chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sinus congestion, Wheezing
Clinical narrative: SHORTNESS OF BREATH (SOB); SHALLOW BREATHING; SOME COUGHING; SINUS CONGESTION; WHEEZING; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. 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, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: interferon beta-1a (injection, route of admin, and batch number were not reported) dose and frequency were not reported from 19-AUG-2021 for drug used for unknown indication. No concomitant medications were reported. On 20-AUG-2021, the patient experienced shortness of breath (sob). On 20-AUG-2021, the patient experienced shallow breathing. On 20-AUG-2021, the patient experienced some coughing. On 20-AUG-2021, the patient experienced sinus congestion. On 20-AUG-2021, the patient experienced wheezing. On 20-AUG-2021, the patient experienced massive headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (sob), shallow breathing, massive headache, some coughing, sinus congestion, and wheezing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: MINOR CHILLS FOR 15 MINUTES; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced minor chills for 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor chills for 15 minutes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, General symptom, Injection site induration, Injection site pain, Rash
Clinical narrative: LARGE, NICKEL TO QUARTER SIZED, HARDENED AREA UNDER THE SKIN ON LEFT ARM AT THE SITE OF INJECTION; BRUISING ON LEFT ARM; NORMAL SYMPTOMS; FEW RASHES ON LEFT ARM; PAINFUL TO TOUCH; This spontaneous report received from a consumer concerned a 26 year old female. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced large, nickel to quarter sized, hardened area under the skin on left arm at the site of injection. On AUG-2021, the patient experienced bruising on left arm. On AUG-2021, the patient experienced normal symptoms. On AUG-2021, the patient experienced few rashes on left arm. On AUG-2021, the patient experienced painful to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from large, nickel to quarter sized, hardened area under the skin on left arm at the site of injection, painful to touch, few rashes on left arm, and bruising on left arm, and the outcome of normal symptoms was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Confusional state, Hallucination, Headache
Clinical narrative: VOILENT HALLUCINATION; FULL BODY TREMORS; CONFUSION; ANXIETY; VIVID DREAMS; HEADACHE; This spontaneous report received from a health care professional (Nurse) concerned a male of an unspecified, age, race and ethnic origin. 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, route of admin not reported, batch number: unknown and expiry: unknown ) dose was not reported, 1 total administered on 18-AUG-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 18-AUG-2021, 12 hours post vaccination, the patient experienced violent hallucination, confusion, vivid dreams, anxiety, full body tremors and headache. He went to physician office. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body tremors, violent hallucination, confusion, anxiety, vivid dreams and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210844101-COVID-19 VACCINE AD26.COV2.S - Violent hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: VOILENT HALLUCINATION; FULL BODY TREMORS; CONFUSION; ANXIETY; VIVID DREAMS; HEADACHE; This spontaneous report received from a health care professional (Nurse) concerned a male of an unspecified, age, race and ethnic origin. 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, route of admin not reported, batch number: unknown and expiry: unknown ) dose was not reported, 1 total administered on 18-AUG-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 18-AUG-2021, 12 hours post vaccination, the patient experienced violent hallucination, confusion, vivid dreams, anxiety, full body tremors and headache. He went to physician office. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body tremors, violent hallucination, confusion, anxiety, vivid dreams and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210844101-COVID-19 VACCINE AD26.COV2.S - Violent hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: DIED OF HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. 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, route of administration not reported, batch number: Unknown)1 total frequency, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died of heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20210844140-COVID-19 VACCINE AD26.COV2.S-died of heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: ITCH ON THE ARM; CHILLS; FEVER; FATIGUE; MUSCLES IN BOTH LEGS HURT; HEADACHE; LUMP (ABOUT ONE INCH NOT CIRCULAR BUT ELONGATED AND IT EXTENDS TO LEFT AND TO RIGHT) ON THE RIGHT ARM AT THE SITE OF THE INJECTION; DIZZINESS; REDNESS ON THE ARM; PAIN ON THE ARM; SWELLING ON THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, penicillin allergy, alcohol user, smoker, and mold allergy, and other pre-existing medical conditions included: The patient did not had any drug abuse/illicit drug use. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril for high blood pressure. On MAR-2021, the patient experienced redness on the arm. On MAR-2021, the patient experienced pain on the arm. On MAR-2021, the patient experienced swelling on the arm. On 25-MAR-2021, the patient experienced lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection. On 25-MAR-2021, the patient experienced dizziness. On 25-MAR-2021, the patient experienced chills. On 25-MAR-2021, the patient experienced fever. On 25-MAR-2021, the patient experienced fatigue. On 25-MAR-2021, the patient experienced muscles in both legs hurt. On 25-MAR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced itch on the arm. Treatment medications (dates unspecified) included: cortisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, muscles in both legs hurt, and headache on 28-MAR-2021, itch on the arm on APR-2021, and fatigue on 29-MAR-2021, had not recovered from lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection, and the outcome of redness on the arm, pain on the arm and swelling on the arm was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: ITCH ON THE ARM; CHILLS; FEVER; FATIGUE; MUSCLES IN BOTH LEGS HURT; HEADACHE; LUMP (ABOUT ONE INCH NOT CIRCULAR BUT ELONGATED AND IT EXTENDS TO LEFT AND TO RIGHT) ON THE RIGHT ARM AT THE SITE OF THE INJECTION; DIZZINESS; REDNESS ON THE ARM; PAIN ON THE ARM; SWELLING ON THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, penicillin allergy, alcohol user, smoker, and mold allergy, and other pre-existing medical conditions included: The patient did not had any drug abuse/illicit drug use. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril for high blood pressure. On MAR-2021, the patient experienced redness on the arm. On MAR-2021, the patient experienced pain on the arm. On MAR-2021, the patient experienced swelling on the arm. On 25-MAR-2021, the patient experienced lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection. On 25-MAR-2021, the patient experienced dizziness. On 25-MAR-2021, the patient experienced chills. On 25-MAR-2021, the patient experienced fever. On 25-MAR-2021, the patient experienced fatigue. On 25-MAR-2021, the patient experienced muscles in both legs hurt. On 25-MAR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced itch on the arm. Treatment medications (dates unspecified) included: cortisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, muscles in both legs hurt, and headache on 28-MAR-2021, itch on the arm on APR-2021, and fatigue on 29-MAR-2021, had not recovered from lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection, and the outcome of redness on the arm, pain on the arm and swelling on the arm was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ITCH ON THE ARM; CHILLS; FEVER; FATIGUE; MUSCLES IN BOTH LEGS HURT; HEADACHE; LUMP (ABOUT ONE INCH NOT CIRCULAR BUT ELONGATED AND IT EXTENDS TO LEFT AND TO RIGHT) ON THE RIGHT ARM AT THE SITE OF THE INJECTION; DIZZINESS; REDNESS ON THE ARM; PAIN ON THE ARM; SWELLING ON THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, penicillin allergy, alcohol user, smoker, and mold allergy, and other pre-existing medical conditions included: The patient did not had any drug abuse/illicit drug use. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril for high blood pressure. On MAR-2021, the patient experienced redness on the arm. On MAR-2021, the patient experienced pain on the arm. On MAR-2021, the patient experienced swelling on the arm. On 25-MAR-2021, the patient experienced lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection. On 25-MAR-2021, the patient experienced dizziness. On 25-MAR-2021, the patient experienced chills. On 25-MAR-2021, the patient experienced fever. On 25-MAR-2021, the patient experienced fatigue. On 25-MAR-2021, the patient experienced muscles in both legs hurt. On 25-MAR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced itch on the arm. Treatment medications (dates unspecified) included: cortisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, muscles in both legs hurt, and headache on 28-MAR-2021, itch on the arm on APR-2021, and fatigue on 29-MAR-2021, had not recovered from lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection, and the outcome of redness on the arm, pain on the arm and swelling on the arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: SWEATING; CHILLS; WEAKNESS; HEADACHE; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sweating, chills, weakness, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, chills, weakness, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain
Clinical narrative: FELT LIKE CRAP; ARM WAS SORE AT THE INJECTION SITE; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced felt like crap, and arm was sore at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore at the injection site, and the outcome of felt like crap was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Swelling face
Clinical narrative: SHORTNESS OF BREATH; CHEST TIGHTNESS; THROAT CLOSURE; FACIAL SWELLING (STARTED 20 MINUTES AFTER THE INJECTION); LITTLE LIGHT HEADED (STARTED 10 MINUTES AFTER THE INJECTION); TONGUE SWELLING (STARTED 20 MINUTES AFTER THE INJECTION); ALLERGIC REACTION; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shortness of breath, chest tightness, throat closure, facial swelling (started 20 minutes after the injection), little light headed (started 10 minutes after the injection), tongue swelling (started 20 minutes after the injection), and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction, shortness of breath, chest tightness, throat closure, facial swelling (started 20 minutes after the injection), little light headed (started 10 minutes after the injection) and tongue swelling (started 20 minutes after the injection) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: SHORTNESS OF BREATH; CHEST TIGHTNESS; THROAT CLOSURE; FACIAL SWELLING (STARTED 20 MINUTES AFTER THE INJECTION); LITTLE LIGHT HEADED (STARTED 10 MINUTES AFTER THE INJECTION); TONGUE SWELLING (STARTED 20 MINUTES AFTER THE INJECTION); ALLERGIC REACTION; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shortness of breath, chest tightness, throat closure, facial swelling (started 20 minutes after the injection), little light headed (started 10 minutes after the injection), tongue swelling (started 20 minutes after the injection), and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction, shortness of breath, chest tightness, throat closure, facial swelling (started 20 minutes after the injection), little light headed (started 10 minutes after the injection) and tongue swelling (started 20 minutes after the injection) was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal
Clinical narrative: BODY REJECTING THE HORMONES AND STOPPED WORKING, SENDING HER INTO MENOPAUSE AGAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy, and concurrent conditions included: shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced body rejecting the hormones and stopped working, sending her into menopause again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body rejecting the hormones and stopped working, sending her into menopause again. This report was non-serious. This case, from the same reporter is linked to 20210844560.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 103 FEVER FOR LIKE A DAY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced 103 fever for like a day. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 fever for like a day. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain assessment, Pain in extremity, Toothache
Clinical narrative: FEELS LIKE A TOOTHACHE TIME 10X; LEFT LEG PAIN; LEFT LEG NUMBNESS; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the patient experienced feels like a toothache time 10x. On JUL-2021, the patient experienced left leg pain. On JUL-2021, the patient experienced left leg numbness. Laboratory data included: Pain scale (NR: not provided) 10 plus. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg pain, and left leg numbness, and the outcome of feels like a toothache time 10x was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: ARM IS JUST A BIT SORE; BODY WAS SORE; CHILLS; EXHAUSTED; AWFUL HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-AUG-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 20-AUG-2021, the patient experienced chills. On 20-AUG-2021, the patient experienced exhausted. On 20-AUG-2021, the patient experienced awful headache. Treatment medications included: paracetamol. On 21-AUG-2021, the patient experienced body was sore. On 22-AUG-2021, the patient experienced arm is just a bit sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body was sore, had not recovered from awful headache, and arm is just a bit sore, and the outcome of exhausted and chills was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: TIRED; LITTLE SORENESS; This spontaneous report received from a patient concerned a 66 year old female. 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, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced little soreness. On 14-MAR-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little soreness on 13-MAR-2021 and tired on 15-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Headache
Clinical narrative: PERSISTENT HEADACHE PAIN; AUDIBLY DISTRESSED; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-AUG-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 AUG-2021, the patient experienced audibly distressed. On 18-AUG-2021, the patient experienced persistent headache pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache pain, and the outcome of audibly distressed was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Bruxism, Chills, Insomnia
Clinical narrative: WAS IN BED THE WHOLE DAY; TEETH SHATTERING; CHILLS/SHIVERS; FEVER; PREVENTING FROM SLEEP; ITCHING (PREVENTING HER FROM SLEEP); RASH; GET BUMPS EVERYWHERE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and didn't change anything in diet or anything other than the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced preventing from sleep. On AUG-2021, the patient experienced itching (preventing her from sleep). On AUG-2021, the patient experienced rash. On AUG-2021, the patient experienced get bumps everywhere. On 08-AUG-2021, the patient experienced teeth shattering. On 08-AUG-2021, the patient experienced chills/shivers. On 08-AUG-2021, the patient experienced fever. On 09-AUG-2021, the patient experienced was in bed the whole day. Laboratory data included: Body temperature (NR: not provided) 102. On 22-AUG-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth shattering, chills/shivers, and fever on 09-AUG-2021, was recovering from itching (preventing her from sleep), had not recovered from rash, and the outcome of get bumps everywhere, was in bed the whole day and preventing from sleep was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: WAS IN BED THE WHOLE DAY; TEETH SHATTERING; CHILLS/SHIVERS; FEVER; PREVENTING FROM SLEEP; ITCHING (PREVENTING HER FROM SLEEP); RASH; GET BUMPS EVERYWHERE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and didn't change anything in diet or anything other than the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced preventing from sleep. On AUG-2021, the patient experienced itching (preventing her from sleep). On AUG-2021, the patient experienced rash. On AUG-2021, the patient experienced get bumps everywhere. On 08-AUG-2021, the patient experienced teeth shattering. On 08-AUG-2021, the patient experienced chills/shivers. On 08-AUG-2021, the patient experienced fever. On 09-AUG-2021, the patient experienced was in bed the whole day. Laboratory data included: Body temperature (NR: not provided) 102. On 22-AUG-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth shattering, chills/shivers, and fever on 09-AUG-2021, was recovering from itching (preventing her from sleep), had not recovered from rash, and the outcome of get bumps everywhere, was in bed the whole day and preventing from sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SYMPTOMS AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-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 AUG-2021, the patient experienced symptoms after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms after receiving vaccine was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Dyspnoea, Headache
Clinical narrative: SHARP CHEST PAIN; COULD NOT CATCH BREATH (HARD TIME TAKING A DEEP BREATH); EXTREME BACK PAIN; BAD CHILLS THAT WONT GO AWAY (FEELING OF FREEZING COLD); FEVER; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced sharp chest pain. On 20-AUG-2021, the patient experienced could not catch breath (hard time taking a deep breath). On 20-AUG-2021, the patient experienced extreme back pain. On 20-AUG-2021, the patient experienced bad chills that wont go away (feeling of freezing cold). On 20-AUG-2021, the patient experienced fever. On 20-AUG-2021, the patient experienced headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not catch breath (hard time taking a deep breath), extreme back pain, bad chills that wont go away (feeling of freezing cold), fever, and headache on 21-AUG-2021, and had not recovered from sharp chest pain. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SHARP CHEST PAIN; COULD NOT CATCH BREATH (HARD TIME TAKING A DEEP BREATH); EXTREME BACK PAIN; BAD CHILLS THAT WONT GO AWAY (FEELING OF FREEZING COLD); FEVER; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced sharp chest pain. On 20-AUG-2021, the patient experienced could not catch breath (hard time taking a deep breath). On 20-AUG-2021, the patient experienced extreme back pain. On 20-AUG-2021, the patient experienced bad chills that wont go away (feeling of freezing cold). On 20-AUG-2021, the patient experienced fever. On 20-AUG-2021, the patient experienced headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not catch breath (hard time taking a deep breath), extreme back pain, bad chills that wont go away (feeling of freezing cold), fever, and headache on 21-AUG-2021, and had not recovered from sharp chest pain. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: WHEN  HE TOUCHES ARM HE HAS SHARP PAIN; CHRONIC FATIGUE; This spontaneous report received from a pharmacist concerned a 47 year old male. 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, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced when he touches arm he has sharp pain, and chronic fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from when he touches arm he has sharp pain, and chronic fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, General symptom, Hypoaesthesia, Impaired work ability, Pain in extremity
Clinical narrative: HEALTH PROBLEMS/HINDERING HEALTH; THEY ARE HINDERING HEALTH AND PERFORMANCE AT WORK; HARD TIME WALKING; LEFT HAND ALL OF FINGERS STAY NUMB EXCEPT PINKY FINGER; LEFT FOOT CONSTANTLY HURTING ABOVE HEEL, ANKLE, AND ACHILLES TENDON; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced health problems/hindering health, they are hindering health and performance at work, hard time walking, left hand all of fingers stay numb except pinky finger, and left foot constantly hurting above heel, ankle, and achilles tendon. Treatment medications (dates unspecified) included: permethrin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left hand all of fingers stay numb except pinky finger, hard time walking, left foot constantly hurting above heel, ankle, and achilles tendon, health problems/hindering health and they are hindering health and performance at work was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced 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. This case, from the same reporter is linked to 20210846404.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT WEIRD; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-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 an unspecified date, the patient experienced felt weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt weird was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES RASH ON LEFT ARM; This spontaneous report received from a consumer concerned a female of unspecified age. 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, 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 patient experienced shingles rash on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles rash on left arm was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: SLIGHTLY TIRED; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to the shingles shot, and concurrent conditions included: colitis, hashimotos, blood pressure, and anxiety, and other pre-existing medical conditions included: Got unspecified shingles shot 3 years ago and was not on Xelganz at the time and she did have a reaction to the shingles shot. She was B+ blood type. Took unspecified medications for high blood pressure and anxiety. The patient experienced drug allergy when treated with benzoyl peroxide, and ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 002A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate for colitis. On an unspecified date, the patient experienced slightly tired, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and the outcome of slightly tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A LITTLE BIT OF PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced a little bit of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little bit of pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired on JUL-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: SYMPTOMS OF FEVER; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 332 pounds, and height was 75 inches. The patient's past medical history included: cigarette smoker, and concurrent conditions included: allergic to mushroom, and non alcohol user, and other pre-existing medical conditions included: Patient had 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: Unknown) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced symptoms of fever. On 19-AUG-2021, the patient experienced fatigue. On 23-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms of fever and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: FELT LIKE FLU FOR ONE WEEK; FEVER FOR 3 DAYS; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced felt like flu for one week, and fever for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like flu for one week, and fever for 3 days. This report was non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: neuropathy in legs, elevated cholesterol, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for elevated cholesterol, pregabalin for neuropathy in legs, and esomeprazole magnesium.  On an unspecified date, the patient experienced loss of smell, and loss of taste. Laboratory data (dates unspecified) included: CT brain scan (NR: not provided) nothing came wrong, and X-ray of nasal sinuses (NR: not provided) nothing came wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of smell, and loss of taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENTS (AES); This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse events (aes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events (aes) was not reported. This report was non-serious.