin), Levaquin (levofloxacin). 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflamed arm. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced swollen arm. On 10-APR-2021, the subject experienced red arm. On 10-APR-2021, the subject experienced hot arm. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced taste alteration. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches, and fatigue on 12-APR-2021, had not recovered from taste alteration, swollen arm, red arm, hot arm, and fever, and the outcome of itchy arm, sore arm and inflamed arm was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Taste disorder
Clinical narrative: TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ITCHY ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with Percocet (oxycodone hydrochloride;paracetamol), morphine ,diphenhydramine, Demerol (pethidine hydrochloride) ,Biaxin (clarithromycin), Levaquin (levofloxacin). 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflamed arm. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced swollen arm. On 10-APR-2021, the subject experienced red arm. On 10-APR-2021, the subject experienced hot arm. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced taste alteration. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches, and fatigue on 12-APR-2021, had not recovered from taste alteration, swollen arm, red arm, hot arm, and fever, and the outcome of itchy arm, sore arm and inflamed arm was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nasopharyngitis, Pain
Clinical narrative: ACHY; TIRED; HEADACHE; FEVER; SWEATING; COLD; This spontaneous report received from a patient concerned a 30 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included unspecified birth control pills.  On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and cold on 12-APR-2021 09:00, headache, and fever on 11-APR-2021, and had not recovered from tired, and achy. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHY; TIRED; HEADACHE; FEVER; SWEATING; COLD; This spontaneous report received from a patient concerned a 30 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included unspecified birth control pills.  On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and cold on 12-APR-2021 09:00, headache, and fever on 11-APR-2021, and had not recovered from tired, and achy. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Injection site reaction, Night sweats
Clinical narrative: ACHINESS; CHILLS; REDNESS/SWELLING AT INJECTION SITE; FEVER; PAIN AT INJECTION SITE; NIGHT SWEATS; This spontaneous report received from a patient concerned a 47 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 or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced night sweats. On 10-APR-2021, the subject experienced pain at injection site. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced redness/swelling at injection site. On 11-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.5 degrees F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, night sweats, chills, and fever on 11-APR-2021, and had not recovered from pain at injection site, and redness/swelling at injection site. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHINESS; CHILLS; REDNESS/SWELLING AT INJECTION SITE; FEVER; PAIN AT INJECTION SITE; NIGHT SWEATS; This spontaneous report received from a patient concerned a 47 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 or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced night sweats. On 10-APR-2021, the subject experienced pain at injection site. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced redness/swelling at injection site. On 11-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.5 degrees F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, night sweats, chills, and fever on 11-APR-2021, and had not recovered from pain at injection site, and redness/swelling at injection site. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Application site nodule, Body temperature, Headache, Pain, Parosmia
Clinical narrative: WEIRD SMELL THROUGH HER NOSE; WEIRD TASTE FROM FOOD; BODY ACHE; KNOT ON INJECTED ARM; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and concurrent conditions included seasonal allergies. 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-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100-101 F. On 05-APR-2021, the subject experienced severe headache. On an unspecified date, the subject experienced weird smell through her nose, weird taste from food, body ache, knot on injected arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and the outcome of fever, knot on injected arm, body ache, weird smell through her nose and weird taste from food was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: WEIRD SMELL THROUGH HER NOSE; WEIRD TASTE FROM FOOD; BODY ACHE; KNOT ON INJECTED ARM; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and concurrent conditions included seasonal allergies. 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-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100-101 F. On 05-APR-2021, the subject experienced severe headache. On an unspecified date, the subject experienced weird smell through her nose, weird taste from food, body ache, knot on injected arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and the outcome of fever, knot on injected arm, body ache, weird smell through her nose and weird taste from food was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Influenza like illness, Pain in extremity, Paraesthesia
Clinical narrative: FLU-LIKE SYMPTOMS/HEADACHE/NAUSEA/VOMITING/FEVER/CHILLS; TINGLING SENSATION IN LEG; SWEATING; HOT FLASHES; EXTREME LEG SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no other medical condition and had no known allergies. 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 09-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tingling sensation in leg. On 09-APR-2021, the subject experienced flu-like symptoms/headache/nausea/vomiting/fever/chills. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced extreme leg soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in leg on APR-2021, had not recovered from extreme leg soreness, and flu-like symptoms/headache/nausea/vomiting/fever/chills, and the outcome of sweating and hot flashes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Productive cough
Clinical narrative: GREEN/YELLOW PHLEGM; COUGH; This spontaneous report received from a patient concerned a 31 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to Left Deltoid for prophylactic vaccination.  No concomitant medications were reported. On 08-APR-2021, the subject experienced cough. On 09-APR-2021, the subject experienced green/yellow phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and green/yellow phlegm. This report was non-serious.