chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal sounds abnormal, Hypersomnia, Influenza virus test, Night sweats, Nightmare
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sleep talking
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Anticoagulant therapy, Arthralgia, Asthenia, Atelectasis
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood insulin, COVID-19, Chest X-ray abnormal, Chills
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pneumonia, Pyrexia, SARS-CoV-2 test positive, Somnolence
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal
Clinical narrative: He got the vaccine, and the next day in the evening he had chills, and then Sunday he was OK until night time and while he was sleeping he was burning up with fever.  Then Monday 4/5/21 he had severe backache, body aches, fever, headache.  He continued with muscle/body aches, headache and joint pains.  Then she took him to the UC due to this on 4/7/21 and his wife asked for a COVID test, but they said he didn't need one, it was reaction to the vaccine, and for him to go home, rest and drink plenty of fluids.  Thursday 4/8/21 she went to the ER and they did a COVID test that was positive, and they prescribed nothing for him to take.  They also informed him to go home and rest.  Chest x-ray showed a small amount of pneumonia in the left lung, no medicine and to drink plenty of fluids.  On Friday they went to a different ER and they did another COVID test that was positive.  They did a chest x-ray that showed no pneumonia, but on the right lung showed atelectasis, his 02 was 91.  He still had the back pain where the kidneys are, headache, still the same symptoms, and she gave him  an albuterol inhaler, and a medical grade oximeter and to go home and rest and drink plenty of fluids.  Saturday night he was using the inhaler, he was coughing.  That evening he had stomach pains and a little more trouble breathing.  Sunday morning 4/11/21 he was up coughing, his oxygen saturation was between 89-91.  At 6:00 AM that morning she called 9-1-1 the stomach pains were 10+, went to the ER again who gave him Morphine for the pain, his oxygen saturation was 88.  They did a chest x-ray CT scan showed COVID lungs in both lungs.  They kept him in the hospital from Monday to Friday on oxygen, blood thinners, steroids, Remdesivir.  He was on Insulin that made his blood sugar go up, (not a diabetic), Protonix as well.  They were also doing nebulizer breathing treatments, incentive spirometry, as well as respiratory therapy.  He was released 4/16/21 and he is still about 4/5 feeling wise for the week.  He has not had a fever for a week, but the brain fog, fatigue is very bad, very weak, does not speak much.  His oxygen saturations is at 93 and not gone higher than that yet.  No stomach pains, no pain at all, just the brain fog and feels fuzzy, groggy, cannot think good.  He said that he is not himself, and that's been going for the entire week since he's been out of the hospital.   He's 5/10 today feeling wise, not feeling well good.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Infectious mononucleosis, Pyrexia
Clinical narrative: MONONUCLEOSIS; CHILLS; FEVER; 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 admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mononucleosis, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and mononucleosis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Peripheral swelling
Clinical narrative: SWELLING OF RIGHT LEG; FUNNY SENSATION IN RIGHT LEG ONLY; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lisinopril allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-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 subject experienced swelling of right leg. On 14-MAR-2021, the subject experienced funny sensation in right leg only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of right leg, and funny sensation in right leg only. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Injection site erythema, Pyrexia
Clinical narrative: TIGHTNESS OF CHEST/RIBS; REDNESS/HEAT/BUMP AT INJECTION SITE; FEVER; HEADACHE; FATIGUE; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tightness of chest/ribs, redness/heat/bump at injection site, fever, headache, and fatigue. The outcome of the fever, headache, fatigue, redness/heat/bump at injection site and tightness of chest/ribs was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Feeling hot, Head discomfort
Clinical narrative: JOINT PAIN; HEAVINESS IN CALVES; DULL HEADACHE; SWELLING FOREHEAD/ SWOLLEN FACE/ LEFT CHEEK SWOLLEN; HEART RACING; PRESSURE IN HEAD; RED FACE; TINGLING IN CALVES AND FEET; NUMBNESS IN FEET; SHORT SHOOTING PAIN IN BACK; FEELING OF WARMTH/ LEFT CHEEK WARM; This spontaneous report received from a patient concerned a 56 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 and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced swelling forehead/ swollen face/ left cheek swollen. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced pressure in head. On 07-APR-2021, the subject experienced red face. On 07-APR-2021, the subject experienced tingling in calves and feet. On 07-APR-2021, the subject experienced numbness in feet. On 07-APR-2021, the subject experienced short shooting pain in back. On 07-APR-2021, the subject experienced feeling of warmth/ left cheek warm. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced heaviness in calves. On 07-APR-2021, the subject experienced dull headache.  Treatment medications (dates unspecified) included: famotidine, prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, and short shooting pain in back on APR-2021, and had not recovered from pressure in head, dull headache, swelling forehead/ swollen face/ left cheek swollen, red face, joint pain, heaviness in calves, tingling in calves and feet, numbness in feet, and feeling of warmth/ left cheek warm. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Palpitations, Paraesthesia
Clinical narrative: JOINT PAIN; HEAVINESS IN CALVES; DULL HEADACHE; SWELLING FOREHEAD/ SWOLLEN FACE/ LEFT CHEEK SWOLLEN; HEART RACING; PRESSURE IN HEAD; RED FACE; TINGLING IN CALVES AND FEET; NUMBNESS IN FEET; SHORT SHOOTING PAIN IN BACK; FEELING OF WARMTH/ LEFT CHEEK WARM; This spontaneous report received from a patient concerned a 56 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 and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced swelling forehead/ swollen face/ left cheek swollen. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced pressure in head. On 07-APR-2021, the subject experienced red face. On 07-APR-2021, the subject experienced tingling in calves and feet. On 07-APR-2021, the subject experienced numbness in feet. On 07-APR-2021, the subject experienced short shooting pain in back. On 07-APR-2021, the subject experienced feeling of warmth/ left cheek warm. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced heaviness in calves. On 07-APR-2021, the subject experienced dull headache.  Treatment medications (dates unspecified) included: famotidine, prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, and short shooting pain in back on APR-2021, and had not recovered from pressure in head, dull headache, swelling forehead/ swollen face/ left cheek swollen, red face, joint pain, heaviness in calves, tingling in calves and feet, numbness in feet, and feeling of warmth/ left cheek warm. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: JOINT PAIN; HEAVINESS IN CALVES; DULL HEADACHE; SWELLING FOREHEAD/ SWOLLEN FACE/ LEFT CHEEK SWOLLEN; HEART RACING; PRESSURE IN HEAD; RED FACE; TINGLING IN CALVES AND FEET; NUMBNESS IN FEET; SHORT SHOOTING PAIN IN BACK; FEELING OF WARMTH/ LEFT CHEEK WARM; This spontaneous report received from a patient concerned a 56 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 and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced swelling forehead/ swollen face/ left cheek swollen. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced pressure in head. On 07-APR-2021, the subject experienced red face. On 07-APR-2021, the subject experienced tingling in calves and feet. On 07-APR-2021, the subject experienced numbness in feet. On 07-APR-2021, the subject experienced short shooting pain in back. On 07-APR-2021, the subject experienced feeling of warmth/ left cheek warm. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced heaviness in calves. On 07-APR-2021, the subject experienced dull headache.  Treatment medications (dates unspecified) included: famotidine, prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, and short shooting pain in back on APR-2021, and had not recovered from pressure in head, dull headache, swelling forehead/ swollen face/ left cheek swollen, red face, joint pain, heaviness in calves, tingling in calves and feet, numbness in feet, and feeling of warmth/ left cheek warm. 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: Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: NOT FEELING WELL; FEVER; NAUSEA; VERY TIRED/FATIGUE; 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 light headed /dizzy after flu shot, drop in blood pressure after flu shot, and active covid-19 infection, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. Concomitant medications included influenza vaccine for prophylactic vaccination. On 15-APR-2021, the subject experienced not feeling well. On 15-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced nausea. On 15-APR-2021, the subject experienced very tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from fever, nausea, and very tired/fatigue, and the outcome of not feeling well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE PAIN/ACHE; FEVER; FATIGUE/ TIREDNESS; HEADACHE; This spontaneous report received from a consumer concerned a 40 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, intramuscular, batch number: 203A21A, expiry: 23/JUN/2021) .5 ml, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle pain/ache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue/ tiredness. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle pain/ache, fatigue/ tiredness, and headache on 09-APR-2021, and fever on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210435796.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: SWOLLEN FACE; This spontaneous report received from a consumer 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, 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 swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen face. This report was non-serious. This case, from the same reporter is linked to 20210431325.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pain in extremity
Clinical narrative: DID NOT HAD MY NORMAL PERIOD; MILD ARM 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, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced mild arm pain. On 15-MAR-2021, the subject experienced did not had my normal period. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm pain on MAR-2021, and had not recovered from did not had my normal period. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: BLOOD PRESSURE SHOT UP 60 POINTS WITHIN 15 MINUTES; 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced blood pressure shot up 60 points within 15 minutes. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) Shot up by 60 points. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure shot up 60 points within 15 minutes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight 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 07-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 tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438448, 20210438524 and 20210439405.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Pain, Pyrexia, Ultrasound scan
Clinical narrative: LEG PULLING; BODY ACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 29 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: 206A21A 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: Diagnostic ultrasound (NR: not provided) Results pending. On 09-APR-2021, the subject experienced leg pulling. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever on 11-APR-2021, and had not recovered from leg pulling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Body temperature, Dizziness, Face and mouth X-ray abnormal
Clinical narrative: FEVER; MUSCLE/BODY ACHE; DIZZINESS; BALANCE DISORDER; STIFF NECK; TIREDNESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported.  The patient's past medical history included miscarriage, and tetanus shot allergy, and concurrent conditions included ehler danlos type iv vascular, anemia, aneurysm, cavernoma, double jointed, hemorrhage, gluten intolerance, grain intolerance, seasonal allergies, and heavy menstrual flow. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced muscle/body ache. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced balance disorder. On APR-2021, the subject experienced stiff neck. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Low sodium and dehydration, and X-ray of nasal sinuses abnormal (NR: not provided) No abnormality found. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F.  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 headache, and the outcome of tiredness, muscle/body ache, dizziness, balance disorder, nausea, stiff neck and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: FEVER; MUSCLE/BODY ACHE; DIZZINESS; BALANCE DISORDER; STIFF NECK; TIREDNESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported.  The patient's past medical history included miscarriage, and tetanus shot allergy, and concurrent conditions included ehler danlos type iv vascular, anemia, aneurysm, cavernoma, double jointed, hemorrhage, gluten intolerance, grain intolerance, seasonal allergies, and heavy menstrual flow. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced muscle/body ache. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced balance disorder. On APR-2021, the subject experienced stiff neck. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Low sodium and dehydration, and X-ray of nasal sinuses abnormal (NR: not provided) No abnormality found. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F.  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 headache, and the outcome of tiredness, muscle/body ache, dizziness, balance disorder, nausea, stiff neck and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; MUSCLE/BODY ACHE; DIZZINESS; BALANCE DISORDER; STIFF NECK; TIREDNESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported.  The patient's past medical history included miscarriage, and tetanus shot allergy, and concurrent conditions included ehler danlos type iv vascular, anemia, aneurysm, cavernoma, double jointed, hemorrhage, gluten intolerance, grain intolerance, seasonal allergies, and heavy menstrual flow. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced muscle/body ache. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced balance disorder. On APR-2021, the subject experienced stiff neck. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Low sodium and dehydration, and X-ray of nasal sinuses abnormal (NR: not provided) No abnormality found. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F.  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 headache, and the outcome of tiredness, muscle/body ache, dizziness, balance disorder, nausea, stiff neck and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FEVER; SORE ARM; This spontaneous report received from a parent 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 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410075.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; SORE ARM; FEVER; NAUSEA; This spontaneous report received from a patient 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced flu like symptoms. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, fever, nausea and sore arm was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation, Dysgeusia, Fatigue, Feeling abnormal, Headache
Clinical narrative: LEGS SWOLLEN FROM THE KNEE DOWN; ARMS FEEL KIND OF WEIRD; FEELING OF LEGS KIND OF DETACHING FROM THE BODY; FEELING LIKE WHEN YOU PRESS YOUR FEET AND IT'S DIFFERENT, NOT PUFFY; ARMS FEEL SWOLLEN; TINGLING IN RIGHT ARM; WHEN GOING TO SLEEP LEGS FEEL VERY HEAVY/LEGS FROM THIGHS TO FEET, ENTIRE LEG, FEELS HEAVY JUST BEFORE FALLING ASLEEP; VERY TIRED; A LITTLE BIT OF HEADACHE; FLAVOR IN HER MOUTH LIKE ORANGE OR CHERRY; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 64 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and medical conditions. the patient did not take medication regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flavor in her mouth like orange or cherry. On 08-APR-2021, the subject experienced very tired. On 08-APR-2021, the subject experienced a little bit of headache. On an unspecified date, the subject experienced legs swollen from the knee down, arms feel kind of weird, feeling of legs kind of detaching from the body, feeling like when you press your feet and it's different, not puffy, arms feel swollen, tingling in right arm, and when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flavor in her mouth like orange or cherry on 08-APR-2021, and very tired, and a little bit of headache on 09-APR-2021, and had not recovered from legs swollen from the knee down, arms feel kind of weird, when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep, feeling of legs kind of detaching from the body, arms feel swollen, tingling in right arm, and feeling like when you press your feet and it's different, not puffy. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia, Peripheral swelling
Clinical narrative: LEGS SWOLLEN FROM THE KNEE DOWN; ARMS FEEL KIND OF WEIRD; FEELING OF LEGS KIND OF DETACHING FROM THE BODY; FEELING LIKE WHEN YOU PRESS YOUR FEET AND IT'S DIFFERENT, NOT PUFFY; ARMS FEEL SWOLLEN; TINGLING IN RIGHT ARM; WHEN GOING TO SLEEP LEGS FEEL VERY HEAVY/LEGS FROM THIGHS TO FEET, ENTIRE LEG, FEELS HEAVY JUST BEFORE FALLING ASLEEP; VERY TIRED; A LITTLE BIT OF HEADACHE; FLAVOR IN HER MOUTH LIKE ORANGE OR CHERRY; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 64 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and medical conditions. the patient did not take medication regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flavor in her mouth like orange or cherry. On 08-APR-2021, the subject experienced very tired. On 08-APR-2021, the subject experienced a little bit of headache. On an unspecified date, the subject experienced legs swollen from the knee down, arms feel kind of weird, feeling of legs kind of detaching from the body, feeling like when you press your feet and it's different, not puffy, arms feel swollen, tingling in right arm, and when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flavor in her mouth like orange or cherry on 08-APR-2021, and very tired, and a little bit of headache on 09-APR-2021, and had not recovered from legs swollen from the knee down, arms feel kind of weird, when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep, feeling of legs kind of detaching from the body, arms feel swollen, tingling in right arm, and feeling like when you press your feet and it's different, not puffy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass, Injection site warmth, Pain in extremity
Clinical narrative: LUMP AT THE INJECTION SITE WAS PURPLY COLOR; INJECTION SITE WAS WARM; SORE ARM; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lump at the injection site was purply color. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced injection site was warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 12-APR-2021, and was recovering from lump at the injection site was purply color, and injection site was warm. This report was non-serious.