chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Inadequate diet, Lethargy, Pyrexia
Clinical narrative: LOW BLOOD PRESSURE; STOMACH HURTING; DIZZINESS; LETHARGY; NOT EATING WELL; NO APPETITE; DIARRHEA; WEAK; HIGH TEMPERATURE OF 102.1; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lung surgery, hernia surgery, tied tubes, and back surgery, and concurrent conditions included: peripheral artery disease, lung cancer, and seasonal allergy, and other pre-existing medical conditions included: Patient had Imder allergy. The patient experienced drug allergy when treated with clotrimazole, oxycodone hydrochloride/paracetamol, and simvastatin.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-JUL-2021, the patient experienced low blood pressure. On 31-JUL-2021, the patient experienced stomach hurting. On 31-JUL-2021, the patient experienced dizziness. On 31-JUL-2021, the patient experienced lethargy. On 31-JUL-2021, the patient experienced not eating well. On 31-JUL-2021, the patient experienced no appetite. On 31-JUL-2021, the patient experienced diarrhea. On 31-JUL-2021, the patient experienced weak. On 31-JUL-2021, the patient experienced high temperature of 102.1. Laboratory data included: Body temperature (NR: not provided) 102.1. The action taken with covid-19 vaccine was not applicable. The outcome of the diarrhea, stomach hurting, low blood pressure, high temperature of 102.1, dizziness, lethargy, not eating well, weak and no appetite was not reported. This report was non-serious. This case, involving the same patient is linked to 20210826468.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Nausea, Pain, Pyrexia
Clinical narrative: EXTREME BODY ACHES; COULD NOT GET OUT OF BED FOR A FULL DAY; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced extreme body aches, could not get out of bed for a full day, fever, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from extreme body aches, could not get out of bed for a full day, fever, and nausea. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: LUMP IN UPPER RIGHT LEG; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: toxemia when pregnant. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821281 expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 13-AUG-2021, the patient experienced lump in upper right leg. The action taken with covid-19 vaccine was not applicable. The outcome of lump in upper right leg was not reported. This report was non-serious. This case is associated with Product Quality Complaint number: 90000189496
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Loss of consciousness, Troponin
Clinical narrative: BLACKED OUT UNCONSCIOUS IMMEDIATELY AFTER THE SHOT; SHOOTING PAIN IN HEART; This spontaneous report received from a patient via social media via a company representative concerned a 38 year old female. The patient's height, and weight were not reported. Patient was healthy. 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: Unknown) dose was not reported,1 total, therapy start date was not reported for prophylactic vaccination. 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 patient was blacked out unconscious immediately after the vaccination with shooting pain in heart. Patient was taken to the emergency room. Patient had elevated troponin levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out unconscious immediately after the shot and shooting pain in heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210827757-covid-19 vaccine ad26.cov2.s-blacked out unconscious immediately after the shot and shooting pain in heart. 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).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: CHILLS; HEADACHES; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, headaches, and extreme exhaustion. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, headaches, and extreme exhaustion. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Pain
Clinical narrative: BURNING SENSATION ALL OVER BODY; NEEDLE AND PIN PAIN ALL OVER; NUMB AFTER JJ JAB; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced burning sensation all over body, needle and pin pain all over, and numb after jj jab. The action taken with covid-19 vaccine was not applicable. The outcome of the numb after jj jab, burning sensation all over body and needle and pin pain all over was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Pyrexia
Clinical narrative: GASTROINTESTINAL SYMPTOMS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, expiry: 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 patient experienced gastrointestinal symptoms, and fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and gastrointestinal symptoms was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Joint swelling, Muscular weakness
Clinical narrative: LITTLE SWOLLEN LEFT KNEE; CALF HURTING ON AND OFF; TINGLING IN BOTH FEET; WEAK PAINFUL LEGS; PAIN WORST IN THE LEFT LEG, LITTLE PAIN IN THE RIGHT LEG WHICH COMES BACK AND FORTH IN THE LAST COUPLE OF WEEKS BUT NOT AS THE LEFT LEG; PAIN MOVING UP FROM THE HIP TO CLOSE TO THE LEFT SIDE OF THE LOWER MIDDLE OF THE BACK, MOST PAIN WAS IN THE LEFT SIDE OF THE BACK; HEART RACING; PAIN IN RIGHT HIP WHICH WENT AWAY (DID NOT HURT ANYMORE) AND SWITCHED TO LEFT HIP AND WENT DOWN TO BOTH LEGS; LIGHT-HEADED; LOWER SPINE STARTED TO HURT WHICH WAS INITIATED BY THE SCIATIC NERVE AREA ON THE RIGHT HIP; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the patient experienced lower spine started to hurt which was initiated by the sciatic nerve area on the right hip. On 14-MAY-2021, the patient experienced light-headed. On 05-JUN-2021, the patient experienced pain in right hip which went away (did not hurt anymore) and switched to left hip and went down to both legs. On 13-JUL-2021, the patient experienced heart racing. On 30-JUL-2021, the patient experienced pain moving up from the hip to close to the left side of the lower middle of the back, most pain was in the left side of the back. On 13-AUG-2021, the patient experienced pain worst in the left leg, little pain in the right leg which comes back and forth in the last couple of weeks but not as the left leg. On an unspecified date, the patient experienced little swollen left knee, calf hurting on and off, tingling in both feet, and weak painful legs. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Spine looked fine. Treatment medications (dates unspecified) included: cyclobenzaprine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from lower spine started to hurt which was initiated by the sciatic nerve area on the right hip on 05-JUN-2021, had not recovered from pain in right hip which went away (did not hurt anymore) and switched to left hip and went down to both legs, pain moving up from the hip to close to the left side of the lower middle of the back, most pain was in the left side of the back, heart racing, and pain worst in the left leg, little pain in the right leg which comes back and forth in the last couple of weeks but not as the left leg, and the outcome of little swollen left knee, calf hurting on and off, light-headed, tingling in both feet and weak painful legs was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Paraesthesia, Spinal pain, X-ray
Clinical narrative: LITTLE SWOLLEN LEFT KNEE; CALF HURTING ON AND OFF; TINGLING IN BOTH FEET; WEAK PAINFUL LEGS; PAIN WORST IN THE LEFT LEG, LITTLE PAIN IN THE RIGHT LEG WHICH COMES BACK AND FORTH IN THE LAST COUPLE OF WEEKS BUT NOT AS THE LEFT LEG; PAIN MOVING UP FROM THE HIP TO CLOSE TO THE LEFT SIDE OF THE LOWER MIDDLE OF THE BACK, MOST PAIN WAS IN THE LEFT SIDE OF THE BACK; HEART RACING; PAIN IN RIGHT HIP WHICH WENT AWAY (DID NOT HURT ANYMORE) AND SWITCHED TO LEFT HIP AND WENT DOWN TO BOTH LEGS; LIGHT-HEADED; LOWER SPINE STARTED TO HURT WHICH WAS INITIATED BY THE SCIATIC NERVE AREA ON THE RIGHT HIP; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the patient experienced lower spine started to hurt which was initiated by the sciatic nerve area on the right hip. On 14-MAY-2021, the patient experienced light-headed. On 05-JUN-2021, the patient experienced pain in right hip which went away (did not hurt anymore) and switched to left hip and went down to both legs. On 13-JUL-2021, the patient experienced heart racing. On 30-JUL-2021, the patient experienced pain moving up from the hip to close to the left side of the lower middle of the back, most pain was in the left side of the back. On 13-AUG-2021, the patient experienced pain worst in the left leg, little pain in the right leg which comes back and forth in the last couple of weeks but not as the left leg. On an unspecified date, the patient experienced little swollen left knee, calf hurting on and off, tingling in both feet, and weak painful legs. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Spine looked fine. Treatment medications (dates unspecified) included: cyclobenzaprine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from lower spine started to hurt which was initiated by the sciatic nerve area on the right hip on 05-JUN-2021, had not recovered from pain in right hip which went away (did not hurt anymore) and switched to left hip and went down to both legs, pain moving up from the hip to close to the left side of the lower middle of the back, most pain was in the left side of the back, heart racing, and pain worst in the left leg, little pain in the right leg which comes back and forth in the last couple of weeks but not as the left leg, and the outcome of little swollen left knee, calf hurting on and off, light-headed, tingling in both feet and weak painful legs was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Myalgia
Clinical narrative: LOSS OF APPETITE; SLIGHT CHILLS; TENDERNESS AT SITE OF INJECTION; FATIGUE; SEVERE MUSCLE ACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 117 pounds, and height was 67 inches. The patient's concurrent conditions included: non-alcohol user, non-smoker, allergy to lotion, and allergy to gum. The patient had no history of drug abuse or illicit drug use and no allergy to any medication. The patient experienced drug allergy when treated with dimeticone for drug used for unknown indication.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B214, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced loss of appetite. On 29-JUL-2021, the patient experienced slight chills. On 29-JUL-2021, the patient experienced tenderness at site of injection. On 29-JUL-2021, the patient experienced fatigue. On 29-JUL-2021, the patient experienced severe muscle ache. The action taken with covid-19 vaccine was not applicable. The outcome of the tenderness at site of injection, fatigue, severe muscle ache, slight chills and loss of appetite was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immune system disorder, Pain, Pyrexia
Clinical narrative: BODY ACHES; HAD A VERY STRONG IMMUNE RESPONSE; CHILLS; 103 DEG FEVER FOR MORE THAN 8 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid, and sniffles. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, had a very strong immune response, chills, and 103 deg fever for more than 8 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine was not applicable. The outcome of the body aches, chills, 103 deg fever for more than 8 hours and had a very strong immune response was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 patient experienced severe reaction. The action taken with covid-19 vaccine was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: MILD HEADACHE; MILD NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 patient experienced mild headache, and mild nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the mild headache and mild nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829201.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: RUNNY NOSE; SORE THROAT; HEADACHE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 250 pounds, and height was 69 inches. The patient's concurrent conditions included: non-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient have No known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced runny nose. On 12-AUG-2021, the patient experienced sore throat. On 12-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The outcome of the runny nose, headache and sore throat was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, 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: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: MORE TIRED THAN USUAL; MUSCLE ACHES; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and not able to drink milk, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced more tired than usual. On 13-AUG-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine was not applicable. The outcome of the more tired than usual and muscle aches was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dizziness, Dysgeusia, Migraine
Clinical narrative: DIZZINESS; VOMITING; NAUSEA; ELEVATED BODY TEMPERATURE; METALLIC TASTE IN THE MOUTH; MIGRAINE HEADACHES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cold, and warm body, and other pre-existing medical conditions included: The patient had extreme sensitivity to all medications and supplements. The patient had not changed her diet nor was she exposed to anything. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Body temperature (NR: not provided) 98.4-98.8. On 07-JUL-2021, the patient experienced migraine headaches. On 07-JUL-2021, the patient experienced metallic taste in the mouth. On 07-JUL-2021, the patient experienced nausea. On 07-JUL-2021, the patient experienced elevated body temperature. Laboratory data included: Body temperature (NR: not provided) 98.8-99.2. On 08-JUL-2021, the patient experienced dizziness. On 08-JUL-2021, the patient experienced vomiting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.4-97.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and vomiting on 11-JUL-2021, nausea on 10-JUL-2021, and elevated body temperature on 28-JUL-2021, had not recovered from migraine headaches, and the outcome of metallic taste in the mouth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829031.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: DIZZINESS; VOMITING; NAUSEA; ELEVATED BODY TEMPERATURE; METALLIC TASTE IN THE MOUTH; MIGRAINE HEADACHES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cold, and warm body, and other pre-existing medical conditions included: The patient had extreme sensitivity to all medications and supplements. The patient had not changed her diet nor was she exposed to anything. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Body temperature (NR: not provided) 98.4-98.8. On 07-JUL-2021, the patient experienced migraine headaches. On 07-JUL-2021, the patient experienced metallic taste in the mouth. On 07-JUL-2021, the patient experienced nausea. On 07-JUL-2021, the patient experienced elevated body temperature. Laboratory data included: Body temperature (NR: not provided) 98.8-99.2. On 08-JUL-2021, the patient experienced dizziness. On 08-JUL-2021, the patient experienced vomiting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.4-97.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and vomiting on 11-JUL-2021, nausea on 10-JUL-2021, and elevated body temperature on 28-JUL-2021, had not recovered from migraine headaches, and the outcome of metallic taste in the mouth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829031.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: RASH; FEVER; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-AUG-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 13-AUG-2021, the patient experienced rash. On 13-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash, and fever. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE  WAS ADMINISTERED WHEN EXPIRED BY 45 MINUTES - 1 HOUR (PAST THE  ALLOWED 6 HOURS AFTER FIRST PUNCTURE); This spontaneous report received from a pharmacist concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced vaccine was administered when expired by 45 minutes - 1 hour (past the allowed 6 hours after first puncture). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered when expired by 45 minutes - 1 hour (past the allowed 6 hours after first puncture) was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEG PAIN ON THE SIDE WHERE PATIENT RECEIVED THE VACCINE (LEFT SIDE); This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced leg pain on the side where patient received the vaccine (left side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain on the side where patient received the vaccine (left side). This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray, Cough, Mononucleosis heterophile test, Nasal discomfort
Clinical narrative: SHARP PAIN IN BACK; COUGH; SORE THROAT (THAT'S GETTING WORSE); NASAL IRRITATION; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 200 pounds, and height was 64 inches. The patient's concurrent conditions included: anxiety, cigarette smoker, non-alcohol user, depression, and attention deficit hyperactivity disorder (adhd), and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient experienced sore throat (that's getting worse). On 03-AUG-2021, the patient experienced nasal irritation. On 05-AUG-2021, Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Negative, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 06-AUG-2021, the patient experienced cough. On 10-AUG-2021, the patient experienced sharp pain in back. On 14-AUG-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. Laboratory data (dates unspecified) included: Mononucleosis heterophile test (NR: not provided) Negative. Treatment medications (dates unspecified) included: azithromycin. The action taken with covid-19 vaccine was not applicable. The patient was recovering from nasal irritation, and cough, and had not recovered from sore throat (that's getting worse), and sharp pain in back. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: SHARP PAIN IN BACK; COUGH; SORE THROAT (THAT'S GETTING WORSE); NASAL IRRITATION; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 200 pounds, and height was 64 inches. The patient's concurrent conditions included: anxiety, cigarette smoker, non-alcohol user, depression, and attention deficit hyperactivity disorder (adhd), and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient experienced sore throat (that's getting worse). On 03-AUG-2021, the patient experienced nasal irritation. On 05-AUG-2021, Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Negative, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 06-AUG-2021, the patient experienced cough. On 10-AUG-2021, the patient experienced sharp pain in back. On 14-AUG-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. Laboratory data (dates unspecified) included: Mononucleosis heterophile test (NR: not provided) Negative. Treatment medications (dates unspecified) included: azithromycin. The action taken with covid-19 vaccine was not applicable. The patient was recovering from nasal irritation, and cough, and had not recovered from sore throat (that's getting worse), and sharp pain in back. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was unknown if the patient had drug abuse or illicit drug usage, consume alcohol and smoke. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced chills. On 14-AUG-2021, the patient experienced fever. On 14-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, chills, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: FELT WARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-AUG-2021, the patient experienced felt warm. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of felt warm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: COUGHING AND HACKING STUFF UP; SWOLLEN LYMPH NODES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced coughing and hacking stuff up, swollen lymph nodes, and headache. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) not reported, and COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine was not applicable. The outcome of the coughing and hacking stuff up, headache and swollen lymph nodes was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: SORE ARM; INCREASED HEART RATE; SHORTNESS OF BREATH; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 165 pounds, and height was 65 inches. The patient's concurrent conditions included: outdoor allergies, social alcohol drinker, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 11:00 for prophylactic vaccination. Concomitant medications included salbutamol. On 13-AUG-2021, the patient experienced increased heart rate. On 13-AUG-2021, the patient experienced shortness of breath. On 13-AUG-2021, the patient experienced dizziness. Laboratory data included: Heart rate (NR: not provided) 115 Beats per minute, 90 Beats per minute. On 14-AUG-2021, the patient experienced sore arm. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 62 Beats per minute (normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from increased heart rate, shortness of breath, dizziness, and sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Formication, Paraesthesia
Clinical narrative: FEELING STRANGE; TINGLING FEET AND FINGERS/FEELING LIKE PINS AND NEEDLES; FEELING AS ALMOST LIKE ANTS GOING UNDER THE SKIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 125 pounds, and height was 163 centimeters. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. Described herself as very healthy, and had not had a reaction to other shots. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and ergocalciferol. On AUG-2021, the patient experienced feeling strange. On AUG-2021, the patient experienced tingling feet and fingers/feeling like pins and needles. On AUG-2021, the patient experienced feeling as almost like ants going under the skin. The action taken with covid-19 vaccine was not applicable. The outcome of the feeling strange, tingling feet and fingers/feeling like pins and needles and feeling as almost like ants going under the skin was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pain in extremity, Peripheral swelling, Soft tissue injury
Clinical narrative: thumb started to swell; A little sore; its soft; feel like fluid; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (thumb started to swell), PAIN IN EXTREMITY (A little sore), SOFT TISSUE INJURY (its soft) and OEDEMA (feel like fluid) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced SOFT TISSUE INJURY (its soft) and OEDEMA (feel like fluid). On an unknown date, the patient experienced PERIPHERAL SWELLING (thumb started to swell) and PAIN IN EXTREMITY (A little sore). At the time of the report, PERIPHERAL SWELLING (thumb started to swell), PAIN IN EXTREMITY (A little sore), SOFT TISSUE INJURY (its soft) and OEDEMA (feel like fluid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medications were not provided by reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site became itchy; Injection site became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE ERYTHEMA (Injection site became red) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE ERYTHEMA (Injection site became red). At the time of the report, VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE ERYTHEMA (Injection site became red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Swelling, Vaccination site irritation
Clinical narrative: swelling on stomach area; legs were achy too; achy joint; injection site was sensitivie to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (injection site was sensitivie to touch), SWELLING (swelling on stomach area), PAIN IN EXTREMITY (legs were achy too) and ARTHRALGIA (achy joint) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included DEXLANSOPRAZOLE (DEXILANT), ESTRADIOL (ESTRADIOL TRANSDERMAL), EZETIMIBE, GLIPIZIDE, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), METFORMIN, METOPROLOL, EVOLOCUMAB (REPATHA SURECLICK), OLMESARTAN MEDOXOMIL (BENICAR), VITAMIN D2 and GUAIFENESIN (MUCINEX) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE IRRITATION (injection site was sensitivie to touch). On 22-Jan-2021, the patient experienced SWELLING (swelling on stomach area), PAIN IN EXTREMITY (legs were achy too) and ARTHRALGIA (achy joint). The patient was treated with FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) for Swelling, at an unspecified dose and frequency. On 14-Jan-2021, VACCINATION SITE IRRITATION (injection site was sensitivie to touch) had resolved. At the time of the report, SWELLING (swelling on stomach area), PAIN IN EXTREMITY (legs were achy too) and ARTHRALGIA (achy joint) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis (The patient has the history of Myasthenia Gravis.) since an unknown date and Type 2 diabetes mellitus (The patient has the history of Type 2 Diabetes Mellitus.) since an unknown date.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills). On 21-Jan-2021, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain under her ribs in L side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain under her ribs in L side) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain under her ribs in L side). At the time of the report, PAIN (pain under her ribs in L side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Muscle discomfort, Muscular weakness, Somnolence
Clinical narrative: Muscular discomfort top of left hand; Diarrhea; Sleepiness; Muscle weakness on right arm; Minor headache; Tenderness at the injection site; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm) and HEADACHE (Minor headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm), HEADACHE (Minor headache), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm), HEADACHE (Minor headache), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.            No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information included new event details and outcome of the earlier reported events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Muscular discomfort top of left hand; Diarrhea; Sleepiness; Muscle weakness on right arm; Minor headache; Tenderness at the injection site; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm) and HEADACHE (Minor headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm), HEADACHE (Minor headache), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm), HEADACHE (Minor headache), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.            No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information included new event details and outcome of the earlier reported events.