chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: FELLING STRANGE; SORE ARM; VERY FATIGUE/GROGGY; 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 06-MAR-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 sore arm, very fatigue/groggy, and felling strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and very fatigue/groggy, and the outcome of felling strange was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN UPON INJECTION; This spontaneous report received from a consumer/other non health professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced pain when receiving injection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain upon injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210312999.  Additional information was received from consumer/other non health professional on 06-MAR-2021. It was determined that 20210317681 was a duplicate of this case. All relevant information regarding this case will be submitted under 20210317609. Upon review following information was updated in the case: Case characteristic of multiple patient was added.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN UPON INJECTION; This spontaneous report received from a consumer/other non health professional concerned a patient of unspecified age and gender. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced pain when receiving injection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain upon injection was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site haemorrhage, Throat irritation
Clinical narrative: BLEEDING AT INJECTION SITE; COLD AIR BURNING SENSATION IN THROAT; ALLERGIC REACTION (DIFFICULTY BREATHING FOR 2 HOURS AFTER INJECTION); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On MAR-2021, the subject experienced bleeding at injection site. On MAR-2021, the subject experienced cold air burning sensation in throat. On MAR-2021, the subject experienced allergic reaction (difficulty breathing for 2 hours after injection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding at injection site, cold air burning sensation in throat and allergic reaction (difficulty breathing for 2 hours after injection) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; 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 dizziness, and pure autonomic failure.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. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 09-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased
Clinical narrative: INCREASE IN HEART RATE; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies to medications. The patient was previously treated with diphenhydramine hydrochloride.  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 07-MAR-2021 at around noon 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 increase in heart rate. On MAR-2021 at about 22:00, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) increased heart rate, by about 30 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and the outcome of increase in heart rate was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021 03:15, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 303 F, and COVID-19 (NR: not provided) Positive. Treatment medications (dates unspecified) included: Oxycodone/Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: HEADACHE; UPSET STOMACH; FATIGUE; 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, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, upset stomach, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, upset stomach and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: FELT A LITTLE FUNNY; SLEEPY; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported, Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced felt little funny. On MAR-2021, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt little funny and sleepy was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Pain, Presyncope
Clinical narrative: FELT LIKE FAINTING; BODY ACHES; BILATERAL HIP PAIN; LIMPING; CHILLS; This spontaneous report received from a patient concerned an 47 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 the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced felt like fainting. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced bilateral hip pain. On 09-MAR-2021, the subject experienced limping. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from chills, body aches, bilateral hip pain, limping, and felt like fainting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; WEAKNESS; MUSCLE PAIN; INCREASED PULSE RATE BY 10 BEATS; This spontaneous report received from a patient concerned a 34 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, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. he batch number was not reported and has been requested No concomitant medications were reported.  On MAR-2021, the subject experienced increased pulse rate by 10 beats. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 08-MAR-2021, and had not recovered from weakness, muscle pain, and increased pulse rate by 10 beats. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Neuralgia, Pain, Pyrexia
Clinical narrative: NERVE PAIN; FEVER; CHILLS; BODY ACHE; 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 past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 08-MAR-2021, the subject experienced nerve pain. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced headache. The symptoms started developing around 7:00 PM of the same day of the administration.  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 fever, and chills, and the outcome of nerve pain, body ache and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Body temperature, Chills, Cough, Pyrexia
Clinical narrative: COUGH; CHILLS; FEVER 103 F; DIFFICULTY KEEPING EYES OPEN; 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 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced difficulty keeping eyes open. On 09-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever 103 f. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 103 f, cough, and chills, and the outcome of difficulty keeping eyes open was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Urticaria, Vomiting
Clinical narrative: HIVES; CHILLS; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced vomiting. On 06-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, vomiting, and headache on 07-MAR-2021, and had not recovered from hives. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: HEADACHE; FEVER; MUSCLE ACHE; INJECTION SITE PAIN; 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 06-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced muscle ache. On 07-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (units unspecified). On 08-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-MAR-2021, was recovering from muscle ache, and had not recovered from headache, and injection site pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: CHILLS TEMPERATURE NOT TAKEN; NAUSEA; TIRED; HEAD IS HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced head is hurting. On 09-MAR-2021, the subject experienced chills temperature not taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills temperature not taken on 09-MAR-2021, and was recovering from nausea, tired, and head is hurting. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE ACHE; LOW GRADE FEVER (CONSUMER FEELS WARM); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included the patient was not pregnant at time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced muscle ache. On 09-MAR-2021, the subject experienced low grade fever (consumer feels warm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, chills, and low grade fever (consumer feels warm). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES UNDER ARM (PAINFUL); 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: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced swollen lymph nodes under arm (painful). On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes under arm (painful) on 10-MAR-2021, and headache on 09-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: VOMITING; NAUSEA PERSISTED ON AND OFF BUT CURRENTLY PRESENT AND WORSE; HEADACHE PERSISTED ON AND OFF BUT CURRENTLY PRESENT AND WORSE; CHILLS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced vomiting. On 05-MAR-2021, the subject experienced nausea persisted on and off but currently present and worse. On 05-MAR-2021, the subject experienced headache persisted on and off but currently present and worse. On 05-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on 06-MAR-2021, and had not recovered from nausea persisted on and off but currently present and worse, and headache persisted on and off but currently present and worse. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure diastolic, Blood pressure diastolic increased, Injection site pain, Pain
Clinical narrative: BODY ACHES; SLIGHT NASAL DRIP; SWOLLEN FINGERS; SORENESS IN JOINTS; ELEVATED DIASTOLIC BLOOD PRESSURE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included neurocardiogenic syncope, junctional rhythm bradycardia, hypothyroidism, cirrhosis, and aphasia from a lacunar infarction of my left thalamus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On an unspecified date, the subject experienced body aches, slight nasal drip, swollen fingers, soreness in joints, elevated diastolic blood pressure, and soreness at injection site. Laboratory data (dates unspecified) included: Diastolic blood pressure (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, slight nasal drip, soreness at injection site, swollen fingers, soreness in joints and elevated diastolic blood pressure was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Upper-airway cough syndrome
Clinical narrative: BODY ACHES; SLIGHT NASAL DRIP; SWOLLEN FINGERS; SORENESS IN JOINTS; ELEVATED DIASTOLIC BLOOD PRESSURE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included neurocardiogenic syncope, junctional rhythm bradycardia, hypothyroidism, cirrhosis, and aphasia from a lacunar infarction of my left thalamus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On an unspecified date, the subject experienced body aches, slight nasal drip, swollen fingers, soreness in joints, elevated diastolic blood pressure, and soreness at injection site. Laboratory data (dates unspecified) included: Diastolic blood pressure (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, slight nasal drip, soreness at injection site, swollen fingers, soreness in joints and elevated diastolic blood pressure was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; 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, batch number: 1805022) dose was not reported, administered on 09-MAR-2021 09:00 pm to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 deg, 100.2 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: HEADACHE; FLU-LIKE SYMPTOMS; BODY ACHES; This spontaneous report received from 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu-like symptoms. On MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, headache, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; 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: 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 an unspecified date, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Palpitations, Pyrexia
Clinical narrative: PALPITATIONS; HEADACHE; 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's past medical history included palpitations, and concurrent conditions included allergies (sinus), and high blood pressure, 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 06:45 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.1 F. On 09-MAR-2021, the subject experienced palpitations. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.3 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations on 10-MAR-2021, was recovering from fever, and had not recovered from headache. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: ABDOMINAL PAIN; 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, intramuscular, batch number: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fever, and abdominal pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and abdominal pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Injection site pain, Pain in extremity
Clinical narrative: BACK PAIN; FEELING CHILLS; LEG PAIN; INJECTION SITE; FEVER OF 99.4; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 23:55 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced back pain, feeling chills, leg pain, injection site, and fever of 99.4. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling chills, leg pain, back pain, injection site and fever of 99.4 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BACK PAIN; FEELING CHILLS; LEG PAIN; INJECTION SITE; FEVER OF 99.4; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 23:55 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced back pain, feeling chills, leg pain, injection site, and fever of 99.4. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling chills, leg pain, back pain, injection site and fever of 99.4 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: NAUSEA; HEADACHE; VOMITING; CHILLS; FEVER OF 101; This spontaneous report received from a patient via a company representative . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported, Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever of 101. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced vomiting. On 08-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fever of 101, chills, nausea, vomiting and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: NAUSEA; HEADACHE; VOMITING; CHILLS; FEVER OF 101; This spontaneous report received from a patient via a company representative . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported, Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever of 101. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced vomiting. On 08-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fever of 101, chills, nausea, vomiting and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Pyrexia
Clinical narrative: JOINT PAIN; NOT FEELING WELL; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetic, high cholesterol, and migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch no. was not reported and has been requested.  No concomitant medications were reported.  On MAR-2021, the subject experienced joint pain. On MAR-2021, the subject experienced not feeling well. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, joint pain, and not feeling well. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: FEVER; CHILLS; HEADACHE AND HEAD HURTS; HARD TO DRIVE; MILD COUGH; HEAD PRESSURE; NAUSEA; DIZZINESS; FLU FEELING; SICK; AWFUL; THROW UP; 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 anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. Concomitant medications included paroxetine hydrochloride for anxiety. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache and head hurts. On MAR-2021, the subject experienced hard to drive. On MAR-2021, the subject experienced mild cough. On MAR-2021, the subject experienced head pressure. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced flu feeling. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced awful. On MAR-2021, the subject experienced throw up. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, nausea, dizziness, flu feeling, and throw up on MAR-2021, had not recovered from headache and head hurts, mild cough, and head pressure, and the outcome of hard to drive, sick and awful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Impaired driving ability, Influenza like illness, Nausea
Clinical narrative: FEVER; CHILLS; HEADACHE AND HEAD HURTS; HARD TO DRIVE; MILD COUGH; HEAD PRESSURE; NAUSEA; DIZZINESS; FLU FEELING; SICK; AWFUL; THROW UP; 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 anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. Concomitant medications included paroxetine hydrochloride for anxiety. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache and head hurts. On MAR-2021, the subject experienced hard to drive. On MAR-2021, the subject experienced mild cough. On MAR-2021, the subject experienced head pressure. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced flu feeling. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced awful. On MAR-2021, the subject experienced throw up. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, nausea, dizziness, flu feeling, and throw up on MAR-2021, had not recovered from headache and head hurts, mild cough, and head pressure, and the outcome of hard to drive, sick and awful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER; CHILLS; HEADACHE AND HEAD HURTS; HARD TO DRIVE; MILD COUGH; HEAD PRESSURE; NAUSEA; DIZZINESS; FLU FEELING; SICK; AWFUL; THROW UP; 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 anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. Concomitant medications included paroxetine hydrochloride for anxiety. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache and head hurts. On MAR-2021, the subject experienced hard to drive. On MAR-2021, the subject experienced mild cough. On MAR-2021, the subject experienced head pressure. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced flu feeling. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced awful. On MAR-2021, the subject experienced throw up. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, nausea, dizziness, flu feeling, and throw up on MAR-2021, had not recovered from headache and head hurts, mild cough, and head pressure, and the outcome of hard to drive, sick and awful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT REALLY SICK; 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 10-MAR-2021 12:00 a.m. 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 10-MAR-2021 15:30, the subject experienced felt really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt really sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BRUTAL NIGHT OF SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 2021, the subject experienced brutal night of side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from brutal night of side effects. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: BODY ACHES IN MUSCLES, ARMS AND LEGS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included skin disease, and back problems, and concurrent conditions included fibromyalgia, epstein barr virus, anxiety, immune deficiency disease: hailey hailey, chronic fatigue syndrome, penicillin allergy, allergy to dogs, allergy to cats, and allergy to dust. The patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient was non-smoker and non-alcohol user. 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 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced headache. On MAR-2021, treatment medications included: paracetamol. On 09-MAR-2021, the subject experienced body aches in muscles, arms and legs. On 09-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches in muscles, arms and legs, and had not recovered from headache, and fever. This report was non-serious.  Version created to correct previously reported information: Treatment drug corrected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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: UNKNWON and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain, Pyrexia, Tinnitus
Clinical narrative: Ringing the in my ears; PAIN ALL OVER THE BODY; Temperature of 101-degrees F; Muscles aches; SORE ON VACCINATION 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, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore on vaccination site. On 09-MAR-2021, the subject experienced ringing the in my ears. On 09-MAR-2021, the subject experienced pain all over the body. On 09-MAR-2021, the subject experienced temperature of 101-degrees f. On 09-MAR-2021, the subject experienced muscles aches. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-MAR-2021 07:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from temperature of 101-degrees f, and the outcome of sore on vaccination site, muscles aches, pain all over the body and ringing the in my ears was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Ringing the in my ears; PAIN ALL OVER THE BODY; Temperature of 101-degrees F; Muscles aches; SORE ON VACCINATION 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, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore on vaccination site. On 09-MAR-2021, the subject experienced ringing the in my ears. On 09-MAR-2021, the subject experienced pain all over the body. On 09-MAR-2021, the subject experienced temperature of 101-degrees f. On 09-MAR-2021, the subject experienced muscles aches. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-MAR-2021 07:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from temperature of 101-degrees f, and the outcome of sore on vaccination site, muscles aches, pain all over the body and ringing the in my ears was not reported. This report was non-serious.