chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Influenza, Pain, Somnolence
Clinical narrative: DIZZINESS AND HEAD WAS SPINNING; SLEEPY AND DROWSINESS; BODY ACHE; FLU; CHILLS; 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, Expiry: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness and head was spinning. On 07-APR-2021, the subject experienced sleepy and drowsiness. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced flu. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and head was spinning, body ache, and chills on 08-APR-2021, and had not recovered from sleepy and drowsiness, and flu. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: INJECTION SITE RED /SWOLLEN/ITCHY /SMALL RASH GROWING INCH BY INCH; This spontaneous report received from a patient concerned a 40 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site red /swollen/itchy /small rash/. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site red /swollen/itchy /small rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Incorrect route of product administration
Clinical narrative: STREAKY LINEAL MASS ON RIGHT SIDE AXILLA; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced inappropriate route of vaccination. On 25-MAR-2021, the subject experienced streaky lineal mass on right side axilla. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from streaky lineal mass on right side axilla, and the outcome of inappropriate route of vaccination was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: SORE SHOULDER; FATIGUE; 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 was not reported, administered on 07-APR-2021 to right arm 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 08-APR-2021, the subject experienced sore shoulder. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore shoulder, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned an 84 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: 0331211-1808980, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 01-APR-2021, and had not recovered from dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Migraine, Pain, Pyrexia
Clinical narrative: BODY ACHES; MIGRAINE; SLIGHT FEVER; FATIGUE; This spontaneous report received from a parent concerned a 23 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 APR-2021, Laboratory data included: Body temperature (NR: not provided) less than 102F. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced slight fever. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 09-APR-2021, was recovering from slight fever, and had not recovered from fatigue, and body aches. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: BODY ACHES; MIGRAINE; SLIGHT FEVER; FATIGUE; This spontaneous report received from a parent concerned a 23 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 APR-2021, Laboratory data included: Body temperature (NR: not provided) less than 102F. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced slight fever. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 09-APR-2021, was recovering from slight fever, and had not recovered from fatigue, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: INJECTED .8ML INSTEAD OF .5 ML OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned multiple patients (11 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced injected.8ml instead of.5 ml of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injected .8ml instead of .5 ml of the janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 60 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: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 25-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Lethargy, Nausea
Clinical narrative: FLU LIKE SYMPTOMS; BODY ACHES; DRY HEAVES; LETHARGY; SEVERE HEADACHES; SEVERE NAUSEA; LOW FEVER; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo. 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced flu like symptoms. On 03-APR-2021, the patient experienced body aches. On 03-APR-2021, the patient experienced dry heaves. On 03-APR-2021, the patient experienced lethargy. On 03-APR-2021, the patient experienced severe headaches. On 03-APR-2021, the patient experienced severe nausea. On 03-APR-2021, the patient experienced low fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, had not recovered from severe nausea, and lethargy, and the outcome of flu like symptoms, low fever, severe headaches and dry heaves was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Retching
Clinical narrative: FLU LIKE SYMPTOMS; BODY ACHES; DRY HEAVES; LETHARGY; SEVERE HEADACHES; SEVERE NAUSEA; LOW FEVER; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo. 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced flu like symptoms. On 03-APR-2021, the patient experienced body aches. On 03-APR-2021, the patient experienced dry heaves. On 03-APR-2021, the patient experienced lethargy. On 03-APR-2021, the patient experienced severe headaches. On 03-APR-2021, the patient experienced severe nausea. On 03-APR-2021, the patient experienced low fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, had not recovered from severe nausea, and lethargy, and the outcome of flu like symptoms, low fever, severe headaches and dry heaves was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: SORE ARM WHEN SOMEONE PRESSES  ON IT; NAUSEA; DULL HEADACHE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included loss of sense of taste, loss of sense of smell, nausea, dull headache, and covid-19 infection. The patient was previously treated with influenza vaccine virosomal for product use for unknown indication.  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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On APR-2021, the subject experienced sore arm when someone presses on it.  On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced dull headache. Treatment medications (dates unspecified) included: ibuprofen, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm when someone presses on it, nausea, and dull headache on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TWO DOSES OF VACCINE ADMINISTERED; 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 2021, the subject experienced two doses of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two doses of vaccine administered was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Nausea
Clinical narrative: NAUSEA; FIBROMYALGIA; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced fibromyalgia. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fibromyalgia, and the outcome of nausea was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle rigidity, Tremor
Clinical narrative: SHAKING; STIFF BODY; SHIVERING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic breathing problems .The  patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced stiff body. On 09-APR-2021, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, shivering and stiff body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: TACHYCARDIA; DIZZINESS; VOMITING; DIARRHEA; NUMBNESS IN HAND; ARM PAIN; HEADACHE; FEVER; NAUSEA; 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 type 1 diabetic. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced tachycardia. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced vomiting. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced numbness in hand. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, dizziness, vomiting, diarrhea, numbness in hand, and fever on 06-APR-2021, and had not recovered from arm pain, headache, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tachycardia, Vomiting
Clinical narrative: TACHYCARDIA; DIZZINESS; VOMITING; DIARRHEA; NUMBNESS IN HAND; ARM PAIN; HEADACHE; FEVER; NAUSEA; 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 type 1 diabetic. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced tachycardia. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced vomiting. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced numbness in hand. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, dizziness, vomiting, diarrhea, numbness in hand, and fever on 06-APR-2021, and had not recovered from arm pain, headache, and nausea. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: NAUSEA; FEVER 101; This spontaneous report received from a consumer concerned a 22 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 09-APR-2021 for prophylactic vaccination .The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever 101.  Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and fever 101. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE ACHES; FEELING TIRED; FEELING WEAK; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung transplant, and liver transplant, and concurrent conditions included hepatitis c.  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 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 fever. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and had not recovered from muscle aches, feeling tired, and feeling weak. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: ELEVATED BLOOD PRESSURE; LIGHT HEADED; CHILLS; BODY ACHE; FEELING HOT; FEELING TIRED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included htn(hypertension), alcohol user, non smoker, and sessional allergy, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested.   Concomitant medications included losartan for hypertension. On 28-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021 10:00, the subject experienced body ache. On 09-APR-2021, the subject experienced elevated blood pressure. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) elevated. On 09-APR-2021 15:00, Laboratory data included: Body temperature (NR: not provided) 97.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 09-APR-2021, and feeling hot on 09-APR-2021 15:00, had not recovered from feeling tired, and light headed, and the outcome of elevated blood pressure was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: ELEVATED BLOOD PRESSURE; LIGHT HEADED; CHILLS; BODY ACHE; FEELING HOT; FEELING TIRED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included htn(hypertension), alcohol user, non smoker, and sessional allergy, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested.   Concomitant medications included losartan for hypertension. On 28-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021 10:00, the subject experienced body ache. On 09-APR-2021, the subject experienced elevated blood pressure. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) elevated. On 09-APR-2021 15:00, Laboratory data included: Body temperature (NR: not provided) 97.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 09-APR-2021, and feeling hot on 09-APR-2021 15:00, had not recovered from feeling tired, and light headed, and the outcome of elevated blood pressure was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pain in extremity
Clinical narrative: ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced zapping pain through legs and shoulders. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced legs burning and achy. On 08-APR-2021, the subject experienced sore joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, legs burning and achy, sore joints and zapping pain through legs and shoulders was not reported. This report was non-serious. This parent/child case is linked to 20210420242.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Persistent L upper arm pain since second dose Moderna on 3/5/21.  Initially pain 8/10, now 2/10 still having localized pain with touch and raising L arm over head.  No redness or warmth.  Patient believes the vaccine was given in too high in the arm and wasn't given correctly.  Physical findings seem to suggest that patient's second Moderna vaccine given on 3/5/21 was given in the L Subacromial bursa and not in the Deltoid muscle
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Rash over/around injection site. Raised, red and itchy. Applied hydrocortisone to help provide relief to itchy. Temporary relief achieved.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Cough, Dyspepsia, Fatigue, Headache
Clinical narrative: 2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Nausea, Pruritus, Pyrexia, Salivary hypersecretion
Clinical narrative: 2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vision blurred
Clinical narrative: 2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer concerned a 17 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no severe allergic reactions .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) 0.5 ml, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site lymphadenopathy, Lymphadenopathy
Clinical narrative: Huge swollen lymph node under armpit of arm that got injection.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for three days after receiving vaccine but it went away after taking Tylenol and returned as soon as the Tylenol wore off.  Arm hurt very bad to touch but not to move.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Injection site pain, Muscular weakness, Nausea
Clinical narrative: Diarrhea, multiple days Sharp, dull stomach pains Pain at injection site from 4/8-4/15 Muscle weakness, slight Nausea
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: Sore vaccination site, started to get brain fog which lead to a headache, fatigue, extreme urge to cough, aches muscles, inability to regulate temperature (back and forth chills and hot waves),  nausea, and sharp pains in my bones.   Treatment: drinking water  Started around 3 and has gotten progressively worse
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hot flush, Myalgia, Nausea, Temperature regulation disorder
Clinical narrative: Sore vaccination site, started to get brain fog which lead to a headache, fatigue, extreme urge to cough, aches muscles, inability to regulate temperature (back and forth chills and hot waves),  nausea, and sharp pains in my bones.   Treatment: drinking water  Started around 3 and has gotten progressively worse
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore vaccination site, started to get brain fog which lead to a headache, fatigue, extreme urge to cough, aches muscles, inability to regulate temperature (back and forth chills and hot waves),  nausea, and sharp pains in my bones.   Treatment: drinking water  Started around 3 and has gotten progressively worse
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity, Swelling
Clinical narrative: Heavy-feeling limbs, muscle aches, sore feet, swollen gland in armpit
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Incorrect dose administered, Syringe issue
Clinical narrative: Pt here for 2nd dose of Pfizer vaccine. Nursing student to administer vaccine to Pt. During injection, nursing student reports an "undefinable" amount of vaccine leaked from patient arm and out of syringe. Recommendation was to administer additional dose of vaccine in other arm. Vaccine administered by RN.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills, fever, slight headache, tiredness
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Full blood count, Laboratory test, Lipase, Liver function test
Clinical narrative: My stomach hurts a lot, i was already sleeping they gave me some medicine, and they did some lab test
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urine analysis
Clinical narrative: My stomach hurts a lot, i was already sleeping they gave me some medicine, and they did some lab test
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTIONS; 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Pharyngeal swelling, Pruritus
Clinical narrative: Patient received first Pfizer COVID vaccine with subsequent shortness of breath, subjective throat swelling and ear pain/itching. Patient was taken to the ED for ongoing evaluation and is taking 50 mg of Benadryl, IV fluids, 125 mg of methylprednisone, and 20 mg famotidine followed by reevaluation. Patient had no additional symptoms and discharged.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 16 year old patient received Moderna vaccine instead of Pfizer. There were extra doses at end of day and we were calling to get additional people in for vaccination.  We used the "golden ticket" process, so cars were not marked as Pfizer or Moderna and all vaccines were on one lane.  Registration identified the patient as needing Pfizer. During vaccination, Moderna was administered. Pt should get 2nd dose of Moderna per CDC. Communicated with mother on error and plan.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Tremor
Clinical narrative: Shaking chills, body aches, fatigue
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Pulsitle tinnitus
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: Patient administered Pfizer vaccine to R deltoid, hub leaked vaccine during injection and patient received less than 50% of the 0.3ml dose.  Readministered second vaccine to L deltoid with full dose completed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Hypertension, Live birth
Clinical narrative: I started having extremely high blood pressure after never having had it before. I ended up in the hospital. I was pregnant and due July 7th and had the baby on April 7th at 27 weeks, she weighed 1 pound and 12 ounces. She is alive and in NICU at this time. I am not sure the two are related, but it happened very suddenly after the vaccine so I just wanted to be sure someone knew in case it was something that someone needed to be aware of. I went to the hospital a total of 24 days over three trips, the final hospital admittance was 14 days from April 1-14th with delivery being on the 7th. At this time the permanent damage and birth defects are unknown and we are working through everything, I am not sure what all is my own health or the vaccine, I just want to report it to help any kind of potential progress with the vaccine and ending the pandemic.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Paraesthesia, Tremor
Clinical narrative: Pt presents with nausea, body shaking, dizziness and L arm tingly beginning today at 1000 today. 3 days post vaccination
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Product dispensing issue, Syringe issue, Underdose
Clinical narrative: Pt here for 2nd dose of Pfizer vaccine. LVN to give vaccine to patient. Upon injection, needle depressed prematurely causing vaccine to leak down pt arm. Less than half of vaccine administered to pt. Per policy, second vaccine administered in other arm successfully.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Periarthritis, Product administered at inappropriate site, Tendon pain
Clinical narrative: Patient had first COVID injection 1/22/21. States vaccine was given too high and hit a nerve and tendon in her arm. Patient has been experiencing pain since and receiving treatment from external neuro-physicial therapist for a partial frozen shoulder.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Covid arm, or vaccine arm.  A large lesion of redness appeared on my left arm (where I got the shot) around 10 days after I received my first dose of Moderna vaccine.  The rash is itchy and it looks very big.  It is a little swelling, too.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: ACHES; CHILLS; 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. 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 aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and chills. This report was non-serious. This case, from the same reporter is linked to 20210422355.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen at injection cite, painful at touch, itchy, and hard at touch It is about four inches big, circular shape Only taken acetaminophen for arm pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Fatigue, Headache, Injection site muscle weakness
Clinical narrative: Day of vaccine: Fever, extreme fatigue, headache,  muscle soreness, lameness of left arm (injection site).  symptoms subsided after ~24hours.  one week post vaccine:  neck ache, subsided after a week.  Sharp pain/radiating heat feeling in left arm at injection site, subsided after a few hours.  Pain/cramping in right lower abdomen/stomach, subsided within 24 hours.    two weeks post vaccine:  slight pain and swelling in right foot.  Many of these are symptoms I experience leading up to and during menstruation as well, which occurred in the week after vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Day of vaccine: Fever, extreme fatigue, headache,  muscle soreness, lameness of left arm (injection site).  symptoms subsided after ~24hours.  one week post vaccine:  neck ache, subsided after a week.  Sharp pain/radiating heat feeling in left arm at injection site, subsided after a few hours.  Pain/cramping in right lower abdomen/stomach, subsided within 24 hours.    two weeks post vaccine:  slight pain and swelling in right foot.  Many of these are symptoms I experience leading up to and during menstruation as well, which occurred in the week after vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Day of vaccine: Fever, extreme fatigue, headache,  muscle soreness, lameness of left arm (injection site).  symptoms subsided after ~24hours.  one week post vaccine:  neck ache, subsided after a week.  Sharp pain/radiating heat feeling in left arm at injection site, subsided after a few hours.  Pain/cramping in right lower abdomen/stomach, subsided within 24 hours.    two weeks post vaccine:  slight pain and swelling in right foot.  Many of these are symptoms I experience leading up to and during menstruation as well, which occurred in the week after vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; NECK PAIN; ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced arm pain. On an unspecified date, the subject experienced joint pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, neck pain, fever and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: BODY PAIN AS IF SPINE WAS BEING RIPPED OUT/BODY ACHE; BODY CHILLS; HEAD HURT; FEVER; SEVERE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was currently using unknown statin (possibly atorvastatin). 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 09-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included apixaban. On 09-APR-2021, the subject experienced body pain as if spine was being ripped out/body ache. On 09-APR-2021, the subject experienced body chills. On 09-APR-2021, the subject experienced head hurt. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced severe nausea. On 10-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 101.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head hurt, body chills, fever, body pain as if spine was being ripped out/body ache and severe nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY PAIN AS IF SPINE WAS BEING RIPPED OUT/BODY ACHE; BODY CHILLS; HEAD HURT; FEVER; SEVERE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was currently using unknown statin (possibly atorvastatin). 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 09-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included apixaban. On 09-APR-2021, the subject experienced body pain as if spine was being ripped out/body ache. On 09-APR-2021, the subject experienced body chills. On 09-APR-2021, the subject experienced head hurt. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced severe nausea. On 10-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 101.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head hurt, body chills, fever, body pain as if spine was being ripped out/body ache and severe nausea was not reported. This report was non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Lip blister, Nasal oedema, Neck pain
Clinical narrative: SWEATING; ACHY; FATIGUE; BLISTER ON INSIDE OF LIP; AREA UNDER NOSTRIL ON RIGHT SIDE  IS SWOLLEN AND TENDER TO THE  TOUCH; SORENESS ON NECK; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0428218, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness on neck. On 07-APR-2021, the subject experienced blister on inside of lip. On 07-APR-2021, the subject experienced area under nostril on right side is swollen and tender to the touch. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced achy. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blister on inside of lip, area under nostril on right side is swollen and tender to the touch, sweating, fatigue, and achy, and the outcome of soreness on neck was not reported. This report was non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SWEATING; ACHY; FATIGUE; BLISTER ON INSIDE OF LIP; AREA UNDER NOSTRIL ON RIGHT SIDE  IS SWOLLEN AND TENDER TO THE  TOUCH; SORENESS ON NECK; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0428218, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness on neck. On 07-APR-2021, the subject experienced blister on inside of lip. On 07-APR-2021, the subject experienced area under nostril on right side is swollen and tender to the touch. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced achy. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blister on inside of lip, area under nostril on right side is swollen and tender to the touch, sweating, fatigue, and achy, and the outcome of soreness on neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort, Nausea, Pyrexia
Clinical narrative: HEAVINESS IN LEG; CHILLS; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a consumer 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in leg. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, nausea, fatigue and heaviness in leg was not reported. This report was non-serious.