chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal
Clinical narrative: JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Disturbance in attention, Feeling abnormal, Hypoaesthesia
Clinical narrative: JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Muscle twitching, Musculoskeletal pain, Nausea, Pain
Clinical narrative: JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Spinal cord oedema, Spinal pain
Clinical narrative: JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: FACE SWELLING; THROAT SWELLING; This spontaneous report received from a consumer 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced face swelling, and throat swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face swelling and throat swelling was not reported. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 15 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced off label use. On 05-JUN-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Erythema, Insomnia, Joint warmth, Pain
Clinical narrative: SWELLING; ALLERGIC REACTION TO THE VACCINE; RIGHT SHOULDER WAS TOO HOT; RIGHT SHOULDER WAS BEET RED; CRYING PAIN; COULD NOT SLEEP; RIGHT SHOULDER WAS ACHING AND HURTING AND HALF-WAY DOWN TO ELBOW; This spontaneous report received from a parent concerned a 47 year old female. The patient's weight was 150 pounds, and height was 68.5 inches. The patient's past medical history included tattoo in left arm, and concurrent conditions included non alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no know allergies and no drug abuse or illicit drug usage. the patient never had any issues with her shoulder or has taken any regular medications. 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 APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced crying pain. On APR-2021, the subject experienced could not sleep. On APR-2021, the subject experienced right shoulder was aching and hurting and half-way down to elbow. On MAY-2021, the subject experienced right shoulder was beet red. On MAY-2021, the subject experienced right shoulder was too hot. On 07-JUN-2021, Laboratory data included: X-ray (NR: not provided) did not see anything, nothing wrong. On an unspecified date, the subject experienced swelling, and allergic reaction to the vaccine. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right shoulder was beet red, and right shoulder was too hot on MAY-2021, had not recovered from right shoulder was aching and hurting and half-way down to elbow, crying pain, and could not sleep, and the outcome of swelling and allergic reaction to the vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, X-ray
Clinical narrative: SWELLING; ALLERGIC REACTION TO THE VACCINE; RIGHT SHOULDER WAS TOO HOT; RIGHT SHOULDER WAS BEET RED; CRYING PAIN; COULD NOT SLEEP; RIGHT SHOULDER WAS ACHING AND HURTING AND HALF-WAY DOWN TO ELBOW; This spontaneous report received from a parent concerned a 47 year old female. The patient's weight was 150 pounds, and height was 68.5 inches. The patient's past medical history included tattoo in left arm, and concurrent conditions included non alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no know allergies and no drug abuse or illicit drug usage. the patient never had any issues with her shoulder or has taken any regular medications. 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 APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced crying pain. On APR-2021, the subject experienced could not sleep. On APR-2021, the subject experienced right shoulder was aching and hurting and half-way down to elbow. On MAY-2021, the subject experienced right shoulder was beet red. On MAY-2021, the subject experienced right shoulder was too hot. On 07-JUN-2021, Laboratory data included: X-ray (NR: not provided) did not see anything, nothing wrong. On an unspecified date, the subject experienced swelling, and allergic reaction to the vaccine. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right shoulder was beet red, and right shoulder was too hot on MAY-2021, had not recovered from right shoulder was aching and hurting and half-way down to elbow, crying pain, and could not sleep, and the outcome of swelling and allergic reaction to the vaccine was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN HANDS; BURNING SENSATION IN RIGHT SHOULDER BLADE THAT MOVED DOWN THE RIGHT SIDE OF BODY TO KNEE; NUMBNESS ON RIGHT SIDE OF THE BODY THAT GOES ACROSS SHOULDERS AND DOWN INTO RIGHT ARM; PAIN IN FINGER; CHILLS; FEVER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos.  On APR-2021, the subject experienced numbness on right side of the body that goes across shoulders and down into right arm. On APR-2021, the subject experienced pain in finger. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced burning sensation in right shoulder blade that moved down the right side of body to knee. On an unspecified date, the subject experienced tingling in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, and the outcome of pain in finger, numbness on right side of the body that goes across shoulders and down into right arm, burning sensation in right shoulder blade that moved down the right side of body to knee and tingling in hands was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: TINGLING IN HANDS; BURNING SENSATION IN RIGHT SHOULDER BLADE THAT MOVED DOWN THE RIGHT SIDE OF BODY TO KNEE; NUMBNESS ON RIGHT SIDE OF THE BODY THAT GOES ACROSS SHOULDERS AND DOWN INTO RIGHT ARM; PAIN IN FINGER; CHILLS; FEVER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos.  On APR-2021, the subject experienced numbness on right side of the body that goes across shoulders and down into right arm. On APR-2021, the subject experienced pain in finger. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced burning sensation in right shoulder blade that moved down the right side of body to knee. On an unspecified date, the subject experienced tingling in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, and the outcome of pain in finger, numbness on right side of the body that goes across shoulders and down into right arm, burning sensation in right shoulder blade that moved down the right side of body to knee and tingling in hands was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a pharmacist 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 30-MAY-2021 01:00 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611858, 20210612634 and 20210612779.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE OUT OF THE VIAL ONE DAY BEFORE THE ADMINISTRATION AND THEN STORED IT IN THE REFRIGERATOR; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients. 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: Unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vaccine out of the vial one day before the administration and then stored it in the refrigerator. On 28-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine out of the vial one day before the administration and then stored it in the refrigerator and poor quality vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative 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 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. 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 arm pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and arm pain, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: BODY ACHE; VOMITING; NAUSEA; FEVER; This spontaneous report received from a parent concerned an 18 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced body ache. On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced nausea. On 05-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, vomiting, nausea, and fever on 06-JUN-2021. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: VOMITING; BODY ACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included diabetes, shortness of breath, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978,expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and the outcome of vomiting was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Nausea, Pyrexia
Clinical narrative: VOMITING; DIARRHEA; PAIN IN STOMACH; NO APPETITE; CANNOT HOLD DOWN FOOD; FEVER; NAUSEA; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced vomiting. On 07-JUN-2021, the subject experienced diarrhea. On 07-JUN-2021, the subject experienced pain in stomach. On 07-JUN-2021, the subject experienced no appetite. On 07-JUN-2021, the subject experienced cannot hold down food. On 07-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting, diarrhea, pain in stomach, no appetite and cannot hold down food was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Regurgitation, Vomiting
Clinical narrative: VOMITING; DIARRHEA; PAIN IN STOMACH; NO APPETITE; CANNOT HOLD DOWN FOOD; FEVER; NAUSEA; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced vomiting. On 07-JUN-2021, the subject experienced diarrhea. On 07-JUN-2021, the subject experienced pain in stomach. On 07-JUN-2021, the subject experienced no appetite. On 07-JUN-2021, the subject experienced cannot hold down food. On 07-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting, diarrhea, pain in stomach, no appetite and cannot hold down food was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Injection site rash, Peripheral swelling
Clinical narrative: injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm; doctor diagnosed with cellulitis; swelling of the entire L arm; injection site circle; Swelling arm and finger; Injection site itchiness; rash at the right side of the waist; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (doctor diagnosed with cellulitis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash at the right side of the waist). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itchiness). On 07-Jan-2021, the patient experienced CELLULITIS (doctor diagnosed with cellulitis) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling of the entire L arm), INJECTION SITE RASH (injection site circle) and PERIPHERAL SWELLING (Swelling arm and finger). On an unknown date, the patient experienced INJECTION SITE PAIN (injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm). On 31-Dec-2020, RASH (rash at the right side of the waist) had resolved. On 08-Jan-2021, PERIPHERAL SWELLING (swelling of the entire L arm) had resolved. At the time of the report, CELLULITIS (doctor diagnosed with cellulitis), INJECTION SITE PRURITUS (Injection site itchiness), INJECTION SITE RASH (injection site circle) and PERIPHERAL SWELLING (Swelling arm and finger) had not resolved and INJECTION SITE PAIN (injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Antibiotics and steroids used as a Treatment medication; 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm; doctor diagnosed with cellulitis; swelling of the entire L arm; injection site circle; Swelling arm and finger; Injection site itchiness; rash at the right side of the waist; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (doctor diagnosed with cellulitis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash at the right side of the waist). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itchiness). On 07-Jan-2021, the patient experienced CELLULITIS (doctor diagnosed with cellulitis) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling of the entire L arm), INJECTION SITE RASH (injection site circle) and PERIPHERAL SWELLING (Swelling arm and finger). On an unknown date, the patient experienced INJECTION SITE PAIN (injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm). On 31-Dec-2020, RASH (rash at the right side of the waist) had resolved. On 08-Jan-2021, PERIPHERAL SWELLING (swelling of the entire L arm) had resolved. At the time of the report, CELLULITIS (doctor diagnosed with cellulitis), INJECTION SITE PRURITUS (Injection site itchiness), INJECTION SITE RASH (injection site circle) and PERIPHERAL SWELLING (Swelling arm and finger) had not resolved and INJECTION SITE PAIN (injection site hurt and large circle at the injection site, hot and burning measuring 10 x 8.5 cm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Antibiotics and steroids used as a Treatment medication; 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Death, Dizziness, Nausea, Pain
Clinical narrative: Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the vaccine was not the cause, he had other medical issues too.  This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the vaccine was not the cause, he had other medical issues too.  This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control, Glycosylated haemoglobin
Clinical narrative: blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (COZAAR), INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-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 DIABETES MELLITUS INADEQUATE CONTROL (blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Glycosylated haemoglobin: higher by 0.3 (abnormal) higher by 0.3.         Treatment details included none yet, but the patient reported following up with HCP about need to change insulin dosing.  Company comment: Very little information is provided for this case and follow-up has been requested. 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.; Sender's Comments: Very little information is provided for this case and follow-up has been requested. 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: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Thrombosis
Clinical narrative: Blood clots in lungs, heart and right leg; felt like someone punched me in the chest; severe shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in lungs, heart and right leg), CHEST DISCOMFORT (felt like someone punched me in the chest) and DYSPNOEA (severe shortness of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots in lungs, heart and right leg) (seriousness criteria hospitalization, medically significant and life threatening), CHEST DISCOMFORT (felt like someone punched me in the chest) (seriousness criterion hospitalization) and DYSPNOEA (severe shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to CHEST DISCOMFORT, DYSPNOEA and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clots in lungs, heart and right leg), CHEST DISCOMFORT (felt like someone punched me in the chest) and DYSPNOEA (severe shortness of breath) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.  After spending 7 days in ICU patient was found to have blood clots in lungs, heart and right leg. This was caused by the moderna vaccination. As per doctors if patient had waited 1 more day patient would have died.  Company Comment  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 28-May-2021: Event thrombosis added.; 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia
Clinical narrative: Diagnosed with covid-19; Fatigued; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (Fatigued) and PYREXIA (Feverish). On 15-Jan-2021, the patient experienced COVID-19 (Diagnosed with covid-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (Diagnosed with covid-19), FATIGUE (Fatigued) and PYREXIA (Feverish) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were reported by the reporter. Treatment details not reported by the reporter.  Company Comment: Very limited information regarding the events has been provided at this time. No further information is expected. Causality for fatigue and pyrexia is assessed as possibly related and for COVID-19 as not applicable.; Sender's Comments: Very limited information regarding the events has been provided at this time. No further information is expected. Causality for fatigue and pyrexia is assessed as possibly related and for COVID-19 as not applicable.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Renal failure, Vaccination site pain
Clinical narrative: kidneys were at failure points; weakness like his running out of gas/lack of stamina; local arm tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of RENAL FAILURE (kidneys were at failure points) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0H0B21A and 0021321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (weakness like his running out of gas/lack of stamina) and VACCINATION SITE PAIN (local arm tenderness at the injection site). On 17-Apr-2021, the patient experienced RENAL FAILURE (kidneys were at failure points) (seriousness criterion medically significant). At the time of the report, RENAL FAILURE (kidneys were at failure points), ASTHENIA (weakness like his running out of gas/lack of stamina) and VACCINATION SITE PAIN (local arm tenderness at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received his first dose of the Moderna vaccine on 15-Mar-2021 and had "zero side effects." The patient reported that his kidney function was normal before the second shot, but a week after the second shot, his kidneys were at failure points. No treatments were taken.  Company comment: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic disorder
Clinical narrative: same bleeding disorder; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC DISORDER (same bleeding disorder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC DISORDER (same bleeding disorder) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGIC DISORDER (same bleeding disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient had a bleeding disorder after getting the vaccine. Her reaction happened one day after she got the vaccine.  No concomitant medications were reported. No corrective treatment was provided.  Very minimal information is available at this time and follow-up has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Very minimal information is available at this time and follow-up has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight tenderness at site of injection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 12Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's spouse) via the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), intramuscularly administered in the left arm on 06Mar2021 10:35 (lot number: EL6206) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient previously received BNT162B2 (lot number: EL9263) intramuscularly, administered in the left arm on 04Feb2021 11:50 as 1st dose, single dose for COVID-19 immunization. The patient had no prior vaccinations. The patient's spouse reported that neither she nor the patient had any side effect from either of the vaccination, (only) slight tenderness at site of injection. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor soreness at vaccination site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (22Mar2021), this case now contains all required information to be considered valid.  This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL92U2) intramuscular, administered in Arm Left on 04Feb2021 23:30 (at the age of 85-years-old) as 1ST DOSE, SINGLE DOSE and second dose via intramuscular, administered in Arm Left on 23Feb2021 12:45 (at the age of 85-years-old) (Batch/Lot Number: EW6203) as 2ND DOSE, SINGLE DOSE both for covid-19 immunisation at Hospital. Medical history was none. The patient's concomitant medications were none. The patient experienced minor soreness at vaccination site on an unspecified date. It was reported that the two shots resulted in absolutely no reaction beyond a minor soreness at the vaccination site, which was gone within 24 his after each shot. patient was scheduled for a dental procedure 16Feb2021 that will require predosing with amoxicillin and a bone graft. Patient wants to know if either of these things will interact with his second dose of vaccine. He stated he had dental appointment for surgery, the strength of the Covid-19 Bone graft to repair the bone where the teeth come out- go back in an put implants into my lower jaw and attach crowns to it I have to take 3 days worth of amoxicillin TID, then day of surgery take a dose of 4 amoxicillin. Prior Vaccinations were reported as none. The outcome of the event was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.