chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sluggishness, Somnolence
Clinical narrative: SLUGGISHNESS; HEAVINESS; PAIN; CHILLS; FEVER; HEADACHES; TIREDNESS; SWEATING; DROWSY; WALKING AROUND LIKE FOG; DID NOT REMEMBER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included normal headache. The patient was previously treated with paracetamol for headache. 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 20-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced walking around like fog. On MAR-2021, the subject experienced did not remember. On 21-MAR-2021, the subject experienced sweating. On 21-MAR-2021, the subject experienced drowsy. On 21-MAR-2021, the subject experienced sluggishness. On 21-MAR-2021, the subject experienced heaviness. On 21-MAR-2021, the subject experienced pain. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headaches. On 21-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, drowsy, pain, chills, and fever on 22-MAR-2021, and walking around like fog, sluggishness, heaviness, did not remember, headaches, and tiredness on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: CHILLS; HEADACHES; NAUSEA; INJECTION SITE SORENESS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headaches. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced injection site soreness. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headaches, and the outcome of nausea, chills, injection site soreness and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MAN SUFFERS RARE SEVERE REACTION TO COVID-19 VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 man suffers rare severe reaction to covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of man suffers rare severe reaction to covid-19 vaccine was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: BODY ACHE; DIZZINESS; GETTING COLDER; SWEATING; CAN'T MOVE LEGS AND INJECTED ARM; HEADACHE; NAUSEA; HIGH FEVER; INJECTION SITE ARM SORENESS; This spontaneous report received from a vaccine facility concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced body ache. On 29-MAR-2021, the subject experienced dizziness. On 29-MAR-2021, the subject experienced getting colder. On 29-MAR-2021, the subject experienced sweating. On 29-MAR-2021, the subject experienced can't move legs and injected arm. On 29-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced high fever. On 29-MAR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, dizziness, nausea, high fever, getting colder, sweating, injection site arm soreness, and can't move legs and injected arm. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; DIZZINESS; GETTING COLDER; SWEATING; CAN'T MOVE LEGS AND INJECTED ARM; HEADACHE; NAUSEA; HIGH FEVER; INJECTION SITE ARM SORENESS; This spontaneous report received from a vaccine facility concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced body ache. On 29-MAR-2021, the subject experienced dizziness. On 29-MAR-2021, the subject experienced getting colder. On 29-MAR-2021, the subject experienced sweating. On 29-MAR-2021, the subject experienced can't move legs and injected arm. On 29-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced high fever. On 29-MAR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, dizziness, nausea, high fever, getting colder, sweating, injection site arm soreness, and can't move legs and injected arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM WAS SORE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch no 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 high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: LITTLE ACHY; HEADACHE; ARM HURTS A LOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On an unspecified date, the subject experienced little achy, headache, and arm hurts a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, arm hurts a lot and little achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: 5 PATIENTS GIVEN 0.3ML OF JANSSEN VACCINE (VERSUS THE STANDARD 0.5ML); PARTIAL/ SPLIT DOSING; This spontaneous report received from a health care professional concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) 0.3 ml, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the 5 patients given 0.3ml of janssen vaccine (versus the standard 0.5ml) at three different facilities. On 29-MAR-2021, the patients administered partial/ split dosing. The health care professional stated that they thought that the vaccine was like the another company vaccine and should be given at 0.3ml. The reporter was unable to obtain the information for the five patients. The five patients were in different facilities. The health care professional was unable to give the names but however they recalled the cities with one of the facilities being an institution for homebound patients. The health care professional further mentioned that she was unsure if a sample would still be available as the remaining vials had been turned in at the end of the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 5 patients given 0.3ml of janssen vaccine (versus the standard 0.5ml) and partial/ split dosing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pain in extremity, Sinus disorder
Clinical narrative: SINUS SYMPTOMS; DRYNESS; SORE ARM; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 29-MAR-2021, the subject experienced sinus symptoms. On 29-MAR-2021, the subject experienced dryness. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 30-MAR-2021, and was recovering from sinus symptoms, and dryness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Frequent bowel movements, Myalgia, Vomiting
Clinical narrative: VOMITED; 25 PLUS TIMES DIARRHEA; SEVERELY RUNNY DIARRHEA; CHILLS; ACHY MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. No concomitant medications were reported. On an unspecified date, the subject experienced vomited, 25 plus times diarrhea, severely runny diarrhea, chills, and achy muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy muscles, vomited, severely runny diarrhea and 25 plus times diarrhea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: ARM WAS A LITTLE SORE; FEVERISH; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 arm was a little sore, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was a little sore and feverish was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fatigue on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Impaired work ability, Pain
Clinical narrative: ACHES; SICK; UNABLE TO WORK; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: UNKNOWN expiry: UNKNOWN) 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 chills, aches, unable to work, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, aches, and sick, and the outcome of unable to work was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included mild covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210359766.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure via breast milk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chills, Dry skin, Eye irritation
Clinical narrative: SKIN LESION; SKIN IS EXTRA DRY; HURTING ARMPIT; ITCHING EYES; BURNING EYES; INJECTION SITE TENDERNESS; FLU LIKE SYMPTOMS; SPENT ALL DAY SATURDAY IN BED, DROWSY; SEVERE UPPER BACK PAIN; SEVERE NECK PAIN; ON AND OFF CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 around 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe upper back pain. On 26-MAR-2021, the subject experienced severe neck pain. On 26-MAR-2021, the subject experienced on and off chills. On 26-MAR-2021, the subject experienced mild headache. On 27-MAR-2021, the subject experienced spent all day saturday in bed, drowsy. On 28-MAR-2021, the subject experienced flu like symptoms. On 29-MAR-2021, the subject experienced hurting armpit. On 29-MAR-2021, the subject experienced itching eyes. On 29-MAR-2021, the subject experienced burning eyes. On 29-MAR-2021, the subject experienced injection site tenderness. On 30-MAR-2021, the subject experienced skin lesion. On 30-MAR-2021, the subject experienced skin is extra dry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe upper back pain, severe neck pain, spent all day saturday in bed, drowsy, flu like symptoms, on and off chills and mild headache on 29-MAR-2021, had not recovered from itching eyes, and burning eyes, and the outcome of hurting armpit, injection site tenderness, skin lesion and skin is extra dry was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Headache, Influenza like illness, Injection site pain, Neck pain
Clinical narrative: SKIN LESION; SKIN IS EXTRA DRY; HURTING ARMPIT; ITCHING EYES; BURNING EYES; INJECTION SITE TENDERNESS; FLU LIKE SYMPTOMS; SPENT ALL DAY SATURDAY IN BED, DROWSY; SEVERE UPPER BACK PAIN; SEVERE NECK PAIN; ON AND OFF CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 around 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe upper back pain. On 26-MAR-2021, the subject experienced severe neck pain. On 26-MAR-2021, the subject experienced on and off chills. On 26-MAR-2021, the subject experienced mild headache. On 27-MAR-2021, the subject experienced spent all day saturday in bed, drowsy. On 28-MAR-2021, the subject experienced flu like symptoms. On 29-MAR-2021, the subject experienced hurting armpit. On 29-MAR-2021, the subject experienced itching eyes. On 29-MAR-2021, the subject experienced burning eyes. On 29-MAR-2021, the subject experienced injection site tenderness. On 30-MAR-2021, the subject experienced skin lesion. On 30-MAR-2021, the subject experienced skin is extra dry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe upper back pain, severe neck pain, spent all day saturday in bed, drowsy, flu like symptoms, on and off chills and mild headache on 29-MAR-2021, had not recovered from itching eyes, and burning eyes, and the outcome of hurting armpit, injection site tenderness, skin lesion and skin is extra dry was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Skin lesion, Somnolence
Clinical narrative: SKIN LESION; SKIN IS EXTRA DRY; HURTING ARMPIT; ITCHING EYES; BURNING EYES; INJECTION SITE TENDERNESS; FLU LIKE SYMPTOMS; SPENT ALL DAY SATURDAY IN BED, DROWSY; SEVERE UPPER BACK PAIN; SEVERE NECK PAIN; ON AND OFF CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 around 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe upper back pain. On 26-MAR-2021, the subject experienced severe neck pain. On 26-MAR-2021, the subject experienced on and off chills. On 26-MAR-2021, the subject experienced mild headache. On 27-MAR-2021, the subject experienced spent all day saturday in bed, drowsy. On 28-MAR-2021, the subject experienced flu like symptoms. On 29-MAR-2021, the subject experienced hurting armpit. On 29-MAR-2021, the subject experienced itching eyes. On 29-MAR-2021, the subject experienced burning eyes. On 29-MAR-2021, the subject experienced injection site tenderness. On 30-MAR-2021, the subject experienced skin lesion. On 30-MAR-2021, the subject experienced skin is extra dry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe upper back pain, severe neck pain, spent all day saturday in bed, drowsy, flu like symptoms, on and off chills and mild headache on 29-MAR-2021, had not recovered from itching eyes, and burning eyes, and the outcome of hurting armpit, injection site tenderness, skin lesion and skin is extra dry was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dry mouth, Feeling hot, Headache
Clinical narrative: FEELING WARM; LIGHTHEADED; DRY MOUTH; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on right arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced headache. On 28-MAR-2021, the subject experienced feeling warm. On 28-MAR-2021, the subject experienced lightheaded. On 28-MAR-2021, the subject experienced dry mouth. On 28-MAR-2021, the subject experienced nausea. On 28-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.9 degree F. Treatment medications (dates unspecified) included: bismuth subsalicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 28-MAR-2021, and the outcome of fever, feeling warm, nausea, lightheaded and dry mouth was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: FEELING WARM; LIGHTHEADED; DRY MOUTH; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on right arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced headache. On 28-MAR-2021, the subject experienced feeling warm. On 28-MAR-2021, the subject experienced lightheaded. On 28-MAR-2021, the subject experienced dry mouth. On 28-MAR-2021, the subject experienced nausea. On 28-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.9 degree F. Treatment medications (dates unspecified) included: bismuth subsalicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 28-MAR-2021, and the outcome of fever, feeling warm, nausea, lightheaded and dry mouth was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: COUGH; CHILLS; 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. The patient's concurrent conditions included cerebral palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 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 MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from cough, and the outcome of chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210358675.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: SORE THROAT; CHILLS; JOINT PAIN IN KNEES ,ANKLES,FINGERS,SHOULDERS; MAJOR HEADACHE; FEVER; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, chills, joint pain in knees, ankles, fingers, shoulders, major headache, fever, fatigue, and muscle ache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.1°-102.3°. 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 major headache, chills, fever, fatigue, joint pain in knees ,ankles ,fingers ,shoulders, muscle ache, and sore throat. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; CHILLS; JOINT PAIN IN KNEES ,ANKLES,FINGERS,SHOULDERS; MAJOR HEADACHE; FEVER; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, chills, joint pain in knees, ankles, fingers, shoulders, major headache, fever, fatigue, and muscle ache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.1°-102.3°. 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 major headache, chills, fever, fatigue, joint pain in knees ,ankles ,fingers ,shoulders, muscle ache, and sore throat. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Injection site pain
Clinical narrative: FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BURNING; TIRED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at around noon on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced feeling very cold. On 25-MAR-2021, the subject experienced aches and pains are almost like she got hit by a train. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced injection site burning. On 25-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 96-97. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning on MAR-2021, had not recovered from tired, chills, and aches and pains are almost like she got hit by a train, and the outcome of feeling very cold was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BURNING; TIRED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at around noon on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced feeling very cold. On 25-MAR-2021, the subject experienced aches and pains are almost like she got hit by a train. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced injection site burning. On 25-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 96-97. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning on MAR-2021, had not recovered from tired, chills, and aches and pains are almost like she got hit by a train, and the outcome of feeling very cold was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: SLEPT FOR 10 HOURS; FELT REALLY BAD; SOME SKIN DISCOLORATION; FELT LIKE THE FLU; REALLY RED RASH WHICH HAD MOVED ON NECK TO EAR AND DOWN TO THE CREASE OF BREAST AND ON THE RIGHT SIDE NEAR EAR AND SOME RED SPOTS ON BOTH SIDES OF BOTTOM FACE; CHILLS; REALLY BAD HEADACHE ABOVE THE EYE; LOW GRADE FEVER; TIRED; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included skin disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 NDC 59676-0580-15 expiry: UNKNOWN) dose was not reported, administered in the left arm on 13-MAR-2021 07:00 for prophylactic vaccination.. No concomitant medications were reported. On 13-MAR-2021 08:15, the subject experienced slept for 10 hours. On 13-MAR-2021 08:15, the subject experienced felt really bad. On 13-MAR-2021 08:15, the subject experienced some skin discoloration. On 13-MAR-2021 08:15, the subject experienced felt like the flu. On 13-MAR-2021 08:15, the subject experienced really red rash which had moved on neck to ear and down to the crease of breast and on the right side near ear and some red spots on both sides of bottom face. On 13-MAR-2021 08:15, the subject experienced chills. On 13-MAR-2021 08:15, the subject experienced really bad headache above the eye. On 13-MAR-2021 08:15, the subject experienced low grade fever. On 13-MAR-2021 08:15, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 10 hours, felt really bad, felt like the flu, chills, really bad headache above the eye, low grade fever, and tired on 14-MAR-2021, had not recovered from really red rash which had moved on neck to ear and down to the crease of breast and on the right side near ear and some red spots on both sides of bottom face, and the outcome of some skin discoloration was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Skin discolouration, Somnolence
Clinical narrative: SLEPT FOR 10 HOURS; FELT REALLY BAD; SOME SKIN DISCOLORATION; FELT LIKE THE FLU; REALLY RED RASH WHICH HAD MOVED ON NECK TO EAR AND DOWN TO THE CREASE OF BREAST AND ON THE RIGHT SIDE NEAR EAR AND SOME RED SPOTS ON BOTH SIDES OF BOTTOM FACE; CHILLS; REALLY BAD HEADACHE ABOVE THE EYE; LOW GRADE FEVER; TIRED; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included skin disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 NDC 59676-0580-15 expiry: UNKNOWN) dose was not reported, administered in the left arm on 13-MAR-2021 07:00 for prophylactic vaccination.. No concomitant medications were reported. On 13-MAR-2021 08:15, the subject experienced slept for 10 hours. On 13-MAR-2021 08:15, the subject experienced felt really bad. On 13-MAR-2021 08:15, the subject experienced some skin discoloration. On 13-MAR-2021 08:15, the subject experienced felt like the flu. On 13-MAR-2021 08:15, the subject experienced really red rash which had moved on neck to ear and down to the crease of breast and on the right side near ear and some red spots on both sides of bottom face. On 13-MAR-2021 08:15, the subject experienced chills. On 13-MAR-2021 08:15, the subject experienced really bad headache above the eye. On 13-MAR-2021 08:15, the subject experienced low grade fever. On 13-MAR-2021 08:15, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 10 hours, felt really bad, felt like the flu, chills, really bad headache above the eye, low grade fever, and tired on 14-MAR-2021, had not recovered from really red rash which had moved on neck to ear and down to the crease of breast and on the right side near ear and some red spots on both sides of bottom face, and the outcome of some skin discoloration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SLIGHT SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced slight soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight soreness at the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: COLD CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced cold chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and cold chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: SHIVERING; NAUSEATED DRIVING BACK HOME; FEVER; BODY ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAR-2021 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 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced nauseated driving back home. On 28-MAR-2021, the subject experienced fever. On 29-MAR-2021 04:00, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body aches, and the outcome of nauseated driving back home and shivering was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021  at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal
Clinical narrative: BLOOD PRESSURE ISSUE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On MAR-2021, the subject experienced blood pressure issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure issue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: DIZZINESS; PAIN UNDER THE LEFT ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, and pain under the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness and pain under the left arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSEBLEED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included vaping, and concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 18:20 on right deltoid for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate for drug used for unknown indication. On 30-MAR-2021 23:00, the subject experienced nosebleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed on 30-MAR-2021 23:10. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODYACHE; CHILL; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 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 bodyache, chill, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chill, headache and bodyache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210358272.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Injection site pruritus, Myalgia
Clinical narrative: INJECTION SITE ITCH; ZERO ENERGY; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. . No concomitant medications were reported. On an unspecified date, the subject experienced injection site itch, zero energy, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the zero energy, injection site itch and muscle aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: SOME CHILLS; TIREDNESS; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 MAR-2021, the subject experienced some chills. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced slight headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, slight headache and some chills was not reported. This report was non-serious.