chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Injection site discolouration, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: INJECTION SITE PURPLE; SWOLLEN ARM; REDNESS ON ARM; ITCHY ON INJECTION SITE; VOMITING BLOOD; DIZZY; UNABLE TO EAT; VOMITING; PAIN IN ARM/ UNABLE TO LIFT ARM ABOVE HEAD; SORENESS AT INJECTION SITE; TIRED; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the patient felt dizzy, was tired, had a fever and soreness at injection site. The patient could not lift her arm above head without being in pain. She was unable to eat anything the entire day. The patient attempted to eat some soup but, threw it up. On 07-APR-2021 at 03:00, the patient woke up and drank some water but within ten minutes she threw that up along with blood and later her temperature was 104.8 (unit unspecified). On 07-APR-2021 afternoon, the patient was not able to eat anything but she drank some gatorade. On 08-APR-2021 afternoon, the patient's fever broke. On 09-APR-2021, the patient was able to go to work; however the patient's arms still hurt and was red and swollen. The patient's injection site began to itch and it continued up to that weekend. On 11-APR-2021, the injection arm was swollen for about an hour. On 13-APR-2021, the patient felt fine but her injection site was purple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting blood, dizzy, unable to eat, redness on arm, itchy on injection site, vomiting, pain in arm/ unable to lift arm above head, soreness at injection site, and tired on APR-2021, swollen arm on 11-APR-2021, and fever on 08-APR-2021, and had not recovered from injection site purple. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210425153-covid-19 vaccine ad26.cov2. s- vomiting blood. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: INJECTION SITE PURPLE; SWOLLEN ARM; REDNESS ON ARM; ITCHY ON INJECTION SITE; VOMITING BLOOD; DIZZY; UNABLE TO EAT; VOMITING; PAIN IN ARM/ UNABLE TO LIFT ARM ABOVE HEAD; SORENESS AT INJECTION SITE; TIRED; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the patient felt dizzy, was tired, had a fever and soreness at injection site. The patient could not lift her arm above head without being in pain. She was unable to eat anything the entire day. The patient attempted to eat some soup but, threw it up. On 07-APR-2021 at 03:00, the patient woke up and drank some water but within ten minutes she threw that up along with blood and later her temperature was 104.8 (unit unspecified). On 07-APR-2021 afternoon, the patient was not able to eat anything but she drank some gatorade. On 08-APR-2021 afternoon, the patient's fever broke. On 09-APR-2021, the patient was able to go to work; however the patient's arms still hurt and was red and swollen. The patient's injection site began to itch and it continued up to that weekend. On 11-APR-2021, the injection arm was swollen for about an hour. On 13-APR-2021, the patient felt fine but her injection site was purple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting blood, dizzy, unable to eat, redness on arm, itchy on injection site, vomiting, pain in arm/ unable to lift arm above head, soreness at injection site, and tired on APR-2021, swollen arm on 11-APR-2021, and fever on 08-APR-2021, and had not recovered from injection site purple. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210425153-covid-19 vaccine ad26.cov2. s- vomiting blood. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: WHOLE BODY SHAKING; FEELING HOT; SWEATING; WEAKNESS; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced whole body shaking. On 11-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced tired. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the whole body shaking, feeling hot, weakness, sweating, tired and diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: WHOLE BODY SHAKING; FEELING HOT; SWEATING; WEAKNESS; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced whole body shaking. On 11-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced tired. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the whole body shaking, feeling hot, weakness, sweating, tired and diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Pain
Clinical narrative: FELT LIKE FAINTING; BODY ACHE; CHILLS; SEVERE HEADACHE; FEVER OF 102 F; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced fever of 102 f. Laboratory data included: Body temperature (NR: not provided) 102 F. On 12-APR-2021, the subject experienced felt like fainting. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like fainting on 12-APR-2021, chills on 13-APR-2021, and fever of 102 f on APR-2021, and had not recovered from severe headache, and body ache. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FELT LIKE FAINTING; BODY ACHE; CHILLS; SEVERE HEADACHE; FEVER OF 102 F; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced fever of 102 f. Laboratory data included: Body temperature (NR: not provided) 102 F. On 12-APR-2021, the subject experienced felt like fainting. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like fainting on 12-APR-2021, chills on 13-APR-2021, and fever of 102 f on APR-2021, and had not recovered from severe headache, and body ache. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Hypokinesia, Migraine, Uterine spasm
Clinical narrative: MIGRAINE; STRONG UTERUS CRAMP; COULDN'T MOVE; BURNING EYES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bilateral mastectomy, and concurrent conditions included penicillin and aspirin allergy, and breast cancer. 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 subject experienced migraine, strong uterus cramp, couldn't move, and burning eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong uterus cramp, migraine, burning eyes and couldn't move was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH, HARD TIME "GETTING OXYGEN"; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath, hard time "getting oxygen". On APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on APR-2021, and had not recovered from shortness of breath, hard time "getting oxygen". This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Laboratory test, Nausea, Swelling
Clinical narrative: ELEVATED CLOT LEVELS; DIZINESS/LIGHTHEADED; NAUSEA; BRUISE ON LEG; SWELLING; WISDOM TOOTH PULLED; This spontaneous report was received from a consumer and concerned a female of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiration date: Unknown) dose was not reported,1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's father reported that on 06-Apr-2021, in urgent care patient's wisdom tooth was pulled.  On 08-APR-2021, the subject experienced diziness/lightheaded, nausea, bruise on leg, swelling  4x4 inches on lower right calf. The next day, the patient's bruise/swelling move to inside of right knee, she had new bruise on leg and went to urgent care; the doctor told her she hit it. On 09-APR-2021, the bruise moved to inside of knee, and the patient was taken to emergency room (ER) where "clot test" showed elevated clot levels and rivaroxaban (Xarelto) was prescribed for treatment. On 10-APR-2021 (Saturday morning), ultrasound was done; result not reported. At the time of report  there was decreased in swelling. The patient's father stated that, the event's might be related to wisdom tooth pulled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated clot levels, diziness/lightheaded, nausea, bruise on leg, and swelling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced elevated clot levels 29 days after receiving the Janssen COVID-19 vaccine and 3 days after the patient's wisdom tooth was pulled out.  The patient had her wisdom tooth pulled out 26th day post vaccination. 2 days later (28 days after the vaccination), the patient experienced dizziness and nausea and was noted to have bruise and swelling (around 4x4 inches) on the right lower leg. The next day, bruise/swelling was noted to reach the area of the right knee, probably the medial side, which prompted consult at the ER. The "clot test"  done as was noted to be elevated (no actual results provided). An ultrasound was also done but the result was not reported. Long periods of immobility (sitting in the dental chair) and the temporal plausibility from the dental procedure to the event of elevated clot levels confounds the temporal plausibility of the elevation of clot level and the vaccine; hence this is assessed as indeterminate per classification of adverse event following immunization. Additional information requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan, Wisdom teeth removal
Clinical narrative: ELEVATED CLOT LEVELS; DIZINESS/LIGHTHEADED; NAUSEA; BRUISE ON LEG; SWELLING; WISDOM TOOTH PULLED; This spontaneous report was received from a consumer and concerned a female of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiration date: Unknown) dose was not reported,1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's father reported that on 06-Apr-2021, in urgent care patient's wisdom tooth was pulled.  On 08-APR-2021, the subject experienced diziness/lightheaded, nausea, bruise on leg, swelling  4x4 inches on lower right calf. The next day, the patient's bruise/swelling move to inside of right knee, she had new bruise on leg and went to urgent care; the doctor told her she hit it. On 09-APR-2021, the bruise moved to inside of knee, and the patient was taken to emergency room (ER) where "clot test" showed elevated clot levels and rivaroxaban (Xarelto) was prescribed for treatment. On 10-APR-2021 (Saturday morning), ultrasound was done; result not reported. At the time of report  there was decreased in swelling. The patient's father stated that, the event's might be related to wisdom tooth pulled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated clot levels, diziness/lightheaded, nausea, bruise on leg, and swelling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced elevated clot levels 29 days after receiving the Janssen COVID-19 vaccine and 3 days after the patient's wisdom tooth was pulled out.  The patient had her wisdom tooth pulled out 26th day post vaccination. 2 days later (28 days after the vaccination), the patient experienced dizziness and nausea and was noted to have bruise and swelling (around 4x4 inches) on the right lower leg. The next day, bruise/swelling was noted to reach the area of the right knee, probably the medial side, which prompted consult at the ER. The "clot test"  done as was noted to be elevated (no actual results provided). An ultrasound was also done but the result was not reported. Long periods of immobility (sitting in the dental chair) and the temporal plausibility from the dental procedure to the event of elevated clot levels confounds the temporal plausibility of the elevation of clot level and the vaccine; hence this is assessed as indeterminate per classification of adverse event following immunization. Additional information requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Giant cell arteritis, Lymphadenopathy
Clinical narrative: TEMPORAL ARTERITIS; CHILLS; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swollen lymph nodes. On 13-MAR-2021, the subject experienced temporal arteritis. On 13-MAR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporal arteritis, swollen lymph nodes, and chills on 2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Malaise, Pain assessment, Pain in extremity
Clinical narrative: CHEST PAIN WHEN LYING; SHORTNESS OF BREATH; ARM PAIN; NOT DOING WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced chest pain when lying. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced not doing well. Laboratory data included: Pain scale (NR: not provided) 4 and a half. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain when lying, arm pain, shortness of breath and not doing well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Muscle spasms, Nausea, Pain
Clinical narrative: MIGRAINES; BODY ACHES; SPASMS; CHILLS; FEVERS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/butalbital/caffeine, and ibuprofen. On 09-APR-2021, the subject experienced migraines. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced spasms. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fevers. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, migraines, body aches, chills, and fevers, and the outcome of spasms was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MIGRAINES; BODY ACHES; SPASMS; CHILLS; FEVERS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/butalbital/caffeine, and ibuprofen. On 09-APR-2021, the subject experienced migraines. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced spasms. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fevers. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, migraines, body aches, chills, and fevers, and the outcome of spasms was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery thrombosis
Clinical narrative: BLOOD CLOT IN CORONARY REGION; 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 not reported, batch number: Unk) dose was not reported, administered on 10-APR-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 APR-2021, the patient experienced blood clot in coronary region. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in coronary region was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a male, unspecified age,  unspecified ethnicity, who experienced blood clot in coronary region after he received the COVID-19 vaccine ad26.cov2.s on an unspecified date. No other details given. The information provided precludes a meaningful medical assessment. Additional information requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: BAD HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and bad headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEG PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included does not take blood thinner. patient's father lost legs to blood clot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 07-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a physician via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, three days after vaccination, the patient died of unknown cause. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Diarrhoea, Fatigue, Headache, Illness
Clinical narrative: DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain in extremity, Pulmonary pain, Vomiting
Clinical narrative: DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea, Nightmare, Pyrexia
Clinical narrative: BAD DREAMS; NO APPETITE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol consumption, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 16/AUG/2070) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced bad dreams. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad dreams, no appetite, fever, and nausea on 10-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: TINY BRUISE AT RIGHT ARM AT INJECTION SITE; RIGHT ARM AT INJECTION SITE HURTING AND IT IS HOT; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included overweight, and concurrent conditions included arthritis, penicillin allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced tiny bruise at right arm at injection site. On 10-APR-2021, the subject experienced right arm at injection site hurting and it is hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny bruise at right arm at injection site, and right arm at injection site hurting and it is hot. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Frequent bowel movements, Haematochezia
Clinical narrative: BLOOD IN STOOL; STOMACH PAIN LIKE A CUT INSIDE; FREQUENT BATHROOM VISITS THREE TIMES IN A ROW; This spontaneous report received from a patient concerned a 44 year old Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, once total, administered on 27-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported.  On 11-Apr-2021, the patient experienced blood in stool (bleeding in feces). It was reported that bleeding was almost like hemorrhage, a lot of blood came out and patient felt like patient was bleeding internally. Patient described pain like stomach was cut inside. The patient felt bad on the side of his stomach all over midsection. He mentioned that it started all of sudden, on same day an hour later he went to the restroom and went 3 times after in a row, on the day of report patient did not use the restroom and the pain was less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from frequent bathroom visits three times in a row on 13-APR-2021, was recovering from stomach pain like a cut inside, and had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210426962-covid-19 vaccine ad26.cov2.s-Blood in stool. 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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Haemorrhage
Clinical narrative: BLOOD IN STOOL; STOMACH PAIN LIKE A CUT INSIDE; FREQUENT BATHROOM VISITS THREE TIMES IN A ROW; This spontaneous report received from a patient concerned a 44 year old Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, once total, administered on 27-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported.  On 11-Apr-2021, the patient experienced blood in stool (bleeding in feces). It was reported that bleeding was almost like hemorrhage, a lot of blood came out and patient felt like patient was bleeding internally. Patient described pain like stomach was cut inside. The patient felt bad on the side of his stomach all over midsection. He mentioned that it started all of sudden, on same day an hour later he went to the restroom and went 3 times after in a row, on the day of report patient did not use the restroom and the pain was less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from frequent bathroom visits three times in a row on 13-APR-2021, was recovering from stomach pain like a cut inside, and had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210426962-covid-19 vaccine ad26.cov2.s-Blood in stool. 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Fatigue, Feeling abnormal, Headache
Clinical narrative: SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Orthostatic hypotension, Pain, Pain assessment, Skin exfoliation
Clinical narrative: SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: FAINTING; NAUSEA; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient's experienced dizziness, nausea and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and fainting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-fainting. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cognitive disorder, Computerised tomogram, Diplopia, Disturbance in attention
Clinical narrative: DOUBLE VISION; SHORT TERM MEMORY LOSS; LACK OF ATTENTION; COGNITIVE DEFICIENCIES; HEADACHE; POSSIBLE INFARCTION DUE TO RECENT EVENT; This spontaneous report received from a health care professional concerned a 67 year old white and not Hispanic or Latino male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced headache and dizziness. On 15-MAR-2021, patient had experienced double vision, trouble reading, lack of attention, short term memory loss and cognitive deficiency. One or two days later, (possibly on 16-MAR-2021), the patient visited emergency room and his computerized axial tomography (CAT) scan was normal. In MAR-2021 (a week after), the patient's symptoms got worsened and he consulted primary care physician. The patient underwent magnetic resonance imaging (MRI) scan which showed possible infarction due to recent event. It was reported that, the patient was yet to visit cardiologist and neurologist for follow up on the MRI scan.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, had not recovered from double vision, short term memory loss, lack of attention, and cognitive deficiencies, and the outcome of possible infarction due to recent event was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427306-covid-19 vaccine ad26.cov2.s-possible infarction due to recent event. 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).