chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, Seizure
Clinical narrative: SEIZURE; JOINTS LOCKED UP/WHOLE BODY LOCKED UP; NO APPETITE; SWEATING; BARELY BEEN OUT OF BED/HOME BOUND; CHILLS; WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, after 23:00 the patient began shaking and had seizure, her mouth was drawn up. On the same day, the patient experienced fever, chills, sweating, weakness, no appetite and her whole body locked up and her joints locked up. According to the patient, she had barely been out of bed and had been home bound since vaccine was administered. The patient visited doctor/healthcare professional's office for events seizures, shaking, mouth drawn and fever. It was reported that, on 02-APR-2021, a nurse came to the patient's home and tried to encourage her to go to the hospital but she declined. On the day of this report, the patient had an appointment via phone video for her pulmonologist and with her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joints locked up/whole body locked up on 28-MAR-2021, was recovering from fever, chills, and sweating, had not recovered from seizure, no appetite, and barely been out of bed/home bound, and the outcome of weakness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Back pain, Chills, Decreased appetite
Clinical narrative: BAD PAIN ON RIGHT SIDE (TOWARDS  THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS,  SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE  HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. 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: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid margin crusting, Gait disturbance, Headache, Injection site pain, Nasal oedema
Clinical narrative: BAD PAIN ON RIGHT SIDE (TOWARDS  THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS,  SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE  HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. 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: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pyrexia, Rhinorrhoea, Thirst
Clinical narrative: BAD PAIN ON RIGHT SIDE (TOWARDS  THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS,  SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE  HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. 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: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: BAD PAIN ON RIGHT SIDE (TOWARDS  THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS,  SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE  HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. 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: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: BLOOD PRESSURE INCREASED; INCREASE GLUCOSE LEVEL; DIZZINESS; This spontaneous report received from a physician concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. 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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced blood pressure increased. On 06-APR-2021, the subject experienced increase glucose level. On 06-APR-2021, the subject experienced dizziness. Laboratory data included: Blood pressure (NR: not provided) Increased, and Glucose (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, blood pressure increased, and increase glucose level. 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: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Palpitations, Pyrexia
Clinical narrative: HEART RACING A LITTLE BIT; FEVER; This spontaneous report received from a patient concerned a 20 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.   No concomitant medications were reported. On 06-APR-2021, the subject experienced heart racing a little bit. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart racing a little bit was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: POTENTIAL UNDER DOSING OF 3 PATIENTS; OFF LABEL USE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced potential under dosing of 3 subjects. On 06-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential under dosing of 3 patients and off label use was not reported. This report was non-serious. This report was associated with product quality compliant: 90000175482
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Eye pain, Feeling abnormal, Influenza like illness, Night sweats
Clinical narrative: NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced eyes pain. On 06-APR-2021, the subject experienced eyes sensitive to light. On 06-APR-2021, the subject experienced felt like flu. On 06-APR-2021, the subject experienced feeling bad. On 06-APR-2021, the subject experienced pain in arm. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 07-APR-2021, the subject experienced night sweats. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes pain, and eyes sensitive to light on 06-APR-2021, felt like flu, and feeling bad on APR-2021, and pain in arm on 07-APR-2021, and had not recovered from night sweats. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment was not required as per standard   procedure as the case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia
Clinical narrative: NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced eyes pain. On 06-APR-2021, the subject experienced eyes sensitive to light. On 06-APR-2021, the subject experienced felt like flu. On 06-APR-2021, the subject experienced feeling bad. On 06-APR-2021, the subject experienced pain in arm. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 07-APR-2021, the subject experienced night sweats. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes pain, and eyes sensitive to light on 06-APR-2021, felt like flu, and feeling bad on APR-2021, and pain in arm on 07-APR-2021, and had not recovered from night sweats. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment was not required as per standard   procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: FAST HEART RATE; FEVER; MUSCLE ACHE; 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 administration not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 at 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, at around 15:30 or 16:00, the patient experienced fever, muscle aches, headache, and a very fast heart rate of more than 160 (unit not provided). On 07-APR-2021, her heart rate was at 130-140. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle ache, headache and fast heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411783-covid-19 vaccine ad26.cov2.s-fast heart rate. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 2021, the subject experienced flu-like symptoms. Laboratory data (dates unspecified) 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 flu-like symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Intracranial aneurysm, Loss of consciousness, Pyrexia
Clinical narrative: PASSED OUT; TERRIBLE FEVER; SMALL ANEURYSM IN BRAIN; 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 hormone therapy, and IVF (In-Vitro Fertilization). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included hormone therapy. On 03-APR-2021, the patient experienced terrible fever and headache after vaccination at night. On 04-APR-2021, the patient passed out which had never happened to her before. She was taken to the emergency room and was diagnosed with a small aneurysm in her brain. The patient was very fearful, this was new and would be getting larger/rupture sooner. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible fever, passed out and small aneurysm in brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210412164-covid-19 vaccine ad26.cov2.s -Small aneurysm in brain, Passed out. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: PIN-PAIN IN ARM; SEVERE CHILLS/ CHATTERING TEETH; 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 and expiry: 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 an unspecified date, the patient experienced pin-pain in arm, and severe chills/ chattering teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pin-pain in arm and severe chills/ chattering teeth was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pruritus
Clinical narrative: SKIN IS EXTREMELY ITCHY; SORE ARM; CHILLS; 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: Unk) dose was not reported, administered on 02-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced skin is extremely itchy. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin is extremely itchy, and the outcome of sore arm, chills and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: VACCINE FELT HOT GOING INTO THE ARM; LEFT ARM SORENESS; HEADACHE; VERY SLIGHT FEVER; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at 10:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced very slight fever. On 05-APR-2021, the subject experienced left arm soreness. On 05-APR-2021, the subject experienced headache. On 05-APR-2021 10:30, the subject experienced vaccine felt hot going into the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 05-APR-2021, was recovering from left arm soreness, and the outcome of vaccine felt hot going into the arm and very slight fever was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site pain, Pain in extremity
Clinical narrative: CHILLS; HEADACHE; INJECTION SITE PAIN ON HIS ARM; FEVER; SORE ARM; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 180 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced injection site pain on his arm. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 06-APR-2021 19:00:00, the subject experienced chills. On 06-APR-2021 19:00:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, had not recovered from headache, and injection site pain on his arm, and the outcome of chills and sore arm was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS; HEADACHE; INJECTION SITE PAIN ON HIS ARM; FEVER; SORE ARM; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 180 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced injection site pain on his arm. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 06-APR-2021 19:00:00, the subject experienced chills. On 06-APR-2021 19:00:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, had not recovered from headache, and injection site pain on his arm, and the outcome of chills and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body ache was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; JOINT ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 30 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: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced joint aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, joint aches, fever, headache and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling of body temperature change, Headache, Insomnia
Clinical narrative: BODY ACHE; SHAKING; FEELING HOT AND THEN COLD; TROUBLED SLEEPING; NOT FEELING HUNGRY; SEVERE HEADACHE; FEELING VERY TIRED; MUSCLE ACHES (WHOLE BODY IN GENERAL ACHES); 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: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced shaking. On APR-2021, the subject experienced feeling hot and then cold. On APR-2021, the subject experienced troubled sleeping. On APR-2021, the subject experienced not feeling hungry. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced feeling very tired. On APR-2021, the subject experienced muscle aches (whole body in general aches). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache, feeling very tired, muscle aches (whole body in general aches), body ache, shaking, feeling hot and then cold, troubled sleeping and not feeling hungry was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain, Tremor
Clinical narrative: BODY ACHE; SHAKING; FEELING HOT AND THEN COLD; TROUBLED SLEEPING; NOT FEELING HUNGRY; SEVERE HEADACHE; FEELING VERY TIRED; MUSCLE ACHES (WHOLE BODY IN GENERAL ACHES); 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: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced shaking. On APR-2021, the subject experienced feeling hot and then cold. On APR-2021, the subject experienced troubled sleeping. On APR-2021, the subject experienced not feeling hungry. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced feeling very tired. On APR-2021, the subject experienced muscle aches (whole body in general aches). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache, feeling very tired, muscle aches (whole body in general aches), body ache, shaking, feeling hot and then cold, troubled sleeping and not feeling hungry was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Insomnia, Pain, Pyrexia
Clinical narrative: MILD ACHINESS; MADE IT DIFFICULT TO SLEEP; LITTLE BIT OF CHILLS; MILD FEVER; MILD SIDE EFFECTS; 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, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On APR-2021, the subject experienced mild side effects. On APR-2021, the subject experienced made it difficult to sleep. On APR-2021, the subject experienced little bit of chills. On APR-2021, the subject experienced mild fever. On 06-APR-2021, the subject experienced mild achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild side effects, mild fever, mild achiness, made it difficult to sleep, and little bit of chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: OVERALL BODY RASH; This spontaneous report received from a patient concerned an 81 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered to left arm, on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced overall body rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overall body rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Throat irritation
Clinical narrative: SCRATCHY THROAT; SORE ARM; LIGHT HEADED; 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced light headed. On 06-APR-2021, the subject experienced scratchy throat. On 06-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, sore arm and light headed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 17:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Rash, Swelling
Clinical narrative: STINGING SENSATION; SWELLING; RASH ON OPPOSITE FOREARM FROM INJECTION SITE; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypothyroidism, and high cholesterol, and concurrent conditions included diabetes insipidus, non smoker, and non alcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020,  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced stinging sensation. On 07-APR-2021, the subject experienced swelling. On 07-APR-2021, the subject experienced rash on opposite forearm from injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, rash on opposite forearm from injection site, swelling, and stinging sensation, and the outcome of tired was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: PAINFUL ARM; COLD CHILLS; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced painful arm. On 06-APR-2021, the subject experienced cold chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful arm, and cold chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: NOSE DRIP; This spontaneous report received from a patient concerned multiple female patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subjects experienced nose drip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210411567.; Reporter's Comments: This report contains multiple patient
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: PARTIAL DOSE WAS ADMINISTERED; VACCINE LITTLE SQUIRTED OUT; 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: Unk) 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 07-APR-2021, the subject experienced partial dose was administered. On 07-APR-2021, the subject experienced vaccine little squirted out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose was administered and vaccine little squirted out was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: DIZZY; PAIN IN ARM; 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, batch number: 2018218 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in arm. On an unspecified date, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and dizzy was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Nasal pruritus, Pruritus, Rhinorrhoea
Clinical narrative: WHOLE FACE FEELS ITCHY; ITCHY EYES; ITCHY NOSE; VERY RUNNY NOSE; WATERING EYES; This spontaneous report received from a patient concerned a 58 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: 1802070 expiry: UNKNOWN) dose was not reported, around 8 to 10 am administered to left arm on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced itchy eyes. On 01-APR-2021, the subject experienced nasal itching. On 01-APR-2021, the subject experienced very runny nose. On 01-APR-2021, the subject experienced watering eyes. On 05-APR-2021, the subject experienced whole face feels itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy eyes, nasal itching, very runny nose, watering eyes, and whole face feels itchy. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 63 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered at left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left shoulder pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus, Rash
Clinical narrative: BODY ACHES; ITCHINESS; BUMP ON FACE UNDER LOWER LINE OF THE EYE/BUMP ON THE RIGHT SIDE OF THE CHEEK/RASH; FATIGUE; 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 was not reported, administered to left arm, on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included paracetamol. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced itchiness. On APR-2021, the subject experienced bump on face under lower line of the eye/bump on the right side of the cheek/rash. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, body aches, itchiness and bump on face under lower line of the eye/bump on the right side of the cheek/rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHINESS; 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. 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 itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchiness was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: BLISTER ON LEFT ARM BY THE SHOULDER/BLISTER ON LEFT SIDE OF THE BACK/BLISTER ON BREAST AREA ABOVE STOMACH; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced blister on left arm by the shoulder/blister on left side of the back/blister on breast area above stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blister on left arm by the shoulder/blister on left side of the back/blister on breast area above stomach. This report was non-serious.