chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Throat tightness
Clinical narrative: GENERAL FLU LIKE SYMPTOMS; INJECTION SITE PAIN; FELT LIKE THROAT CLOSING; 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt like throat closing. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced general flu like symptoms. Treatment medications (dates unspecified) included: acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine hydrochloride, and oxymetazoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on APR-2021, and was recovering from felt like throat closing, and general flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: NOT FEELING GOOD; NAUSEOUS; EXHAUSTED; 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. The patient's concurrent conditions included anxiety, and other pre-existing medical conditions included patient changed medication from one anti-anxiety medicine to another anti-anxiety.  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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced not feeling good. On 2021, the subject experienced nauseous. On 2021, the subject experienced exhausted. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling good, nauseous, headache and exhausted was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product preparation issue
Clinical narrative: PHARMACIST COMBINED VOLUME FROM SEPARATE VIALS; 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pharmacist combined volume from separate vials, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pharmacist combined volume from separate vials and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210334020.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Lethargy, Muscle spasms, Pain
Clinical narrative: CRAMPS ON LEGS; BODY ACHES; LETHARGIC; HEADACHE ON SIDES OF TEMPLES; SORE RIGHT ARM; BUMP AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 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 drug allergies, patient had not reported any medical conditions. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced sore right arm. On 12-APR-2021, the subject experienced bump at injection site. On 14-APR-2021, the subject experienced body aches. On 14-APR-2021, the subject experienced lethargic. On 14-APR-2021, the subject experienced headache on sides of temples. On 15-APR-2021, the subject experienced cramps on legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargic, and sore right arm on 15-APR-2021, and had not recovered from bump at injection site, headache on sides of temples, and cramps on legs. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CRAMPS ON LEGS; BODY ACHES; LETHARGIC; HEADACHE ON SIDES OF TEMPLES; SORE RIGHT ARM; BUMP AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 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 drug allergies, patient had not reported any medical conditions. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced sore right arm. On 12-APR-2021, the subject experienced bump at injection site. On 14-APR-2021, the subject experienced body aches. On 14-APR-2021, the subject experienced lethargic. On 14-APR-2021, the subject experienced headache on sides of temples. On 15-APR-2021, the subject experienced cramps on legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargic, and sore right arm on 15-APR-2021, and had not recovered from bump at injection site, headache on sides of temples, and cramps on legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; WALKING DIFFICULTY; DIFFICULTY IN STANDING; SEVERE LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced walking difficulty. On MAR-2021, the subject experienced difficulty in standing. On MAR-2021, the subject experienced severe leg pain. On 20-MAR-2021, the subject experienced joint pain. On 20-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from walking difficulty, difficulty in standing, and fever, and was recovering from joint pain, and severe leg pain. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Myalgia, Nausea, Pain assessment
Clinical narrative: TINGING IN THE RIGHT LEG, MOSTLY IN LOWER RIGHT LEG; NO APPETITE; SEVERE HEADACHE; MUSCLE SORENESS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 165 pounds, and height was 162.56 centimeters. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced no appetite. On 13-APR-2021, the subject experienced severe headache. On 13-APR-2021, the subject experienced muscle soreness. On 13-APR-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) Headache - 9.5/10, Muscle Ache 7.5/10. Treatment medications included: paracetamol. On 14-APR-2021 20:30, the subject experienced tinging in the right leg, mostly in lower right leg. On 15-APR-2021, Laboratory data included: Pain scale (NR: not provided) Headache - 1 to 2.5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinging in the right leg, mostly in lower right leg, severe headache, muscle soreness, nausea, and no appetite. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGING IN THE RIGHT LEG, MOSTLY IN LOWER RIGHT LEG; NO APPETITE; SEVERE HEADACHE; MUSCLE SORENESS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 165 pounds, and height was 162.56 centimeters. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced no appetite. On 13-APR-2021, the subject experienced severe headache. On 13-APR-2021, the subject experienced muscle soreness. On 13-APR-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) Headache - 9.5/10, Muscle Ache 7.5/10. Treatment medications included: paracetamol. On 14-APR-2021 20:30, the subject experienced tinging in the right leg, mostly in lower right leg. On 15-APR-2021, Laboratory data included: Pain scale (NR: not provided) Headache - 1 to 2.5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinging in the right leg, mostly in lower right leg, severe headache, muscle soreness, nausea, and no appetite. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: GENERAL MALAISE; FEVER; INJECTION SITE SWELLING; INJECTION SITE REDNESS; INJECTION SITE VERY WARM TO TOUCH; INJECTION SITE HIVES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 230 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included asthma, low thyroid, pollen allergy, sesame allergy, abstain from alcohol and and non smoker. The patient was not pregnant at the time of reporting. The patient had 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included levothyroxine for low thyroid.  On 12-APR-2021, the subject experienced injection site very warm to touch. On 12-APR-2021, the subject experienced injection site hives. On 12-APR-2021, the subject experienced injection site swelling. On 12-APR-2021, the subject experienced injection site redness. On 13-APR-2021, the subject experienced general malaise. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) ranging from 99 to 100 degree Fahrenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, injection site swelling, injection site redness, injection site hives, general malaise, and injection site very warm to touch. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: GENERAL MALAISE; FEVER; INJECTION SITE SWELLING; INJECTION SITE REDNESS; INJECTION SITE VERY WARM TO TOUCH; INJECTION SITE HIVES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 230 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included asthma, low thyroid, pollen allergy, sesame allergy, abstain from alcohol and and non smoker. The patient was not pregnant at the time of reporting. The patient had 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included levothyroxine for low thyroid.  On 12-APR-2021, the subject experienced injection site very warm to touch. On 12-APR-2021, the subject experienced injection site hives. On 12-APR-2021, the subject experienced injection site swelling. On 12-APR-2021, the subject experienced injection site redness. On 13-APR-2021, the subject experienced general malaise. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) ranging from 99 to 100 degree Fahrenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, injection site swelling, injection site redness, injection site hives, general malaise, and injection site very warm to touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pain, Pruritus, Pyrexia, Skin exfoliation
Clinical narrative: DRY SKIN ON THE FACE, NECK, EAR, AND EYES; ITCHY SKIN ON THE FACE, NECK, EAR, AND EYES; FLAKY SKIN ON THE FACE, NECK, EARS, AND EYES; FEVER; ACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. Non-company suspect drugs included: diphenhydramine hydrochloride (tablet, batch number: UNKNOWN, route of admin was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included ibuprofen.  On 10-APR-2021 21:00, the subject experienced ache. On 10-APR-2021 21:00, the subject experienced fever. On 11-APR-2021, the subject experienced dry skin on the face, neck, ear, and eyes. On 11-APR-2021, the subject experienced itchy skin on the face, neck, ear, and eyes. On 11-APR-2021, the subject experienced flaky skin on the face, neck, ears, and eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and fever on 11-APR-2021, and had not recovered from dry skin on the face, neck, ear, and eyes, itchy skin on the face, neck, ear, and eyes, and flaky skin on the face, neck, ears, and eyes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a 2 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine exposure via breast milk. This report was non-serious. This parent/child case is linked.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION ALL OVER CHEST AND HANDS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced severe reaction all over chest and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction all over chest and hands was not reported. This report was non-serious. This case, from the Others is linked to 20210411605.; Sender's Comments: V0: MAC comment not required for non-serious cases as per standard protocol
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: FLU-LIKE SYMPTOMS; NERVE PAIN ON LEFT SIDE AND GOES FROM SHOULDER, ARM, CHEST, AND INTO FINGERS; CHILLS; TIREDNESS; MUSCLE ACHES; NAUSEA; FEVER; PAIN AT THE INJECTION SITE; 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 concurrent conditions included seasonal allergies, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced flu-like symptoms. On 07-APR-2021, the subject experienced nerve pain on left side and goes from shoulder, arm, chest, and into fingers. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, muscle aches, nausea, and fever on 12-APR-2021, and had not recovered from nerve pain on left side and goes from shoulder, arm, chest, and into fingers, tiredness, and pain at the injection site. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuralgia, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; NERVE PAIN ON LEFT SIDE AND GOES FROM SHOULDER, ARM, CHEST, AND INTO FINGERS; CHILLS; TIREDNESS; MUSCLE ACHES; NAUSEA; FEVER; PAIN AT THE INJECTION SITE; 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 concurrent conditions included seasonal allergies, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced flu-like symptoms. On 07-APR-2021, the subject experienced nerve pain on left side and goes from shoulder, arm, chest, and into fingers. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, muscle aches, nausea, and fever on 12-APR-2021, and had not recovered from nerve pain on left side and goes from shoulder, arm, chest, and into fingers, tiredness, and pain at the injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: CRAMPS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 subject experienced cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cramps was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: BONE PAIN; FEVER; HEADACHE; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced bone pain, fever, headache, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, bone pain, nausea and muscle pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428556.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: BODY ACHES; SORE ARM; This spontaneous report received from a patient via a company representative 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: BASEBALL SIZE HARD LUMP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced baseball size hard lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of baseball size hard lump was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Impaired work ability, Injection site warmth
Clinical narrative: This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test positive. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to go work. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 06-APR-2021, the subject experienced warm throughout right arm at injection site. On 06-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced stomach/abdominal pain. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and warm throughout right arm at injection site on APR-2021, had not recovered from severe headache, and fatigue, and the outcome of unable to go work was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: BACK PAIN; GENERAL BODY ACHES; This spontaneous report received from a patient via a company representative concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced back pain. On 2021, the subject experienced general body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, and general body aches on 2021. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a health care professional. 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: 1802068 expiry: 25-MAY-2021) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, headache, and nausea on 28-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210429909.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Palpitations
Clinical narrative: WEAKNESS; TIREDNESS; FEVER; NAUSEA; HEART RACING; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient. 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 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced dizziness and lightheadedness. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, dizziness and lightheadedness, weakness, tiredness, nausea, and fever on APR-2021. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: WEAKNESS; TIREDNESS; FEVER; NAUSEA; HEART RACING; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient. 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 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced dizziness and lightheadedness. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, dizziness and lightheadedness, weakness, tiredness, nausea, and fever on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hyperhidrosis, Hypoaesthesia, Illness, Myalgia
Clinical narrative: SICKNESS; SWEATING; MUSCLE ACHE; NAUSEA; PAIN IN RIGHT ARM; NUMBNESS IN RIGHT ARM; DIFFICULTY IN WALKING; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dehydration, 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included dulaglutide, and insulin. On 06-APR-2021, the patient experienced numbness in right arm. On 06-APR-2021, the patient experienced difficulty in walking. On 06-APR-2021, the patient experienced pain in right arm. On 10-APR-2021, the patient experienced sickness. On 10-APR-2021, the patient experienced sweating. On 10-APR-2021, the patient experienced muscle ache. On 10-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sickness on APR-2021, and had not recovered from pain in right arm, numbness in right arm, difficulty in walking, muscle ache, sweating, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: SICKNESS; SWEATING; MUSCLE ACHE; NAUSEA; PAIN IN RIGHT ARM; NUMBNESS IN RIGHT ARM; DIFFICULTY IN WALKING; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dehydration, 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included dulaglutide, and insulin. On 06-APR-2021, the patient experienced numbness in right arm. On 06-APR-2021, the patient experienced difficulty in walking. On 06-APR-2021, the patient experienced pain in right arm. On 10-APR-2021, the patient experienced sickness. On 10-APR-2021, the patient experienced sweating. On 10-APR-2021, the patient experienced muscle ache. On 10-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sickness on APR-2021, and had not recovered from pain in right arm, numbness in right arm, difficulty in walking, muscle ache, sweating, and nausea. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS  KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; 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 borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, 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, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS  KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; 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 borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, 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, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Polymerase chain reaction
Clinical narrative: SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS  KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; 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 borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, 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, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: DIZZINESS; CHILLS; EXCRUCIATING HEADACHE; FATIGUE; STOMACH QUEASINESS; 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 (form of admin and route of admin were not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced excruciating headache. On 02-APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced stomach queasiness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and stomach queasiness on 11-APR-2021, and chills on 03-APR-2021, and had not recovered from excruciating headache, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; GENERAL DISCOMFORT; CHILLS; SEVERE BODY ACHES; FATIGUE; HEADACHE; FEVER; SORENESS; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's past medical history included mild rash. The patient experienced drug allergy when treated with ampicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 12:38 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 19:30, the subject experienced soreness. On 08-APR-2021 19:30, the subject experienced fever. On 08-APR-2021 22:30, the subject experienced severe body aches. On 08-APR-2021 22:30, the subject experienced chills. On 08-APR-2021 22:30, the subject experienced fatigue. On 08-APR-2021 22:30, the subject experienced headache. On 09-APR-2021, the subject experienced general discomfort. On 11-APR-2021, the subject experienced soreness at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021 20:00, had not recovered from severe body aches, and the outcome of soreness at injection site, fever, chills, fatigue, general discomfort and soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SORENESS AT INJECTION SITE; GENERAL DISCOMFORT; CHILLS; SEVERE BODY ACHES; FATIGUE; HEADACHE; FEVER; SORENESS; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's past medical history included mild rash. The patient experienced drug allergy when treated with ampicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 12:38 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 19:30, the subject experienced soreness. On 08-APR-2021 19:30, the subject experienced fever. On 08-APR-2021 22:30, the subject experienced severe body aches. On 08-APR-2021 22:30, the subject experienced chills. On 08-APR-2021 22:30, the subject experienced fatigue. On 08-APR-2021 22:30, the subject experienced headache. On 09-APR-2021, the subject experienced general discomfort. On 11-APR-2021, the subject experienced soreness at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021 20:00, had not recovered from severe body aches, and the outcome of soreness at injection site, fever, chills, fatigue, general discomfort and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: STOMACH CRAMPING; HEADACHE; This spontaneous report received from a consumer 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 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced stomach cramping. On APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and stomach cramping was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and injection site pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: IN BAD SHAPE/TRYING TO GET STRENGTH BACK; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced in bad shape/trying to get strength back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of in bad shape/trying to get strength back was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned an adult 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: 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 fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210436136.
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Somnolence
Clinical narrative: TOOK TWO NAPS; FEELING SLOW MOTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 2021, the subject experienced took two naps. On 2021, the subject experienced feeling slow motion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling slow motion on 2021, and the outcome of took two naps was not reported. This report was non-serious. This case, from the same reporter is linked to 20210431321.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Soreness of the injection site reoccurred after previously going away after initial injection. Same day itching started to occur, followed by swelling around the injection site (photo for reference if needed). This felt like an allergic reaction to me (I have had allergy shots in the past for preventative).  Swelling and soreness have been off and on since.  Started googling and seems to be a similar reaction as ?covid arm?