chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lip swelling, Malaise, Pyrexia
Clinical narrative: UPPER LIP SWELLING; OVERALL UNWELL FEELING; FEVER OF 100.6 F; HEADACHE; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included graves disease due to hyperthyroidism, penicillin allergy, and sulfonamide allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced upper lip swelling. On 29-JUL-2021, the subject experienced overall unwell feeling. On 29-JUL-2021, the subject experienced fever of 100.6 f. On 29-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.6 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 100.6 f on 29-JUL-2021, was recovering from overall unwell feeling, and headache, and had not recovered from upper lip swelling. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, General physical health deterioration, Hypokinesia, Injection site pain, Insomnia
Clinical narrative: COULD NOT LIFT HIS ARM OVER HIS HEAD; BODY WAS DETERIORATING; FIDGETY; PAIN AT INJECTION SITE; PAIN WAS WAKING HIM UP; SEVERE MUSCLE SPASMS; NECK PAIN; SHOULDER PAIN/PAIN IN ELBOW; PAIN IN ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, non alcoholic, and smoker. The patient does not have any allergies. The patient does not have medical history of 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: 205A21A, expiry: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 27-MAY-2021, the subject experienced severe muscle spasms. On 27-MAY-2021, the subject experienced neck pain. On 27-MAY-2021, the subject experienced shoulder pain/pain in elbow. On 27-MAY-2021, the subject experienced pain in arm. On 01-JUN-2021, the subject experienced pain was waking him up. On an unspecified date, the subject experienced fidgety, could not lift his arm over his head, body was deteriorating, and pain at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain was waking him up, pain at injection site, fidgety, severe muscle spasms, neck pain, shoulder pain/pain in elbow, and pain in arm, and the outcome of could not lift his arm over his head and body was deteriorating was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Pain in extremity, Restlessness
Clinical narrative: COULD NOT LIFT HIS ARM OVER HIS HEAD; BODY WAS DETERIORATING; FIDGETY; PAIN AT INJECTION SITE; PAIN WAS WAKING HIM UP; SEVERE MUSCLE SPASMS; NECK PAIN; SHOULDER PAIN/PAIN IN ELBOW; PAIN IN ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, non alcoholic, and smoker. The patient does not have any allergies. The patient does not have medical history of 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: 205A21A, expiry: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 27-MAY-2021, the subject experienced severe muscle spasms. On 27-MAY-2021, the subject experienced neck pain. On 27-MAY-2021, the subject experienced shoulder pain/pain in elbow. On 27-MAY-2021, the subject experienced pain in arm. On 01-JUN-2021, the subject experienced pain was waking him up. On an unspecified date, the subject experienced fidgety, could not lift his arm over his head, body was deteriorating, and pain at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain was waking him up, pain at injection site, fidgety, severe muscle spasms, neck pain, shoulder pain/pain in elbow, and pain in arm, and the outcome of could not lift his arm over his head and body was deteriorating was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: OCCASIONAL STINGING/PULSATING PAIN; SHARP PAIN IN BOTH ARMS; SHARP PAIN ON WRIST OCCASIONALLY; This spontaneous report received from a patient concerned a 76 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: 1805020, expiry: 09-JUL-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin calcium. On an unspecified date, the subject experienced occasional stinging/pulsating pain, sharp pain in both arms, and sharp pain on wrist occasionally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from occasional stinging/pulsating pain, and the outcome of sharp pain in both arms and sharp pain on wrist occasionally was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: BODY ACHES; SORE ARM / ARM HURTS; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and sore arm / arm hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm / arm hurts and body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: SORE LYMPH NODE; This spontaneous report received from a patient via a company representative concerned an adult 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: Unknown) dose was not reported, administered on JUL-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 JUL-2021, the subject experienced sore lymph node. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore lymph node was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Feeling cold, Headache, Injection site pain, Pain of skin
Clinical narrative: SKIN SENSITIVITY; PAIN OF SKIN; FELT SOMETHING BURSTING INSIDE; FELT COLD; STRONG HEADACHE AFTER THE VACCINE IN THE MIDDLE OF MY EYES; PAIN UPON INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included surgery, craniotomy, and tumor in head, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUL-2021, the subject experienced skin sensitivity. On 24-JUL-2021, the subject experienced pain of skin. On 24-JUL-2021, the subject experienced felt something bursting inside. On 24-JUL-2021, the subject experienced felt cold. On 24-JUL-2021, the subject experienced strong headache after the vaccine in the middle of my eyes. On 24-JUL-2021, the subject experienced pain upon injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin sensitivity, pain of skin, felt something bursting inside, felt cold, strong headache after the vaccine in the middle of my eyes, and pain upon injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: SKIN SENSITIVITY; PAIN OF SKIN; FELT SOMETHING BURSTING INSIDE; FELT COLD; STRONG HEADACHE AFTER THE VACCINE IN THE MIDDLE OF MY EYES; PAIN UPON INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included surgery, craniotomy, and tumor in head, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUL-2021, the subject experienced skin sensitivity. On 24-JUL-2021, the subject experienced pain of skin. On 24-JUL-2021, the subject experienced felt something bursting inside. On 24-JUL-2021, the subject experienced felt cold. On 24-JUL-2021, the subject experienced strong headache after the vaccine in the middle of my eyes. On 24-JUL-2021, the subject experienced pain upon injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin sensitivity, pain of skin, felt something bursting inside, felt cold, strong headache after the vaccine in the middle of my eyes, and pain upon injection. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Tremor
Clinical narrative: SHAKING; BODY ACHES; SEVERE CHILLS; SORENESS IN ARM AT INJECTION SITE; BAD HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 125 pounds, and height was 65 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no past medical history. patient had no known allergies patient had no drug abuse or illicit drug usage. patient received multivitamin as past drug. The patient was previously treated with betamethasone dipropionate for psoriasis, citalopram for anxiety, depression, ergocalciferol, and ascorbic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 17:15 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced shaking. On 29-JUL-2021, the subject experienced body aches. On 29-JUL-2021, the subject experienced severe chills. On 29-JUL-2021, the subject experienced soreness in arm at injection site. On 29-JUL-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and severe chills on 29-JUL-2021, and had not recovered from bad headache, body aches, and soreness in arm at injection site. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Formication, Hot flush, Hypoaesthesia
Clinical narrative: BURNS UP; MUSCLE SPASM; LITTLE BRUISES POPPING; FELT FUNNY LIKE SOMETHING WAS CRAWLING / FELT A CRAWLING ON SHOULDER; TENDER UP UNDER TOES; FELT LEFT ARM TINGLING WHICH WAS LIKE GOING TO GO LIMP OR PARALYZE/ FELT TINGLE IN BOTTOM OF FEET UP TO TOES AND BENEATH THE TOES/ SHOULDER TINGLES; NUMB FEELING IN LEFT ARM; FEVER; HOT FLASHES; SORE ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180503, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced felt left arm tingling which was like going to go limp or paralyze/ felt tingle in bottom of feet up to toes and beneath the toes/ shoulder tingles. On 10-APR-2021, the subject experienced numb feeling in left arm. On 10-APR-2021, the subject experienced fever. On JUL-2021, the subject experienced burns up. On JUL-2021, the subject experienced muscle spasm. On JUL-2021, the subject experienced little bruises popping. On JUL-2021, the subject experienced felt funny like something was crawling / felt a crawling on shoulder. On JUL-2021, the subject experienced tender up under toes. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, and sore arm, and fever on 17-APR-2021, had not recovered from felt left arm tingling which was like going to go limp or paralyze/ felt tingle in bottom of feet up to toes and beneath the toes/ shoulder tingles, numb feeling in left arm, and muscle spasm, and the outcome of little bruises popping, felt funny like something was crawling / felt a crawling on shoulder, tender up under toes and burns up was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Paraesthesia, Pyrexia, Tenderness
Clinical narrative: BURNS UP; MUSCLE SPASM; LITTLE BRUISES POPPING; FELT FUNNY LIKE SOMETHING WAS CRAWLING / FELT A CRAWLING ON SHOULDER; TENDER UP UNDER TOES; FELT LEFT ARM TINGLING WHICH WAS LIKE GOING TO GO LIMP OR PARALYZE/ FELT TINGLE IN BOTTOM OF FEET UP TO TOES AND BENEATH THE TOES/ SHOULDER TINGLES; NUMB FEELING IN LEFT ARM; FEVER; HOT FLASHES; SORE ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180503, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced felt left arm tingling which was like going to go limp or paralyze/ felt tingle in bottom of feet up to toes and beneath the toes/ shoulder tingles. On 10-APR-2021, the subject experienced numb feeling in left arm. On 10-APR-2021, the subject experienced fever. On JUL-2021, the subject experienced burns up. On JUL-2021, the subject experienced muscle spasm. On JUL-2021, the subject experienced little bruises popping. On JUL-2021, the subject experienced felt funny like something was crawling / felt a crawling on shoulder. On JUL-2021, the subject experienced tender up under toes. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, and sore arm, and fever on 17-APR-2021, had not recovered from felt left arm tingling which was like going to go limp or paralyze/ felt tingle in bottom of feet up to toes and beneath the toes/ shoulder tingles, numb feeling in left arm, and muscle spasm, and the outcome of little bruises popping, felt funny like something was crawling / felt a crawling on shoulder, tender up under toes and burns up was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: DRY COUGH; SORE THROAT; RUNNY NOSE; FEVER; HEADACHE; This spontaneous report received from a patient 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced dry cough. On JUL-2021, the subject experienced sore throat. On JUL-2021, the subject experienced runny nose. On JUL-2021, the subject experienced fever. On JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dry cough, fever, sore throat, headache and runny nose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE GIVEN PAST THE 6 HOURS ALLOWABLE TIME LIMIT; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced administration of expired vaccine given past the 6 hours allowable time limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine given past the 6 hours allowable time limit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Pain, Pyrexia
Clinical narrative: BODY IN PAIN; LOSS OF SMELL; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic rhinitis. 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 28-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-JUL-2021, the subject experienced body in pain. On 25-JUL-2021, the subject experienced loss of smell. On 25-JUL-2021, the subject experienced chills. On 25-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body in pain, loss of smell, fever, and chills. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Fibromyalgia, Headache, Insomnia
Clinical narrative: PAIN INTENSIFIED; COULD NOT GET OUT OF BED; SKIN FEELS LIKE BURNING; FEELS LIKE BRAIN NOT WORKING WELL; ITCHY BACK, ARMS AND SKIN; HIVES ON ALL OVER BOTH ARMS BILATERALLY AND POSSIBLE HIVES ON THE BACK; HEADACHE; PAIN THAT FELT LIKE A FIBRAL FLARE /FEELS LIKE WORSE FIBRAL PAIN  ALL OVER BODY; COULD NOT SLEEP LAST NIGHT DUE TO THE PAIN; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included fibromyalgia, allergic to sulfa drugs, migraines, plantar fasciitis, depression, bipolar disorder, high blood pressure, anxiety, back pain, and insomnia. 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 28-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced pain that felt like a fibral flare /feels like worse fibral pain all over body. On 28-JUL-2021, the subject experienced could not sleep last night due to the pain. On 28-JUL-2021, the subject experienced headache. On 29-JUL-2021, the subject experienced pain intensified. On 29-JUL-2021, the subject experienced could not get out of bed. On 29-JUL-2021, the subject experienced skin feels like burning. On 29-JUL-2021, the subject experienced feels like brain not working well. On 29-JUL-2021, the subject experienced itchy back, arms and skin. On 29-JUL-2021, the subject experienced hives on all over both arms bilaterally and possible hives on the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep last night due to the pain on 29-JUL-2021, and had not recovered from pain that felt like a fibral flare /feels like worse fibral pain all over body, pain intensified, could not get out of bed, headache, skin feels like burning, hives on all over both arms bilaterally and possible hives on the back, feels like brain not working well, and itchy back, arms and skin. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: PAIN INTENSIFIED; COULD NOT GET OUT OF BED; SKIN FEELS LIKE BURNING; FEELS LIKE BRAIN NOT WORKING WELL; ITCHY BACK, ARMS AND SKIN; HIVES ON ALL OVER BOTH ARMS BILATERALLY AND POSSIBLE HIVES ON THE BACK; HEADACHE; PAIN THAT FELT LIKE A FIBRAL FLARE /FEELS LIKE WORSE FIBRAL PAIN  ALL OVER BODY; COULD NOT SLEEP LAST NIGHT DUE TO THE PAIN; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included fibromyalgia, allergic to sulfa drugs, migraines, plantar fasciitis, depression, bipolar disorder, high blood pressure, anxiety, back pain, and insomnia. 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 28-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced pain that felt like a fibral flare /feels like worse fibral pain all over body. On 28-JUL-2021, the subject experienced could not sleep last night due to the pain. On 28-JUL-2021, the subject experienced headache. On 29-JUL-2021, the subject experienced pain intensified. On 29-JUL-2021, the subject experienced could not get out of bed. On 29-JUL-2021, the subject experienced skin feels like burning. On 29-JUL-2021, the subject experienced feels like brain not working well. On 29-JUL-2021, the subject experienced itchy back, arms and skin. On 29-JUL-2021, the subject experienced hives on all over both arms bilaterally and possible hives on the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep last night due to the pain on 29-JUL-2021, and had not recovered from pain that felt like a fibral flare /feels like worse fibral pain all over body, pain intensified, could not get out of bed, headache, skin feels like burning, hives on all over both arms bilaterally and possible hives on the back, feels like brain not working well, and itchy back, arms and skin. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: LETHARGIC; TIRED; SLIGHT FEVER; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lethargic, tired, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, lethargic and slight fever was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Formication, Rash, Swelling face
Clinical narrative: FACE SWELLING; RASH ON FACE AND NECK; LOSS OF APPETITE; SKIN FEELS LIKE CRAWLING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-JUL-2021 15:12 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced skin feels like crawling. On 27-JUL-2021, the subject experienced loss of appetite. On 29-JUL-2021, the subject experienced face swelling. On 29-JUL-2021, the subject experienced rash on face and neck. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face swelling, rash on face and neck, and loss of appetite, and the outcome of skin feels like crawling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: VOMITING; DIARRHEA; BODY ACHES AND PAINS; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 07-AUG-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced vomiting, diarrhea, body aches and pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, diarrhea, body aches and pains. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Polyhydramnios, Pregnancy test, Ultrasound foetal
Clinical narrative: Polyhydramnios at 32 weeks; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of POLYHYDRAMNIOS (Polyhydramnios at 32 weeks) in a 30-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Miscarriage. Concurrent medical conditions included Latex allergy. Concomitant products included SERTRALINE from 04-Jan-2020 to an unknown date for Anxiety, FAMOTIDINE (PEPCID AC) from 02-Jan-2020 to 19-Mar-2021 for GERD, VITAMIN B6 from 08-Jan-2020 to 24-Sep-2020 and DOXYLAMINE SUCCINATE (UNISOM ) from 08-Jan-2020 to 24-Sep-2020 for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 11-Feb-2021, the patient experienced POLYHYDRAMNIOS (Polyhydramnios at 32 weeks) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The cesarean delivery occurred on 19-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 4252 grams (9lbs 6oz) with an APGAR score of 7 at 1 minute. The outcome was reported as Term Birth w Complications. Infant's birth weigh was 9lb 6oz and length was 21 inches. Perinatal complications for infant: retained fetal lung fluid. APGAR Score at 5 min - 7. On 19-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, POLYHYDRAMNIOS (Polyhydramnios at 32 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2020, Pregnancy test: positive (Positive) Positive. On 22-Nov-2020, Ultrasound foetal: normal (normal) Normal findings.. On 11-Feb-2021, Ultrasound foetal: abnormal (abnormal) Polyhydramnios at 32 weeks.     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.   This case was linked to MOD-2021-095848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Internal review on 21 JUL 2021 , resulting updates of fetal outcome; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: symptoms of COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (symptoms of COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 COVID-19 (symptoms of COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (symptoms of COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant FU-Reporter provided event details on her own; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Hypersensitivity
Clinical narrative: severe allergic reaction; Chest tightness; shortness of breath\ difficulty breathing; sever reaction happened for 7 mins/Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (sever reaction happened for 7 mins/Anaphylactic reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis and Hives. Previously administered products included for Product used for unknown indication: Anesthesia (Patient threw up for several hours.) in March 1997, taxotere (chemo IV) ((chemo IV) Difficulty breathing, stridor, chest tightness) in April 2004, taxotere (chemo IV) ((chemo IV) Difficulty breathing, stridor, chest tightness) in April 2004, taxotere (chemo IV) ((chemo IV) Difficulty breathing, stridor, chest tightness) in April 2004 and Moviprep in July 2015. Past adverse reactions to the above products included Chest tightness with taxotere (chemo IV); Difficulty breathing with taxotere (chemo IV); Stridor with taxotere (chemo IV); and Vomiting with Anesthesia and Moviprep. Concurrent medical conditions included Hypertension since January 2021, Bradycardia (Pacemaker) since 01-Oct-2020 and Seafood allergy (Lobster allergy causes Hives) since 1986. Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]), MONASCUS PURPUREUS (RED YEAST RICE), MULTIVITAMIN [VITAMINS NOS], CALCIUM and LISINOPRIL for an unknown indication.    On 29-Jan-2021 at 4:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (shortness of breath\ difficulty breathing). 29-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (sever reaction happened for 7 mins/Anaphylactic reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction). On 29-Jan-2021, CHEST DISCOMFORT (Chest tightness), DYSPNOEA (shortness of breath\ difficulty breathing) and ANAPHYLACTIC REACTION (sever reaction happened for 7 mins/Anaphylactic reaction) had resolved. At the time of the report, HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    The patient went to the ER and got pumped with something (Unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Updated patient demographics, medical history , allergies. Updated event , concomitant medications and treatment medications.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: full blown covid symptoms; feeling crappy; worn out; terrible chills; body aches over her entire body; headache; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown covid symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown covid symptoms) (seriousness criterion medically significant), MALAISE (feeling crappy), FATIGUE (worn out), CHILLS (terrible chills), MYALGIA (body aches over her entire body) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (full blown covid symptoms), MALAISE (feeling crappy), FATIGUE (worn out), CHILLS (terrible chills), MYALGIA (body aches over her entire body) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  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 23-Jul-2021: Non Significant FU-Patient denies to provide contact information and denied for further FU; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: full blown covid symptoms; feeling crappy; worn out; terrible chills; body aches over her entire body; headache; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown covid symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown covid symptoms) (seriousness criterion medically significant), MALAISE (feeling crappy), FATIGUE (worn out), CHILLS (terrible chills), MYALGIA (body aches over her entire body) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (full blown covid symptoms), MALAISE (feeling crappy), FATIGUE (worn out), CHILLS (terrible chills), MYALGIA (body aches over her entire body) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  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 23-Jul-2021: Non Significant FU-Patient denies to provide contact information and denied for further FU; 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: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Inappropriate schedule of product administration
Clinical narrative: Fall; Patient is potentially receiving the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (Fall) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039R20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Alzheimer's disease and Behaviour disorder. Concomitant products included MEMANTINE for Alzheimer's disease, ALLOPURINOL for Gout, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VITAMIN D [VITAMIN D NOS] for Vitamin D deficiency, OLANZAPINE (ZYPREXA), MELATONIN, CALCIUM, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]) and FERROUS SULFATE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fall) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is potentially receiving the second dose of the vaccine more than 36 days after the first dose). At the time of the report, FALL (Fall) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is potentially receiving the second dose of the vaccine more than 36 days after the first dose) had resolved.            No Treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone follow-up received. Daughter reported patient received second dose. Daughter also reported father was hospitalized due to fall at nursing home unrelated to vaccine. Declined further follow-up.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #   039R20A with  associated Adverse Event of Fall .Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus, Vaccination site pain
Clinical narrative: some hearing loss; Developed tinnitus; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Developed tinnitus) and DEAFNESS (some hearing loss) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 13-Apr-2021, the patient experienced TINNITUS (Developed tinnitus) (seriousness criterion medically significant). On an unknown date, the patient experienced DEAFNESS (some hearing loss) (seriousness criterion medically significant). At the time of the report, TINNITUS (Developed tinnitus) had not resolved and DEAFNESS (some hearing loss) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications was not reported. The treatment details was not reported. Patient experienced with developed tinnitus 2/3 weeks after 1st shot. Met with an audiologist and ENT doctor on 06-Apr-2021.  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.   This case was linked to MOD-2021-255352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: significant follow up document: height, weight, ethnicity 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Osteoarthritis, Pain
Clinical narrative: Rheumatoid Arthritis; stiffed and inflamed hands; stiffed and inflamed hands,swelling; inflamed hands; osteoarthritis; can not close her hand all the way in the morning; severe pain; pain in her both wrists; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (stiffed and inflamed hands), PERIPHERAL SWELLING (stiffed and inflamed hands,swelling), PERIPHERAL SWELLING (inflamed hands), OSTEOARTHRITIS (osteoarthritis), MOBILITY DECREASED (can not close her hand all the way in the morning), PAIN (severe pain) and ARTHRALGIA (pain in her both wrists). The patient was treated with PREDNISONE at an unspecified dose and frequency; HYDROXYCHLOROQUINE at an unspecified dose and frequency; MELOXICAM at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), MUSCULOSKELETAL STIFFNESS (stiffed and inflamed hands), PERIPHERAL SWELLING (stiffed and inflamed hands,swelling), PERIPHERAL SWELLING (inflamed hands), OSTEOARTHRITIS (osteoarthritis), MOBILITY DECREASED (can not close her hand all the way in the morning), PAIN (severe pain) and ARTHRALGIA (pain in her both wrists) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.   This case was linked to MOD-2021-260274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Case has been  upgraded to Serious for the IME event of Rheumatoid Arthritis.; 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.