chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral swelling, Skin reaction, Swelling face
Clinical narrative: FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urine analysis
Clinical narrative: FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. 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.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pulmonary hypertension
Clinical narrative: HEADACHE; ACHY ARM; This spontaneous report received from a patient concerned an 89 year old male. The patient's weight was 73.6 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary hypertension.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included selexipag for drug used for unknown indication, tadalafil non-company for drug used for unknown indication, and macitentan for pulmonary hypertension. On an unspecified date, the subject experienced headache, and achy arm. Laboratory data (dates unspecified) included: Pulmonary hypertension (NR: not provided) ICD-9 and ICD-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and achy arm was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal discomfort, Nausea, Pain, Pyrexia
Clinical narrative: PAIN; DRY HEAVING CONTINUOUSLY; BACK DISCOMFORT; DISCOMFORT IN SCAR TISSUE FROM HIS PRIOR SURGERIES; CHILLS; FEVER; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgeries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced pain, dry heaving continuously, back discomfort, and discomfort in scar tissue from his prior surgeries. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea, had not recovered from dry heaving continuously, and the outcome of chills, fever, pain, back discomfort and discomfort in scar tissue from his prior surgeries was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Retching, Scar pain, Vomiting
Clinical narrative: PAIN; DRY HEAVING CONTINUOUSLY; BACK DISCOMFORT; DISCOMFORT IN SCAR TISSUE FROM HIS PRIOR SURGERIES; CHILLS; FEVER; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgeries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced pain, dry heaving continuously, back discomfort, and discomfort in scar tissue from his prior surgeries. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea, had not recovered from dry heaving continuously, and the outcome of chills, fever, pain, back discomfort and discomfort in scar tissue from his prior surgeries was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Band sensation, Hyperhidrosis, Injection site pain
Clinical narrative: UPPER BACK PAIN (BETWEEN  SHOULDER BLADES) RADIATING TO  THE CHEST CALLED MS HUG; SWEATS; ALLOVER WEAKNESS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 in left arm  for prophylactic vaccination. Concomitant medications included diazepam for multiple sclerosis. On 11-APR-2021, the subject experienced upper back pain (between shoulder blades) radiating to the chest called ms hug. On 11-APR-2021, the subject experienced sweats. On 11-APR-2021, the subject experienced allover weakness. On 11-APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upper back pain (between shoulder blades) radiating to the chest called ms hug, sweats, allover weakness, and soreness at injection site. This report was non-serious.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fibrin D dimer, Pain in extremity
Clinical narrative: CONSISTENT PAIN WHILE WAKING RESTING IN RIGHT CALF MUSCLE; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dairy allergy, wheat allergy, and gluten allergy, and other pre-existing medical conditions included the patient had give birth 4 times with healthy delivery. The patient never got a clot before, not overweight. The patient was not pregnant at the time of report. The patient was non-smoker and alcohol user. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient experienced consistent pain (pain to touch ) while waking and resting in right calf muscle. She did not take anything for that pain. The patient had no swelling. She had normal temperature. On 13-APR-2021, the patient went to MD for D-dimer to be measured because her physician recommended to do so since she was going to have a long flight on 14-APR-2021. The physician had a concern for having a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from consistent pain while waking resting in right calf muscle on 23-MAR-2021. This report was non serious..
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Headache, Night sweats, Pyrexia
Clinical narrative: SEVERE BRUISING ON BILATERAL LEGS  STARTED OFF DARK RED, BLUE GREEN AND PURPLE; FULL BODY NIGHT TIME SWEATING; FEVER; POUNDING HEADACHES THAT COME AND GO; BLOOD CLOTS ALL OVER MY LEGS; This spontaneous report was received from a patient and concerned female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, no known allergies, and born with slight thalassemia. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiry date: unknown) dose was not reported, administered on 02-APR-2021, at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had a fever of 102 Fahrenheit on 02-APR-2021. On 07-APR-2021, the patient noticed severe bruising on her bilateral legs, and stated that they were each about the size of a half dollar they started off dark red, turned blue, purple and noted they kept popping up. She stated that they were now blue and green in color. The patient felt that if she did not do something both her legs would be covered. She stated they were blood clots all over her legs. The patient had a visit to emergency room for the severe bruising on bilateral legs started off dark red and turned blue, green and purple. She also reported full body night time sweating every night and pounding headaches that come and go, especially upon standing.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-APR-2021, had not recovered from severe bruising on bilateral legs started off dark red, blue green and purple, and full body night time sweating, and the outcome of blood clots all over my legs and pounding headaches that come and go was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A female of unspecified age experienced fever the day of vaccine and 5 days later experienced bruising on bilateral legs the size of a half dollar. They varied in color. The patient visited the emergency room but details of diagnosis and treatment were not provided. There was no confirmation of a diagnosed thrombotic event. Based on the information provided, a meaningful medical assessment can not be made. Additional information will be requested, including contact with the patient and/or treating physician for further assessment.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain, Spinal pain, Testicular pain
Clinical narrative: LEFT TESTICULAR PAIN; SPINAL PAIN; LEFT KIDNEY PAIN; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 2, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZA expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced left testicular pain. On 11-APR-2021, the subject experienced spinal pain. On 11-APR-2021, the subject experienced left kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left testicular pain, spinal pain, and left kidney pain. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard operating procedures.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia
Clinical narrative: DIFFICULTY IN MOVING RIGHT ARM; NUMBNESS IN ARM; This spontaneous report received from a parent concerned a 22 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, the subject experienced difficulty in moving right arm. On APR-2021, the subject experienced numbness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty in moving right arm and numbness in arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH/SEVERE RASH ON FACE NECK AND ARMS; 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 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The company has requested follow-up for batch number. No concomitant medications were reported. On 12-APR-2021, the subject experienced rash/severe rash on face neck and arms. Treatment medications (dates unspecified) included: cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash/severe rash on face neck and arms. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Influenza like illness
Clinical narrative: EXTREMELY HEAVY MENSTRUAL CYCLE; FLU LIKE SYMPTOMS (FEVER, FELT HOT, CHILLS, HEADACHE AND SORENESS/PAIN); This spontaneous report received from a patient concerned a 36 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: 201A21A, and batch number: 201A21A 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 flu like symptoms (fever, felt hot, chills, headache and soreness/pain). On an unspecified date, the subject experienced extremely heavy menstrual cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely heavy menstrual cycle, and flu like symptoms (fever, felt hot, chills, headache and soreness/pain). This report was non-serious. This case, from the same reporter is linked to 20210436455 and 20210438566.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: SWELLING OF FACE; 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of face. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: BODY ACHE; RASH ON FOREARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, and rash on forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on forearm and body ache was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Pain, Pharyngeal swelling
Clinical narrative: LIGHT HEADEDNESS; SWELLING IN FACE; SWELLING IN THE THROAT AREA; THYROID PROBLEMS; BALANCE PROBLEMS; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported.  The patient's past medical history included colon cancer, sinus problems, neck injury, jaw virus, and hashimoto disease and concurrent conditions included allergy to hay fever, allergy to cleaners, allergy to rubber gloves, steroids allergy, and allergy to some chemotherapy medications, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced light headedness, swelling in face, swelling in the throat area, thyroid problems, balance problems, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thyroid problems, light headedness, swelling in face, fever, chills, balance problems, body aches and swelling in the throat area was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Thyroid disorder
Clinical narrative: LIGHT HEADEDNESS; SWELLING IN FACE; SWELLING IN THE THROAT AREA; THYROID PROBLEMS; BALANCE PROBLEMS; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported.  The patient's past medical history included colon cancer, sinus problems, neck injury, jaw virus, and hashimoto disease and concurrent conditions included allergy to hay fever, allergy to cleaners, allergy to rubber gloves, steroids allergy, and allergy to some chemotherapy medications, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced light headedness, swelling in face, swelling in the throat area, thyroid problems, balance problems, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thyroid problems, light headedness, swelling in face, fever, chills, balance problems, body aches and swelling in the throat area was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Heart rate increased, Nausea, Pain
Clinical narrative: HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; 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 pre-existing medical conditions included had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative.  On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia, Rash, Urticaria
Clinical narrative: HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; 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 pre-existing medical conditions included had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative.  On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 12-APR-2021, and had not recovered from body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Nasal congestion, Oropharyngeal pain, Productive cough
Clinical narrative: STUFFY NOSE; SORE THROAT; DARK GREEN MUCOUS; VOCAL CHORDS ARE AFFECTED; SUSPECTED COVID 19; TERRIBLE COUGH; DIZZY; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes. 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 24-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced dizzy. On an unspecified date, the subject experienced terrible cough, stuffy nose, sore throat, dark green mucous, vocal chords are affected, and suspected COVID 19. Treatment medications (dates unspecified) included: fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, had not recovered from stuffy nose, sore throat, terrible cough, dark green mucous, and vocal chords are affected, and the outcome of suspected COVID 19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vocal cord disorder
Clinical narrative: STUFFY NOSE; SORE THROAT; DARK GREEN MUCOUS; VOCAL CHORDS ARE AFFECTED; SUSPECTED COVID 19; TERRIBLE COUGH; DIZZY; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes. 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 24-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced dizzy. On an unspecified date, the subject experienced terrible cough, stuffy nose, sore throat, dark green mucous, vocal chords are affected, and suspected COVID 19. Treatment medications (dates unspecified) included: fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, had not recovered from stuffy nose, sore throat, terrible cough, dark green mucous, and vocal chords are affected, and the outcome of suspected COVID 19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: HEADACHE; DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced muscle pain. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, and muscle pain on 12-APR-2021, and fatigue, and headache on 13-APR-2021, and was recovering from nausea, and dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: HEADACHE; DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced muscle pain. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, and muscle pain on 12-APR-2021, and fatigue, and headache on 13-APR-2021, and was recovering from nausea, and dizziness. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Nausea, Presyncope, Therapeutic product effect decreased
Clinical narrative: LETHARGIC; EYE FLOATERS; ALMOST PASSED OUT; MIGRAINE TYPE OF HEADACHE; FELT NAUSEOUS; LOSS OF EFFECT; This spontaneous report received from a patient concerned a 57 year old female. The patient's concurrent conditions included sulfa allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of effect. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced eye floaters. On 08-APR-2021, the subject experienced almost passed out. On 08-APR-2021, the subject experienced migraine type of headache. On 08-APR-2021, the subject experienced felt nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye floaters, and felt nauseous on 09-APR-2021, had not recovered from migraine type of headache, and lethargic, and the outcome of almost passed out and loss of effect was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: LETHARGIC; EYE FLOATERS; ALMOST PASSED OUT; MIGRAINE TYPE OF HEADACHE; FELT NAUSEOUS; LOSS OF EFFECT; This spontaneous report received from a patient concerned a 57 year old female. The patient's concurrent conditions included sulfa allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of effect. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced eye floaters. On 08-APR-2021, the subject experienced almost passed out. On 08-APR-2021, the subject experienced migraine type of headache. On 08-APR-2021, the subject experienced felt nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye floaters, and felt nauseous on 09-APR-2021, had not recovered from migraine type of headache, and lethargic, and the outcome of almost passed out and loss of effect was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: LEG PAIN; SEVERE HEAD PAIN; This spontaneous report received from a consumer via a company representative concerned a 20 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain, and severe head pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe head pain, and the outcome of leg pain was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: 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 2021, the subject experienced possible stomach ache. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and possible stomach ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: CYST LIKE LUMP THAT APPEARED ON A TENDON; 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up on batch/lot number.  No concomitant medications were reported. On APR-2021, the subject experienced cyst like lump that appeared on a tendon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cyst like lump that appeared on a tendon was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea
Clinical narrative: TERRIBLE BACKACHE FROM THE BASE OF HER NECK TO THE BOTTOM OF HER BACK; CHILLS; POUNDING HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 53 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced terrible backache from the base of her neck to the bottom of her back. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pounding headache. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on APR-2021, and had not recovered from pounding headache, and terrible backache from the base of her neck to the bottom of her back. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling abnormal, Hot flush
Clinical narrative: SHORTNESS OF BREATH; BRAIN FOG; HOT FLASHES; CHILLS; 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 12-APR-2021 for prophylactic vaccination.  The batch number was not reported. The company was unable to perform follow up to request batch number/lot number. No concomitant medications were reported. On 12-APR-2021 22:00, the subject experienced hot flashes. On 12-APR-2021 22:00, the subject experienced chills.  On 13-APR-2021, the subject experienced brain fog. On 14-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, hot flashes, and chills on 14-APR-2021, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: REACTIONS SEVERE ENOUGH TO WARRANT REPORTING; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced reactions severe enough to warrant reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactions severe enough to warrant reporting was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: COVID arm (red, itchy rash on arm near injection site starting 6 days after 2nd dose)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Chills, fever, vomiting, diarrhea, muscle aches, fatigue, and an angry red rash that started on my left foot and gradually moved up underneath my knee. It was red, hot to the touch, swollen, and painful.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Chills, fever, vomiting, diarrhea, muscle aches, fatigue, and an angry red rash that started on my left foot and gradually moved up underneath my knee. It was red, hot to the touch, swollen, and painful.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Vomiting
Clinical narrative: Chills, fever, vomiting, diarrhea, muscle aches, fatigue, and an angry red rash that started on my left foot and gradually moved up underneath my knee. It was red, hot to the touch, swollen, and painful.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Peripheral swelling, Pyrexia, Rash, Vaccination complication
Clinical narrative: Swelling and rashes on the left arm and both the palms of the hands. There was also fever for a couple of days with severe headache.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach cramps and diarrhea,  Came on suddenly and lasted around 12 hours (about 4 to 5 acute episodes during time period)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Nasopharyngitis
Clinical narrative: Dizziness, sweating, cold, clammy, BP 118/69 (pulse 73). Lay down, given water.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This is being reported since the Moderna COVID-19 vaccine dose #1 was given in error for a 17 year old. Only the Pfizer vaccine is approved for 16-17 year old individuals. There are no adverse events associated with this incident.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Itching at injection site, pain at injection site, hard lump about the size of a quarter at injection almost 2 weeks after injection, slight discoloration like a bruise
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Skin tightness
Clinical narrative: None stated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood test normal, Headache, Magnetic resonance imaging normal, Mydriasis
Clinical narrative: Nueropathy (numbness weakness tingling) on right side.  Loss of vision 30 minutes right side.  Headaches, temple pain, sinus pain.  Shots of random pain throughout body.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Sinus pain
Clinical narrative: Nueropathy (numbness weakness tingling) on right side.  Loss of vision 30 minutes right side.  Headaches, temple pain, sinus pain.  Shots of random pain throughout body.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Influenza like illness, Lethargy, Muscular weakness
Clinical narrative: Severe headache, vomiting, muscle weakness high fever. Arm pain, very lethargic most of the next day. Was unable to make it to bathroom without assistance. 18 to 20 hours later still have the head ache and muscle weakness. am able to walk to bathroom unassisted. Slowly returning to normal. My whole body was weak and aching. Like the worst flu you've had .This started about 6 to 9 hours after the second injection and lasted over night with a high fever in the middle of the night and most of the next day.  At around 10:22 pm the symptoms have begun to subside.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Severe headache, vomiting, muscle weakness high fever. Arm pain, very lethargic most of the next day. Was unable to make it to bathroom without assistance. 18 to 20 hours later still have the head ache and muscle weakness. am able to walk to bathroom unassisted. Slowly returning to normal. My whole body was weak and aching. Like the worst flu you've had .This started about 6 to 9 hours after the second injection and lasted over night with a high fever in the middle of the night and most of the next day.  At around 10:22 pm the symptoms have begun to subside.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose increased, Blood pressure increased
Clinical narrative: Abdominal discomfort. Uncontrolled and increasing Blood pressure Uncontrolled and increasing blood glucose levels
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Syncope, flushing/dizziness, sweating, BP 92/50 (pulse 77). F/u pulse 116/56, O2 sat 99%.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain, Thrombosis
Clinical narrative: Experienced blood clots in my nose every night for about 10 nights after receiving vaccine injection.  Didn't think anything of it until I mentioned it to my mom who received her vaccine at the same time & place from the SAME BOTTLE and she too was waking with bloody clots in her nose. I experienced a reoccurrence for 4 days in mid April. I wouldn't have said anything but friends nagged us after the J&J blood clotting issue.  (We both also experienced severe piercing & throbbing pain in the bone beneath the injection  for about 14 days.) I mentioned both events to my GP on 3/26/21
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: This event is reported because patient received the wrong 2nd dose COVID-19 vaccine. Patient received 1st dose Moderna at another facility on 3/24/21. On 4/19/21, patient came to our facility intending to receive 2nd dose Moderna, but was inadvertently given Pfizer instead. There was no adverse event, this is reported since an error was made.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Fever, chills, hot flashes, sweating, nausea, vomiting, headache, weakness, fatigue, body aches
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, hot flashes, sweating, nausea, vomiting, headache, weakness, fatigue, body aches