chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: BAD RASH ALL OVER BODY, LEGS, TORSO, ON BACK; ITCHY RASH; DIARRHEA; HEADACHE; REALLY TIRED/ WORN OUT; RINGING IN EARS; THROWING UP; GENERAL MUSCLE ACHES; SEVERE CHILLS; LIPS WERE SWOLLEN; COUGHING; CONGESTION; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 1855791 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 02-JAN-2022 at 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022 at 19:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced headache and took 2-500 milligrams (mg) of Extra Strength acetaminophen tablets.  At 23:00 the patient came to the bedroom coughing, throwing up (which was reported to be recovered the same night) and was complaining of severe chills, general muscle aches, was really tired/ worn out, had ringing in the ears, and her lips were swollen. The patient had no fever reported. The patient drank tea and wrapped up in blankets. On 03-JAN-2022 after 04:00 morning, the patient experienced bad rash all over her body, on her legs, up her torso, on her back, but not on her arms or face and that the bed was shaking with her scratching from the itching (coded as itchy rash) and diarrhea in the morning. The patient took 2 more acetaminophen 500mg tablets at 4am. It was reported that the patient still had the rash, muscle aches, cough a little bit to clear up the congestion, worn out tired, and chills at the morning, while the ringing in the ears was gone in the morning. On an unspecified date in JAN-2022, the patient experienced congestion. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips were swollen, and ringing in ears on 03-JAN-2022, and throwing up on 02-JAN-2022, had not recovered from coughing, severe chills, general muscle aches, really tired/worn out, diarrhea, bad rash all over body, legs, torso, on back, and itchy rash, and the outcome of headache and congestion was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Myalgia, Nasal congestion, Rash, Rash pruritic
Clinical narrative: BAD RASH ALL OVER BODY, LEGS, TORSO, ON BACK; ITCHY RASH; DIARRHEA; HEADACHE; REALLY TIRED/ WORN OUT; RINGING IN EARS; THROWING UP; GENERAL MUSCLE ACHES; SEVERE CHILLS; LIPS WERE SWOLLEN; COUGHING; CONGESTION; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 1855791 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 02-JAN-2022 at 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022 at 19:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced headache and took 2-500 milligrams (mg) of Extra Strength acetaminophen tablets.  At 23:00 the patient came to the bedroom coughing, throwing up (which was reported to be recovered the same night) and was complaining of severe chills, general muscle aches, was really tired/ worn out, had ringing in the ears, and her lips were swollen. The patient had no fever reported. The patient drank tea and wrapped up in blankets. On 03-JAN-2022 after 04:00 morning, the patient experienced bad rash all over her body, on her legs, up her torso, on her back, but not on her arms or face and that the bed was shaking with her scratching from the itching (coded as itchy rash) and diarrhea in the morning. The patient took 2 more acetaminophen 500mg tablets at 4am. It was reported that the patient still had the rash, muscle aches, cough a little bit to clear up the congestion, worn out tired, and chills at the morning, while the ringing in the ears was gone in the morning. On an unspecified date in JAN-2022, the patient experienced congestion. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips were swollen, and ringing in ears on 03-JAN-2022, and throwing up on 02-JAN-2022, had not recovered from coughing, severe chills, general muscle aches, really tired/worn out, diarrhea, bad rash all over body, legs, torso, on back, and itchy rash, and the outcome of headache and congestion was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vomiting
Clinical narrative: BAD RASH ALL OVER BODY, LEGS, TORSO, ON BACK; ITCHY RASH; DIARRHEA; HEADACHE; REALLY TIRED/ WORN OUT; RINGING IN EARS; THROWING UP; GENERAL MUSCLE ACHES; SEVERE CHILLS; LIPS WERE SWOLLEN; COUGHING; CONGESTION; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 1855791 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 02-JAN-2022 at 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022 at 19:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced headache and took 2-500 milligrams (mg) of Extra Strength acetaminophen tablets.  At 23:00 the patient came to the bedroom coughing, throwing up (which was reported to be recovered the same night) and was complaining of severe chills, general muscle aches, was really tired/ worn out, had ringing in the ears, and her lips were swollen. The patient had no fever reported. The patient drank tea and wrapped up in blankets. On 03-JAN-2022 after 04:00 morning, the patient experienced bad rash all over her body, on her legs, up her torso, on her back, but not on her arms or face and that the bed was shaking with her scratching from the itching (coded as itchy rash) and diarrhea in the morning. The patient took 2 more acetaminophen 500mg tablets at 4am. It was reported that the patient still had the rash, muscle aches, cough a little bit to clear up the congestion, worn out tired, and chills at the morning, while the ringing in the ears was gone in the morning. On an unspecified date in JAN-2022, the patient experienced congestion. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips were swollen, and ringing in ears on 03-JAN-2022, and throwing up on 02-JAN-2022, had not recovered from coughing, severe chills, general muscle aches, really tired/worn out, diarrhea, bad rash all over body, legs, torso, on back, and itchy rash, and the outcome of headache and congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: USUAL SIDE EFFECTS; 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, and batch number were not reported, expiry: 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 usual side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of usual side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned a 10-decade (over 90 years)old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that "One of my customers is over 90 years old she is on chemo and was pushed into taking the vaccine now she has blood clots on top of all the other problems she had".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220102495-Covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: BAD HEADACHE; PRETTY FATIGUED; 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. No past medical history or concurrent conditions were 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 DEC-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 an unspecified date, the patient experienced bad headache, and pretty fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache and pretty fatigued was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: SEVERE CHEST PAIN AFTER JNJ; This spontaneous report received from a parent 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. 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 severe chest pain after JNJ. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe chest pain after JNJ was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINES; This spontaneous report received from a consumer 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, and batch number were not reported) 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 migraines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraines was not reported. This report was non-serious. This case, from the same reporter is linked to 20211203554.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: ACHES; COUGHING; SORE THROAT; FEVER; HEADACHE; FATIGUE; 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. The patient's pre-existing medical conditions included: Patient had taken cardio miracle supplement. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 number. Concomitant medications included artemisia absinthium herb, and copper.  On an unspecified date, the patient experienced aches, coughing, sore throat, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, coughing, headache, sore throat and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHES; COUGHING; SORE THROAT; FEVER; HEADACHE; FATIGUE; 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. The patient's pre-existing medical conditions included: Patient had taken cardio miracle supplement. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 number. Concomitant medications included artemisia absinthium herb, and copper.  On an unspecified date, the patient experienced aches, coughing, sore throat, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, coughing, headache, sore throat and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Loss of personal independence in daily activities, Pain, Pyrexia, Sinus congestion
Clinical narrative: COUGH; CONGESTION; BODY ACHES; HAVE HAD TO MISS DAYS OF ACTIVITY; FEVER; 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced cough, congestion, body aches, have had to miss days of activity, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cough, congestion, body aches and have had to miss days of activity was not reported. This report was non-serious. This case, from the same reporter is linked to 20220102687 and 20220102250.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Loss of personal independence in daily activities, Nasal congestion, Pain, Pyrexia
Clinical narrative: COUGH; CONGESTION; BODY ACHES; HAD TO MISS DAYS OF ACTIVITY; FEVER; This spontaneous report received from a parent 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, and batch number were not reported) 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 cough, congestion, body aches, had to miss days of activity, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cough, congestion, body aches and had to miss days of activity was not reported. This report was non-serious. This case, from the same reporter is linked to 20220102652 and 20220102250.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Myalgia, Pain in extremity
Clinical narrative: CHEST PAIN; ITCHY (FEELS NEED TO SCRATCH BODY); HEAVINESS IN THE CHEST; NUMBNESS AND TINGLING IN THE ARMS AND LEGS; SORE ARM; HEADACHE; MUSCLE ACHES; 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: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced sore arm, headache, and muscle aches. On 31-DEC-2021, the patient experienced chest pain, itchy (feels need to scratch body), heaviness in the chest, and numbness and tingling in the arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and muscle aches, and had not recovered from numbness and tingling in the arms and legs, chest pain, itchy (feels need to scratch body), and heaviness in the chest. This report was non-serious. This report was associated with product complaint number.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: CHEST PAIN; ITCHY (FEELS NEED TO SCRATCH BODY); HEAVINESS IN THE CHEST; NUMBNESS AND TINGLING IN THE ARMS AND LEGS; SORE ARM; HEADACHE; MUSCLE ACHES; 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: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced sore arm, headache, and muscle aches. On 31-DEC-2021, the patient experienced chest pain, itchy (feels need to scratch body), heaviness in the chest, and numbness and tingling in the arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and muscle aches, and had not recovered from numbness and tingling in the arms and legs, chest pain, itchy (feels need to scratch body), and heaviness in the chest. This report was non-serious. This report was associated with product complaint number.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: TERRIBLE ACHES AND PAINS; CHILLS; HIGH FEVERS; HEADACHES; 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, and batch number were not reported) dose, (Dose number in series:1) 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 terrible aches and pains, chills, high fevers, and headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) over 102 for 4 days. (Dose number in series:1 )  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fevers, and the outcome of chills, headaches and terrible aches and pains was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 298 pounds, and height was 68 inches. The patient's past medical history included: numerous back/neck surgeries from accidents, and concurrent conditions included: latex allergy, and drug allergy to ASA (Aspirin), diazepam, and gabapentin. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 21-OCT-2021 for prophylactic vaccination on left arm. The patient reported that, she was fine and had no issues post initial vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855114, and expiry: unknown) dose was not reported, 1 total, administered on 30-DEC-2021 for prophylactic vaccination on left arm (dose number in series 2). No concomitant medications were reported.  On 03-JAN-2022  in the morning the patient had no complaints but experienced nausea with vomiting twice since 17:00. The patient described it as liquid only (no food) (dose number in series 2) and denied any other complaint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and vomiting was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Erectile dysfunction
Clinical narrative: ERECTILE DYSFUNCTION/NOT BEEN ABLE TO HOLD, OR EVEN GET AN ERECTION; TAKING A TOLL ON MENTALLY; This spontaneous report received from a consumer concerned a 42 year old male of unknown race and ethnicity. 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, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced erectile dysfunction/not been able to hold or even get an erection, and taking a toll on mentally. Reporter stated that "I am writing to inform you that I believe your covid vaccine does cause erectile dysfunction. The patient and reporter never had an issue with his sexual performance. He was vaccinated and ever since had not been able to hold or even get an erection. Reporter also stated that patient had an appointment with a urologist on 10-JAN-2022. Reporter felt at the very least patient should be compensated for the financial loss he will incure. Not to mention the embarrassment and humiliation that come along with erectile dysfunction. It was really taking a toll on him mentally. They may seek counsel and go public if no action was taken". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from erectile dysfunction/not been able to hold, or even get an erection, and the outcome of taking a toll on mentally was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220103319-covid-19 vaccine ad26.cov2.s- Erectile dysfunction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Hypoacusis, Pain in extremity
Clinical narrative: STUTTER WHEN HE TALKS; SENSITIVE TO NOISE; RUNNY NOSE; SOMETHING WRONG IN BODY; NOISE IN THE EARS LIKE BLOWING OUT LIKE RAINING INSIDE; PAIN IN THE HEAD LIKE BLOWING OUT; PAIN IN SHOULDER; LITTLE PAIN IN THE ARM; This spontaneous report received from a patient 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 was not reported, administered on 22-NOV-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 23-NOV-2021, the patient experienced little pain in the arm. On 24-NOV-2021, the patient experienced pain in shoulder. On 25-NOV-2021, the patient experienced pain in the head like blowing out. On an unspecified date, the patient experienced stutter when he talks, sensitive to noise, runny nose, something wrong in body, and noise in the ears like blowing out like raining inside. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little pain in the arm, pain in shoulder, pain in the head like blowing out, noise in the ears like blowing out like raining inside, runny nose, sensitive to noise, stutter when he talks and something wrong in body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Speech disorder, Tinnitus
Clinical narrative: STUTTER WHEN HE TALKS; SENSITIVE TO NOISE; RUNNY NOSE; SOMETHING WRONG IN BODY; NOISE IN THE EARS LIKE BLOWING OUT LIKE RAINING INSIDE; PAIN IN THE HEAD LIKE BLOWING OUT; PAIN IN SHOULDER; LITTLE PAIN IN THE ARM; This spontaneous report received from a patient 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 was not reported, administered on 22-NOV-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 23-NOV-2021, the patient experienced little pain in the arm. On 24-NOV-2021, the patient experienced pain in shoulder. On 25-NOV-2021, the patient experienced pain in the head like blowing out. On an unspecified date, the patient experienced stutter when he talks, sensitive to noise, runny nose, something wrong in body, and noise in the ears like blowing out like raining inside. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little pain in the arm, pain in shoulder, pain in the head like blowing out, noise in the ears like blowing out like raining inside, runny nose, sensitive to noise, stutter when he talks and something wrong in body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: STAGE 3 KIDNEY DISEASE; This spontaneous report received from a consumer concerned multiple patients of unspecified sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  As per the reporter, on an unspecified date, "many other people were complaining of stage 3 kidney disease after getting the J and J vaccine" (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 3 kidney disease was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220100154.; Sender's Comments: V0: 20220104344 -Covid-19 vaccine ad26.cov2.s- Stage 3 kidney disease. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram, Thrombosis
Clinical narrative: BLOOD CLOTS; STROKE WHILE ON VACATION; COULD NO LONGER SPEAK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. He had a Computed axial tomography (CAT) scan and all his regular checkups. He was fine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total administered 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.  It was reported that, after vaccination he had a stroke while he was on vacation and could no longer speak. Now he wanted to get back to his original place so that he can stay alive, for that he needed to pay for air ambulance. He was healthy and now he had all these blood clots (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, and could no longer speak, and the outcome of stroke while on vacation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220104382-Covid-19 vaccine ad26.CoV-2.s- Blood clots, Stroke while on vacation. 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).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50-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: 204B21A, and expiry: unknown) dose was not reported, dose number in series was 01, 01 total was administered at right deltoid region on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient experienced symptoms of body aching and fever and suspected coronavirus disease-19 (COVID-19) infection. On 31-DEC-2021, patient took a COVID-19 home test [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid diagnostic test] and the result was positive, and hence the event of suspected clinical vaccination failure. On an unspecified date, patient experienced other symptoms of cough, stuffy, runny nose, fatigue and was experiencing them at the time of report (04-JAN-2022) (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected COVID-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210057.; Sender's Comments: V0:20220104395-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; 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, and batch number were not reported) 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 tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious. This case, from the same reporter is linked to 20220105609.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; NASAL CONGESTION; STOMACH DISCOMFORT; FEVER; HEADACHES; This spontaneous report received from a patient 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, treatment medications included: ibuprofen. On 02-JAN-2022, the patient experienced sore throat, nasal congestion, stomach discomfort, fever, and headaches. Laboratory data included: COVID-19 antigen test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, nasal congestion, stomach discomfort, fever, and headaches on 03-JAN-2022. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: SORE THROAT; NASAL CONGESTION; STOMACH DISCOMFORT; FEVER; HEADACHES; This spontaneous report received from a patient 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, treatment medications included: ibuprofen. On 02-JAN-2022, the patient experienced sore throat, nasal congestion, stomach discomfort, fever, and headaches. Laboratory data included: COVID-19 antigen test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, nasal congestion, stomach discomfort, fever, and headaches on 03-JAN-2022. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure on medication, non smoker and non alcohol user 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: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced suspected covid-19 infection and hence suspected clinical vaccination failure. On 28-DEC-2021 at night after work, He had symptoms of cough, chills, stuffy nose and high fever. Patient reported that when he coughed his chest hurt. He visited his daughter that night to check on her and she told him she has Covid-19 virus. He was within 6 feet of his daughter for up to 20 minutes. On 02-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. During the report he mentioned symptom of headache as well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority.; Sender's Comments: V0- 20220104490-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) 1 total, dose was not reported administered to right arm on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced sore throat, nasal congestion and felt very tired (confirmed covid-19 infection). On 03-JAN-2022, the patient had diarrhea but feels better on the day of reporting and on the same day given sample for covid test and the polymerase chain reaction (PCR) test results showed covid-19 positive (confirmed clinical vaccination failure). The patient was fully vaccinated and had not taken booster dose yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000210121.; Sender's Comments: V0-20220104569-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: NOT HAD A FEVER BLISTER SINCE RECEIVING VACCINE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cold sore, and other pre-existing medical conditions included: The only thing that helps is L-Lysine and diet, avoiding L-Arginine. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included lysine for cold sore. On an unspecified date, the patient experienced not had a fever blister since receiving vaccine (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not had a fever blister since receiving vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220100902 (dose number in series 2).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Headache, Nasal congestion, Pain
Clinical narrative: BODY ACHES; CONGESTION; HIGH FEVER; HEADACHES; COUGH; This spontaneous report received from a patient concerned a female of 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 previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, Expiry: unknown) dose was not reported, frequency one total administered at right arm on 15-MAR-2021 for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received a booster of non-company suspect vaccine included: mrna 1273 (form of admin and route of admin were not reported, batch number: 939904, expiry: unknown) dose was not reported, administered at right arm on 29-OCT-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 30-DEC-2021, the patient experienced cough and headaches (Dose number in series 2). Laboratory data included: COVID-19 antigen test (NR: not provided) negative.  On 31-DEC-2021, the patient experienced body aches, congestion, and high fever (Dose number in series 2). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. On 02-JAN-2022, Laboratory data included: COVID-19 polymerase chain reaction (PCR) test (NR: not provided) awaiting result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with mrna 1273 was not applicable.  The patient recovered from body aches, high fever and headaches on 02-JAN-2022 and had not recovered from cough and congestion. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHES; CONGESTION; HIGH FEVER; HEADACHES; COUGH; This spontaneous report received from a patient concerned a female of 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 previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, Expiry: unknown) dose was not reported, frequency one total administered at right arm on 15-MAR-2021 for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received a booster of non-company suspect vaccine included: mrna 1273 (form of admin and route of admin were not reported, batch number: 939904, expiry: unknown) dose was not reported, administered at right arm on 29-OCT-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 30-DEC-2021, the patient experienced cough and headaches (Dose number in series 2). Laboratory data included: COVID-19 antigen test (NR: not provided) negative.  On 31-DEC-2021, the patient experienced body aches, congestion, and high fever (Dose number in series 2). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. On 02-JAN-2022, Laboratory data included: COVID-19 polymerase chain reaction (PCR) test (NR: not provided) awaiting result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with mrna 1273 was not applicable.  The patient recovered from body aches, high fever and headaches on 02-JAN-2022 and had not recovered from cough and congestion. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000210186.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: COLD; BODY ACHES EVERYWHERE; HARD TO SLEEP; SHIVERING; FEVER; 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 pre-existing medical conditions included: The patient was feeling normal all day until fever comes. The patient took some medicine and cat was purring and cuddling with patient in bed. 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 03-JAN-2022 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 03-JAN-2022, the patient experienced cold, body aches everywhere, hard to sleep, shivering, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold, body aches everywhere, hard to sleep and shivering was not reported. This report was non-serious.