chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: HEADACHE; NAUSEA; LIGHT HEADEDNESS; SHORTNESS OF BREATH; BODY ACHES; LEG ACHES; FEVER; BACK ACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 25 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 patient did not have any relevant medical history. patient had no known drug allergies. patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 201A21A expiry: 20-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced back ache. On 03-JUN-2021, the subject experienced shortness of breath. On 03-JUN-2021, the subject experienced body aches. On 03-JUN-2021, the subject experienced leg aches. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced muscle aches. On 04-JUN-2021, the subject experienced light headedness. On 04-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, back ache, leg aches, light headedness, shortness of breath, headache, muscle aches, body aches, and nausea. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: HEADACHE; NAUSEA; LIGHT HEADEDNESS; SHORTNESS OF BREATH; BODY ACHES; LEG ACHES; FEVER; BACK ACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 25 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 patient did not have any relevant medical history. patient had no known drug allergies. patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 201A21A expiry: 20-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced back ache. On 03-JUN-2021, the subject experienced shortness of breath. On 03-JUN-2021, the subject experienced body aches. On 03-JUN-2021, the subject experienced leg aches. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced muscle aches. On 04-JUN-2021, the subject experienced light headedness. On 04-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, back ache, leg aches, light headedness, shortness of breath, headache, muscle aches, body aches, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100ISH FEVER FOR ABOUT 24 HOURS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced 100ish fever for about 24 hours. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 100ish fever for about 24 hours on 2021. This report was non-serious.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Bone pain, Burning sensation
Clinical narrative: BONE PAIN; JOINT PAIN; PAIN RADIATING TO THE FRONT AND INTO THE MUSCLES AT SITE OF INJECTION; BURNING SENSATION; STABBING FEELING 6 ON 10 PAIN SCALE; MILD ITCHING LIKE A BUG CRAWLING UNDER THE SKIN; MUSCLE TIGHTNESS OR TENSION; SHOULDER DISCOMFORT; TOP OF SHOULDER PAIN; This spontaneous report received from a patient concerned a 76 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included electrocardiogram t wave inversion, and concurrent conditions included alcohol consumer, and other pre-existing medical conditions included drug abuse. The patient experienced drug allergy when treated with levothyroxine sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shoulder discomfort. On MAY-2021, the subject experienced top of shoulder pain. On 20-MAY-2021, the subject experienced muscle tightness or tension. On 26-MAY-2021, the subject experienced burning sensation. On 26-MAY-2021, the subject experienced stabbing feeling 6 on 10 pain scale. On 26-MAY-2021, the subject experienced mild itching like a bug crawling under the skin. On 27-MAY-2021, the subject experienced bone pain. On 27-MAY-2021, the subject experienced joint pain. On 27-MAY-2021, the subject experienced pain radiating to the front and into the muscles at site of injection. On 02-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) normal, Body temperature (NR: not provided) 96.6, Heart rate (NR: not provided) 72 bpm, and Weight (NR: not provided) 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle tightness or tension, burning sensation, stabbing feeling 6 on 10 pain scale, mild itching like a bug crawling under the skin, top of shoulder pain, shoulder discomfort, joint pain, bone pain and pain radiating to the front and into the muscles at site of injection was not reported. This report was non-serious.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Injection site pain, Muscle tightness, Musculoskeletal discomfort, Pain
Clinical narrative: BONE PAIN; JOINT PAIN; PAIN RADIATING TO THE FRONT AND INTO THE MUSCLES AT SITE OF INJECTION; BURNING SENSATION; STABBING FEELING 6 ON 10 PAIN SCALE; MILD ITCHING LIKE A BUG CRAWLING UNDER THE SKIN; MUSCLE TIGHTNESS OR TENSION; SHOULDER DISCOMFORT; TOP OF SHOULDER PAIN; This spontaneous report received from a patient concerned a 76 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included electrocardiogram t wave inversion, and concurrent conditions included alcohol consumer, and other pre-existing medical conditions included drug abuse. The patient experienced drug allergy when treated with levothyroxine sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shoulder discomfort. On MAY-2021, the subject experienced top of shoulder pain. On 20-MAY-2021, the subject experienced muscle tightness or tension. On 26-MAY-2021, the subject experienced burning sensation. On 26-MAY-2021, the subject experienced stabbing feeling 6 on 10 pain scale. On 26-MAY-2021, the subject experienced mild itching like a bug crawling under the skin. On 27-MAY-2021, the subject experienced bone pain. On 27-MAY-2021, the subject experienced joint pain. On 27-MAY-2021, the subject experienced pain radiating to the front and into the muscles at site of injection. On 02-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) normal, Body temperature (NR: not provided) 96.6, Heart rate (NR: not provided) 72 bpm, and Weight (NR: not provided) 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle tightness or tension, burning sensation, stabbing feeling 6 on 10 pain scale, mild itching like a bug crawling under the skin, top of shoulder pain, shoulder discomfort, joint pain, bone pain and pain radiating to the front and into the muscles at site of injection was not reported. This report was non-serious.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Weight
Clinical narrative: BONE PAIN; JOINT PAIN; PAIN RADIATING TO THE FRONT AND INTO THE MUSCLES AT SITE OF INJECTION; BURNING SENSATION; STABBING FEELING 6 ON 10 PAIN SCALE; MILD ITCHING LIKE A BUG CRAWLING UNDER THE SKIN; MUSCLE TIGHTNESS OR TENSION; SHOULDER DISCOMFORT; TOP OF SHOULDER PAIN; This spontaneous report received from a patient concerned a 76 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included electrocardiogram t wave inversion, and concurrent conditions included alcohol consumer, and other pre-existing medical conditions included drug abuse. The patient experienced drug allergy when treated with levothyroxine sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shoulder discomfort. On MAY-2021, the subject experienced top of shoulder pain. On 20-MAY-2021, the subject experienced muscle tightness or tension. On 26-MAY-2021, the subject experienced burning sensation. On 26-MAY-2021, the subject experienced stabbing feeling 6 on 10 pain scale. On 26-MAY-2021, the subject experienced mild itching like a bug crawling under the skin. On 27-MAY-2021, the subject experienced bone pain. On 27-MAY-2021, the subject experienced joint pain. On 27-MAY-2021, the subject experienced pain radiating to the front and into the muscles at site of injection. On 02-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) normal, Body temperature (NR: not provided) 96.6, Heart rate (NR: not provided) 72 bpm, and Weight (NR: not provided) 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle tightness or tension, burning sensation, stabbing feeling 6 on 10 pain scale, mild itching like a bug crawling under the skin, top of shoulder pain, shoulder discomfort, joint pain, bone pain and pain radiating to the front and into the muscles at site of injection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED; PUNCTURED VIAL WAS STORED IN THE REFRIGERATOR FOR  6 HOURS AND 36 MINUTES; This spontaneous report received from a pharmacist concerned a 56 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: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced punctured vial was stored in the refrigerator for 6 hours and 36 minutes. On 02-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered and punctured vial was stored in the refrigerator for 6 hours and 36 minutes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Crying, Feeling abnormal
Clinical narrative: ALMOST DIED; SOBBING FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced almost died, and sobbing for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from almost died, and sobbing for 3 days. 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Paraesthesia
Clinical narrative: DIZZY; TINGLY ALL OVER BODY; LITTLE NUMBNESS IN TONGUE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included in remission breast cancer, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced dizzy. On 04-JUN-2021, the subject experienced tingly all over body. On 04-JUN-2021, the subject experienced little numbness in tongue. On 04-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, tingly all over body, little numbness in tongue, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRE DOSE GIVEN; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUN-2021, the subject experienced expire dose given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expire dose given was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination.  On 03-JUN-2021, the subject experienced revaccination with different covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Fatigue, Limb discomfort
Clinical narrative: INJECTION SITE HAS A MASS BRUISE COLOR BLACK AND BLUE WITH RED DOT  IN THE MIDDLE; LT ARM IS HEAVY; NO ENERGY; WORN OUT; This spontaneous report received from a patient concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer, asthma, hypertension, arthritis, and carpal tunnel, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAY-2021, the subject experienced injection site has a mass bruise color black and blue with red dot in the middle. On 29-MAY-2021, the subject experienced lt arm is heavy. On 29-MAY-2021, the subject experienced no energy. On 29-MAY-2021, the subject experienced worn out. On 29-MAY-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, no energy, lt arm is heavy, and worn out, and the outcome of injection site has a mass bruise color black and blue with red dot in the middle was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Headache
Clinical narrative: PAIN IN BACK; PAIN IN CHEST; PAIN IN HEAD; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced pain in back. On 05-JUN-2021, the subject experienced pain in chest. On 05-JUN-2021, the subject experienced pain in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in back, pain in head, and pain in chest. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: RED BLOTCHES, ENTIRE BODY; SORE ARM; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red blotches, entire body. On 30-MAY-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and red blotches, entire body. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Cold sweat, Hypoaesthesia
Clinical narrative: FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUSEA; COLD SWEATS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced cold sweats. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 03-JUN-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced feeling numb on right side including arm and leg. On 04-JUN-2021, the subject experienced weakness on right side including arm and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, chills, and fever on 04-JUN-2021, had not recovered from nausea, and weakness on right side including arm and leg, and the outcome of feeling numb on right side including arm and leg was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUSEA; COLD SWEATS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced cold sweats. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 03-JUN-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced feeling numb on right side including arm and leg. On 04-JUN-2021, the subject experienced weakness on right side including arm and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, chills, and fever on 04-JUN-2021, had not recovered from nausea, and weakness on right side including arm and leg, and the outcome of feeling numb on right side including arm and leg was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: SHIVERS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic reaction to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 05-JUN-2021, the subject experienced shivers. On 05-JUN-2021, the subject experienced nausea. On 05-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivers, and the outcome of nausea and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Piloerection
Clinical narrative: GOOSEBUMPS THROUGHOUT THE NIGHT AND THE FOLLOWING DAY; CHILLS THROUGHOUT THE NIGHT AND THE FOLLOWING DAY; STRONG HEADACHE THROUGHOUT THE NIGHT AND THE FOLLOWING DAY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the subject experienced goosebumps throughout the night and the following day. On 01-JUN-2021, the subject experienced chills throughout the night and the following day. On 01-JUN-2021, the subject experienced strong headache throughout the night and the following day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache throughout the night and the following day, chills throughout the night and the following day and goosebumps throughout the night and the following day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611877.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 390 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included asthma, diabetes, hypertension, hypothyroid, hyperlipidemia, sleep apnea, arthritis, collapsed spinal disc, lymphedema, allergic to tobacco smoke, and non smoker, and other pre-existing medical conditions included the patient had allergies to non-steroidal anti-inflammatory drugs (nsaids), adverse drug reactions (adrs) to most statins. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Headache, Nausea, Pain
Clinical narrative: Body aches, chills, headache, nausea, and constipation
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Very painful breasts ever since date (indicated). No problems detected by gynecologist
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Soreness  and stiffness  of arm and under arm extending down the left side  more persistent on Sunday June 6, 2021.  Rash noted at injection site on Monday June 7, 2021, itching of injection site on Tuesday  June 8, at approximately 2:30 am
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Heart rate increased, Injection site pain
Clinical narrative: High Fever, chills, fatigue, shortness of breath, rapid heart rate, pain at injection site,
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High Fever, chills, fatigue, shortness of breath, rapid heart rate, pain at injection site,
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHES; EXHAUSTED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206a21a, and expiry: 23-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced aches, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exhausted, and aches. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspepsia
Clinical narrative: INDIGESTION; UPSET STOMACH; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced indigestion. On 05-JUN-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from indigestion, and upset stomach. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site rash
Clinical narrative: cellulitis; vaccination site rash; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (cellulitis) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, CELLULITIS (cellulitis) and VACCINATION SITE RASH (vaccination site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment for the events included an antibiotic and then a steroid, oral prednisone for 5 days following which the reaction resolved within 48 hours.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Chills, Lip swelling, Swollen tongue, Tongue discolouration
Clinical narrative: Vision went off; White tongue; Tongue swelled up; Lip swelled up; Chills real bad; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision went off) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced BLINDNESS (Vision went off) (seriousness criterion medically significant), TONGUE DISCOLOURATION (White tongue), SWOLLEN TONGUE (Tongue swelled up), LIP SWELLING (Lip swelled up) and CHILLS (Chills real bad). At the time of the report, BLINDNESS (Vision went off), TONGUE DISCOLOURATION (White tongue), SWOLLEN TONGUE (Tongue swelled up) and LIP SWELLING (Lip swelled up) outcome was unknown and CHILLS (Chills real bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-Jun-2021 contains significant information. Onset date of the events ( Tongue swelled up, Lip swelled up) were added. New events (White tongue, Vision went off) were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Oropharyngeal blistering, Pain, Plague
Clinical narrative: plague build up; blisters; pain.; cold sores all in her mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLAGUE (plague build up) and OROPHARYNGEAL BLISTERING (blisters) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ORAL HERPES (cold sores all in her mouth). On an unknown date, the patient experienced PLAGUE (plague build up) (seriousness criterion medically significant), OROPHARYNGEAL BLISTERING (blisters) (seriousness criterion medically significant) and PAIN (pain.). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency and LIDOCAINE (LIDOCAINE 5% EXTRA) at an unspecified dose and frequency. At the time of the report, PLAGUE (plague build up), ORAL HERPES (cold sores all in her mouth) and PAIN (pain.) outcome was unknown and OROPHARYNGEAL BLISTERING (blisters) had not resolved.            Concomitant medication and treatment information was not provided Action taken for Moderna COVID-19 (mRNA-1273) vaccine not applicable In the source document the reportes refers "plague buils up", this term appears to be a typo error for "plaque build up".  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.   This case was linked.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Joint swelling, Neuropathic arthropathy, Oedema peripheral, Peripheral swelling
Clinical narrative: Diagnosed with Charcot Foot; Leg edema; Leg huge from knee down after 2nd dose; Leg hot after 2nd dose; Right foot swelling after 2nd dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021. The most recent information was received on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHIC ARTHROPATHY (Diagnosed with Charcot Foot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event.  Concomitant products included ATORVASTATIN for Product used for unknown indication, SPIRONOLACTONE, PARACETAMOL (TYLENOL ARTHRITIS), ALLOPURINOL, DULOXETINE, LEVOTHYROXINE and PREGABALIN for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right foot swelling after 2nd dose). On 12-Mar-2021, the patient experienced JOINT SWELLING (Leg huge from knee down after 2nd dose) and FEELING HOT (Leg hot after 2nd dose). On 05-May-2021, the patient experienced NEUROPATHIC ARTHROPATHY (Diagnosed with Charcot Foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Leg edema). At the time of the report, NEUROPATHIC ARTHROPATHY (Diagnosed with Charcot Foot), PERIPHERAL SWELLING (Right foot swelling after 2nd dose), JOINT SWELLING (Leg huge from knee down after 2nd dose), FEELING HOT (Leg hot after 2nd dose) and OEDEMA PERIPHERAL (Leg edema) outcome was unknown.            No treatment information was provided. Patient informed that inflammation of feet was not related to Moderna vaccine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26 May 2021, upgraded the case to serious with the addition of new events Charcot foot and neuropathy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia, Lymphadenopathy, Neuropathy peripheral
Clinical narrative: neuropathy; Numbness in left leg; Pain in Left leg; Swollen LN in groin; hard time breathing; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma (stage 4 lymphoma) on 18-Aug-2018, Leukemia and Back surgery. Concurrent medical conditions included Leg pain. Concomitant products included AMLODIPINE and ATENOLOL for Hypertension, ONDANSETRON for Nausea, PREGABALIN (LYRICA) for Nerve pain, ZINC for Supplementation therapy, MULTIVITAMIN [VITAMINS NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in left leg), PAIN IN EXTREMITY (Pain in Left leg), LYMPHADENOPATHY (Swollen LN in groin), DYSPNOEA (hard time breathing) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), HYPOAESTHESIA (Numbness in left leg), PAIN IN EXTREMITY (Pain in Left leg), LYMPHADENOPATHY (Swollen LN in groin), DYSPNOEA (hard time breathing) and FATIGUE (fatigue) outcome was unknown.            Patient also undergone to Chemotherapy, radiation.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 and events are updated with patient historical condition; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: neuropathy; Numbness in left leg; Pain in Left leg; Swollen LN in groin; hard time breathing; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma (stage 4 lymphoma) on 18-Aug-2018, Leukemia and Back surgery. Concurrent medical conditions included Leg pain. Concomitant products included AMLODIPINE and ATENOLOL for Hypertension, ONDANSETRON for Nausea, PREGABALIN (LYRICA) for Nerve pain, ZINC for Supplementation therapy, MULTIVITAMIN [VITAMINS NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in left leg), PAIN IN EXTREMITY (Pain in Left leg), LYMPHADENOPATHY (Swollen LN in groin), DYSPNOEA (hard time breathing) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), HYPOAESTHESIA (Numbness in left leg), PAIN IN EXTREMITY (Pain in Left leg), LYMPHADENOPATHY (Swollen LN in groin), DYSPNOEA (hard time breathing) and FATIGUE (fatigue) outcome was unknown.            Patient also undergone to Chemotherapy, radiation.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 and events are updated with patient historical condition; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hospitalisation, Inappropriate schedule of product administration, Inflammation, Vaccination site erythema
Clinical narrative: hospitalization; 2nd dose given beyond 36 days; allergic reaction; inflamed; itching a lot; Swollen arm; Really red; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (hospitalization) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037AZ1B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Patient's medical history included No Adverse event.  Concomitant products included ROSUVASTATINE [ROSUVASTATIN] for Cholesterol, METFORMIN for Diabetes, METHIMAZOLE for Thyroid disorder NOS, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), HYDROCHLOROTHIAZID, ALPRAZOLAM, TEMAZEPAM and DOXAZOSIN for an unknown indication.  On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 36 days), ALLERGY TO VACCINE (allergic reaction), INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (itching a lot), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Really red). On an unknown date, the patient experienced HOSPITALISATION (hospitalization) (seriousness criterion hospitalization). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 36 days) had resolved. At the time of the report, HOSPITALISATION (hospitalization), ALLERGY TO VACCINE (allergic reaction), INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (itching a lot), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Really red) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Concomitant medications and details about second dose were  added. Adverse events for second dose were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: hospitalization; 2nd dose given beyond 36 days; allergic reaction; inflamed; itching a lot; Swollen arm; Really red; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (hospitalization) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037AZ1B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Patient's medical history included No Adverse event.  Concomitant products included ROSUVASTATINE [ROSUVASTATIN] for Cholesterol, METFORMIN for Diabetes, METHIMAZOLE for Thyroid disorder NOS, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), HYDROCHLOROTHIAZID, ALPRAZOLAM, TEMAZEPAM and DOXAZOSIN for an unknown indication.  On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 36 days), ALLERGY TO VACCINE (allergic reaction), INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (itching a lot), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Really red). On an unknown date, the patient experienced HOSPITALISATION (hospitalization) (seriousness criterion hospitalization). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 36 days) had resolved. At the time of the report, HOSPITALISATION (hospitalization), ALLERGY TO VACCINE (allergic reaction), INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (itching a lot), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Really red) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Concomitant medications and details about second dose were  added. Adverse events for second dose were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.