chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received two doses on April 6th, 2021 / Havrix vaccine expired on March 6th, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B).   On 6th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 6th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and an unknown time after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The reporter reported that the patient received the vaccine which was already expired on 6th March 2021. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Glossodynia, Hypertension, Hypotension, Paraesthesia oral
Clinical narrative: This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative negative, COVID-19 virus test (NR: not provided) Negative negative, and PCR (NR: not provided) Negative negative.  On 08-MAR-2021, the subject experienced tongue tingling with bumps/mouth with tingling and bumps/lips with tingling. On 09-MAR-2021, the subject experienced pimples on tongue (1 pimple on left side and 3 pimples on right) /with bumps. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced pain on tongue (tip hurts). On 09-MAR-2021, the subject experienced fever and chills. On 10-MAR-2021, the subject experienced low blood pressure. Laboratory data included: Low blood pressure (NR: not provided) 90/58 Unit unspecified. On 11-MAR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure high (NR: not provided) 160/90 Unit unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue tingling with bumps/mouth with tingling and bumps/lips with tingling, and low blood pressure on 11-MAR-2021, high blood pressure on 13-MAR-2021, and fever and chills on 10-MAR-2021, and had not recovered from pimples on tongue (1 pimple on left side and 3 pimples on right)/with bumps, diarrhea, and pain on tongue (tip hurts). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia, SARS-CoV-2 test, Tongue eruption
Clinical narrative: This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative negative, COVID-19 virus test (NR: not provided) Negative negative, and PCR (NR: not provided) Negative negative.  On 08-MAR-2021, the subject experienced tongue tingling with bumps/mouth with tingling and bumps/lips with tingling. On 09-MAR-2021, the subject experienced pimples on tongue (1 pimple on left side and 3 pimples on right) /with bumps. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced pain on tongue (tip hurts). On 09-MAR-2021, the subject experienced fever and chills. On 10-MAR-2021, the subject experienced low blood pressure. Laboratory data included: Low blood pressure (NR: not provided) 90/58 Unit unspecified. On 11-MAR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure high (NR: not provided) 160/90 Unit unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue tingling with bumps/mouth with tingling and bumps/lips with tingling, and low blood pressure on 11-MAR-2021, high blood pressure on 13-MAR-2021, and fever and chills on 10-MAR-2021, and had not recovered from pimples on tongue (1 pimple on left side and 3 pimples on right)/with bumps, diarrhea, and pain on tongue (tip hurts). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: RED SPOT ON INJECTION SITE; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 150 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included non smoker, wine-one glass with dinner, and short term memory stroke, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on right arm with 2" length of needle on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included apixaban for due to stroke. On 14-MAR-2021, the subject experienced red spot on injection site. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red spot on injection site on 15-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 vaccinated at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.  Version created to amend previously reported information on 16-Mar-2021. Upon review the following information was amended: Therapy end date was added. Product vaccine facility No information (Vaccine) re-entered in red font. DD correction done as reporter details were available.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: ACHE; WEAK; FEELS TIRED; 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 pre-existing medical conditions included unknown. 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. Concomitant medications included ustekinumab. On an unspecified date, the subject experienced ache, weak, and feels tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feels tired, weak and ache was not reported. This report was non-serious.  Version (2) created to amend previously reported information on 18/Mar/2021. Upon review the following information was amended: Labeling of event (weak) updated to labeled from unlabeled
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dry skin, Fatigue, Feeling abnormal, Headache
Clinical narrative: SMALL RED BLOTCHES ON FACE AND NECK; RAISED RASH ON HIS RIGHT HIP, NECK AND FACE; TINGLING IN ARMS AND BACK; FOGGY; FATIGUE; ABDOMINAL PAIN; LOW GRADE HEADACHE; INJECTION SITE PAIN; UNUSUAL PAIN THROUGHOUT BODY; PAIN AT LOWER EXTEMITIES; DARK SKIN ON BACK; WEIRD SENSATION WITH ROUGH SKIN; STRETCHED SKIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:45 for prophylactic vaccination on upper right arm. No concomitant medications were reported. On MAR-2021, the subject experienced weird sensation with rough skin. On MAR-2021, the subject experienced stretched skin. On 21-MAR-2021, the subject experienced abdominal pain. On 21-MAR-2021, the subject experienced unusual pain throughout body. On 21-MAR-2021, the subject experienced pain at lower extremities. On 21-MAR-2021, the subject experienced low grade headache. On 21-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced foggy. On 22-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced tingling in arms and back. On MAR-2021, the subject experienced dark skin on back. On 02-APR-2021, the subject experienced small red blotches on face and neck. On 02-APR-2021, the subject experienced raised rash on his right hip, neck and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from unusual pain throughout body, pain at lower extremities, low grade headache, and injection site pain, was recovering from abdominal pain, had not recovered from foggy, fatigue, tingling in arms and back, dark skin on back, and raised rash on his right hip, neck and face, and the outcome of weird sensation with rough skin, stretched skin and small red blotches on face and neck was not reported. This report was non-serious.  Additional information was received on 05-Apr-2021: The following information was updated and incorporated into the case: events feeling tingling in arms, weird sensation with a rough skin, darker skin, stretched skin, raised rash on hip, neck and face, small red blotches on face and neck added.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia, Rash macular
Clinical narrative: SMALL RED BLOTCHES ON FACE AND NECK; RAISED RASH ON HIS RIGHT HIP, NECK AND FACE; TINGLING IN ARMS AND BACK; FOGGY; FATIGUE; ABDOMINAL PAIN; LOW GRADE HEADACHE; INJECTION SITE PAIN; UNUSUAL PAIN THROUGHOUT BODY; PAIN AT LOWER EXTEMITIES; DARK SKIN ON BACK; WEIRD SENSATION WITH ROUGH SKIN; STRETCHED SKIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:45 for prophylactic vaccination on upper right arm. No concomitant medications were reported. On MAR-2021, the subject experienced weird sensation with rough skin. On MAR-2021, the subject experienced stretched skin. On 21-MAR-2021, the subject experienced abdominal pain. On 21-MAR-2021, the subject experienced unusual pain throughout body. On 21-MAR-2021, the subject experienced pain at lower extremities. On 21-MAR-2021, the subject experienced low grade headache. On 21-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced foggy. On 22-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced tingling in arms and back. On MAR-2021, the subject experienced dark skin on back. On 02-APR-2021, the subject experienced small red blotches on face and neck. On 02-APR-2021, the subject experienced raised rash on his right hip, neck and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from unusual pain throughout body, pain at lower extremities, low grade headache, and injection site pain, was recovering from abdominal pain, had not recovered from foggy, fatigue, tingling in arms and back, dark skin on back, and raised rash on his right hip, neck and face, and the outcome of weird sensation with rough skin, stretched skin and small red blotches on face and neck was not reported. This report was non-serious.  Additional information was received on 05-Apr-2021: The following information was updated and incorporated into the case: events feeling tingling in arms, weird sensation with a rough skin, darker skin, stretched skin, raised rash on hip, neck and face, small red blotches on face and neck added.
Sex: M
Vaccine: COVID19
Symptoms: Rash papular, Skin discolouration, Skin disorder
Clinical narrative: SMALL RED BLOTCHES ON FACE AND NECK; RAISED RASH ON HIS RIGHT HIP, NECK AND FACE; TINGLING IN ARMS AND BACK; FOGGY; FATIGUE; ABDOMINAL PAIN; LOW GRADE HEADACHE; INJECTION SITE PAIN; UNUSUAL PAIN THROUGHOUT BODY; PAIN AT LOWER EXTEMITIES; DARK SKIN ON BACK; WEIRD SENSATION WITH ROUGH SKIN; STRETCHED SKIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:45 for prophylactic vaccination on upper right arm. No concomitant medications were reported. On MAR-2021, the subject experienced weird sensation with rough skin. On MAR-2021, the subject experienced stretched skin. On 21-MAR-2021, the subject experienced abdominal pain. On 21-MAR-2021, the subject experienced unusual pain throughout body. On 21-MAR-2021, the subject experienced pain at lower extremities. On 21-MAR-2021, the subject experienced low grade headache. On 21-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced foggy. On 22-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced tingling in arms and back. On MAR-2021, the subject experienced dark skin on back. On 02-APR-2021, the subject experienced small red blotches on face and neck. On 02-APR-2021, the subject experienced raised rash on his right hip, neck and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from unusual pain throughout body, pain at lower extremities, low grade headache, and injection site pain, was recovering from abdominal pain, had not recovered from foggy, fatigue, tingling in arms and back, dark skin on back, and raised rash on his right hip, neck and face, and the outcome of weird sensation with rough skin, stretched skin and small red blotches on face and neck was not reported. This report was non-serious.  Additional information was received on 05-Apr-2021: The following information was updated and incorporated into the case: events feeling tingling in arms, weird sensation with a rough skin, darker skin, stretched skin, raised rash on hip, neck and face, small red blotches on face and neck added.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: RASH ON TORSO; HIVES; A SLIGHT RAISE IN BODY TEMPERATURE; NAUSEA; MILD FEVER; LETHARGY; TIREDNESS; CHILLS; MUSCLE FATIGUE; INFLAMMED JOINTS; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and other pre-existing medical conditions included the patient ha no known drug allergies. The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced muscle fatigue. On 20-MAR-2021, the subject experienced inflamed joints. On 20-MAR-2021, the subject experienced lethargy. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced a slight raise in body temperature. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced mild fever. On 21-MAR-2021, the subject experienced rash on torso. On 21-MAR-2021, the subject experienced hives. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) a slight raise in temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle fatigue, inflamed joints, and tiredness on MAR-2021, and nausea, and mild fever on 20-MAR-2021, had not recovered from rash on torso, and hives, and the outcome of chills, lethargy and a slight raise in body temperature was not reported. This report was non-serious.  Version created to amend previously reported information on 23-Mar-2021. Upon review the following information was amended: Event Lethargy Labeled  Muscle fatigue labeled  Hives labeled.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Muscle fatigue, Nausea, Pyrexia, Rash
Clinical narrative: RASH ON TORSO; HIVES; A SLIGHT RAISE IN BODY TEMPERATURE; NAUSEA; MILD FEVER; LETHARGY; TIREDNESS; CHILLS; MUSCLE FATIGUE; INFLAMMED JOINTS; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and other pre-existing medical conditions included the patient ha no known drug allergies. The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced muscle fatigue. On 20-MAR-2021, the subject experienced inflamed joints. On 20-MAR-2021, the subject experienced lethargy. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced a slight raise in body temperature. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced mild fever. On 21-MAR-2021, the subject experienced rash on torso. On 21-MAR-2021, the subject experienced hives. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) a slight raise in temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle fatigue, inflamed joints, and tiredness on MAR-2021, and nausea, and mild fever on 20-MAR-2021, had not recovered from rash on torso, and hives, and the outcome of chills, lethargy and a slight raise in body temperature was not reported. This report was non-serious.  Version created to amend previously reported information on 23-Mar-2021. Upon review the following information was amended: Event Lethargy Labeled  Muscle fatigue labeled  Hives labeled.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: RASH ON TORSO; HIVES; A SLIGHT RAISE IN BODY TEMPERATURE; NAUSEA; MILD FEVER; LETHARGY; TIREDNESS; CHILLS; MUSCLE FATIGUE; INFLAMMED JOINTS; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and other pre-existing medical conditions included the patient ha no known drug allergies. The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced muscle fatigue. On 20-MAR-2021, the subject experienced inflamed joints. On 20-MAR-2021, the subject experienced lethargy. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced a slight raise in body temperature. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced mild fever. On 21-MAR-2021, the subject experienced rash on torso. On 21-MAR-2021, the subject experienced hives. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) a slight raise in temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle fatigue, inflamed joints, and tiredness on MAR-2021, and nausea, and mild fever on 20-MAR-2021, had not recovered from rash on torso, and hives, and the outcome of chills, lethargy and a slight raise in body temperature was not reported. This report was non-serious.  Version created to amend previously reported information on 23-Mar-2021. Upon review the following information was amended: Event Lethargy Labeled  Muscle fatigue labeled  Hives labeled.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PREFILLED SYRINGE WITH TEMPERATURE  EXCURSION INJECTED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned an adult female.. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 0900 hrs to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced incorrect product storage. On 31-MAR-2021 09:00, the subject experienced prefilled syringe with temperature excursion injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the prefilled syringe with temperature excursion injected and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Swelling
Clinical narrative: BRUISING/ KNOT AT INJECTION SITE/ WARMNESS AT INJECTION SITE/ TENDER TO THE TOUCH/ RED AT INJECTION SITE/ SWELLING; SWELLING WORSE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sleep apnea, high cholesterol treated/controlled, seasonal allergies, sulfa drug allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 27-MAR-2021, the subject experienced bruising/ knot at injection site/ warmness at injection site/ tender to the touch/ red at injection site/ swelling. On 27-MAR-2021, the subject experienced swelling worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising/ knot at injection site/ warmness at injection site/ tender to the touch/ red at injection site/ swelling, and had not recovered from swelling worse. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia, Pain in extremity
Clinical narrative: TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient experienced drug allergy when treated with ibuprofen.  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 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tension, Vomiting
Clinical narrative: TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient experienced drug allergy when treated with ibuprofen.  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 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The company was unable to perform follow up to request batch number.  No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASH ON BACK, ARMS AND LEGS; ITCHY; This spontaneous report received from a patient concerned a 59 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced rash on back, arms and legs. On an unspecified date, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on back, arms and legs, and the outcome of itchy was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Malaise, Pyrexia
Clinical narrative: FEVER; DON'T FEEL GOOD; HEADACHE; DEHYDRATED; FREEZING; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic. The patient was previously treated with for vitamin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination.vaccinated at 11:30 pm in right deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced don't feel good. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced dehydrated. On 31-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, don't feel good, headache, dehydrated and freezing was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and anaphylactic reaction, and concurrent conditions included sulfonamide allergy, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced confirmed covid-19 infection. On 30-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Influenza like illness, Pain of skin, Sensitive skin
Clinical narrative: SENSTIVE SKIN; DIZZY; BRAIN FOG; SENSITIVE SKIN WHICH FELT ACHY; FLU LIKE SYMPTOMS/CHILLS/FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flu like symptoms/chills/fever. On 17-MAR-2021, the subject experienced senstive skin. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced brain fog. On 17-MAR-2021, the subject experienced sensitive skin which felt achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms/chills/fever, senstive skin, dizzy, brain fog and sensitive skin which felt achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: EXTREME THIRST THAT COULD NOT QUENCH; 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, after 8 to 12 hours the subject experienced extreme thirst that could not quench. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme thirst that could not quench on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered to left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in jaw
Clinical narrative: CHEST TIGHTNESS; LOWER JAW PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 161.54 centimeters. The patient's concurrent conditions included polysorbate 80 and oxalate sensitivity.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022,  expiry: 25/MAY/2021) dose was not reported, On 15-MAR-2021 administered on Left arm for covid-19 virus prevention. No concomitant medications were reported. On 17-MAR-2021, the subject experienced chest tightness. On 17-MAR-2021, the subject experienced lower jaw pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, and lower jaw pain on 19-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: FELT LITTLE ARM HEAVINESS FROM INJECTION SITE IN LEFT ARM GOING DOWN TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 13:45 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced felt little arm heaviness from injection site in left arm going down to elbow. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt little arm heaviness from injection site in left arm going down to elbow and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error
Clinical narrative: A LOT OF THE LIQUID CAME OUT THE SIDE OF THE SYRINGE; This spontaneous report received from a pharmacist 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced a lot of the liquid came out the side of the syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a lot of the liquid came out the side of the syringe was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: 6TH DOSE ADMINISTERED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 2021, the subject experienced 6th dose administered. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of 6th dose administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: SLIGHT SWELLING TO ARM; ARM IS SORE; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced slight swelling to arm. On MAR-2021, the subject experienced arm is sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is sore and slight swelling to arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypoaesthesia, Hypotension, Injection site pain
Clinical narrative: LOW BLOOD PRESSURE; HEADACHE; FEELS SORE TO MOVE HER ARM; LEFT ARM SORENESS AT AND AROUND INJECTION SITE; NUMBNESS ALL OVER HER BODY BUT MOSTLY IN HER LEGS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was not reported and height was 65 inches. The patient's concurrent conditions included high blood pressure, alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered on 30-MAR-2021 10:00 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive, Negative. On 30-MAR-2021, the subject experienced numbness all over her body but mostly in her legs. On 30-MAR-2021, the subject experienced trouble sleeping. On 30-MAR-2021, the subject experienced feels sore to move her arm. On 30-MAR-2021, the subject experienced left arm soreness at and around injection site. Treatment medications included: paracetamol. On 30-MAR-2021 16:00, the subject experienced headache. On 31-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 110/68 mmHg. On 31-MAR-2021 10:30, the subject experienced low blood pressure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from trouble sleeping, had not recovered from headache, numbness all over her body but mostly in her legs, and feels sore to move her arm, and the outcome of left arm soreness at and around injection site and low blood pressure was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: LOW BLOOD PRESSURE; HEADACHE; FEELS SORE TO MOVE HER ARM; LEFT ARM SORENESS AT AND AROUND INJECTION SITE; NUMBNESS ALL OVER HER BODY BUT MOSTLY IN HER LEGS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was not reported and height was 65 inches. The patient's concurrent conditions included high blood pressure, alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered on 30-MAR-2021 10:00 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive, Negative. On 30-MAR-2021, the subject experienced numbness all over her body but mostly in her legs. On 30-MAR-2021, the subject experienced trouble sleeping. On 30-MAR-2021, the subject experienced feels sore to move her arm. On 30-MAR-2021, the subject experienced left arm soreness at and around injection site. Treatment medications included: paracetamol. On 30-MAR-2021 16:00, the subject experienced headache. On 31-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 110/68 mmHg. On 31-MAR-2021 10:30, the subject experienced low blood pressure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from trouble sleeping, had not recovered from headache, numbness all over her body but mostly in her legs, and feels sore to move her arm, and the outcome of left arm soreness at and around injection site and low blood pressure was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Flushing, Injection site pain
Clinical narrative: FLUSHING OF FACE; FEELS UNCOMFORTABLE, LIKE A SUNBURN; JOINT PAIN; FEVER; SORENESS AT INJECTION SITE; FATIGUE; 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 type 2 diabetes, hashimoto's disease, seasonal allergies, tobacco allergy, trees allergy, and grass allergy. The patient experienced skin reaction when treated with cefaclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced joint pain. On 27-MAR-2021, the subject experienced fever. On 27-MAR-2021, the subject experienced soreness at injection site. On 27-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. On 29-MAR-2021, the subject experienced flushing of face. On 29-MAR-2021, the subject experienced feels uncomfortable, like a sunburn. On 30-MAR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, fever, and fatigue on 29-MAR-2021, and soreness at injection site on MAR-2021, had not recovered from flushing of face, and the outcome of feels uncomfortable, like a sunburn was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sunburn
Clinical narrative: FLUSHING OF FACE; FEELS UNCOMFORTABLE, LIKE A SUNBURN; JOINT PAIN; FEVER; SORENESS AT INJECTION SITE; FATIGUE; 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 type 2 diabetes, hashimoto's disease, seasonal allergies, tobacco allergy, trees allergy, and grass allergy. The patient experienced skin reaction when treated with cefaclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced joint pain. On 27-MAR-2021, the subject experienced fever. On 27-MAR-2021, the subject experienced soreness at injection site. On 27-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. On 29-MAR-2021, the subject experienced flushing of face. On 29-MAR-2021, the subject experienced feels uncomfortable, like a sunburn. On 30-MAR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, fever, and fatigue on 29-MAR-2021, and soreness at injection site on MAR-2021, had not recovered from flushing of face, and the outcome of feels uncomfortable, like a sunburn was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pain, Pyrexia
Clinical narrative: BODY ACHE; BARELY SLEPT; CRAZY CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number is not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, barely slept, crazy chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (units unspecified), 100.3 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body ache, crazy chills and barely slept was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERING; FEVER; This spontaneous report received from a patient concerned a 24 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering, and fever. This report was non-serious.