chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: MIGRAINE; FEVER; SHAKING UNCONTROLLABLY; BODY TWITCHING; BODY ACHING; This spontaneous report received from a parent concerned a White, Not Hispanic/Latino 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 05:00 for prophylactic vaccination. batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the patient experienced migraine, fever, shaking uncontrollably, body twitching, and body aching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, fever, shaking uncontrollably, body twitching and body aching was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Insomnia, Myalgia, Pain
Clinical narrative: SHAKING; MUSCLE PAIN ON BOTH BICEPS, AND BOTH SHOULDERS, ON HIS NECK AND BACK; HEADACHE; ALL OVER SORENESS; COULD NOT SLEEP ALL NIGHT; FEVER; 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 09-MAR-2021 12:00 to Left Arm for covid-19 prevention. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle pain on both biceps, and both shoulders, on his neck and back. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced all over soreness. On 09-MAR-2021, the subject experienced could not sleep all night. Laboratory data included: Body temperature (NR: not provided) 98.7 F. On 10-MAR-2021, the subject experienced shaking. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and shaking on 10-MAR-2021, was recovering from muscle pain on both biceps, and both shoulders, on his neck and back, had not recovered from headache, and all over soreness, and the outcome of could not sleep all night was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SHAKING; MUSCLE PAIN ON BOTH BICEPS, AND BOTH SHOULDERS, ON HIS NECK AND BACK; HEADACHE; ALL OVER SORENESS; COULD NOT SLEEP ALL NIGHT; FEVER; 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 09-MAR-2021 12:00 to Left Arm for covid-19 prevention. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle pain on both biceps, and both shoulders, on his neck and back. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced all over soreness. On 09-MAR-2021, the subject experienced could not sleep all night. Laboratory data included: Body temperature (NR: not provided) 98.7 F. On 10-MAR-2021, the subject experienced shaking. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and shaking on 10-MAR-2021, was recovering from muscle pain on both biceps, and both shoulders, on his neck and back, had not recovered from headache, and all over soreness, and the outcome of could not sleep all night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Heart rate, Heart rate increased
Clinical narrative: SPEEDY HEART RATE; MILD HEADACHE; LOW GRADE FEVER; FLUSHED FACE; VERY FATIGUED; 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 anaphylactic reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced mild headache. On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021, the subject experienced flushed face. On 09-MAR-2021, the subject experienced very fatigued. On 10-MAR-2021, the subject experienced speedy heart rate. Laboratory data included: Heart rate (NR: not provided) 123 decreased to 116. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, low grade fever, and flushed face on 10-MAR-2021, and had not recovered from speedy heart rate, and very fatigued. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SPEEDY HEART RATE; MILD HEADACHE; LOW GRADE FEVER; FLUSHED FACE; VERY FATIGUED; 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 anaphylactic reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced mild headache. On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021, the subject experienced flushed face. On 09-MAR-2021, the subject experienced very fatigued. On 10-MAR-2021, the subject experienced speedy heart rate. Laboratory data included: Heart rate (NR: not provided) 123 decreased to 116. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, low grade fever, and flushed face on 10-MAR-2021, and had not recovered from speedy heart rate, and very fatigued. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Injection site haemorrhage, Product administration error
Clinical narrative: BLED ALL THE WAY DOWN HER ARM; SHOCK DOWN HER ARM; DRUG ADMINISTRATION ERROR; This spontaneous report received from a patient concerned a patient 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced bleeding. On 09-MAR-2021, the subject experienced shock down her arm. On 09-MAR-2021, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding, and shock down her arm on 09-MAR-2021, and the outcome of drug administration error was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chest pain, Chills, Initial insomnia, Myalgia
Clinical narrative: LEFT ARM PAIN; ALL OVER MUSCLE PAIN; CHILLS; NAUSEA; TOOK A WHILE TO FALL ASLEEP; SAW FACES AND ANIMALS 2 HOURS  POST IMMUNIZATION; MILD CHEST 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, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced all over muscle pain. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced took a while to fall asleep. On 10-MAR-2021, the subject experienced saw faces and animals 2 hours post immunization. On 10-MAR-2021, the subject experienced mild chest pain. On an unspecified date, the subject experienced left arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from took a while to fall asleep, and saw faces and animals 2 hours post immunization on 10-MAR-2021, and left arm pain, and had not recovered from all over muscle pain, chills, nausea, and mild chest pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: LEFT ARM PAIN; ALL OVER MUSCLE PAIN; CHILLS; NAUSEA; TOOK A WHILE TO FALL ASLEEP; SAW FACES AND ANIMALS 2 HOURS  POST IMMUNIZATION; MILD CHEST 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, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced all over muscle pain. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced took a while to fall asleep. On 10-MAR-2021, the subject experienced saw faces and animals 2 hours post immunization. On 10-MAR-2021, the subject experienced mild chest pain. On an unspecified date, the subject experienced left arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from took a while to fall asleep, and saw faces and animals 2 hours post immunization on 10-MAR-2021, and left arm pain, and had not recovered from all over muscle pain, chills, nausea, and mild chest pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Chills, Diarrhoea, Dyspnoea
Clinical narrative: ANXIETY; INJECTION SITE PAIN; DIARRHEA; SHORTNESS OF BREATH; NAUSEA; VOMITING; HEADACHE; CHILLS; MUSCLE ACHES; LOW/CENTRE BACK PAIN; 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 past medical history included hydrocephalus. The patient experienced rhabdomyolysis when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced shortness of breath. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced vomiting. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced muscle aches. On 05-MAR-2021, the subject experienced low/centre back pain. On 06-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced anxiety. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, chills, and muscle aches on 06-MAR-2021, and low/centre back pain on 05-MAR-2021, and had not recovered from diarrhea, shortness of breath, nausea, injection site pain, vomiting, and anxiety. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Vomiting
Clinical narrative: ANXIETY; INJECTION SITE PAIN; DIARRHEA; SHORTNESS OF BREATH; NAUSEA; VOMITING; HEADACHE; CHILLS; MUSCLE ACHES; LOW/CENTRE BACK PAIN; 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 past medical history included hydrocephalus. The patient experienced rhabdomyolysis when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced shortness of breath. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced vomiting. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced muscle aches. On 05-MAR-2021, the subject experienced low/centre back pain. On 06-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced anxiety. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, chills, and muscle aches on 06-MAR-2021, and low/centre back pain on 05-MAR-2021, and had not recovered from diarrhea, shortness of breath, nausea, injection site pain, vomiting, and anxiety. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: CHILLY; ACHES; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 03:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced chilly. On 10-MAR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, and the outcome of chilly was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a 36 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 04:15 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Paraesthesia oral, Pruritus
Clinical narrative: HEADACHE; FATIGUE/ FEELING TIRED; UPSET STOMACH; ITCHINESS; TINGLING LIPS; 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 allergy to antibiotic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fatigue/ feeling tired. On 09-MAR-2021, the subject experienced upset stomach. On 09-MAR-2021, the subject experienced itchiness. On 09-MAR-2021, the subject experienced tingling lips. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: cetirizine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue/ feeling tired, upset stomach, itchiness and tingling lips was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Pain in extremity, Pyrexia
Clinical narrative: FEVER; BACK PAIN; SORE ARM; STOMACH ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 10:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced back pain. On 09-MAR-2021, the subject experienced sore arm. On 09-MAR-2021, the subject experienced stomach ache. 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 had not recovered from fever, back pain, sore arm, and stomach ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: FLU-LIKE SYMPTOMS; HEADACHE; TIREDNESS; FEELING UNWELL; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced feeling unwell. On 08-MAR-2021 21:00, the subject experienced flu-like symptoms. On 08-MAR-2021 21:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, headache, and tiredness, and the outcome of feeling unwell was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES; FEVER; 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 11:00 a.m. to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021 19:00 p.m., the patient experienced muscle aches. On 08-MAR-2021 19:00 p.m., the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: FATIGUE; WEAKNESS; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient  experienced fatigue, and weakness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and weakness was not reported. This report was non-serious..
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder, Pain in extremity
Clinical narrative: TROUBLE MOVING FINGERS; WRIST PAIN; FOREARM PAIN; .This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered at on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced trouble moving fingers. On 07-MAR-2021, the subject experienced wrist pain. On 07-MAR-2021, the subject experienced forearm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble moving fingers, wrist pain and forearm pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: SWELLING OF EYES; SWELLING OF FACE; 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 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of eyes. On 09-MAR-2021, the subject experienced swelling of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of eyes and swelling of face was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: BACK PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included dementia, and bad back. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 11:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021 21:00, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Muscle spasms
Clinical narrative: CRAMPS IN LEFT LEG AND FOOT; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced cramps in left leg and foot. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on MAR-2021, and the outcome of cramps in left leg and foot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Neck pain
Clinical narrative: SHIVERING; BACK ACHE; NECK PAIN; SLIGHT 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, intramuscular, batch number: 620-126, and batch number: 620-126 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced shivering. On 10-MAR-2021, the subject experienced back ache. On 10-MAR-2021, the subject experienced neck pain. On 10-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering, back ache, slight headache, and neck pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SKIN RASHES; This spontaneous report received from a patient (HCP) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pork allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 07-MAR-2021, the subject experienced skin rashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin rashes. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per the standard procedure case assessed as non -serious
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain
Clinical narrative: DIZZINESS; HEADACHE; ACHES; CHILLS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced aches. On 07-MAR-2021, the subject experienced chills. On 10-MAR-2021 20:30, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, aches, and chills on 09-MAR-2021, and had not recovered from dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: EXPECTED SIDE EFFECTS; This spontaneous report received from a health care professional 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced expected side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expected side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Fatigue, Hypoaesthesia oral, Nausea
Clinical narrative: WEAKNESS; NO TASTE; NAUSEOUS; FATIGUE; BODY ACHES; NUMB LIPS; SWOLLEN FACE RIGHT SIDE; BLURRED VISION; 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, intramuscular, batch number: Unknown, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced weakness. On 06-MAR-2021, the subject experienced no taste. On 06-MAR-2021, the subject experienced nauseous. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced numb lips. On 06-MAR-2021, the subject experienced swollen face right side. On 06-MAR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, no taste, body aches, numb lips, nauseous, fatigue, swollen face right side, and blurred vision. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling face, Vision blurred
Clinical narrative: WEAKNESS; NO TASTE; NAUSEOUS; FATIGUE; BODY ACHES; NUMB LIPS; SWOLLEN FACE RIGHT SIDE; BLURRED VISION; 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, intramuscular, batch number: Unknown, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced weakness. On 06-MAR-2021, the subject experienced no taste. On 06-MAR-2021, the subject experienced nauseous. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced numb lips. On 06-MAR-2021, the subject experienced swollen face right side. On 06-MAR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, no taste, body aches, numb lips, nauseous, fatigue, swollen face right side, and blurred vision. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: ACCIDENTAL OCCUPATIONAL EXPOSURE TO PRODUCT; This spontaneous report received from a health care professional 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, topical, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced accidental occupational exposure to product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidental occupational exposure to product was not reported. This report was non-serious. This case, from the same reporter is linked to 20210317249.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: ITCHY ON THE ARM WHERE GOT SHOT; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received Covid-19 Vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-Mar-2021, the patient experienced itchy on the arm where she got shot. The action taken with Covid-19 Vaccine AD26.COV2.S was not applicable. The patient recovered from itchy on the arm where got shot on 08-Mar-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: LOST APPETITE; FEVER; STRONG BODY ACHES; 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced strong body aches. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from strong body aches, and fever, and the outcome of lost appetite was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: BODY ACHES; SORE 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, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 08-MAR-2021, the subject experienced sore arm. On 09-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASH; ITCHING; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) ) 0.5 ml, administered on 02-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced rash. On 09-MAR-2021, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, and itching. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: FEVER OF 102.7F; NAUSEA; VOMITING; CHILLS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included not asked. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805618 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 09-MAR-2021 19:45, the subject experienced fever of 102.7f. On 09-MAR-2021 19:45, the subject experienced nausea. On 09-MAR-2021 19:45, the subject experienced vomiting. On 09-MAR-2021 19:45, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 102.7f, nausea, vomiting, and chills. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sciatica, Spinal pain
Clinical narrative: SEVERE PAIN IN LUMBAR REGION OF SPINE; HEADACHE-3 DAYS; SEVERE SCIATIC NERVE PAIN IN LOWER LEFT LEG AND CONTINUING GOING DOWN THE KNEE WITH A LOT OF PAIN; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included herniated disk, non smoker, non-alcohol user, diabetic type 2, high blood pressure (HBP), arthritis spine, penicillin allergy, bee sting allergy, ragweed allergy, juniper allergy, strawberry allergy, grape allergy, asthma, and chronic pain, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was not ill at time of vaccination, had no previous history of similar events and had not experienced any adverse events after previous vaccinations. The patient did not have acute illness 30 days prior to vaccination and hospitalization in last 30 days. Patient had no family history of any disease or allergy related to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:15 upper left arm for prophylactic vaccination. Concomitant medications included nebivolol hydrochloride for high blood pressure, hydrocodone for pain, and metformin non-company for type 2 diabetes. On 09-MAR-2021, the subject experienced severe sciatic nerve pain in lower left leg and continuing going down the knee with a lot of pain. On 09-MAR-2021, the subject experienced headache-3 days. On 09-MAR-2021 21:00, the subject experienced severe pain in lumbar region of spine. On 10-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sciatic nerve pain in lower left leg and continuing going down the knee with a lot of pain, and severe pain in lumbar region of spine on 23-MAR-2021, and headache-3 days on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210322279.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: heart beating fast; chest pain; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beating fast), CHEST PAIN (chest pain) and DYSPNOEA (difficulty of breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.    On 06-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 5:00 PM, the patient experienced HEART RATE INCREASED (heart beating fast) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and DYSPNOEA (difficulty of breathing) (seriousness criterion medically significant). On 06-Apr-2021, HEART RATE INCREASED (heart beating fast) and DYSPNOEA (difficulty of breathing) had resolved. On 07-Apr-2021, CHEST PAIN (chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Electrocardiogram: abnormal (abnormal) She took an electrocardiogram (ECG) with her home cardio machine and reported that her heart was beating extremely bad.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment included for the events were metoprolol 75mg that night, 25mg in the morning of the next day (07 Apr2021) and 50mg that night. The patient reported that she was now feeling fine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Body temperature, Chills, Feeling cold, Illness
Clinical narrative: in and out of consciousness; got very sick; vomiting a lot after taking alcohol; chills; fever (102.4); cold; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING COLD (cold), CHILLS (chills) and PYREXIA (fever (102.4)). On 08-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness) (seriousness criterion medically significant), ILLNESS (got very sick) and VOMITING (vomiting a lot after taking alcohol). On 06-Apr-2021, FEELING COLD (cold), CHILLS (chills) and PYREXIA (fever (102.4)) had resolved. On 09-Apr-2021, ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness), ILLNESS (got very sick) and VOMITING (vomiting a lot after taking alcohol) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 102.4 (High) fever.         No relevant concomitant medications were provided. He was taking acetaminophen.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: in and out of consciousness; got very sick; vomiting a lot after taking alcohol; chills; fever (102.4); cold; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING COLD (cold), CHILLS (chills) and PYREXIA (fever (102.4)). On 08-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness) (seriousness criterion medically significant), ILLNESS (got very sick) and VOMITING (vomiting a lot after taking alcohol). On 06-Apr-2021, FEELING COLD (cold), CHILLS (chills) and PYREXIA (fever (102.4)) had resolved. On 09-Apr-2021, ALTERED STATE OF CONSCIOUSNESS (in and out of consciousness), ILLNESS (got very sick) and VOMITING (vomiting a lot after taking alcohol) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 102.4 (High) fever.         No relevant concomitant medications were provided. He was taking acetaminophen.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Throat tightness, Tryptase
Clinical narrative: anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure; lightheadedness; throat closure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) (seriousness criterion medically significant), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Tryptase: elevated (High) Elevation persisted 3 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Before her 2nd dose, she pre-treated with Motrin and Claritin.  Concomitant product use was not provided by the reporter. Treatment for the event anaphylactic reaction included EpiPen and intravenous Benadryl.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-073832 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.