chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Pain in extremity
Clinical narrative: The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced intense, deep pain in upper left thigh. On 23-MAR-2021, the subject experienced headache. Treatment medications included: acetylsalicylic acid. On an unspecified date, the subject experienced chest discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense, deep pain in upper left thigh on 26-MAR-2021, and the outcome of headache and chest discomfort was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sleep talking
Clinical narrative: COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKING IN SLEEP; BROKE INTO A SWEAT/ SWEATED TERRIBLY LAST NIGHT; VIVID DREAMS; This spontaneous report received from a patient's wife concerned a 53 year old 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: unknown) dose was not reported, administered to right arm on 02-APR-2021 around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-APR-2021, the patient experienced 102.7 fever, some dry cough. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 04-APR-2021, the patient experienced chills, broke into a sweat and had vivid dreams. Laboratory data included: Body temperature (NR: not provided) 102 F, 101 F. On 05-APR-2021, the patient also had brain fog, two nights of bad dreams, talking in sleep, back pain, fatigue, slept all day. Laboratory data included: Body temperature (NR: not provided) upto 102.7 F. On 06-APR-2021, the patient experienced stomach gurgling, diarrhea, weakness, burping, body ache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 03:40, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the patient experienced muscle aches, back ache was at level 9, sweated terribly at night and the patient went to urgent care and they did flu test. Laboratory data included: Rapid influenza diagnostic test (NR: not provided) Negative. On 08/Apr-2021, the patient had stomach still gurgling, back ache was at level 9, tiredness, weakness, achiness, brain fog, fever was back at a 100F and diarrhea. On the same day, the patient was tested positive for Covid-19 (coded to confirmed Covid-19 Infection: chills, fever, muscle aches, joint pain, diarrhea, back pain/ back ache, dry cough, fatigue/ tiredness, weakness, and body ache/ achiness). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-Apr-2021 he was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, Covid infection, stomach gurgling, and broke into a sweat/ sweated terribly last night, and the outcome of 2 nights of bad dreams, talking in sleep, vivid dreams, slept all day and burping was not reported. This report was serious (Hospitalization Caused / Prolonged). Initial information was received on 07-APR-2021. With additional information obtained via telephone follow up from a wife on 15-Apr-2021 case was assessed as serious.; Sender's Comments: 20210413330- Covid-19 vaccine ad26.cov2.s- Covid infection. 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.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKING IN SLEEP; BROKE INTO A SWEAT/ SWEATED TERRIBLY LAST NIGHT; VIVID DREAMS; This spontaneous report received from a patient's wife concerned a 53 year old 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: unknown) dose was not reported, administered to right arm on 02-APR-2021 around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-APR-2021, the patient experienced 102.7 fever, some dry cough. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 04-APR-2021, the patient experienced chills, broke into a sweat and had vivid dreams. Laboratory data included: Body temperature (NR: not provided) 102 F, 101 F. On 05-APR-2021, the patient also had brain fog, two nights of bad dreams, talking in sleep, back pain, fatigue, slept all day. Laboratory data included: Body temperature (NR: not provided) upto 102.7 F. On 06-APR-2021, the patient experienced stomach gurgling, diarrhea, weakness, burping, body ache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 03:40, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the patient experienced muscle aches, back ache was at level 9, sweated terribly at night and the patient went to urgent care and they did flu test. Laboratory data included: Rapid influenza diagnostic test (NR: not provided) Negative. On 08/Apr-2021, the patient had stomach still gurgling, back ache was at level 9, tiredness, weakness, achiness, brain fog, fever was back at a 100F and diarrhea. On the same day, the patient was tested positive for Covid-19 (coded to confirmed Covid-19 Infection: chills, fever, muscle aches, joint pain, diarrhea, back pain/ back ache, dry cough, fatigue/ tiredness, weakness, and body ache/ achiness). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-Apr-2021 he was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, Covid infection, stomach gurgling, and broke into a sweat/ sweated terribly last night, and the outcome of 2 nights of bad dreams, talking in sleep, vivid dreams, slept all day and burping was not reported. This report was serious (Hospitalization Caused / Prolonged). Initial information was received on 07-APR-2021. With additional information obtained via telephone follow up from a wife on 15-Apr-2021 case was assessed as serious.; Sender's Comments: 20210413330- Covid-19 vaccine ad26.cov2.s- Covid infection. 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.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal
Clinical narrative: COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKING IN SLEEP; BROKE INTO A SWEAT/ SWEATED TERRIBLY LAST NIGHT; VIVID DREAMS; This spontaneous report received from a patient's wife concerned a 53 year old 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: unknown) dose was not reported, administered to right arm on 02-APR-2021 around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-APR-2021, the patient experienced 102.7 fever, some dry cough. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 04-APR-2021, the patient experienced chills, broke into a sweat and had vivid dreams. Laboratory data included: Body temperature (NR: not provided) 102 F, 101 F. On 05-APR-2021, the patient also had brain fog, two nights of bad dreams, talking in sleep, back pain, fatigue, slept all day. Laboratory data included: Body temperature (NR: not provided) upto 102.7 F. On 06-APR-2021, the patient experienced stomach gurgling, diarrhea, weakness, burping, body ache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 03:40, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the patient experienced muscle aches, back ache was at level 9, sweated terribly at night and the patient went to urgent care and they did flu test. Laboratory data included: Rapid influenza diagnostic test (NR: not provided) Negative. On 08/Apr-2021, the patient had stomach still gurgling, back ache was at level 9, tiredness, weakness, achiness, brain fog, fever was back at a 100F and diarrhea. On the same day, the patient was tested positive for Covid-19 (coded to confirmed Covid-19 Infection: chills, fever, muscle aches, joint pain, diarrhea, back pain/ back ache, dry cough, fatigue/ tiredness, weakness, and body ache/ achiness). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-Apr-2021 he was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, Covid infection, stomach gurgling, and broke into a sweat/ sweated terribly last night, and the outcome of 2 nights of bad dreams, talking in sleep, vivid dreams, slept all day and burping was not reported. This report was serious (Hospitalization Caused / Prolonged). Initial information was received on 07-APR-2021. With additional information obtained via telephone follow up from a wife on 15-Apr-2021 case was assessed as serious.; Sender's Comments: 20210413330- Covid-19 vaccine ad26.cov2.s- Covid infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site reaction, Pain
Clinical narrative: HEADACHE; MILD OVER ALL ACHY FEELING; INJECTION SITE WAS RED AND SWOLLEN; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site was red and swollen. On 02-APR-2021, the subject experienced mild over all achy feeling. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild over all achy feeling, was recovering from injection site was red and swollen, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: HEAD ACHE; FEVER; BODY ACHE; TENOSYNOVITIS; CHILLS; ANKLE 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 02-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 body ache. On APR-2021, the subject experienced tenosynovitis. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced ankle pain. On 02-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 04-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced head ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body ache, head ache, chills, ankle pain and tenosynovitis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenosynovitis
Clinical narrative: HEAD ACHE; FEVER; BODY ACHE; TENOSYNOVITIS; CHILLS; ANKLE 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 02-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 body ache. On APR-2021, the subject experienced tenosynovitis. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced ankle pain. On 02-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 04-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced head ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body ache, head ache, chills, ankle pain and tenosynovitis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced product administered to subject of inappropriate age. On 08-APR-2021, the subject experienced off label use. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, fever, headache and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420704.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Musculoskeletal pain
Clinical narrative: 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: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest tightness. On APR-2021, the subject experienced muscle pain in butt. On APR-2021, the subject experienced overly tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest tightness, muscle pain in butt, and overly tired. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 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, 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 covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive (units unspecified). 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.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling cold, Heart rate increased, Pain, Sensory disturbance
Clinical narrative: HEART BEATING LIKE CRAZY; CELLS REJECTING THE FOREIGN MATERIAL, FEEL IT COMING OUT OF MY SKIN; SHADOWS DANCE IN VISION; WHOLE BODY HURTS; GUT FEELS HEAVY; BODY FEELS 5-10 DEGREES COLDER; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced heart beating like crazy, cells rejecting the foreign material, feel it coming out of my skin, shadows dance in vision, whole body hurts, gut feels heavy, and body feels 5-10 degrees colder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body feels 5-10 degrees colder, shadows dance in vision, whole body hurts, cells rejecting the foreign material, feel it coming out of my skin, heart beating like crazy and gut feels heavy was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: HEART BEATING LIKE CRAZY; CELLS REJECTING THE FOREIGN MATERIAL, FEEL IT COMING OUT OF MY SKIN; SHADOWS DANCE IN VISION; WHOLE BODY HURTS; GUT FEELS HEAVY; BODY FEELS 5-10 DEGREES COLDER; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced heart beating like crazy, cells rejecting the foreign material, feel it coming out of my skin, shadows dance in vision, whole body hurts, gut feels heavy, and body feels 5-10 degrees colder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body feels 5-10 degrees colder, shadows dance in vision, whole body hurts, cells rejecting the foreign material, feel it coming out of my skin, heart beating like crazy and gut feels heavy was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS; This spontaneous report received from a consumer concerned multiple patients. 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 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421103.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pyrexia, Vaginal haemorrhage
Clinical narrative: BLEEDING; BODY PAIN/ EVERYTHING HURTS; BAD FEELING; HIGH FEVER (104F); 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 administration not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 11:00 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 subject experienced bleeding. On APR-2021, the subject experienced body pain/ everything hurts. On APR-2021, the subject experienced bad feeling. On APR-2021, the subject experienced high fever (104f).  Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever (104f), bleeding, and body pain/ everything hurts, and the outcome of bad feeling was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Ear discomfort, Feeling cold, Feeling jittery
Clinical narrative: 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: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling of faint and dizzy, feeling jittery, feeling cold, body aches, burning sensation on the arm, burning sensation in ears, her head was hurting, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning sensation on the arm, had not recovered from feeling of faint and dizzy, and the outcome of her head was hurting, headache, fever, feeling jittery, feeling cold, body aches and burning sensation in ears was not reported. 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: Headache, Pain, Pyrexia
Clinical narrative: 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: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling of faint and dizzy, feeling jittery, feeling cold, body aches, burning sensation on the arm, burning sensation in ears, her head was hurting, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning sensation on the arm, had not recovered from feeling of faint and dizzy, and the outcome of her head was hurting, headache, fever, feeling jittery, feeling cold, body aches and burning sensation in ears was not reported. 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: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; VERY TIRED, FEEL WIPED OUT; This spontaneous report received from a health care professional 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shortness of breath, and very tired, feel wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very tired, feel wiped out and shortness of breath was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436940.; Sender's Comments:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Chest discomfort, Diarrhoea
Clinical narrative: FEELING OUT OF SORTS; INTESTINAL CONFUSION; NAUSEA; NIGHT SWEATS; DIARRHEA; BLOOD PRESSURE SPIKED; LIGHTHEADEDNESS/DIZZINESS; PRESSURE IN HEAD; PRESSURE IN CHEST OR FEELING LIKE A CINDERBLOCK IS ON THE CHEST; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced blood pressure spiked. On 06-APR-2021, the subject experienced lightheadedness/dizziness. On 06-APR-2021, the subject experienced pressure in head. On 06-APR-2021, the subject experienced pressure in chest or feeling like a cinderblock is on the chest. Laboratory data included: Blood pressure (NR: not provided) 160/90, 140/85. On 07-APR-2021, the subject experienced night sweats. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced intestinal confusion. On 07-APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 110/74. On 09-APR-2021, the subject experienced feeling out of sorts. On 10-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/90. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness/dizziness on 06-APR-2021, pressure in head on 10-APR-2021, night sweats, and diarrhea on 08-APR-2021, and intestinal confusion, and nausea on 08-APR-2021 18:00, had not recovered from blood pressure spiked, and pressure in chest or feeling like a cinderblock is on the chest, and the outcome of feeling out of sorts was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Head discomfort, Nausea, Night sweats
Clinical narrative: FEELING OUT OF SORTS; INTESTINAL CONFUSION; NAUSEA; NIGHT SWEATS; DIARRHEA; BLOOD PRESSURE SPIKED; LIGHTHEADEDNESS/DIZZINESS; PRESSURE IN HEAD; PRESSURE IN CHEST OR FEELING LIKE A CINDERBLOCK IS ON THE CHEST; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced blood pressure spiked. On 06-APR-2021, the subject experienced lightheadedness/dizziness. On 06-APR-2021, the subject experienced pressure in head. On 06-APR-2021, the subject experienced pressure in chest or feeling like a cinderblock is on the chest. Laboratory data included: Blood pressure (NR: not provided) 160/90, 140/85. On 07-APR-2021, the subject experienced night sweats. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced intestinal confusion. On 07-APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 110/74. On 09-APR-2021, the subject experienced feeling out of sorts. On 10-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/90. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness/dizziness on 06-APR-2021, pressure in head on 10-APR-2021, night sweats, and diarrhea on 08-APR-2021, and intestinal confusion, and nausea on 08-APR-2021 18:00, had not recovered from blood pressure spiked, and pressure in chest or feeling like a cinderblock is on the chest, and the outcome of feeling out of sorts was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: 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 11-APR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and achiness. This report was non-serious. This report was associated with product quality complaint: 90000175989. The suspected product quality complaint has been confirmed to be voided(did not meet PQC criteria) based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: TINGLING SENSATION OF PINS AND NEEDLE; HEADACHE; FEVER; MUSCULAR ACHES; ITCHING; 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tingling sensation of pins and needle, headache, fever, muscular aches, and itching. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, muscular aches, itching and tingling sensation of pins and needle was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Ear pain, Feeling cold
Clinical narrative: NERVE PAIN IN LEG AND ARM; EAR ACHE; FELT COLD; CHILLS; JOINT PAIN IN KNEES; HEADACHE; PRESSURE IN CHEST; NO SLEEP; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and restless leg syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced no sleep. On 10-APR-2021, the subject experienced pressure in chest. On 10-APR-2021, the subject experienced ear ache. On 10-APR-2021, the subject experienced felt cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced joint pain in knees. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced nerve pain in leg and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no sleep on 10-APR-2021, was recovering from nerve pain in leg and arm, and had not recovered from joint pain in knees, ear ache, pressure in chest, felt cold, chills, and headache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Neuralgia
Clinical narrative: NERVE PAIN IN LEG AND ARM; EAR ACHE; FELT COLD; CHILLS; JOINT PAIN IN KNEES; HEADACHE; PRESSURE IN CHEST; NO SLEEP; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and restless leg syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced no sleep. On 10-APR-2021, the subject experienced pressure in chest. On 10-APR-2021, the subject experienced ear ache. On 10-APR-2021, the subject experienced felt cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced joint pain in knees. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced nerve pain in leg and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no sleep on 10-APR-2021, was recovering from nerve pain in leg and arm, and had not recovered from joint pain in knees, ear ache, pressure in chest, felt cold, chills, and headache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills
Clinical narrative: CHILLS; TEMPERATURE; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included factor v. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-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 chills. On APR-2021, the subject experienced temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and temperature was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced confirmed covid-19 infection. 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 patient had not recovered from confirmed covid-19 infection. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard operating procedures
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; 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: Unknown) dose was not reported, administered on 03-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 confirmed covid-19 infection. 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 confirmed covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be this report indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time had elapsed for immunity to develop (10 days elapsed between vaccine and test). there was not sufficient time elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. case is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: 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, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insomnia was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422183 and 20210439461.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose, Body temperature, Diarrhoea, Heart rate
Clinical narrative: SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontaneous report received from a parent concerned a 21 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced body aches/body pain. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced shaky. Laboratory data included: Blood glucose (NR: not provided) 120, and Heart rate (NR: not provided) 145. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, stomach pain, diarrhea, body aches/body pain, fever 101f, heart racing and shaky was not reported. 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Pyrexia, Tremor
Clinical narrative: SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontaneous report received from a parent concerned a 21 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced body aches/body pain. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced shaky. Laboratory data included: Blood glucose (NR: not provided) 120, and Heart rate (NR: not provided) 145. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, stomach pain, diarrhea, body aches/body pain, fever 101f, heart racing and shaky was not reported. 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Computerised tomogram, Confusional state, Disturbance in attention
Clinical narrative: FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.