chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; RECUPERED FROM COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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 administration, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 01, 01 total was 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 an unspecified date, the patient experienced suspected clinical vaccination failure, and recupered from coronavirus disease (suspected covid-19 infection) recently (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recupered from covid-19, 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 (PQC): 90000213849 The suspected product quality complaint has been confirmed to be this record describes an adverse event (recuperated from covid-19) however, based on the updated guidance "Janssen covid-19 vaccine: definitions of lack of effect (LOE) and on-label-use for post booster dose" this case does not meet the definition for a product quality complaint (PQC) since the only indication is that the patient had covid but does not refer to any symptoms or polymerase chain reaction (PCR) tests and does not allege the vaccine did not work. This record will be voided as no pqc, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220150309-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: Expired product administered
Clinical narrative: This spontaneous report received from a health care professional 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced administration of expired vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cold sweat, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; CLAMMY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: 2 knee surgeries, and 2 elbow surgeries, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 24-JAN-2022, the patient experienced cough, scratchy/tickly throat, mild temperature or fever, clammy, runny nose, and sneezing and on an unspecified date, the patient experienced cold like symptoms which was coded as confirmed covid-19 infection. On 24-JAN-2022, the patient experienced clammy. On 25-JAN-2022, the patient experienced confirmed clinical vaccination failure 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 the clammy, confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213828.; Sender's Comments: V0- 20220150402-Covid-19 vaccine ad26.CoV-2.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
Age: 34.0
Sex: F
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 34 years old female with unspecified 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 administration not reported, batch number: 204B21A and expiry: 11-DEC-2021) dose was not reported, dose number in series 1, 01 total administered on 22-JUL-2021 on right arm for prophylactic vaccination. Concomitant medications included fluoxetine for anxiety, bupropion hydrochloride for unknown indication, levothyroxine for thyroid, and ascorbic acid/calcium pantothenate/cyanocobalamin/ergocalciferol/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin sodium phosphate/thiamine mononitrate/tocopheryl acetate for unknown indication.  On 18-JAN-2022, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (cough, congestion, froggy voice). On 19-JAN-2022, Laboratory data included: coronavirus disease (COVID)-19 virus test (NR: not provided) positive. On 22-JAN-2022 The patient felt much better (dose number in series 1). The patient confirmed she had not yet received a booster vaccination. 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: 90000213953.; Sender's Comments: V0:20220150411-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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 42 years old male of an unspecified 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 administration not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, dose number in series was 1, 01 in total was administered on 27-MAR-2021 for prophylactic vaccination.  No adverse events were reported for covid-19 vaccine ad26.cov2.s (dose number in series was 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, dose number in series was 2, 01 total, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had covid-19 infection (dose number in series was 2). On an unspecified date patient had done rapid test: severe acute respiratory syndrome (SARS-CoV-2) test which was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a white female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on 23-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 01-NOV-2021 for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JAN-2022, the patient experienced Slight runny nose (suspected covid-19 infection). On 26-JAN-2022, the patient tested positive on using the "Bi Nax Now take home" antigen test (suspected clinical vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0: 20220150499-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine 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
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom, Pain, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: NEUROLOGIC SYMPTOMS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS CONGESTION; BODY ACHE; FEELING SNIFFY; SORE ARM; This spontaneous report received from a patient concerned a 56 year old white male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, cigarette smoker, alcohol use, and arthritis. The Patient had no known drug allergies. Blood type is A negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 07-SEP-2021) dose was not reported, dose number in series was 1, 01 in total, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, after vaccination, the patient had sore arm for couple of hours. On 20-MAY-2021, the patient had body ache and was feeling sniffy. On 23-JAN-2022, the patient had sinus congestion. The patient reported having occasional sneezing (4 times in a row), congestion, runny nose (suspected covid-19 infection). The patient's symptoms got worse over the next two days, so he decided to test. On 25-JAN-2022, the patient woke up a little achy as he didn't take Ibuprofen. At night, while eating, patient noticed that he couldn't taste or smell and it continued the next day morning. Patient also felt tired/ lethargic. The patient tested positive using home test, COVID-19 virus test (NR: not provided) Positive, sent by the government at 19:00 hours (suspected clinical vaccination failure) (dose number in series was 1). Patient was unaware on how he contracted Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on MAY-2021, was recovering from body ache, and feeling sniffy, had not recovered from suspected covid-19 infection and sinus congestion, and the outcome of neurologic symptoms and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220150539-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
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion, Suspected COVID-19, Vaccination failure
Clinical narrative: NEUROLOGIC SYMPTOMS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS CONGESTION; BODY ACHE; FEELING SNIFFY; SORE ARM; This spontaneous report received from a patient concerned a 56 year old white male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, cigarette smoker, alcohol use, and arthritis. The Patient had no known drug allergies. Blood type is A negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 07-SEP-2021) dose was not reported, dose number in series was 1, 01 in total, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, after vaccination, the patient had sore arm for couple of hours. On 20-MAY-2021, the patient had body ache and was feeling sniffy. On 23-JAN-2022, the patient had sinus congestion. The patient reported having occasional sneezing (4 times in a row), congestion, runny nose (suspected covid-19 infection). The patient's symptoms got worse over the next two days, so he decided to test. On 25-JAN-2022, the patient woke up a little achy as he didn't take Ibuprofen. At night, while eating, patient noticed that he couldn't taste or smell and it continued the next day morning. Patient also felt tired/ lethargic. The patient tested positive using home test, COVID-19 virus test (NR: not provided) Positive, sent by the government at 19:00 hours (suspected clinical vaccination failure) (dose number in series was 1). Patient was unaware on how he contracted Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on MAY-2021, was recovering from body ache, and feeling sniffy, had not recovered from suspected covid-19 infection and sinus congestion, and the outcome of neurologic symptoms and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220150539-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
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Diarrhoea, Dyspnoea, Migraine
Clinical narrative: RETURN OF VERTIGO EPISODES; WORSENING OF  PRE-EXISTING MIGRAINES; SEVERE DIARRHEA; VOMITING; NAUSEA; STOMACH PAIN; RACING HEARTBEAT AND PALPITATIONS; ANXIETY; HAD TO CATCH A BREATH; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 146 pounds, and height was 65 inches. The patient's concurrent conditions included: pre-existing migraines, and vertigo, and other pre-existing medical conditions included: The patient had no other conditions such as diabetes or obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced racing heartbeat and palpitations, anxiety, and had to catch a breath. On 04-MAY-2021, the patient experienced stomach pain. On 04-MAY-2021, the patient experienced worsening of pre-existing migraines. On 04-MAY-2021, the patient experienced severe diarrhea. On 04-MAY-2021, the patient experienced vomiting. On 04-MAY-2021, the patient experienced nausea. On 08-MAY-2021, the patient experienced return of vertigo episodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, severe diarrhea, vomiting, and nausea on MAY-2021, was recovering from worsening of pre-existing migraines, and the outcome of return of vertigo episodes, i have been having racing heartbeat and palpitations, anxiety and had to catch a breath was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Vertigo, Vomiting
Clinical narrative: RETURN OF VERTIGO EPISODES; WORSENING OF  PRE-EXISTING MIGRAINES; SEVERE DIARRHEA; VOMITING; NAUSEA; STOMACH PAIN; RACING HEARTBEAT AND PALPITATIONS; ANXIETY; HAD TO CATCH A BREATH; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 146 pounds, and height was 65 inches. The patient's concurrent conditions included: pre-existing migraines, and vertigo, and other pre-existing medical conditions included: The patient had no other conditions such as diabetes or obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced racing heartbeat and palpitations, anxiety, and had to catch a breath. On 04-MAY-2021, the patient experienced stomach pain. On 04-MAY-2021, the patient experienced worsening of pre-existing migraines. On 04-MAY-2021, the patient experienced severe diarrhea. On 04-MAY-2021, the patient experienced vomiting. On 04-MAY-2021, the patient experienced nausea. On 08-MAY-2021, the patient experienced return of vertigo episodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, severe diarrhea, vomiting, and nausea on MAY-2021, was recovering from worsening of pre-existing migraines, and the outcome of return of vertigo episodes, i have been having racing heartbeat and palpitations, anxiety and had to catch a breath was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS (POOR QUALITY DRUG ADMINISTERED); OFF LABEL USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced administered vaccine stored outside recommended conditions (poor quality drug administered), off label use, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored outside recommended conditions (poor quality drug administered), off label use and incorrect product storage was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Feeling abnormal, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEELING WEIRD; DEHYDRATED; This spontaneous report received from a patient concerned a 36 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: 11-DEC-2021) dose was not reported, 1 total administered on 17-AUG-2021 (between 19:00 to 23:00 hours) to right arm for prophylactic vaccination. No concomitant medications were reported. On 26-JAN-2022, the patient started feeling weird while at work and around 12:00 AM, followed by patient started having chills and was freezing. On the same day around between 14:15 and 14:30 hours, the patient did home covid test (Unspecified test) and got positive result in less than 5 minutes which was  suspected clinical vaccination failure and suspected covid-19 infection. After 15:00 hours, patient experienced headache, gunk in his throat, and was dehydrated. 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 the feeling weird, dehydrated, suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000214020.; Sender's Comments: V0.20220150702-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: Arthritis reactive
Clinical narrative: REACTIVE ARTHRITIS IN LEFT KNEE AND HIP; This spontaneous report received from a patient via a company representative concerned a 62 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No prior health issues. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. On an unspecified date, the patient experienced sick (dose number in series 1). The outcome of sick was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered at left shoulder on an unspecified date 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 reactive arthritis in left knee and hip, and dire pain (both events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reactive arthritis in left knee and hip. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220153538.; Sender's Comments: V0: 20220150708-COVID-19 VACCINE AD26.COV2.S- reactive arthritis in left knee and hip. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Bone pain, Electrocardiogram, Fatigue
Clinical narrative: NUMBING PAIN IN NECK; WEIGHT GAINING; NUMBING PAIN IN ARM; RIGHT SIDE OF NECK A BIT SWOLLEN; SWELLING IN CHEST; SWOLLEN MUMP WHERE THE NECK SHOULDER AND COLLAR BONE MEET; HEADACHE; SWOLLEN LYMPH NODES ON BEGINING OF THE NECK AND CLOSE TO COLLAR BONE; FLU LIKE SYMPTOMS; SENSITIVE TO COLD; PAINFUL SKIN; PAIN IN ANKLES; SORE SHOULDER; JOINTS IN KNEES WERE PAINFUL SPECIALLY THE LEFT ONE (NUMB/PAIN); HIGH BLOOD PRESSURE; FELT HOT; BONE ACHES AROUND THE JOINTS (NUMB/PAINFUL); WEIRD FEELING; SLEPT MORE; MUSCLES ACHES; FATIGUED; This spontaneous report received from a patient concerned a 34 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: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced bone aches around the joints (numb/painful), weird feeling, slept more, muscles aches, and fatigued. On 24-DEC-2021, the patient experienced high blood pressure. On 24-DEC-2021, the patient experienced felt hot. On 24-DEC-2021, the patient experienced joints in knees were painful specially the left one (numb/pain). On 25-DEC-2021, the patient experienced swollen lymph nodes on begining of the neck and close to collar bone, sensitive to cold, painful skin, flu like symptoms, pain in ankles, and sore shoulder. On JAN-2022, Laboratory data included: Blood pressure (NR: not provided) increased, 164/113, and Scan (NR: not provided) no clot found. On 13-JAN-2022, the patient experienced right side of neck a bit swollen, swelling in chest, swollen mump where the neck shoulder and collar bone meet, and headache. Laboratory data included: EKG (NR: not provided) all normal. On an unspecified date, the patient experienced numbing pain in neck, weight gaining, and numbing pain in arm. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone aches around the joints (numb/painful) on 01-JAN-2022, weird feeling, flu like symptoms, and muscles aches on 30-DEC-2021, felt hot, sensitive to cold, painful skin, joints in knees were painful specially the left one (numb/pain), and pain in ankles, and fatigued on 26-DEC-2021, had not recovered from high blood pressure, sore shoulder, swollen lymph nodes on begining of the neck and close to collar bone, right side of neck a bit swollen, numbing pain in arm, headache, swollen mump where the neck shoulder and collar bone meet, and numbing pain in neck, and the outcome of swelling in chest, weight gaining and slept more was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, Hypersomnia, Hypertension
Clinical narrative: NUMBING PAIN IN NECK; WEIGHT GAINING; NUMBING PAIN IN ARM; RIGHT SIDE OF NECK A BIT SWOLLEN; SWELLING IN CHEST; SWOLLEN MUMP WHERE THE NECK SHOULDER AND COLLAR BONE MEET; HEADACHE; SWOLLEN LYMPH NODES ON BEGINING OF THE NECK AND CLOSE TO COLLAR BONE; FLU LIKE SYMPTOMS; SENSITIVE TO COLD; PAINFUL SKIN; PAIN IN ANKLES; SORE SHOULDER; JOINTS IN KNEES WERE PAINFUL SPECIALLY THE LEFT ONE (NUMB/PAIN); HIGH BLOOD PRESSURE; FELT HOT; BONE ACHES AROUND THE JOINTS (NUMB/PAINFUL); WEIRD FEELING; SLEPT MORE; MUSCLES ACHES; FATIGUED; This spontaneous report received from a patient concerned a 34 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: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced bone aches around the joints (numb/painful), weird feeling, slept more, muscles aches, and fatigued. On 24-DEC-2021, the patient experienced high blood pressure. On 24-DEC-2021, the patient experienced felt hot. On 24-DEC-2021, the patient experienced joints in knees were painful specially the left one (numb/pain). On 25-DEC-2021, the patient experienced swollen lymph nodes on begining of the neck and close to collar bone, sensitive to cold, painful skin, flu like symptoms, pain in ankles, and sore shoulder. On JAN-2022, Laboratory data included: Blood pressure (NR: not provided) increased, 164/113, and Scan (NR: not provided) no clot found. On 13-JAN-2022, the patient experienced right side of neck a bit swollen, swelling in chest, swollen mump where the neck shoulder and collar bone meet, and headache. Laboratory data included: EKG (NR: not provided) all normal. On an unspecified date, the patient experienced numbing pain in neck, weight gaining, and numbing pain in arm. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone aches around the joints (numb/painful) on 01-JAN-2022, weird feeling, flu like symptoms, and muscles aches on 30-DEC-2021, felt hot, sensitive to cold, painful skin, joints in knees were painful specially the left one (numb/pain), and pain in ankles, and fatigued on 26-DEC-2021, had not recovered from high blood pressure, sore shoulder, swollen lymph nodes on begining of the neck and close to collar bone, right side of neck a bit swollen, numbing pain in arm, headache, swollen mump where the neck shoulder and collar bone meet, and numbing pain in neck, and the outcome of swelling in chest, weight gaining and slept more was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Myalgia, Neck pain, Pain in extremity
Clinical narrative: NUMBING PAIN IN NECK; WEIGHT GAINING; NUMBING PAIN IN ARM; RIGHT SIDE OF NECK A BIT SWOLLEN; SWELLING IN CHEST; SWOLLEN MUMP WHERE THE NECK SHOULDER AND COLLAR BONE MEET; HEADACHE; SWOLLEN LYMPH NODES ON BEGINING OF THE NECK AND CLOSE TO COLLAR BONE; FLU LIKE SYMPTOMS; SENSITIVE TO COLD; PAINFUL SKIN; PAIN IN ANKLES; SORE SHOULDER; JOINTS IN KNEES WERE PAINFUL SPECIALLY THE LEFT ONE (NUMB/PAIN); HIGH BLOOD PRESSURE; FELT HOT; BONE ACHES AROUND THE JOINTS (NUMB/PAINFUL); WEIRD FEELING; SLEPT MORE; MUSCLES ACHES; FATIGUED; This spontaneous report received from a patient concerned a 34 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: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced bone aches around the joints (numb/painful), weird feeling, slept more, muscles aches, and fatigued. On 24-DEC-2021, the patient experienced high blood pressure. On 24-DEC-2021, the patient experienced felt hot. On 24-DEC-2021, the patient experienced joints in knees were painful specially the left one (numb/pain). On 25-DEC-2021, the patient experienced swollen lymph nodes on begining of the neck and close to collar bone, sensitive to cold, painful skin, flu like symptoms, pain in ankles, and sore shoulder. On JAN-2022, Laboratory data included: Blood pressure (NR: not provided) increased, 164/113, and Scan (NR: not provided) no clot found. On 13-JAN-2022, the patient experienced right side of neck a bit swollen, swelling in chest, swollen mump where the neck shoulder and collar bone meet, and headache. Laboratory data included: EKG (NR: not provided) all normal. On an unspecified date, the patient experienced numbing pain in neck, weight gaining, and numbing pain in arm. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone aches around the joints (numb/painful) on 01-JAN-2022, weird feeling, flu like symptoms, and muscles aches on 30-DEC-2021, felt hot, sensitive to cold, painful skin, joints in knees were painful specially the left one (numb/pain), and pain in ankles, and fatigued on 26-DEC-2021, had not recovered from high blood pressure, sore shoulder, swollen lymph nodes on begining of the neck and close to collar bone, right side of neck a bit swollen, numbing pain in arm, headache, swollen mump where the neck shoulder and collar bone meet, and numbing pain in neck, and the outcome of swelling in chest, weight gaining and slept more was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Scan, Swelling, Temperature intolerance, Weight increased
Clinical narrative: NUMBING PAIN IN NECK; WEIGHT GAINING; NUMBING PAIN IN ARM; RIGHT SIDE OF NECK A BIT SWOLLEN; SWELLING IN CHEST; SWOLLEN MUMP WHERE THE NECK SHOULDER AND COLLAR BONE MEET; HEADACHE; SWOLLEN LYMPH NODES ON BEGINING OF THE NECK AND CLOSE TO COLLAR BONE; FLU LIKE SYMPTOMS; SENSITIVE TO COLD; PAINFUL SKIN; PAIN IN ANKLES; SORE SHOULDER; JOINTS IN KNEES WERE PAINFUL SPECIALLY THE LEFT ONE (NUMB/PAIN); HIGH BLOOD PRESSURE; FELT HOT; BONE ACHES AROUND THE JOINTS (NUMB/PAINFUL); WEIRD FEELING; SLEPT MORE; MUSCLES ACHES; FATIGUED; This spontaneous report received from a patient concerned a 34 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: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced bone aches around the joints (numb/painful), weird feeling, slept more, muscles aches, and fatigued. On 24-DEC-2021, the patient experienced high blood pressure. On 24-DEC-2021, the patient experienced felt hot. On 24-DEC-2021, the patient experienced joints in knees were painful specially the left one (numb/pain). On 25-DEC-2021, the patient experienced swollen lymph nodes on begining of the neck and close to collar bone, sensitive to cold, painful skin, flu like symptoms, pain in ankles, and sore shoulder. On JAN-2022, Laboratory data included: Blood pressure (NR: not provided) increased, 164/113, and Scan (NR: not provided) no clot found. On 13-JAN-2022, the patient experienced right side of neck a bit swollen, swelling in chest, swollen mump where the neck shoulder and collar bone meet, and headache. Laboratory data included: EKG (NR: not provided) all normal. On an unspecified date, the patient experienced numbing pain in neck, weight gaining, and numbing pain in arm. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone aches around the joints (numb/painful) on 01-JAN-2022, weird feeling, flu like symptoms, and muscles aches on 30-DEC-2021, felt hot, sensitive to cold, painful skin, joints in knees were painful specially the left one (numb/pain), and pain in ankles, and fatigued on 26-DEC-2021, had not recovered from high blood pressure, sore shoulder, swollen lymph nodes on begining of the neck and close to collar bone, right side of neck a bit swollen, numbing pain in arm, headache, swollen mump where the neck shoulder and collar bone meet, and numbing pain in neck, and the outcome of swelling in chest, weight gaining and slept more was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: DIED; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 84 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: 1821286, expiry: unknown) dose was not reported, 1 total administered on 16-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, the patient contracted Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). On 09-JAN-2022, the patient died. On 09-JAN-2022, the patient died from unknown cause of death. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 09-JAN-2022, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint number 90000213926.; Sender's Comments: V0: 20220150815 -COVID-19 VACCINE AD26.COV2.S-Died. 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).  V0: 20220150815-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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This solicited report received from a patient: Adverse Event Rates RECOVER concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 an unspecified date, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and fever was related.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: HAS ADVERSE REACTION HE THOUGHT HE MIGHT LOSE HIS LEGS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number was 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 an adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of an adverse reaction was not reported. This report was non-serious.
Age: 44.0
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 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 (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported,1 total administered on 25-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-JAN-2022, the patient experienced symptoms of fever, cough, sore throat and are still ongoing (suspected covid19 infection). On 26-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number was requested.; Sender's Comments: V0: 20220151060-JANSSEN 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: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, Headache, Oropharyngeal pain, Pain
Clinical narrative: BODYACHE; SORE THROAT; LOSING VOICE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies and no known medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bodyache, sore throat, losing voice, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F, and COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, bodyache, headache, sore throat and losing voice was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000214026. The suspected product quality complaint has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: BODYACHE; SORE THROAT; LOSING VOICE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies and no known medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bodyache, sore throat, losing voice, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F, and COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, bodyache, headache, sore throat and losing voice was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000214026. The suspected product quality complaint has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.
Sex: F
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 54 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: partial lung removal, and smoker, and concurrent conditions included: diabetes, and abstains from alcohol, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (could not hold water, vomiting) when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2021) dose was not reported, 1 total was administered to right arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-NOV-2021, the patient had home test (COVID-19 virus test) (NR: not provided) which was resulted positive for covid (covid-19 infection). On 09-NOV-2021, the patient visited clinic (physician office visit) and was infused (possibly a monoclonal antibody). During that the patient had nasal swab test (possibly a PCR test) (COVID-19 virus test) (NR: not provided) which was resulted positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed clinical vaccination failure, and confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213814. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. a manufacturing related root cause could not be identified (Void: N) based on the Regulatory Authority evaluation/investigation performed.  Initial information was processed along with the additional information received on 28-JAN-2022. The following information was updated and incorporated into the case narrative: product quality complaint result.; Sender's Comments: V0: 20220151290-JANSSEN COVID-19 VACCINE Ad26.COV2.S Confirmed 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. 20220151290-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed covid-19 infection. 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).