chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Breast discomfort, Dyspnoea, Electrocardiogram, Hypotension
Clinical narrative: BREATHING PROBLEMS; THICK HEAVY/SWOLLEN LEGS; LOW BLOOD PRESSURE; PRESSURE IN BREAST AREA; LUMP AT INJECTION SITE; HOT URINE; HUGE RASH ON ARM, SHOULDER AND BACK; INJECTION SITE PAIN/ PAIN DURING INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pressure in breast area. On 30-MAR-2021, the subject experienced lump at injection site. On 30-MAR-2021, the subject experienced hot urine. On 30-MAR-2021, the subject experienced huge rash on arm, shoulder and back. On 30-MAR-2021, the subject experienced injection site pain/ pain during injection. On 10-APR-2021, the subject experienced breathing problems. On 10-APR-2021, the subject experienced thick heavy/swollen legs. On 10-APR-2021, the subject experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) LOW, and Oxygen saturation (NR: not provided) 90s down to 83. On 13-APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) No issue in Heart, and X-ray (NR: not provided) No issue in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing problems, thick heavy/swollen legs, and injection site pain/ pain during injection on 18-APR-2021, low blood pressure on 10-APR-2021, pressure in breast area on 30-MAR-2021, lump at injection site on 17-APR-2021, hot urine on 01-APR-2021, and huge rash on arm, shoulder and back on 19-APR-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Oxygen saturation, Peripheral swelling, Rash
Clinical narrative: BREATHING PROBLEMS; THICK HEAVY/SWOLLEN LEGS; LOW BLOOD PRESSURE; PRESSURE IN BREAST AREA; LUMP AT INJECTION SITE; HOT URINE; HUGE RASH ON ARM, SHOULDER AND BACK; INJECTION SITE PAIN/ PAIN DURING INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pressure in breast area. On 30-MAR-2021, the subject experienced lump at injection site. On 30-MAR-2021, the subject experienced hot urine. On 30-MAR-2021, the subject experienced huge rash on arm, shoulder and back. On 30-MAR-2021, the subject experienced injection site pain/ pain during injection. On 10-APR-2021, the subject experienced breathing problems. On 10-APR-2021, the subject experienced thick heavy/swollen legs. On 10-APR-2021, the subject experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) LOW, and Oxygen saturation (NR: not provided) 90s down to 83. On 13-APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) No issue in Heart, and X-ray (NR: not provided) No issue in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing problems, thick heavy/swollen legs, and injection site pain/ pain during injection on 18-APR-2021, low blood pressure on 10-APR-2021, pressure in breast area on 30-MAR-2021, lump at injection site on 17-APR-2021, hot urine on 01-APR-2021, and huge rash on arm, shoulder and back on 19-APR-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urine abnormality, X-ray
Clinical narrative: BREATHING PROBLEMS; THICK HEAVY/SWOLLEN LEGS; LOW BLOOD PRESSURE; PRESSURE IN BREAST AREA; LUMP AT INJECTION SITE; HOT URINE; HUGE RASH ON ARM, SHOULDER AND BACK; INJECTION SITE PAIN/ PAIN DURING INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pressure in breast area. On 30-MAR-2021, the subject experienced lump at injection site. On 30-MAR-2021, the subject experienced hot urine. On 30-MAR-2021, the subject experienced huge rash on arm, shoulder and back. On 30-MAR-2021, the subject experienced injection site pain/ pain during injection. On 10-APR-2021, the subject experienced breathing problems. On 10-APR-2021, the subject experienced thick heavy/swollen legs. On 10-APR-2021, the subject experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) LOW, and Oxygen saturation (NR: not provided) 90s down to 83. On 13-APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) No issue in Heart, and X-ray (NR: not provided) No issue in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing problems, thick heavy/swollen legs, and injection site pain/ pain during injection on 18-APR-2021, low blood pressure on 10-APR-2021, pressure in breast area on 30-MAR-2021, lump at injection site on 17-APR-2021, hot urine on 01-APR-2021, and huge rash on arm, shoulder and back on 19-APR-2021. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: DIARRHEA; VOMITING; HEADACHE; This spontaneous report received from a consumer concerned a 7 decade 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, vomiting, and headache on 27-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: RASPY VOICE; This spontaneous report received from a patient concerned an adult 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: Unk) dose was not reported, administered on 10-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 10-MAR-2021, the subject experienced raspy voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raspy voice was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: NO ENERGY; TIREDNESS; LIGHT HEADED; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and sleep, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with alprazolam for sleep, and curcuma longa rhizome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) .5 ml, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced light headed. On 07-APR-2021, the subject experienced no energy. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed on 06-APR-2021, and no energy, and tiredness on 07-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: PARESTHESIA; WEAKNESS IN LEGS; This spontaneous report received from a consumer concerned a 38 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, the subject experienced weakness in legs. On 18-APR-2021, the subject experienced paresthesia.  Treatment medications included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paresthesia, and weakness in legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SLIGHT ARM ACHE; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced slight arm ache, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and slight arm ache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210440719, 20210439367 and 20210439312.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: ACHY; FATIGUE; MILD HEADACHE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 64 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: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the subject experienced achy. On 17-APR-2021, the subject experienced fatigue. On 17-APR-2021, the subject experienced mild headache. On 17-APR-2021, the subject experienced slight fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98-99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild headache, achy, fatigue, and slight fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SOME ACHINESS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 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 some achiness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some achiness, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Suspected COVID-19
Clinical narrative: FEELING LIKE HE HAD COVID SYMTOMS; SPENT 2 DAYS IN BED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-APR-2021 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 feeling like he had covid symptoms, and spent 2 days in bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spent 2 days in bed and feeling like he had covid symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: DIZZINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced dizziness. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from headache, nausea, and dizziness. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear disorder, Fatigue, Headache
Clinical narrative: INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE  NEXT TO IT; COULD HARDLY  SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; 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 viral meningitis, nausea, and headache, and concurrent conditions included clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Insomnia, Pyrexia, Sensory disturbance, Sensory loss
Clinical narrative: INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE  NEXT TO IT; COULD HARDLY  SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; 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 viral meningitis, nausea, and headache, and concurrent conditions included clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE  NEXT TO IT; COULD HARDLY  SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; 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 viral meningitis, nausea, and headache, and concurrent conditions included clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Headache, Pain, Pain in extremity
Clinical narrative: BODY ACHES; INNER GROIN PAIN; LEG TENDERNESS CAUSE TROUBLE IN WALKING FELT ARTHRITIC AND CALF PAIN; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and had no drug abuse or illicit drug usage. The patient did not experienced any pain prior to vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 15:17 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced inner groin pain. On 09-APR-2021, the subject experienced leg tenderness cause trouble in walking felt arthritic and calf pain. On 09-APR-2021, the subject experienced severe headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache on 10-APR-2021, and had not recovered from body aches, leg tenderness cause trouble in walking felt arthritic and calf pain, and inner groin pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 135 pounds, and height was 63 inches. 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, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fatigue on 13-APR-2021. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Diarrhoea, Influenza, Myalgia, Pain in extremity
Clinical narrative: GENERAL FLU; Loose stools; Arm soreness; muscle soreness; FEVER OF 102; This spontaneous report received from a patient concerned a 34 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: UNKNOWN) dose was not reported, administered on 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 general flu. On APR-2021, the subject experienced loose stools. On APR-2021, the subject experienced arm soreness. On APR-2021, the subject experienced muscle soreness. On APR-2021, the subject experienced fever of 102. Laboratory data included: Body temperature increased (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, muscle soreness, fever of 102, general flu and loose stools was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: GENERAL FLU; Loose stools; Arm soreness; muscle soreness; FEVER OF 102; This spontaneous report received from a patient concerned a 34 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: UNKNOWN) dose was not reported, administered on 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 general flu. On APR-2021, the subject experienced loose stools. On APR-2021, the subject experienced arm soreness. On APR-2021, the subject experienced muscle soreness. On APR-2021, the subject experienced fever of 102. Laboratory data included: Body temperature increased (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, muscle soreness, fever of 102, general flu and loose stools was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: HEADACHE; SEVERE SHAKES; BODY ACHES; SEVERE CHILLS; FEVER; 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced severe shakes. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced severe chills. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 08:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe shakes, severe chills, and fever on 26-MAR-2021, body aches on 28-MAR-2021, and headache on 27-MAR-2021. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: VOMITING; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a 50 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: Unk) 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 vomiting, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and vomiting was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SEVERE PAIN IN LEFT FOOT; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced severe pain in left foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe pain in left foot was not reported. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: RASH ON RIGHT ARM; HIVES ON RIGHT ARM; This spontaneous report received from a consumer concerned an 83 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced rash on right arm, and hives on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives on right arm and rash on right arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a parent concerned a 21 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced terrible body ache, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible body ache, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210439312, 20210439367 and 20210440719.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Chills; Joint Pain; MILD FEVER; Muscle Aches; Fatigue; Headaches; INJECTION SITE SORENESS; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 50 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included liver transplants, and concurrent conditions included Crohn's disease, osteopenia, hyperparathyroidism, and sluggish kidneys. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 13:30 for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease, tramadol for Crohn's disease pain, levothyroxine sodium for hyperparathyroidism, azathioprine for immunosuppressant, and tacrolimus for immunosuppressant.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced mild fever. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced headaches. On 06-MAR-2021, the subject experienced injection site soreness. On 06-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 99.8 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, mild fever, muscle aches, headaches, injection site soreness, and injection site swelling on 10-MAR-2021, and fatigue on MAR-2021. This report was non-serious.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Chills; Joint Pain; MILD FEVER; Muscle Aches; Fatigue; Headaches; INJECTION SITE SORENESS; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 50 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included liver transplants, and concurrent conditions included Crohn's disease, osteopenia, hyperparathyroidism, and sluggish kidneys. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 13:30 for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease, tramadol for Crohn's disease pain, levothyroxine sodium for hyperparathyroidism, azathioprine for immunosuppressant, and tacrolimus for immunosuppressant.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced mild fever. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced headaches. On 06-MAR-2021, the subject experienced injection site soreness. On 06-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 99.8 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, mild fever, muscle aches, headaches, injection site soreness, and injection site swelling on 10-MAR-2021, and fatigue on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Nausea, Oropharyngeal pain
Clinical narrative: NAUSEA; DIZZINESS; WEAKNESS; ARM PAIN; THROAT PAIN; 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: 1808980, expiry: 20/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced throat pain. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced headache. On 19-APR-2021, the subject experienced dizziness. On 19-APR-2021, the subject experienced weakness. On 19-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat pain, arm pain, and headache on APR-2021, and had not recovered from nausea, weakness, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: NAUSEA; DIZZINESS; WEAKNESS; ARM PAIN; THROAT PAIN; 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: 1808980, expiry: 20/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced throat pain. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced headache. On 19-APR-2021, the subject experienced dizziness. On 19-APR-2021, the subject experienced weakness. On 19-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat pain, arm pain, and headache on APR-2021, and had not recovered from nausea, weakness, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; SHOULDER PAIN; ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included guillain barre syndrome. 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 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) Not Reported. On MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced shoulder pain. On MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, shoulder pain and arm pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: PERIPHERAL NEUROPATHY SYMPTOMS IN  FEET DISAPPEARED FOR 6 DAYS (UNEXPECTED THERAPEUTIC BENEFIT); 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 peripheral neuropathy bilateral feet, and diabetes. 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 2021, the subject experienced peripheral neuropathy symptoms in feet disappeared for 6 days (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of peripheral neuropathy symptoms in feet disappeared for 6 days (unexpected therapeutic benefit) was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash
Clinical narrative: SORE; RASH ALL OVER THE BODY; SHIVERING; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included graves disease, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. 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 has been requested. No concomitant medications were reported.  On 14-APR-2021, the subject experienced sore. On 14-APR-2021, the subject experienced rash all over the body. On 14-APR-2021, the subject experienced shivering. On 14-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, rash all over the body, shivering, fever, and tiredness on 14-APR-2021. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: DIZZY; WEAKNESS; MUSCLE ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. 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, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included paracetamol. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced weakness. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, weakness, muscle ache, headache, and fever on 20-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin reaction
Clinical narrative: MARKS ON BOTH ARMS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the subject experienced marks on both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of marks on both arms was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from vaccination coordinator via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID:) concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sesame seeds allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:38 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Syncope
Clinical narrative: SYNCOPE; HYPOTENSION; This spontaneous report received from an other health care professional (nurse) concerned a 45 year old white not Hispanic male. This report was received from news/social media. 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: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The patient was administered vaccine from an outdoor vaccination site with outdoor temperature around 70-80 degrees. No concomitant medications were reported.  On an unspecified date APR-2021, the patient experienced syncope and hypotension, and was hospitalized (date unspecified). The patient was treated with unspecified fluid. The patient was discharged on an unknown date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, and hypotension on APR-2021. This report was serious (Hospitalization Caused/Prolonged). This case, from the same reporter is linked to 20210415566 (master case); Sender's Comments: V0: 20210441626-covid-19 vaccine ad26.cov2.s-syncope, hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus rash
Clinical narrative: LUPUS TYPE RASH ON FACE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. . The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced lupus type rash on face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lupus type rash on face was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PERSISTED ARM PAIN; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and nonsmoker. The patient experienced drug allergy when treated with codeine, and hydrocodone bitartrate/paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced persisted arm pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persisted arm pain. This report was non-serious.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: SHINGLES; RASH; This spontaneous report received from a patient concerned a 62 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rash. On 30-MAR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash, and shingles. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and headache was not reported. This report was non-serious.