chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: POSSIBLE INCORRECT INJECTION SITE; This spontaneous report received from a patient concerned a 72 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: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced possible incorrect injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible incorrect injection site was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: SLIGHT DIFFICULTY IN BREATHING; CHILLS; FATIGUE; HEADACHE; INTERMITTENT FEVER; MUSCLE PAIN (BACK AND JOINT PAIN); This spontaneous report received from a patient concerned a 38 year old. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight difficulty in breathing. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced intermittent fever. On 10-APR-2021, the subject experienced muscle pain (back and joint pain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight difficulty in breathing, chills, fatigue, headache, and intermittent fever on 11-APR-2021, and had not recovered from muscle pain (back and joint pain). This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SLIGHT DIFFICULTY IN BREATHING; CHILLS; FATIGUE; HEADACHE; INTERMITTENT FEVER; MUSCLE PAIN (BACK AND JOINT PAIN); This spontaneous report received from a patient concerned a 38 year old. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight difficulty in breathing. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced intermittent fever. On 10-APR-2021, the subject experienced muscle pain (back and joint pain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight difficulty in breathing, chills, fatigue, headache, and intermittent fever on 11-APR-2021, and had not recovered from muscle pain (back and joint pain). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: ALREADY VACCINATED TWO TIMES AND RECEIVED JANSSEN COVID19 VACCINE ACCIDENTALLY; This spontaneous report received from a pharmacist 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: 1808978, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced already vaccinated two times and received Janssen covid19 vaccine accidentally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of already vaccinated two times and received Janssen covid19 vaccine accidentally was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle tightness, Neck pain, Oedema peripheral
Clinical narrative: SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin tightness
Clinical narrative: SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Muscle spasms, Nausea, Pruritus
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Ear pruritus, Headache, Muscle spasms, Throat irritation
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Headache, Metabolic function test, Muscle spasms
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Red blood cell sedimentation rate normal, Urine analysis, Visual impairment
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood count, Eye pain, Fear, Headache
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Macular fibrosis, Metamorphopsia, Muscle spasms, Ophthalmological examination
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pupil dilation procedure, Retinal function test abnormal, Tinnitus, Urine analysis
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Muscle spasms
Clinical narrative: ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; 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 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: JOINT ACHE; TIREDNESS; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination.  On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced tiredness. On 14-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, tiredness, and soreness on the injection site on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Lymph node pain, Pain
Clinical narrative: PAINFUL ARMPIT; PAINFUL LYMPH NODES; BODY ACHES; CHILLS/FEELS LIKE FREEZING ALL NIGHT; FEVER; SUPER TIRED; 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 08-APR-2021 for prophylactic vaccination. The patient had no known drug allergies. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On APR-2021, the subject experienced painful armpit. On APR-2021, the subject experienced painful lymph nodes. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced chills/feels like freezing all night. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced super tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills/feels like freezing all night, painful armpit, super tired, body aches and painful lymph nodes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAINFUL ARMPIT; PAINFUL LYMPH NODES; BODY ACHES; CHILLS/FEELS LIKE FREEZING ALL NIGHT; FEVER; SUPER TIRED; 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 08-APR-2021 for prophylactic vaccination. The patient had no known drug allergies. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On APR-2021, the subject experienced painful armpit. On APR-2021, the subject experienced painful lymph nodes. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced chills/feels like freezing all night. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced super tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills/feels like freezing all night, painful armpit, super tired, body aches and painful lymph nodes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SEVERE RASH OVER ENTIRE BODY; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced severe rash over entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe rash over entire body was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a consumer concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Suffocation feeling
Clinical narrative: FEELING SMOTHERED FROM THE HEAT; CHILLS; A SEVERE HEADACHE; FEVERISH; This spontaneous report received from a patient concerned a 75 year old. 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: 043H21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced feeling smothered from the heat. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced a severe headache. On 08-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling smothered from the heat, and chills on 09-APR-2021, had not recovered from a severe headache, and the outcome of feverish was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Tremor
Clinical narrative: SHAKING; SORE ARM; HEADACHE; NAUSEA; VERY SICK; This spontaneous report received from a patient concerned an adult 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 16-MAR-2021, the subject experienced shaking. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, headache, and nausea on 18-MAR-2021, had not recovered from sore arm, and the outcome of very sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: A LITTLE BIT OF STUFFINESS/STUFFINESS; ACHINESS/ VERY PAINFUL SHOT THAT REALLY HURT BAD FOR LIKE 15 MINS; COLD CHILLS WITHOUT FEVER/CHILLS BUT NO FEVER; SCRATCHY THROAT; ON/OFF HEADACHE AT BASE OF NECK; EXTREME THIRST; PAINFUL ARM AT INJECTION SITE/INJECTION SITE PAIN; VERY FATIGUED/FATIGUE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 140 pounds, and height was 65.5 inches. The patient's concurrent conditions included asthma, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.3 F, 98.6 F. On 01-APR-2021, the subject experienced extreme thirst. On 01-APR-2021, the subject experienced painful arm at injection site/injection site pain. On 01-APR-2021, the subject experienced very fatigued/fatigue. On 03-APR-2021, the subject experienced on/off headache at base of neck. On 07-APR-2021, the subject experienced scratchy throat. On 07-APR-2021, the subject experienced a little bit of stuffiness/stuffiness. On 07-APR-2021, the subject experienced achiness/ very painful shot that really hurt bad for like 15 mins. On 07-APR-2021, the subject experienced cold chills without fever/chills but no fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from painful arm at injection site/injection site pain on 01-APR-2021, and on/off headache at base of neck on 08-APR-2021, and had not recovered from very fatigued/fatigue, cold chills without fever/chills but no fever, scratchy throat, extreme thirst, a little bit of stuffiness/stuffiness, and achiness/ very painful shot that really hurt bad for like 15 mins. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Thirst, Throat irritation
Clinical narrative: A LITTLE BIT OF STUFFINESS/STUFFINESS; ACHINESS/ VERY PAINFUL SHOT THAT REALLY HURT BAD FOR LIKE 15 MINS; COLD CHILLS WITHOUT FEVER/CHILLS BUT NO FEVER; SCRATCHY THROAT; ON/OFF HEADACHE AT BASE OF NECK; EXTREME THIRST; PAINFUL ARM AT INJECTION SITE/INJECTION SITE PAIN; VERY FATIGUED/FATIGUE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 140 pounds, and height was 65.5 inches. The patient's concurrent conditions included asthma, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.3 F, 98.6 F. On 01-APR-2021, the subject experienced extreme thirst. On 01-APR-2021, the subject experienced painful arm at injection site/injection site pain. On 01-APR-2021, the subject experienced very fatigued/fatigue. On 03-APR-2021, the subject experienced on/off headache at base of neck. On 07-APR-2021, the subject experienced scratchy throat. On 07-APR-2021, the subject experienced a little bit of stuffiness/stuffiness. On 07-APR-2021, the subject experienced achiness/ very painful shot that really hurt bad for like 15 mins. On 07-APR-2021, the subject experienced cold chills without fever/chills but no fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from painful arm at injection site/injection site pain on 01-APR-2021, and on/off headache at base of neck on 08-APR-2021, and had not recovered from very fatigued/fatigue, cold chills without fever/chills but no fever, scratchy throat, extreme thirst, a little bit of stuffiness/stuffiness, and achiness/ very painful shot that really hurt bad for like 15 mins. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site inflammation, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: INJECTION SITE SWELLING; ITCHING AT THE SITE OF INJECTION; INFLAMMATION AT THE SITE OF INJECTION; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned an adult 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) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching at the site of injection. On 06-APR-2021, the subject experienced inflammation at the site of injection. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and low grade fever on 09-APR-2021, was recovering from itching at the site of injection, and inflammation at the site of injection, and the outcome of injection site swelling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: ARM PAIN; HEADACHE; TIRED; MUSCLE ACHES; FEVER; PAIN AT SITE(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 not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at site (left arm). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced arm pain. The outcome of the headache, tired, muscle aches, pain at site(left arm), fever and arm pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ARM PAIN; HEADACHE; TIRED; MUSCLE ACHES; FEVER; PAIN AT SITE(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 not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at site (left arm). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced arm pain. The outcome of the headache, tired, muscle aches, pain at site(left arm), fever and arm pain was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, and was recovering from headache. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Tremor, Urticaria
Clinical narrative: ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Injection site hypersensitivity
Clinical narrative: CHILLS; JOINT PAIN; SENSITIVITY AT THE INJECTION SITE; MUSCLE ACHES; HEADACHE; FEVER UP TO 101 FAHRENHEIT; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pernicious anemia, non smoker, and ketosis, and other pre-existing medical conditions included the patient 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 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included cyanocobalamin for pernicious anemia. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced sensitivity at the injection site. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever up to 101 fahrenheit .Laboratory data included: Body temperature (NR: not provided) 98 F, 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, muscle aches, headache, and fever up to 101 fahrenheit ,on 10-APR-2021, and had not recovered from sensitivity at the injection site. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: CHILLS; JOINT PAIN; SENSITIVITY AT THE INJECTION SITE; MUSCLE ACHES; HEADACHE; FEVER UP TO 101 FAHRENHEIT; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pernicious anemia, non smoker, and ketosis, and other pre-existing medical conditions included the patient 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 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included cyanocobalamin for pernicious anemia. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced sensitivity at the injection site. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever up to 101 fahrenheit .Laboratory data included: Body temperature (NR: not provided) 98 F, 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, muscle aches, headache, and fever up to 101 fahrenheit ,on 10-APR-2021, and had not recovered from sensitivity at the injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: DIZZINESS; NAUSEA; EXHAUSTION; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 138 pounds, and height was 64 inches. The patient's past medical history included food allergy, and migraine, and concurrent conditions included mitral valve prolapse, iodine allergy, contrast allergy, and sulfa allergy. The patient experienced drug allergy when treated with bupivacaine hydrochloride, and lidocaine. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 09-APR-2021, the subject experienced exhaustion. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 08-APR-2021, and had not recovered from exhaustion, nausea, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Tremor
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies were reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced shaking. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced tiredness. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of shaking, vomiting, tiredness and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies were reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced shaking. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced tiredness. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of shaking, vomiting, tiredness and body aches was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Thinking abnormal
Clinical narrative: COLD AND HOT FLASHES; NOT THINKING WELL; This spontaneous report received from a parent concerned a 31 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced cold and hot flashes. On 08-APR-2021, the subject experienced not thinking well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold and hot flashes, and not thinking well. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: FAST HEART RATE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included supraventricular tachycardia, nonsmoker, and non alcohol, and other pre-existing medical conditions included patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 23:45 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fast heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate on 09-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Insomnia, Nausea, Retching
Clinical narrative: DRY HEAVES; DIZZINESS; NOT SLEEPING; THROWING UP/NOT ABLE TO KEEP FLUID/BILE COMING UP; NAUSEA; DEHYDRATION; This spontaneous report received from a consumer concerned a 63 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: 1808978) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dehydration. On 31-MAR-2021, the subject experienced dry heaves. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced not sleeping. On 31-MAR-2021, the subject experienced throwing up/not able to keep fluid/bile coming up. On 31-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry heaves, nausea, dizziness, not sleeping, and throwing up/not able to keep fluid/bile coming up, and the outcome of dehydration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DRY HEAVES; DIZZINESS; NOT SLEEPING; THROWING UP/NOT ABLE TO KEEP FLUID/BILE COMING UP; NAUSEA; DEHYDRATION; This spontaneous report received from a consumer concerned a 63 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: 1808978) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dehydration. On 31-MAR-2021, the subject experienced dry heaves. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced not sleeping. On 31-MAR-2021, the subject experienced throwing up/not able to keep fluid/bile coming up. On 31-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry heaves, nausea, dizziness, not sleeping, and throwing up/not able to keep fluid/bile coming up, and the outcome of dehydration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Injection site discomfort
Clinical narrative: MILD STOMACH ISSUES; SOME DISCOMFORT ON THE ARM OF ADMINISTRATION; HEADACHE; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild stomach issues. On APR-2021, the subject experienced some discomfort on the arm of administration. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild stomach issues, headache and some discomfort on the arm of administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417098.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hangover
Clinical narrative: CHILLS; HANGOVER; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced hangover. On 09-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and hangover was not reported. This report was non-serious.