chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Groin pain, Myalgia, Nausea
Clinical narrative: LEFT GROIN PAIN RADIATING TO THE LEFT LEG/ HARD TO WALK; MUSCLE ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol hydrochloride. On 10-APR-2021, the subject experienced left groin pain radiating to the left leg/ hard to walk. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, nausea, and fatigue on 11-APR-2021, and had not recovered from left groin pain radiating to the left leg/ hard to walk. 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: Chills, Pain
Clinical narrative: ACHE/ACHY CHILLS; CHILLS/ACHY CHILLS; 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 number.   No concomitant medications were reported. On an unspecified date, the subject experienced ache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210420375.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pyrexia
Clinical narrative: SEVERE SIDE EFFECTS; NASTY FEVER LASTING MORE THAN 24 HRS; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects, and nasty fever lasting more than 24 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nasty fever lasting more than 24 hrs and severe side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420571.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Feeling hot, Hangover
Clinical narrative: GROGGY; BODY FELT LIKE FIRE; FEELING OF STRONG HANG OVER; HEADACHE BETWEEN THE EYES AND OVER THE EYES; WEAKNESS; SERIOUS CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 34 year old of unspecified 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, and batch number were not reported) dose was not reported, administered on 09-APR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced serious chills. On APR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-APR-2021, the subject experienced groggy. On 10-APR-2021, the subject experienced body felt like fire. On 10-APR-2021, the subject experienced feeling of strong hang over. On 10-APR-2021, the subject experienced headache between the eyes and over the eyes. On 10-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from serious chills, and high fever on APR-2021, was recovering from feeling of strong hang over, and headache between the eyes and over the eyes, had not recovered from weakness, and groggy, and the outcome of body felt like fire was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Somnolence
Clinical narrative: GROGGY; BODY FELT LIKE FIRE; FEELING OF STRONG HANG OVER; HEADACHE BETWEEN THE EYES AND OVER THE EYES; WEAKNESS; SERIOUS CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 34 year old of unspecified 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, and batch number were not reported) dose was not reported, administered on 09-APR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced serious chills. On APR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-APR-2021, the subject experienced groggy. On 10-APR-2021, the subject experienced body felt like fire. On 10-APR-2021, the subject experienced feeling of strong hang over. On 10-APR-2021, the subject experienced headache between the eyes and over the eyes. On 10-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from serious chills, and high fever on APR-2021, was recovering from feeling of strong hang over, and headache between the eyes and over the eyes, had not recovered from weakness, and groggy, and the outcome of body felt like fire was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Headache
Clinical narrative: HEART RATE OF 111-121; BLOOD PRESSURE OF 155/81; O2 SATURATION OF 99 %; CHILLS; HEADACHE; FEVER SPIKED 103.8; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced heart rate of 111-121. On 09-APR-2021, the subject experienced blood pressure of 155/81. On 09-APR-2021, the subject experienced o2 saturation of 99 %. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever spiked 103.8. Laboratory data included: Blood pressure (NR: not provided) 155/81 (unit not provided), 129/78 (unit not provided), Body temperature (NR: not provided) 101.8 to 102.8 (unit not provided), 103.8 (unit not provided), Heart rate (NR: not provided) 111-121 (unit not provided), and O2 saturation (NR: not provided) 99 %. On 09-APR-2021 21:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever spiked 103.8, and the outcome of chills, headache, heart rate of 111-121, blood pressure of 155/81 and o2 saturation of 99 % was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: HEART RATE OF 111-121; BLOOD PRESSURE OF 155/81; O2 SATURATION OF 99 %; CHILLS; HEADACHE; FEVER SPIKED 103.8; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced heart rate of 111-121. On 09-APR-2021, the subject experienced blood pressure of 155/81. On 09-APR-2021, the subject experienced o2 saturation of 99 %. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever spiked 103.8. Laboratory data included: Blood pressure (NR: not provided) 155/81 (unit not provided), 129/78 (unit not provided), Body temperature (NR: not provided) 101.8 to 102.8 (unit not provided), 103.8 (unit not provided), Heart rate (NR: not provided) 111-121 (unit not provided), and O2 saturation (NR: not provided) 99 %. On 09-APR-2021 21:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever spiked 103.8, and the outcome of chills, headache, heart rate of 111-121, blood pressure of 155/81 and o2 saturation of 99 % was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: RASH ON BOTH LEGS; ITCHINESS AT RASH SITE; BURNING SENSATION AT RASH SITE; This spontaneous report received from a patient concerned a 49 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: 202A21A, and  expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:31:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced rash on both legs. On 09-APR-2021, the subject experienced itchiness at rash site. On 09-APR-2021, the subject experienced burning sensation at rash site. Treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both legs, itchiness at rash site, and burning sensation at rash site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Malaise, Pain
Clinical narrative: BODY ACHES; FEELING HOT; BEING IN BED THE WHOLE DAY; BAD HEADACHE; 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, 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 body aches, feeling hot, being in bed the whole day, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, feeling hot, bad headache and being in bed the whole day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420044, 20210422653 and 20210420756.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Electrocardiogram, Fatigue
Clinical narrative: DIARRHEA; VOMITING; DEHYDRATED; FASTER HEART RATE; LIP SWELLING; TONGUE SWELLING; FEELINGS AROUND MOUTH; CHILLS; TIRED; OXYGEN LEVELS DROPPED DOWN; 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) dose was not reported, administered on 06-APR-2021 09:10 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, shortly after about 5-10 minutes of vaccination, the patient started experiencing feelings around mouth and lips and tongue got swollen. The Paramedic on site gave 2, 25mg of Benadryl and monitored the patient for 45 minutes and things settled. The patient was released to come home where, the patient began experiencing chills that lasted for about 2 hrs. The patient was tired which was normal but oxygen level dropped to 90 so, the patient had oxygen in house for a breathing situation; then the patient was okay about 3 hours later. On 07-APR-2021, approximately about 4:00 am, the patient had severe vomiting and diarrhea. Vomiting and diarrhea lasted for about 5 hrs. The patient was dehydrated and went to the emergency room (ER) where an electrocardiogram (EKG) was done as the patient had a fast heart rate. The patient was administered IV fluids and monitored for about 3 hrs. Chills returned but the patient came home at about 1:00 pm. The patient stated that the reaction showed that immune system of the patient kicked in. The patient was slowly advancing the diet and was doing better at the time of this report.  Laboratory data included: OXYGEN LEVEL (NR: not provided) on 06-Apr-2021 was 90, ECG (NR: not provided) on 07-Apr-2021 was UNKNOWN, and Heart rate (NR: not provided) on 07-Apr-2021 was FASTER. Treatment medications (dates unspecified) included: 2 doses of diphenhydramine hydrochloride of 25 mg for lips swelling & tongue swelling and feelings around mouth and oxygen for oxygen level dropped and IV fluids for diarrhea, vomiting, dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen levels dropped down, and lips swelling and tongue swelling, on an unspecified date and from diarrhea, and vomiting on 07-APR-2021, and was recovering from chills, tired, faster heart rate, dehydrated, lips swelling and tongue swelling, and feelings abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421308-covid-19 vaccine ad26.cov2. s- oxygen levels dropped down, Severe diarrhea, vomiting, dehydration ,lips swelling and tongue swelling, faster heart rate. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Swollen tongue, Vomiting
Clinical narrative: DIARRHEA; VOMITING; DEHYDRATED; FASTER HEART RATE; LIP SWELLING; TONGUE SWELLING; FEELINGS AROUND MOUTH; CHILLS; TIRED; OXYGEN LEVELS DROPPED DOWN; 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) dose was not reported, administered on 06-APR-2021 09:10 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, shortly after about 5-10 minutes of vaccination, the patient started experiencing feelings around mouth and lips and tongue got swollen. The Paramedic on site gave 2, 25mg of Benadryl and monitored the patient for 45 minutes and things settled. The patient was released to come home where, the patient began experiencing chills that lasted for about 2 hrs. The patient was tired which was normal but oxygen level dropped to 90 so, the patient had oxygen in house for a breathing situation; then the patient was okay about 3 hours later. On 07-APR-2021, approximately about 4:00 am, the patient had severe vomiting and diarrhea. Vomiting and diarrhea lasted for about 5 hrs. The patient was dehydrated and went to the emergency room (ER) where an electrocardiogram (EKG) was done as the patient had a fast heart rate. The patient was administered IV fluids and monitored for about 3 hrs. Chills returned but the patient came home at about 1:00 pm. The patient stated that the reaction showed that immune system of the patient kicked in. The patient was slowly advancing the diet and was doing better at the time of this report.  Laboratory data included: OXYGEN LEVEL (NR: not provided) on 06-Apr-2021 was 90, ECG (NR: not provided) on 07-Apr-2021 was UNKNOWN, and Heart rate (NR: not provided) on 07-Apr-2021 was FASTER. Treatment medications (dates unspecified) included: 2 doses of diphenhydramine hydrochloride of 25 mg for lips swelling & tongue swelling and feelings around mouth and oxygen for oxygen level dropped and IV fluids for diarrhea, vomiting, dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen levels dropped down, and lips swelling and tongue swelling, on an unspecified date and from diarrhea, and vomiting on 07-APR-2021, and was recovering from chills, tired, faster heart rate, dehydrated, lips swelling and tongue swelling, and feelings abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421308-covid-19 vaccine ad26.cov2. s- oxygen levels dropped down, Severe diarrhea, vomiting, dehydration ,lips swelling and tongue swelling, faster heart rate. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Diarrhoea, Electrocardiogram, Heart rate, Hypoaesthesia oral
Clinical narrative: DIARRHEA; VOMITING; DEHYDRATED; FASTER HEART RATE; LIP SWELLING; TONGUE SWELLING; FEELINGS AROUND MOUTH; CHILLS; TIRED; OXYGEN LEVELS DROPPED DOWN; 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) dose was not reported, administered on 06-APR-2021 09:10 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, shortly after about 5-10 minutes of vaccination, the patient started experiencing feelings around mouth and lips and tongue got swollen. The Paramedic on site gave 2, 25mg of Benadryl and monitored the patient for 45 minutes and things settled. The patient was released to come home where, the patient began experiencing chills that lasted for about 2 hrs. The patient was tired which was normal but oxygen level dropped to 90 so, the patient had oxygen in house for a breathing situation; then the patient was okay about 3 hours later. On 07-APR-2021, approximately about 4:00 am, the patient had severe vomiting and diarrhea. Vomiting and diarrhea lasted for about 5 hrs. The patient was dehydrated and went to the emergency room (ER) where an electrocardiogram (EKG) was done as the patient had a fast heart rate. The patient was administered IV fluids and monitored for about 3 hrs. Chills returned but the patient came home at about 1:00 pm. The patient stated that the reaction showed that immune system of the patient kicked in. The patient was slowly advancing the diet and was doing better at the time of this report.  Laboratory data included: OXYGEN LEVEL (NR: not provided) on 06-Apr-2021 was 90, ECG (NR: not provided) on 07-Apr-2021 was UNKNOWN, and Heart rate (NR: not provided) on 07-Apr-2021 was FASTER. Treatment medications (dates unspecified) included: 2 doses of diphenhydramine hydrochloride of 25 mg for lips swelling & tongue swelling and feelings around mouth and oxygen for oxygen level dropped and IV fluids for diarrhea, vomiting, dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen levels dropped down, and lips swelling and tongue swelling, on an unspecified date and from diarrhea, and vomiting on 07-APR-2021, and was recovering from chills, tired, faster heart rate, dehydrated, lips swelling and tongue swelling, and feelings abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421308-covid-19 vaccine ad26.cov2. s- oxygen levels dropped down, Severe diarrhea, vomiting, dehydration ,lips swelling and tongue swelling, faster heart rate. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: DIARRHEA; VOMITING; DEHYDRATED; FASTER HEART RATE; LIP SWELLING; TONGUE SWELLING; FEELINGS AROUND MOUTH; CHILLS; TIRED; OXYGEN LEVELS DROPPED DOWN; 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) dose was not reported, administered on 06-APR-2021 09:10 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, shortly after about 5-10 minutes of vaccination, the patient started experiencing feelings around mouth and lips and tongue got swollen. The Paramedic on site gave 2, 25mg of Benadryl and monitored the patient for 45 minutes and things settled. The patient was released to come home where, the patient began experiencing chills that lasted for about 2 hrs. The patient was tired which was normal but oxygen level dropped to 90 so, the patient had oxygen in house for a breathing situation; then the patient was okay about 3 hours later. On 07-APR-2021, approximately about 4:00 am, the patient had severe vomiting and diarrhea. Vomiting and diarrhea lasted for about 5 hrs. The patient was dehydrated and went to the emergency room (ER) where an electrocardiogram (EKG) was done as the patient had a fast heart rate. The patient was administered IV fluids and monitored for about 3 hrs. Chills returned but the patient came home at about 1:00 pm. The patient stated that the reaction showed that immune system of the patient kicked in. The patient was slowly advancing the diet and was doing better at the time of this report.  Laboratory data included: OXYGEN LEVEL (NR: not provided) on 06-Apr-2021 was 90, ECG (NR: not provided) on 07-Apr-2021 was UNKNOWN, and Heart rate (NR: not provided) on 07-Apr-2021 was FASTER. Treatment medications (dates unspecified) included: 2 doses of diphenhydramine hydrochloride of 25 mg for lips swelling & tongue swelling and feelings around mouth and oxygen for oxygen level dropped and IV fluids for diarrhea, vomiting, dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen levels dropped down, and lips swelling and tongue swelling, on an unspecified date and from diarrhea, and vomiting on 07-APR-2021, and was recovering from chills, tired, faster heart rate, dehydrated, lips swelling and tongue swelling, and feelings abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421308-covid-19 vaccine ad26.cov2. s- oxygen levels dropped down, Severe diarrhea, vomiting, dehydration ,lips swelling and tongue swelling, faster heart rate. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; 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 concurrent conditions included bursitis. 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 pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain 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: Swollen tongue, Toothache
Clinical narrative: TEETH ACHED; SWOLLEN FRENULUM OF TONGUE; 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, 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 teeth ached, and swollen frenulum of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the teeth ached and swollen frenulum of tongue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Chest pain, Chills, Decreased appetite, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; APPETITE LOST; LOSS OF TASTE; CHEST PAIN; CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hepatitis c.  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 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shortness of breath, appetite lost, loss of taste, chest pain, chills, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, chest pain, shortness of breath, tiredness, appetite lost, and loss of taste. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: SHORTNESS OF BREATH; APPETITE LOST; LOSS OF TASTE; CHEST PAIN; CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hepatitis c.  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 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shortness of breath, appetite lost, loss of taste, chest pain, chills, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, chest pain, shortness of breath, tiredness, appetite lost, and loss of taste. 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT EXTREMELY SICK; This spontaneous report received from a consumer via a company representative concerned a 25 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: Unk) 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 confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced felt extremely sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt extremely sick. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; PERSISTENT HEADACHE; MUSCLE ACHE; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19. 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 an unspecified date, the subject experienced chills, persistent headache, muscle ache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, persistent headache, muscle ache, fatigue and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417710.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, SARS-CoV-2 test, Somnolence
Clinical narrative: SICK; WANT TO SLEEP ALL DAY; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 49 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: 043a1a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced want to sleep all day. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced sick. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and tiredness, and the outcome of want to sleep all day and sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling hot, Headache
Clinical narrative: SHORTNESS OF BREATHE; HEAD, FORHEAD AND EARS ARE HOT; HEADACHE; LITTLE EXTRA FATIGUE; This spontaneous report received from a patient concerned a 22 year old of unspecified 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, expiry: 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 10-APR-2021, the subject experienced shortness of breathe. On 10-APR-2021, the subject experienced head, forhead and ears are hot. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced little extra fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, head, forhead and ears are hot, shortness of breathe, and little extra fatigue. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oral disorder, Pain, Pyrexia
Clinical narrative: BUMP INSIDE LEFT SIDE OF MOUTH; BODY ACHES; SWELLING; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary blood disorder, and other pre-existing medical conditions included 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced bump inside left side of mouth. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, fatigue, headaches, body aches, bump inside left side of mouth, and swelling. This report was non-serious.; Sender's Comments: v0:Medical assessment comment not required as per standard operating procedures.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: BUMP INSIDE LEFT SIDE OF MOUTH; BODY ACHES; SWELLING; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary blood disorder, and other pre-existing medical conditions included 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced bump inside left side of mouth. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, fatigue, headaches, body aches, bump inside left side of mouth, and swelling. This report was non-serious.; Sender's Comments: v0:Medical assessment comment not required as per standard operating procedures.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 180 pounds, and height was 64 inches. The patient's past medical history included gout, and concurrent conditions included allergy to grass, and allergy to hay. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Injection site pain
Clinical narrative: FATIGUE; DIARRHEA; INJECTION SITE PAIN; LIGHT HEADEDNESS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, iodine allergy, kiwi fruit skin allergy, non alcohol user, and smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness on 09-APR-2021, and diarrhea on 11-APR-2021, was recovering from fatigue, and had not recovered from injection site pain. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Influenza like illness
Clinical narrative: BLOOD PRESSURE KEEPS GOING UP; FLU LIKE SYMPTOMS/CHILLS/HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, hypokalemia, anxiety, depression, penicillin allergy, non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with lisinopril, and ibuprofen for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for prevention. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140s (unit not specified). On 09-APR-2021, the subject experienced blood pressure keeps going up. On 09-APR-2021, the subject experienced flu like symptoms/chills/headache. Laboratory data included: Blood pressure (NR: not provided) 156/78 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120s (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms/chills/headache, and had not recovered from blood pressure keeps going up. 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1862072, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. On 09-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) POSITIVE. On 10-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR 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.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: SLEEPY; RUNNY NOSE; ABDOMINAL NOISES; PAIN IN EXTREMITY/ ARM WAS HURTING; NAUSEA; FEVER; SORE MUSCLE; HEADACHE; This spontaneous report received from a patient concerned a 25 year old. 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleepy, runny nose, abdominal noises, pain in extremity/ arm was hurting, nausea, fever, sore muscle, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, sleepy, fever, runny nose, sore muscle, headache, pain in extremity/ arm was hurting and abdominal noises was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Somnolence
Clinical narrative: SLEEPY; RUNNY NOSE; ABDOMINAL NOISES; PAIN IN EXTREMITY/ ARM WAS HURTING; NAUSEA; FEVER; SORE MUSCLE; HEADACHE; This spontaneous report received from a patient concerned a 25 year old. 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleepy, runny nose, abdominal noises, pain in extremity/ arm was hurting, nausea, fever, sore muscle, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, sleepy, fever, runny nose, sore muscle, headache, pain in extremity/ arm was hurting and abdominal noises was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Nausea
Clinical narrative: INTERMITTENT HEART RACING; BODY ACHES; CHILLS; WEAKNESS; 101 TEMPERATURE; NAUSEA; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and 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 intermittent heart racing. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced 101 temperature. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 101 temperature, chills, nausea, body aches, severe fatigue, weakness, and intermittent heart racing. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: INTERMITTENT HEART RACING; BODY ACHES; CHILLS; WEAKNESS; 101 TEMPERATURE; NAUSEA; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and 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 intermittent heart racing. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced 101 temperature. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 101 temperature, chills, nausea, body aches, severe fatigue, weakness, and intermittent heart racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Headache, Nausea
Clinical narrative: NAUSEA; HEADACHE; SHORTNESS OF BREATH; NOT HUNGRY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced not hungry. On 10-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced nausea, and headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, shortness of breath, not hungry and headache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious..