chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: LIGHT HEADEDNESS; SORE THROAT; CHEST HEAVINESS; APPETITE LOST; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced appetite lost. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced chest heaviness. On 25-MAY-2021, the subject experienced light headedness. On 25-MAY-2021, the subject experienced sore throat. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, fever, and headache on 23-MAY-2021, and had not recovered from light headedness, sore throat, chest heaviness, and appetite lost. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: LIGHT HEADEDNESS; SORE THROAT; CHEST HEAVINESS; APPETITE LOST; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced appetite lost. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced chest heaviness. On 25-MAY-2021, the subject experienced light headedness. On 25-MAY-2021, the subject experienced sore throat. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, fever, and headache on 23-MAY-2021, and had not recovered from light headedness, sore throat, chest heaviness, and appetite lost. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Injection site swelling, Pain
Clinical narrative: VOMITING; DIARRHEA; ACHES/ PAINS; FEVER; POUNDING HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight was 215 pounds, and height was 74 inches. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included tadalafil for gastric disorder, colestipol, and levothyroxine. On 24-MAY-2021, the subject experienced vomiting. On 24-MAY-2021, the subject experienced diarrhea. On 24-MAY-2021, the subject experienced aches/ pains. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced pounding headache. On 24-MAY-2021, the subject experienced swelling at injection site. On 25-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, vomiting, diarrhea, aches/ pains, pounding headache, and swelling at injection site. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: VOMITING; DIARRHEA; ACHES/ PAINS; FEVER; POUNDING HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight was 215 pounds, and height was 74 inches. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included tadalafil for gastric disorder, colestipol, and levothyroxine. On 24-MAY-2021, the subject experienced vomiting. On 24-MAY-2021, the subject experienced diarrhea. On 24-MAY-2021, the subject experienced aches/ pains. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced pounding headache. On 24-MAY-2021, the subject experienced swelling at injection site. On 25-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, vomiting, diarrhea, aches/ pains, pounding headache, and swelling at injection site. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Muscle spasms, Peripheral swelling
Clinical narrative: RIGHT HAND CRAMPING AND PULSATING PRETTY GOOD; RIGHT HAND SWOLLEN; UNABLE TO CLOSE HAND COMPLETELY; This spontaneous report received from a patient concerned an adult male. The patient's weight was 240 pounds, and height was 73 inches. The patient's past medical history included ablation, and stents, and concurrent conditions included heart issue, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported batch number: 1808986 expiry: 04-JUL-2021) dose was not reported, administered on 24-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced right hand swollen. On MAY-2021, the subject experienced unable to close hand completely. On 25-MAY-2021, the subject experienced right hand cramping and pulsating pretty good. The action taken with covid-19 vaccine was not applicable. The patient was recovering from right hand cramping and pulsating pretty good, right hand swollen, and unable to close hand completely. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE/ PUT 10 VIALS INTO THE FREEZER INSTEAD  OF THE FRIDGE; 5 DOSES OF VACCINE GIVEN AFTER BEING PUT INTO FREEZER AFTER RECEIVING FROM MANUFACTURER; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced 5 doses of vaccine given after being put into freezer after receiving from manufacturer. On an unspecified date, the subject experienced incorrect product storage/ put 10 vials into the freezer instead of the fridge. The action taken with covid-19 vaccine  was not applicable. The outcome of the 5 doses of vaccine given after being put into freezer after receiving from manufacturer and incorrect product storage/ put 10 vials into the freezer instead of the fridge was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Diaphragmalgia, Dyspnoea
Clinical narrative: BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADACHE; INJECTION SITE PAIN; SENSITIVE SKIN; CHILLS; FEVERISH; TIRED; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced sensitive skin. On 23-MAY-2021, the subject experienced chills. On 23-MAY-2021, the subject experienced feverish. On 23-MAY-2021, the subject experienced tired. On 23-MAY-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 98.7. On 24-MAY-2021, the subject experienced pain near diaphragm. On 24-MAY-2021, the subject experienced difficulty breathing and shortness of breath. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced bruised easily. The action taken with covid-19 vaccine was not applicable. The patient recovered from sensitive skin, chills, and feverish on 24-MAY-2021, was recovering from chest pain, pain near diaphragm, and headache, had not recovered from difficulty breathing and shortness of breath, and injection site pain, and the outcome of tired and bruised easily was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Increased tendency to bruise, Injection site pain, Pyrexia
Clinical narrative: BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADACHE; INJECTION SITE PAIN; SENSITIVE SKIN; CHILLS; FEVERISH; TIRED; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced sensitive skin. On 23-MAY-2021, the subject experienced chills. On 23-MAY-2021, the subject experienced feverish. On 23-MAY-2021, the subject experienced tired. On 23-MAY-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 98.7. On 24-MAY-2021, the subject experienced pain near diaphragm. On 24-MAY-2021, the subject experienced difficulty breathing and shortness of breath. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced bruised easily. The action taken with covid-19 vaccine was not applicable. The patient recovered from sensitive skin, chills, and feverish on 24-MAY-2021, was recovering from chest pain, pain near diaphragm, and headache, had not recovered from difficulty breathing and shortness of breath, and injection site pain, and the outcome of tired and bruised easily was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADACHE; INJECTION SITE PAIN; SENSITIVE SKIN; CHILLS; FEVERISH; TIRED; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced sensitive skin. On 23-MAY-2021, the subject experienced chills. On 23-MAY-2021, the subject experienced feverish. On 23-MAY-2021, the subject experienced tired. On 23-MAY-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 98.7. On 24-MAY-2021, the subject experienced pain near diaphragm. On 24-MAY-2021, the subject experienced difficulty breathing and shortness of breath. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced bruised easily. The action taken with covid-19 vaccine was not applicable. The patient recovered from sensitive skin, chills, and feverish on 24-MAY-2021, was recovering from chest pain, pain near diaphragm, and headache, had not recovered from difficulty breathing and shortness of breath, and injection site pain, and the outcome of tired and bruised easily was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Contusion, Injection site pain, Neck pain, Psoriasis
Clinical narrative: BOWELS UPSET AND YELLOW SLIME COMING OUT SINCE DAY OF SHOT; BURNING IN ARM; SEVERE PAIN IN ARM AT INJECTION SITE; PSORIASIS; NECK PAIN; BRUISE HAVING THE SIZE OF 50 CENT PIECE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, severe gastroparesis, internal tremors, and psoriasis, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included adalimumab for psoriasis, ixekizumab for psoriasis, risankizumab for psoriasis, and ustekinumab for psoriasis.  On MAY-2021, the subject experienced neck pain. On MAY-2021, the subject experienced bruise having the size of 50 cent piece. On MAY-2021, the subject experienced psoriasis. On 10-MAY-2021, the subject experienced bowels upset and yellow slime coming out since day of shot. On 10-MAY-2021, the subject experienced burning in arm. On 10-MAY-2021, the subject experienced severe pain in arm at injection site. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from bowels upset and yellow slime coming out since day of shot, had not recovered from severe pain in arm at injection site, and burning in arm, and the outcome of psoriasis, neck pain and bruise having the size of 50 cent piece was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: BOWELS UPSET AND YELLOW SLIME COMING OUT SINCE DAY OF SHOT; BURNING IN ARM; SEVERE PAIN IN ARM AT INJECTION SITE; PSORIASIS; NECK PAIN; BRUISE HAVING THE SIZE OF 50 CENT PIECE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, severe gastroparesis, internal tremors, and psoriasis, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included adalimumab for psoriasis, ixekizumab for psoriasis, risankizumab for psoriasis, and ustekinumab for psoriasis.  On MAY-2021, the subject experienced neck pain. On MAY-2021, the subject experienced bruise having the size of 50 cent piece. On MAY-2021, the subject experienced psoriasis. On 10-MAY-2021, the subject experienced bowels upset and yellow slime coming out since day of shot. On 10-MAY-2021, the subject experienced burning in arm. On 10-MAY-2021, the subject experienced severe pain in arm at injection site. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from bowels upset and yellow slime coming out since day of shot, had not recovered from severe pain in arm at injection site, and burning in arm, and the outcome of psoriasis, neck pain and bruise having the size of 50 cent piece was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced loss of taste, and loss of smell. The action taken with covid-19 vaccine  was not applicable. The outcome of the loss of taste and loss of smell was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash
Clinical narrative: FLUSHING IN THE FACE; RASH ACROSS NECK, EARS, LEFT CHEST; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included removal of lymph nodes, covid-19 infection, and hives, and concurrent conditions included breast cancer, latex allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with lidocaine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201a21a, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced flushing in the face. On 25-MAY-2021, the subject experienced rash across neck, ears, left chest. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from rash across neck, ears, left chest, and flushing in the face. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Muscle discomfort
Clinical narrative: MUSCLE DISCOMFORT IN CALF; MASSIVE PAIN IN HEAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle discomfort in calf, and massive pain in head. The action taken with covid-19 vaccine  was not applicable. The outcome of the muscle discomfort in calf and massive pain in head was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dry skin, Pruritus
Clinical narrative: SEVERELY DRY SKIN; ACHY BACK; ITCHINESS IN LEGS/ARMS/BUTTOCK/BACK/BELLY/UNDER ARM; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced severely dry skin. On 22-MAY-2021, the subject experienced achy back. On 22-MAY-2021, the subject experienced itchiness in legs/arms/buttock/back/belly/under arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from severely dry skin, achy back, and itchiness in legs/arms/buttock/back/belly/under arm. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest discomfort, Chills, Dizziness
Clinical narrative: BACK PAIN; SHORTNESS OF BREATH; CHEST TIGHTNESS; EXHAUSTED/VERY TIRED; HEADACHE; CHILLS; FEVER; DIZZINESS; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included desvenlafaxine for depression. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Between 100.3 -102.7. Treatment medications included: acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine hydrochloride. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced exhausted. On 22-MAY-2021, the subject experienced shortness of breath. On 22-MAY-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness on 22-MAY-2021, and fever on 21-MAY-2021, had not recovered from headache, back pain, exhausted, shortness of breath, and chest tightness, and the outcome of chills was not reported. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Pyrexia
Clinical narrative: BACK PAIN; SHORTNESS OF BREATH; CHEST TIGHTNESS; EXHAUSTED/VERY TIRED; HEADACHE; CHILLS; FEVER; DIZZINESS; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included desvenlafaxine for depression. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Between 100.3 -102.7. Treatment medications included: acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine hydrochloride. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced exhausted. On 22-MAY-2021, the subject experienced shortness of breath. On 22-MAY-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness on 22-MAY-2021, and fever on 21-MAY-2021, had not recovered from headache, back pain, exhausted, shortness of breath, and chest tightness, and the outcome of chills was not reported. This report was non-serious.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Physical product label issue, Product administration error, Product storage error
Clinical narrative: LOOSE PIECE OF PAPER AROUND BOTTLE; PRODUCT STORAGE ERROR; ADMINISTRATION ERROR; USE OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 42 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced use of expired vaccine. On 25-MAY-2021, the subject experienced administration error. On an unspecified date, the subject experienced loose piece of paper around bottle, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the use of expired vaccine, loose piece of paper around bottle, product storage error and administration error was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: RECEIVED EXPIRED DOSE OF VACCINE; TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a health care professional concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced received expired dose of vaccine. On 24-MAY-2021, the subject experienced temperature excursion issue. The action taken with covid-19 vaccine was not applicable. The outcome of the received expired dose of vaccine and temperature excursion issue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: NECK AND SHOULDER STIFFNESS; RASH AT SITE OF INJECTION; PAIN AT SITE OF INJECTION; HEADACHE; REDNESS AT SITE OF INJECTION; MILD FEVER; TINNITUS; 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 pre-existing medical conditions included the patient had no history of tinnitus. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tinnitus. On an unspecified date, the subject experienced neck and shoulder stiffness, rash at site of injection, pain at site of injection, headache, redness at site of injection, and mild fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tinnitus, and the outcome of pain at site of injection, neck and shoulder stiffness, headache, redness at site of injection, mild fever and rash at site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pyrexia, Tinnitus
Clinical narrative: NECK AND SHOULDER STIFFNESS; RASH AT SITE OF INJECTION; PAIN AT SITE OF INJECTION; HEADACHE; REDNESS AT SITE OF INJECTION; MILD FEVER; TINNITUS; 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 pre-existing medical conditions included the patient had no history of tinnitus. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tinnitus. On an unspecified date, the subject experienced neck and shoulder stiffness, rash at site of injection, pain at site of injection, headache, redness at site of injection, and mild fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tinnitus, and the outcome of pain at site of injection, neck and shoulder stiffness, headache, redness at site of injection, mild fever and rash at site of injection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTRATION; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk, expiry: 25-MAY-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced expired vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administration was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Urticaria
Clinical narrative: HIVES ON UPPER THIGHS THAT ARE ITCHY; HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was not reported and height was 165.1 centimeters. The patient's past medical history included pulmonary embolism, and concurrent conditions included marijuana abuse, alcohol use, non smoker, and penicillin allergy.  The patient was previously treated with rivaroxaban for pulmonary embolism. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced hives on upper thighs that are itchy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 25-MAY-2021, and had not recovered from hives on upper thighs that are itchy. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash, Rash erythematous
Clinical narrative: HIVES ON UPPER THIGHS THAT ARE ITCHY; HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was not reported and height was 165.1 centimeters. The patient's past medical history included pulmonary embolism, and concurrent conditions included marijuana abuse, alcohol use, non smoker, and penicillin allergy.  The patient was previously treated with rivaroxaban for pulmonary embolism. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced hives on upper thighs that are itchy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 25-MAY-2021, and had not recovered from hives on upper thighs that are itchy. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Pain in extremity, Paraesthesia oral
Clinical narrative: Anaphylactic reaction; tingling in the roof of mouth; arm soreness; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (tingling in the roof of mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (mast cell disease, its autoimmune.), Nausea, Vomiting, Numbness and Nerve pain. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and CIMETIDINE (H2 BLOCKER [CIMETIDINE]) for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling in the roof of mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at a dose of 400 mg; EPINEPHRINE (EPIPEN) for Swelling, at a dose of UNK dosage form; ALBUTEROL [SALBUTAMOL] at a dose of UNK dosage form; IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) at a dose of UNK dosage form; BUDESONIDE (PULMICORT) at a dose of UNK dosage form and ARFORMOTEROL TARTRATE (BROVANA) at a dose of UNK dosage form. At the time of the report, PARAESTHESIA ORAL (tingling in the roof of mouth) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Benadryl 300 mg and EpiPen. Then Albuterol, Duoneb, Pulmicort, Brovana, Epinephrin and 900 Benadryl.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25 May 2021 includes no new information; 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. The patient's medical history of mast cell disease autoimmune remains a risk factor.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Heart rate, Heart rate increased, Malaise
Clinical narrative: eight hours after vaccination felt very sick, indisposed; palpitations; eight hours after vaccination felt very bad; felt something in the chest like a tremendous pressure; Heart Beat was 76 and in a second raised to 151-152; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (eight hours after vaccination felt very sick, indisposed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (eight hours after vaccination felt very sick, indisposed) (seriousness criterion hospitalization), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad). On an unknown date, the patient experienced PALPITATIONS (palpitations). The patient was hospitalized for 5 days due to MALAISE. At the time of the report, MALAISE (eight hours after vaccination felt very sick, indisposed), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad) outcome was unknown and PALPITATIONS (palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: 76, 151-152 (Inconclusive) 76, 151-152 beats/min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient went to emergency and was hospitalized for 5 days.  Treatment details included acetylsalicylic acid for the blood flow and heart.  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.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant; additional events added with details. Case upgraded to serious.; Reporter's Comments: .; 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: eight hours after vaccination felt very sick, indisposed; palpitations; eight hours after vaccination felt very bad; felt something in the chest like a tremendous pressure; Heart Beat was 76 and in a second raised to 151-152; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (eight hours after vaccination felt very sick, indisposed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (eight hours after vaccination felt very sick, indisposed) (seriousness criterion hospitalization), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad). On an unknown date, the patient experienced PALPITATIONS (palpitations). The patient was hospitalized for 5 days due to MALAISE. At the time of the report, MALAISE (eight hours after vaccination felt very sick, indisposed), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad) outcome was unknown and PALPITATIONS (palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: 76, 151-152 (Inconclusive) 76, 151-152 beats/min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient went to emergency and was hospitalized for 5 days.  Treatment details included acetylsalicylic acid for the blood flow and heart.  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.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant; additional events added with details. Case upgraded to serious.; Reporter's Comments: .; 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Cough, Decreased appetite, Dyspnoea, Gait inability
Clinical narrative: Mild heart failure; His heart has a fast beat; Shortness of breath/ difficulty breathing; Extremely weak; His heart beat was irregular and a little higher then normal; Coughed a couple of times on the call; Patient said that he has lost his appetite; Very very ill; Walking was very difficult; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Mild heart failure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CARDIAC FAILURE (Mild heart failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath/ difficulty breathing), MUSCULAR WEAKNESS (Extremely weak), HEART RATE IRREGULAR (His heart beat was irregular and a little higher then normal), COUGH (Coughed a couple of times on the call), DECREASED APPETITE (Patient said that he has lost his appetite), ILLNESS (Very very ill), GAIT INABILITY (Walking was very difficult) and PALPITATIONS (His heart has a fast beat). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to CARDIAC FAILURE. On 10-Apr-2021, CARDIAC FAILURE (Mild heart failure) had resolved. At the time of the report, DYSPNOEA (Shortness of breath/ difficulty breathing), MUSCULAR WEAKNESS (Extremely weak), HEART RATE IRREGULAR (His heart beat was irregular and a little higher then normal), COUGH (Coughed a couple of times on the call) and DECREASED APPETITE (Patient said that he has lost his appetite) had not resolved and ILLNESS (Very very ill), GAIT INABILITY (Walking was very difficult) and PALPITATIONS (His heart has a fast beat) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Additional information included events were added, hospitalization details was updated, hence case was upgraded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Illness, Muscular weakness, Palpitations
Clinical narrative: Mild heart failure; His heart has a fast beat; Shortness of breath/ difficulty breathing; Extremely weak; His heart beat was irregular and a little higher then normal; Coughed a couple of times on the call; Patient said that he has lost his appetite; Very very ill; Walking was very difficult; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Mild heart failure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CARDIAC FAILURE (Mild heart failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath/ difficulty breathing), MUSCULAR WEAKNESS (Extremely weak), HEART RATE IRREGULAR (His heart beat was irregular and a little higher then normal), COUGH (Coughed a couple of times on the call), DECREASED APPETITE (Patient said that he has lost his appetite), ILLNESS (Very very ill), GAIT INABILITY (Walking was very difficult) and PALPITATIONS (His heart has a fast beat). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to CARDIAC FAILURE. On 10-Apr-2021, CARDIAC FAILURE (Mild heart failure) had resolved. At the time of the report, DYSPNOEA (Shortness of breath/ difficulty breathing), MUSCULAR WEAKNESS (Extremely weak), HEART RATE IRREGULAR (His heart beat was irregular and a little higher then normal), COUGH (Coughed a couple of times on the call) and DECREASED APPETITE (Patient said that he has lost his appetite) had not resolved and ILLNESS (Very very ill), GAIT INABILITY (Walking was very difficult) and PALPITATIONS (His heart has a fast beat) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Additional information included events were added, hospitalization details was updated, hence case was upgraded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pneumonia, Pyrexia
Clinical narrative: Pneumonia; Fever; Head ache; body ache and muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), PYREXIA (Fever), HEADACHE (Head ache) and MYALGIA (body ache and muscle pain). At the time of the report, PNEUMONIA (Pneumonia), PYREXIA (Fever), HEADACHE (Head ache) and MYALGIA (body ache and muscle pain) outcome was unknown.            Concomitant product use was not provided. On an unspecified date, the patient had fever, headache, body ache, and muscle pain. Later, she developed with pneumonia. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 (Moderna COVID-19 Vaccine); therefore, the action taken in response to the events was not applicable.  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.