chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This case was associated with product quality complaint 20210340676.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, low grade fever, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: ITCHINESS; TINGLING OF FEET; RASH ALL OVER BODY; This spontaneous report received from a parent 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, intramuscular, 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 itchiness, tingling of feet, and rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body, itchiness and tingling of feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; FELT VERY TIRED; MUSCLE ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced shortness of breath. On 17-MAR-2021, the subject experienced felt very tired. On 17-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, headache, and fever on 17-MAR-2021, and had not recovered from felt very tired, 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 assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; BODY ACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 pain, and body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache and pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Vomiting
Clinical narrative: BODY PAIN; THREW UP; SICK; CHILLS; This spontaneous report received from a consumer 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 2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced body pain. On 2021, the subject experienced threw up. On 2021, the subject experienced sick. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, threw up, sick, and chills on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Feeling hot, Pyrexia
Clinical narrative: FEVER OF 103; HOT; CHILLS AND SHIVERING; SHAKING; FREEZING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  On 20-MAR-2021 the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry date: unknown) dose was not reported, frequency 1 total, in left deltoid, for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced fever of 103, hot, chills, shivering. On same day, about 4 hours after receiving the vaccine she reported shaking and freezing, being very cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from chills, and shivering on 20-MAR-2021, and had not recovered from fever of 103, and hot. The outcome of the shaking and freezing was not reported. This report was non-serious.; Sender's Comments: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FEVER OF 103; HOT; CHILLS AND SHIVERING; SHAKING; FREEZING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  On 20-MAR-2021 the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry date: unknown) dose was not reported, frequency 1 total, in left deltoid, for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced fever of 103, hot, chills, shivering. On same day, about 4 hours after receiving the vaccine she reported shaking and freezing, being very cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from chills, and shivering on 20-MAR-2021, and had not recovered from fever of 103, and hot. The outcome of the shaking and freezing was not reported. This report was non-serious.; Sender's Comments: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Feeling hot, Headache
Clinical narrative: BODY ACHES; JOINT PAIN; EXTREMELY THIRSTY; HOT; BACKACHE; CHILLS; 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 was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number is not provided and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced joint pain. On 20-MAR-2021, the subject experienced extremely thirsty. On 20-MAR-2021, the subject experienced hot. On 20-MAR-2021, the subject experienced backache. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-MAR-2021, and had not recovered from headache, extremely thirsty, body aches, joint pain, hot, and backache. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thirst
Clinical narrative: BODY ACHES; JOINT PAIN; EXTREMELY THIRSTY; HOT; BACKACHE; CHILLS; 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 was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number is not provided and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced joint pain. On 20-MAR-2021, the subject experienced extremely thirsty. On 20-MAR-2021, the subject experienced hot. On 20-MAR-2021, the subject experienced backache. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-MAR-2021, and had not recovered from headache, extremely thirsty, body aches, joint pain, hot, and backache. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Pyrexia
Clinical narrative: CHILLS; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25/MAY/2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The patient vaccinated at right arm. No concomitant medications were reported. On 12-MAR-2021, the subject experienced injection site pain. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.6 F, 100.1 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 injection site pain on 14-MAR-2021, and had not recovered from fever, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Fatigue, Headache, Injection site erythema
Clinical narrative: HEADACHE; FATIGUE; NAUSEA; CLAMMY; MUSCLE ACHE; REDNESS AT INJECTION SITE; RASH AT INJECTION SITE; FEVER; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no health issues, no allergies. patient never had adverse reaction to vaccine prior. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25/MAY/2021) dose was not reported, administered on 20-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced clammy. On 20-MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced redness at injection site. On 20-MAR-2021, the subject experienced rash at injection site. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.3. On 21-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-MAR-2021, was recovering from fatigue, nausea, and muscle ache, had not recovered from clammy, and headache, and the outcome of redness at injection site and rash at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Myalgia, Nausea, Pyrexia
Clinical narrative: HEADACHE; FATIGUE; NAUSEA; CLAMMY; MUSCLE ACHE; REDNESS AT INJECTION SITE; RASH AT INJECTION SITE; FEVER; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no health issues, no allergies. patient never had adverse reaction to vaccine prior. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25/MAY/2021) dose was not reported, administered on 20-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced clammy. On 20-MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced redness at injection site. On 20-MAR-2021, the subject experienced rash at injection site. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.3. On 21-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-MAR-2021, was recovering from fatigue, nausea, and muscle ache, had not recovered from clammy, and headache, and the outcome of redness at injection site and rash at injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART PALPITATIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced heart palpitations. The batch number was not provided and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations on MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: LITTLE PURPLE GRAPE SIZE BUMP; LEFT ARM STUNG; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced left arm stung. On MAR-2021, the subject experienced pain iin left arm. On 18-MAR-2021, the subject experienced little purple grape size bump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little purple grape size bump, and the outcome of left arm stung and pain in left arm was not reported. This report was non-serious. this case was associated with product quality complaint number : 90000173607 The suspected product quality complaint has been confirmed to be void ( confirmed no pqc was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER  (101.2 AND 103.5F); NAUSEA; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever (101.2 and 103.5f). On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (101.2 and 103.5f), chills, and nausea. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: BODY ACHES; HEADACHE; NAUSEA; LOW GRADE FEVER; MUSCLE ACHE; BURNING AT INJECTION SITE; LEFT ARM SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. gatorade since symptoms appeared with minimal improvement.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022, and batch number: 1085022) dose was not reported, administered on 19-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 19-MAR-2021 07:15, the subject experienced burning at injection site. On 19-MAR-2021 07:15, the subject experienced left arm soreness at injection site. On 19-MAR-2021 15:30, the subject experienced body aches. On 19-MAR-2021 15:30, the subject experienced headache. On 19-MAR-2021 15:30, the subject experienced nausea. On 19-MAR-2021 15:30, the subject experienced low grade fever. On 19-MAR-2021 15:30, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site on 19-MAR-2021, and had not recovered from headache, body aches, nausea, low grade fever, left arm soreness at injection site, and muscle ache. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; NAUSEA; LOW GRADE FEVER; MUSCLE ACHE; BURNING AT INJECTION SITE; LEFT ARM SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. gatorade since symptoms appeared with minimal improvement.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022, and batch number: 1085022) dose was not reported, administered on 19-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 19-MAR-2021 07:15, the subject experienced burning at injection site. On 19-MAR-2021 07:15, the subject experienced left arm soreness at injection site. On 19-MAR-2021 15:30, the subject experienced body aches. On 19-MAR-2021 15:30, the subject experienced headache. On 19-MAR-2021 15:30, the subject experienced nausea. On 19-MAR-2021 15:30, the subject experienced low grade fever. On 19-MAR-2021 15:30, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site on 19-MAR-2021, and had not recovered from headache, body aches, nausea, low grade fever, left arm soreness at injection site, and muscle ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Parkinson, no smoking, and no alcohol use, and other pre-existing medical conditions included no known allergies and no 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: 108609, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: FEELING LAZY; BACKACHES; LEGS ACHE; HEADACHE; TIRED; BAD MUSCLE ACHE IN SHOULDER AND NECK; REDNESS AT INJECTION SITE; SWOLLEN INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced redness at injection site. On MAR-2021, the subject experienced swollen injection site. On 19-MAR-2021, the subject experienced feeling lazy. On 19-MAR-2021, the subject experienced backaches. On 19-MAR-2021, the subject experienced legs ache. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced bad muscle ache in shoulder and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, backaches, legs ache, and bad muscle ache in shoulder and neck, had not recovered from tired, redness at injection site, and swollen injection site, and the outcome of feeling lazy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Laziness, Myalgia, Pain in extremity
Clinical narrative: FEELING LAZY; BACKACHES; LEGS ACHE; HEADACHE; TIRED; BAD MUSCLE ACHE IN SHOULDER AND NECK; REDNESS AT INJECTION SITE; SWOLLEN INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced redness at injection site. On MAR-2021, the subject experienced swollen injection site. On 19-MAR-2021, the subject experienced feeling lazy. On 19-MAR-2021, the subject experienced backaches. On 19-MAR-2021, the subject experienced legs ache. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced bad muscle ache in shoulder and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, backaches, legs ache, and bad muscle ache in shoulder and neck, had not recovered from tired, redness at injection site, and swollen injection site, and the outcome of feeling lazy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Cold sweat, Dizziness, Gait disturbance
Clinical narrative: COLD SWEATS; WEAK; VERTIGO; UNSTEADY GAIT; DIZZINESS; UNBALANCED; MILD SORENESS AT THE LOCATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mild soreness at the location. On 18-MAR-2021, the subject experienced vertigo. On 18-MAR-2021, the subject experienced unsteady gait. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced unbalanced. On 18-MAR-2021, the subject experienced weak. On 19-MAR-2021, the subject experienced cold sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild soreness at the location on 11-MAR-2021, was recovering from cold sweats, had not recovered from vertigo, weak, and dizziness, and the outcome of unsteady gait and unbalanced was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vertigo
Clinical narrative: COLD SWEATS; WEAK; VERTIGO; UNSTEADY GAIT; DIZZINESS; UNBALANCED; MILD SORENESS AT THE LOCATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mild soreness at the location. On 18-MAR-2021, the subject experienced vertigo. On 18-MAR-2021, the subject experienced unsteady gait. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced unbalanced. On 18-MAR-2021, the subject experienced weak. On 19-MAR-2021, the subject experienced cold sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild soreness at the location on 11-MAR-2021, was recovering from cold sweats, had not recovered from vertigo, weak, and dizziness, and the outcome of unsteady gait and unbalanced was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: BODY ACHES; STOMACH A LITTLE OFF; HEADACHE; 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 asthma, and hypertension. 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 21-MAR-2021 11:45 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021 22:00, the subject experienced body aches. On 21-MAR-2021 22:00, the subject experienced stomach a little off. On 21-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, and stomach a little off. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: RASH ON STOMACH; FATIGUE; 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-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:45, in left arm, for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced rash on stomach. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on stomach, and fatigue. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Nausea, Pyrexia
Clinical narrative: CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 71 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: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 08-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 20-MAR-2021 05:00, the subject experienced chills. On 20-MAR-2021 05:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from chills, fever, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight 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 20-MAR-2021 to right arm 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 20-MAR-2021, the patient experienced body aches. On 20-MAR-2021, the subject experienced fever. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from fever, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Pyrexia
Clinical narrative: DIARRHEA; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 06:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 20-MAR-2021 16:00, the subject experienced diarrhea. On 20-MAR-2021 16:00, the subject experienced chills. On 20-MAR-2021 16:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and diarrhea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: SORE LEFT ARM; FEVER; NAUSEA; LIGHT HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 09:00 on left arm for prophylactic vaccination. The batch number was not reported, and is requested. No concomitant medications were reported. On 14-MAR-2021 17:00, the subject experienced light headache. On 14-MAR-2021 18:30, the subject experienced fever. On 14-MAR-2021 18:30, the subject experienced nausea. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.3 F. On an unspecified date, the subject experienced sore left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021 08:00, and the outcome of light headache, nausea and sore left arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Irritability, Muscle fatigue, Myalgia
Clinical narrative: STOMACH ACHE; DIARRHEA; GROUCHY; SORE THROAT; FEELS MUSCLY; LEGS HURT; MUSCLE SORENESS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mitochondrial disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on right arm on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stomach ache. On 17-MAR-2021, the subject experienced diarrhea. On 17-MAR-2021, the subject experienced grouchy. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced feels muscly. On 17-MAR-2021, the subject experienced legs hurt. On 17-MAR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, diarrhea, grouchy, muscle soreness, legs hurt, sore throat, and feels muscly. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: STOMACH ACHE; DIARRHEA; GROUCHY; SORE THROAT; FEELS MUSCLY; LEGS HURT; MUSCLE SORENESS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mitochondrial disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on right arm on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stomach ache. On 17-MAR-2021, the subject experienced diarrhea. On 17-MAR-2021, the subject experienced grouchy. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced feels muscly. On 17-MAR-2021, the subject experienced legs hurt. On 17-MAR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, diarrhea, grouchy, muscle soreness, legs hurt, sore throat, and feels muscly. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; CHILLS; 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 11:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7. On 20-MAR-2021, treatment medications included: paracetamol. On 20-MAR-2021 16:00, the subject experienced headache. On 20-MAR-2021 17:00, the subject experienced chills. On 20-MAR-2021 22:45, the subject experienced fever. On an unspecified date, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-MAR-2021, had not recovered from headache, and the outcome of fever and body ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Paranasal sinus discomfort, Pyrexia
Clinical narrative: SINUS PRESSURE BEHIND EYES WHICH WAS MOVING TO THE FOREHEAD; HEADACHE; FEVER OF 99.9F; 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: Unk) dose was not reported, administered on 18-MAR-2021 11:30:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sinus pressure behind eyes which was moving to the forehead. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever of 99.9f. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The batch number was not reported and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus pressure behind eyes which was moving to the forehead, headache, and fever of 99.9f. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Head discomfort, Palpitations, Restlessness
Clinical narrative: SHAKEN; UNABLE TO REST; HEART RACING; HEAVY HEAD; A LITTLE DIFFICULTY IN BREATHING; TIREDNESS; 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, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced heavy head. On 19-MAR-2021, the subject experienced a little difficulty in breathing. On an unspecified date, the subject experienced shaken, and unable to rest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart racing, heavy head, tiredness, and a little difficulty in breathing, and the outcome of shaken and unable to rest was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKEN; UNABLE TO REST; HEART RACING; HEAVY HEAD; A LITTLE DIFFICULTY IN BREATHING; TIREDNESS; 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, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced heavy head. On 19-MAR-2021, the subject experienced a little difficulty in breathing. On an unspecified date, the subject experienced shaken, and unable to rest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart racing, heavy head, tiredness, and a little difficulty in breathing, and the outcome of shaken and unable to rest was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dyspnoea, Nasal congestion, Pain, Rash
Clinical narrative: CONGESTION IN NOSE; TROUBLE BREATHING; RASH ALL OVER BODY; BRUISE ON LEG; BODY ACHES; CHEST CONGESTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 05/MAY/2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination in left deltoid. No concomitant medications were reported. On 13-MAR-2021, the subject experienced congestion in nose. On 13-MAR-2021, the subject experienced trouble breathing. On 13-MAR-2021, the subject experienced rash all over body. On 13-MAR-2021, the subject experienced bruise on leg. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced chest congestion. Treatment medications (dates unspecified) included: prednisolone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body, bruise on leg, trouble breathing, body aches, congestion in nose and chest congestion was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: CONGESTION IN NOSE; TROUBLE BREATHING; RASH ALL OVER BODY; BRUISE ON LEG; BODY ACHES; CHEST CONGESTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 05/MAY/2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination in left deltoid. No concomitant medications were reported. On 13-MAR-2021, the subject experienced congestion in nose. On 13-MAR-2021, the subject experienced trouble breathing. On 13-MAR-2021, the subject experienced rash all over body. On 13-MAR-2021, the subject experienced bruise on leg. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced chest congestion. Treatment medications (dates unspecified) included: prednisolone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body, bruise on leg, trouble breathing, body aches, congestion in nose and chest congestion was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; FEVER; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a parent concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced tiredness. On 21-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 100 degrees F. 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, fever, tiredness, and muscle ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Feeling hot, Headache, Malaise, Pain
Clinical narrative: FEELING DISORIENTED; PULSATING PAIN IN THE BACK OF THE HEAD; STARTING TO FEEL UNWELL; FEELING HOT; WHOLE BODY WAS HURTING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling disoriented. On 20-MAR-2021, the subject experienced pulsating pain in the back of the head. On 20-MAR-2021, the subject experienced starting to feel unwell. On 20-MAR-2021, the subject experienced feeling hot. On 20-MAR-2021, the subject experienced whole body was hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from starting to feel unwell, pulsating pain in the back of the head, feeling hot, whole body was hurting, and feeling disoriented. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious