chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site pain, Insomnia, Nausea, Pain
Clinical narrative: PAIN IN WHOLE RIGHT ARM AND BOTH LEGS; PAIN AT INJECTION SITE; FATIGUE; PAIN IN LEFT HIP; SHOOTING PAIN IN HEAD; SWELLING OF BOTH LEGS; PAIN OVER EYES; PAIN IN BRIDGE AND SIDE OF NOSE; STOMACH ACHE; NAUSEA; SEVERE HEADACHE; INSOMNIA; BLEEDING AT INJECTION SITE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included superficial blood clot, and concurrent conditions included no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 17/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced insomnia. On 08-APR-2021, the subject experienced bleeding at injection site. On 11-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced stomach ache. On 15-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced fatigue. On 15-APR-2021, the subject experienced pain in left hip. On 15-APR-2021, the subject experienced pain in whole right arm and both legs. On 15-APR-2021, the subject experienced shooting pain in head. On 15-APR-2021, the subject experienced swelling of both legs. On 15-APR-2021, the subject experienced pain over eyes. On 15-APR-2021, the subject experienced pain in bridge and side of nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and stomach ache on 11-APR-2021, insomnia on 09-APR-2021, and bleeding at injection site on 08-APR-2021, recovered with sequelae from severe headache on 11-APR-2021, and had not recovered from pain at injection site, fatigue, pain in left hip, shooting pain in head, pain over eyes, pain in bridge and side of nose, pain in whole right arm and both legs, and swelling of both legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rhinalgia
Clinical narrative: PAIN IN WHOLE RIGHT ARM AND BOTH LEGS; PAIN AT INJECTION SITE; FATIGUE; PAIN IN LEFT HIP; SHOOTING PAIN IN HEAD; SWELLING OF BOTH LEGS; PAIN OVER EYES; PAIN IN BRIDGE AND SIDE OF NOSE; STOMACH ACHE; NAUSEA; SEVERE HEADACHE; INSOMNIA; BLEEDING AT INJECTION SITE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included superficial blood clot, and concurrent conditions included no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 17/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced insomnia. On 08-APR-2021, the subject experienced bleeding at injection site. On 11-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced stomach ache. On 15-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced fatigue. On 15-APR-2021, the subject experienced pain in left hip. On 15-APR-2021, the subject experienced pain in whole right arm and both legs. On 15-APR-2021, the subject experienced shooting pain in head. On 15-APR-2021, the subject experienced swelling of both legs. On 15-APR-2021, the subject experienced pain over eyes. On 15-APR-2021, the subject experienced pain in bridge and side of nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and stomach ache on 11-APR-2021, insomnia on 09-APR-2021, and bleeding at injection site on 08-APR-2021, recovered with sequelae from severe headache on 11-APR-2021, and had not recovered from pain at injection site, fatigue, pain in left hip, shooting pain in head, pain over eyes, pain in bridge and side of nose, pain in whole right arm and both legs, and swelling of both legs. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: RED ITCHY BURNING BUMPS SPREAD TO HANDS AND LEGS; RED ITCHY BURNING BUMPS ON STOMACH; This spontaneous report received from a patient concerned a 58 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: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced red itchy burning bumps on stomach. On 15-APR-2021, the subject experienced red itchy burning bumps spread to hands and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red itchy burning bumps on stomach, and red itchy burning bumps spread to hands and legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; MILD FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-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 APR-2021, the subject experienced body aches. On APR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and mild fatigue on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210432815.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush
Clinical narrative: HEADACHE; HOT FLASHES; 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 fibromyalgia, and arthritis. The patient was previously treated with tramadol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol for drug used for unknown indication.  On 09-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes on 10-APR-2021, and headache on 12-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vomiting
Clinical narrative: LIGHT HEADEDNESS; VOMITING; EXTREME HEADACHE; PROLONGED FATIGUE/EXTREME FATIGUE; 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced extreme headache. On 09-APR-2021, the subject experienced prolonged fatigue/extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and extreme headache on APR-2021, and had not recovered from prolonged fatigue/extreme fatigue, and light headedness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site reaction, Somnolence
Clinical narrative: KNOT AND REDNESS AT INJECTION SITE; TIREDNESS; CHILLS; FEELING SLEEPY; 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling sleepy. On an unspecified date, the subject experienced knot and redness at injection site, and tiredness. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knot and redness at injection site, tiredness, chills and feeling sleepy was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache
Clinical narrative: ABDOMINAL PAIN; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 51 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced abdominal pain. On 10-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, and the outcome of severe headache was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise, Nausea
Clinical narrative: FELT AWFUL LIKE SHE WAS GOING TO DIE; FELT CRAPPY; NAUSEA; FELT TIRED/EXHAUSTION/FATIGUE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included vaccination adverse reaction, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient was previously treated with influenza vaccine for prophylactic vaccination; and experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced felt crappy. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced felt tired/exhaustion/fatigue. On 14-APR-2021, treatment medications included: paracetamol. On 18-APR-2021, the subject experienced felt awful like she was going to die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt crappy, and nausea on 15-APR-2021, and felt tired/exhaustion/fatigue on APR-2021, and had not recovered from felt awful like she was going to die. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; This spontaneous report received from a consumer 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 reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurred vision was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Body temperature increased, Decreased appetite, Fatigue, Headache
Clinical narrative: LACK OF APPETITE; BODY OVERHEATING; SWEATING; HEADACHE; LOW GRADE FEVER; TIREDNESS; EYES FEELING HEAVY; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no known drug allergies, drug abuse or illicit reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21/JUN/2021) dose was not reported, administered on 10-APR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced eyes feeling heavy. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced lack of appetite. On 11-APR-2021, the subject experienced body overheating. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced low grade fever. Laboratory data included: Low grade fever (NR: not provided) 99.3 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body overheating, and sweating on 13-APR-2021, and low grade fever on 12-APR-2021, had not recovered from headache, tiredness, and lack of appetite, and the outcome of eyes feeling heavy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: LACK OF APPETITE; BODY OVERHEATING; SWEATING; HEADACHE; LOW GRADE FEVER; TIREDNESS; EYES FEELING HEAVY; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no known drug allergies, drug abuse or illicit reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21/JUN/2021) dose was not reported, administered on 10-APR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced eyes feeling heavy. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced lack of appetite. On 11-APR-2021, the subject experienced body overheating. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced low grade fever. Laboratory data included: Low grade fever (NR: not provided) 99.3 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body overheating, and sweating on 13-APR-2021, and low grade fever on 12-APR-2021, had not recovered from headache, tiredness, and lack of appetite, and the outcome of eyes feeling heavy was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Sluggishness
Clinical narrative: NOSE BLEED; SLIGHT HEADACHE; SLUGGISHNESS; 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 gluten allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A 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 sluggishness. On 07-APR-2021, the subject experienced slight headache. On 15-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, and slight headache on 07-APR-2021, and had not recovered from nose bleed. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FELT LIKE IN FOG; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included furosemide for blood pressure, spironolactone for blood pressure, and metoprolol for drug used for unknown indication.  On APR-2021, the subject experienced felt like in fog. On 07-APR-2021, the subject experienced dry heaves. On 07-APR-2021, the subject experienced coughing. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced queasy/nausea. Treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced felt cold. On 08-APR-2021, the subject experienced headache. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, tiredness, and fever on 08-APR-2021, and headache on 11-APR-2021, had not recovered from severe chills, dizzy, queasy/nausea, and dry heaves, and the outcome of felt cold and felt like in fog was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Pyrexia, Retching
Clinical narrative: DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FELT LIKE IN FOG; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included furosemide for blood pressure, spironolactone for blood pressure, and metoprolol for drug used for unknown indication.  On APR-2021, the subject experienced felt like in fog. On 07-APR-2021, the subject experienced dry heaves. On 07-APR-2021, the subject experienced coughing. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced queasy/nausea. Treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced felt cold. On 08-APR-2021, the subject experienced headache. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, tiredness, and fever on 08-APR-2021, and headache on 11-APR-2021, had not recovered from severe chills, dizzy, queasy/nausea, and dry heaves, and the outcome of felt cold and felt like in fog was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FELT LIKE IN FOG; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included furosemide for blood pressure, spironolactone for blood pressure, and metoprolol for drug used for unknown indication.  On APR-2021, the subject experienced felt like in fog. On 07-APR-2021, the subject experienced dry heaves. On 07-APR-2021, the subject experienced coughing. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced queasy/nausea. Treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced felt cold. On 08-APR-2021, the subject experienced headache. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, tiredness, and fever on 08-APR-2021, and headache on 11-APR-2021, had not recovered from severe chills, dizzy, queasy/nausea, and dry heaves, and the outcome of felt cold and felt like in fog was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Feeling hot, Headache, Nausea
Clinical narrative: ITCHY FACE; RED FACE; WARM FACE; SWOLLEN FACE; DRY FACE; NAUSEA; HEADACHE; THROAT FELT SWOLLEN; This spontaneous report received from a patient concerned a 41 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced throat felt swollen. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 21-MAR-2021, the subject experienced itchy face. On 21-MAR-2021, the subject experienced red face. On 21-MAR-2021, the subject experienced warm face. On 21-MAR-2021, the subject experienced swollen face. On 21-MAR-2021, the subject experienced dry face. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, treatment medications included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat felt swollen, nausea, and headache on 21-MAR-2021, had not recovered from itchy face, red face, warm face, and swollen face, and the outcome of dry face was not reported. This report was non-serious.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swelling face
Clinical narrative: ITCHY FACE; RED FACE; WARM FACE; SWOLLEN FACE; DRY FACE; NAUSEA; HEADACHE; THROAT FELT SWOLLEN; This spontaneous report received from a patient concerned a 41 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced throat felt swollen. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 21-MAR-2021, the subject experienced itchy face. On 21-MAR-2021, the subject experienced red face. On 21-MAR-2021, the subject experienced warm face. On 21-MAR-2021, the subject experienced swollen face. On 21-MAR-2021, the subject experienced dry face. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, treatment medications included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat felt swollen, nausea, and headache on 21-MAR-2021, had not recovered from itchy face, red face, warm face, and swollen face, and the outcome of dry face was not reported. This report was non-serious.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 4 year old was administered Kinrix and Infanrix at the same clinic visit / only supposed to receive Kinrix; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose and wrong vaccine administered were 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 provided as follows: The patient was administered Kinrix and Infanrix at the same clinic visit, which led to accidental overdose. The patient was only supposed to receive Kinrix, which led to wrong vaccine administered. No further information available. The reporter consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Lethargy, Nausea, Pain in extremity
Clinical narrative: LETHARGIC/TIRED; NO APPETITE; MINOR ARM SORENESS; CHILLS; SLIGHT FEVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced lethargic/tired, no appetite, minor arm soreness, chills, slight fever, slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and the outcome of minor arm soreness, chills, slight fever, lethargic/tired and slight nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LETHARGIC/TIRED; NO APPETITE; MINOR ARM SORENESS; CHILLS; SLIGHT FEVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced lethargic/tired, no appetite, minor arm soreness, chills, slight fever, slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and the outcome of minor arm soreness, chills, slight fever, lethargic/tired and slight nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood blister, Petechiae
Clinical narrative: BLOOD BLISTER; PETECHIAE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced blood blister, and petechiae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood blister and petechiae was not reported. This report was non-serious.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Pain, Pyrexia
Clinical narrative: NUMBNESS ON LEFT ARM; FEVER; HEADACHE; NAUSEA; BODYACHE; This spontaneous report received from a patient concerned a 41 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced numbness on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyache, fever, headache, and nausea on APR-2021, and the outcome of numbness on left arm was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Head discomfort, Muscle twitching
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 concurrent conditions included acid reflux, and eye twitches. 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 10-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye twitching. On 13-APR-2021, the subject experienced slight pressure on side of head. On 13-APR-2021, the subject experienced burning sensation in chest. On 13-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye twitching, slight pressure on side of head, burning sensation in chest, and shortness of breath. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING SENSATION ON FACE AND RIGHT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 08:45 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 APR-2021, the subject experienced tingling sensation on face and right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling sensation on face and right arm was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Lethargy
Clinical narrative: BACK ACHE; LETHARGY; MINOR CHILLS; This spontaneous report received from a patient via a company representative concerned a 25 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: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced back ache. On 10-APR-2021, the subject experienced lethargy. On 10-APR-2021, the subject experienced minor chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back ache, lethargy, and minor chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vascular pain
Clinical narrative: SORE VEIN NEAR LEFT COLLER BONE; COLLAR BONE AREA SWOLLEN; 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, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient experienced sore vein near left coller bone. On 14-APR-2021, the patient experienced collar bone area swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore vein near left coller bone and collar bone area swollen was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: INSOMNIA; FEVER; MUSCLES SORENESS ON THE BACK; FATIGUE; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the 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: 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 insomnia. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscles soreness on the back. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, fever, and light headache on 06-APR-2021, and had not recovered from fatigue, and muscles soreness on the back. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: ACHING BODY; SORE ARM; FATIGUE; HEADACHE; SHOOTING PAIN IN LEG; FEVER; DIZZY AND LIGHTHEADED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on any chronic medications. 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 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dizzy and lightheaded. On 05-APR-2021, the subject experienced fever.  On 07-APR-2021, the subject experienced shooting pain in leg. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced aching body, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching body, sore arm, and fatigue, dizzy and lightheaded on 14-APR-2021, shooting pain in leg on 11-APR-2021, and fever on 06-APR-2021, and was recovering from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHING BODY; SORE ARM; FATIGUE; HEADACHE; SHOOTING PAIN IN LEG; FEVER; DIZZY AND LIGHTHEADED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on any chronic medications. 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 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dizzy and lightheaded. On 05-APR-2021, the subject experienced fever.  On 07-APR-2021, the subject experienced shooting pain in leg. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced aching body, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching body, sore arm, and fatigue, dizzy and lightheaded on 14-APR-2021, shooting pain in leg on 11-APR-2021, and fever on 06-APR-2021, and was recovering from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Rash, Urticaria
Clinical narrative: BODY SOAR; RASH ( HIVES) ARM, LEGS, AND THIGH; TIRED; RASH ( HIVES) ARM, LEGS, AND THIGH; SORE ARM; 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced body soar. On 13-APR-2021, the subject experienced rash (hives) arm, legs, and thigh. On 13-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced rash (hives) arm, legs, and thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, body soar, rash (hives) arm, legs, and thigh, tired, and rash ( hives) arm, legs, and thigh. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report received from a patient concerned a 69 year old female (local case ID# 002498740). The patient's height, and weight were not reported. The patient's concurrent conditions included giant cell arthritis, polymyalgia rheumatica, and rheumatoid arthritis.  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 15-MAR-2021 for prophylactic vaccination. Concomitant medications included tocilizumab. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers   On 16-MAR-2021, the subject experienced nerve issue. On 16-MAR-2021, the subject experienced throat ache. On 16-MAR-2021, the subject experienced pain. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced left arm swollen. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced little red around injection site. On 16-MAR-2021, the subject experienced swollen around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, throat ache, tired, pain, sick, nerve issue, left arm swollen, little red around injection site, and swollen around injection site. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Oropharyngeal pain, Pain, Peripheral swelling
Clinical narrative: This spontaneous report received from a patient concerned a 69 year old female (local case ID# 002498740). The patient's height, and weight were not reported. The patient's concurrent conditions included giant cell arthritis, polymyalgia rheumatica, and rheumatoid arthritis.  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 15-MAR-2021 for prophylactic vaccination. Concomitant medications included tocilizumab. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers   On 16-MAR-2021, the subject experienced nerve issue. On 16-MAR-2021, the subject experienced throat ache. On 16-MAR-2021, the subject experienced pain. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced left arm swollen. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced little red around injection site. On 16-MAR-2021, the subject experienced swollen around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, throat ache, tired, pain, sick, nerve issue, left arm swollen, little red around injection site, and swollen around injection site. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Hyperhidrosis, Lethargy, Limb injury
Clinical narrative: BRUISE ON SHIN; HIT SHIN ON CAR; LOWER BACK PAIN; EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; TENDERNESS; ARM PAIN; BAD COLD; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bad cold. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced hot and cold sweats. On 07-APR-2021, the subject experienced tenderness. On 07-APR-2021, the subject experienced arm pain. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced extra saliva production. On 11-APR-2021, the subject experienced lower back pain. On 12-APR-2021, the subject experienced bruise on shin. On 12-APR-2021, the subject experienced hit shin on car. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, and tenderness on APR-2021, and arm pain on 11-APR-2021, had not recovered from lower back pain, lethargy, bruise on shin, and hit shin on car, and the outcome of bad cold was not reported. This report was non-serious.