chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Feeling abnormal, Limb discomfort, Pruritus, Rash
Clinical narrative: Her skin feels burned; A raised welt that itches; A raised welt; He arm reaction is the same as her penicillin response; The rash is moving to the underside of her arm; Her upper arm looked like a ham; Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed; Over 2 hours after the shot she couldn't speak; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Over 2 hours after the shot she couldn't speak), LIMB DISCOMFORT (Her upper arm looked like a ham), FEELING ABNORMAL (Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed), SKIN BURNING SENSATION (Her skin feels burned) and PRURITUS (A raised welt that itches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052ED1A and 939676) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced DYSARTHRIA (Over 2 hours after the shot she couldn't speak) and FEELING ABNORMAL (Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed). On 24-Jul-2021, the patient experienced LIMB DISCOMFORT (Her upper arm looked like a ham), SKIN BURNING SENSATION (Her skin feels burned), PRURITUS (A raised welt that itches), URTICARIA (A raised welt), VACCINATION COMPLICATION (He arm reaction is the same as her penicillin response) and RASH (The rash is moving to the underside of her arm). At the time of the report, DYSARTHRIA (Over 2 hours after the shot she couldn't speak), LIMB DISCOMFORT (Her upper arm looked like a ham), FEELING ABNORMAL (Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed), SKIN BURNING SENSATION (Her skin feels burned), PRURITUS (A raised welt that itches), URTICARIA (A raised welt), VACCINATION COMPLICATION (He arm reaction is the same as her penicillin response) and RASH (The rash is moving to the underside of her arm) outcome was unknown. Not Provided          Relevant concomitant medications were not reported by reporter Treatment information was not reported by reporter   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Additional information received on 31-08-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Urticaria, Vaccination complication
Clinical narrative: Her skin feels burned; A raised welt that itches; A raised welt; He arm reaction is the same as her penicillin response; The rash is moving to the underside of her arm; Her upper arm looked like a ham; Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed; Over 2 hours after the shot she couldn't speak; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Over 2 hours after the shot she couldn't speak), LIMB DISCOMFORT (Her upper arm looked like a ham), FEELING ABNORMAL (Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed), SKIN BURNING SENSATION (Her skin feels burned) and PRURITUS (A raised welt that itches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052ED1A and 939676) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced DYSARTHRIA (Over 2 hours after the shot she couldn't speak) and FEELING ABNORMAL (Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed). On 24-Jul-2021, the patient experienced LIMB DISCOMFORT (Her upper arm looked like a ham), SKIN BURNING SENSATION (Her skin feels burned), PRURITUS (A raised welt that itches), URTICARIA (A raised welt), VACCINATION COMPLICATION (He arm reaction is the same as her penicillin response) and RASH (The rash is moving to the underside of her arm). At the time of the report, DYSARTHRIA (Over 2 hours after the shot she couldn't speak), LIMB DISCOMFORT (Her upper arm looked like a ham), FEELING ABNORMAL (Just over 2 hours she couldn't feel the weight of her body in the chair as if she were paralyzed), SKIN BURNING SENSATION (Her skin feels burned), PRURITUS (A raised welt that itches), URTICARIA (A raised welt), VACCINATION COMPLICATION (He arm reaction is the same as her penicillin response) and RASH (The rash is moving to the underside of her arm) outcome was unknown. Not Provided          Relevant concomitant medications were not reported by reporter Treatment information was not reported by reporter   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Additional information received on 31-08-2021 contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Eye pruritus, Inflammation, Pruritus, Vaccination site warmth
Clinical narrative: itchy break out by corner of her eye; itchy; Bumps on both areas that are raised; Warm injection site; Within the last 3 weeks have what appears to be "insect bites"; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy break out by corner of her eye), PRURITUS (itchy), INFLAMMATION (Bumps on both areas that are raised), VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Within the last 3 weeks have what appears to be "insect bites") in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 02A21A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration. Concomitant products included VITAMINS NOS for Vitamin supplementation.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-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 EYE PRURITUS (itchy break out by corner of her eye), PRURITUS (itchy), INFLAMMATION (Bumps on both areas that are raised), VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Within the last 3 weeks have what appears to be "insect bites"). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, EYE PRURITUS (itchy break out by corner of her eye), PRURITUS (itchy), INFLAMMATION (Bumps on both areas that are raised), VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Within the last 3 weeks have what appears to be "insect bites") outcome was unknown.            Patient took blood thinner and injection for macular degeneration as concomitant medications and doesn't know whether insect bites are related to vaccine or if antibodies are wearing off.   This case was linked to MOD-2021-297651 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Excruciating pain in the left arm; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Excruciating pain in the left arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041A21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Cancer and Immunocompromised.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Excruciating pain in the left arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 19-Mar-2021, PAIN IN EXTREMITY (Excruciating pain in the left arm) had resolved. On 20-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-297590, MOD-2021-297591 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus, Swelling
Clinical narrative: itch; gets red; swells; pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), ERYTHEMA (gets red), SWELLING (swells) and MYALGIA (pain all over body) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch), ERYTHEMA (gets red), SWELLING (swells) and MYALGIA (pain all over body). At the time of the report, PRURITUS (itch), ERYTHEMA (gets red), SWELLING (swells) and MYALGIA (pain all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Death, Illness
Clinical narrative: unknown cause of death; got real sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (unknown cause of death) and ILLNESS (got real sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (unknown cause of death) (seriousness criteria death and medically significant) and ILLNESS (got real sick) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication information not provided.  Treatment information not provided.  Reporter girl friend  is a truck driver and knows a few people who got real sick from getting it and passed away. He said they got the Moderna vaccine. He does not know if it is from the shot. He did not provide any further information.  Very limited information regarding the patient, product, events, clinical details and concomitant medications has been provided at this time. Cause of death not provided. Lack of information limits the causality assessment.; Sender's Comments: Very limited information regarding the patient, product, events, clinical details and concomitant medications has been provided at this time. Cause of death not provided. Lack of information limits the causality assessment.; Reported Cause(s) of Death: unknown cause of death
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma worsened and was out of control; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma worsened and was out of control) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Iodine contrast media allergy (Allergic to Iodine dye contrast), Asthma (Moderate persistent asthma, uncomplicated), Arthritis, Pain, Spinal stenosis, Degenerative disc disease, Pancreatic cyst, Intervertebral disc bulging (Bulging disc) and Bone spur (Spurs).    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHMA (Asthma worsened and was out of control). At the time of the report, ASTHMA (Asthma worsened and was out of control) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Administered 1 ml instead of 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1 ml instead of 0.5 ml) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1 ml instead of 0.5 ml). On 26-Aug-2021, ACCIDENTAL OVERDOSE (Administered 1 ml instead of 0.5 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Hypokinesia, Poor quality sleep, Sleep apnoea syndrome
Clinical narrative: feels sleepy/he's asleep; sleep paralysis; lucid dreaming; he wakes up; he cannot move; when he sleeps he has difficulty breathing; feels very tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up) and HYPOKINESIA (he cannot move) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, 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 experienced SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up), HYPOKINESIA (he cannot move), SLEEP APNOEA SYNDROME (when he sleeps he has difficulty breathing) and FATIGUE (feels very tired/fatigued). At the time of the report, SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up), HYPOKINESIA (he cannot move), SLEEP APNOEA SYNDROME (when he sleeps he has difficulty breathing) and FATIGUE (feels very tired/fatigued) outcome was unknown.            No Concomitant medications were provided. No Treatment medications were provided.   This case was linked to MOD-2021-297626 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep paralysis, Somnolence
Clinical narrative: feels sleepy/he's asleep; sleep paralysis; lucid dreaming; he wakes up; he cannot move; when he sleeps he has difficulty breathing; feels very tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up) and HYPOKINESIA (he cannot move) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, 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 experienced SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up), HYPOKINESIA (he cannot move), SLEEP APNOEA SYNDROME (when he sleeps he has difficulty breathing) and FATIGUE (feels very tired/fatigued). At the time of the report, SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up), HYPOKINESIA (he cannot move), SLEEP APNOEA SYNDROME (when he sleeps he has difficulty breathing) and FATIGUE (feels very tired/fatigued) outcome was unknown.            No Concomitant medications were provided. No Treatment medications were provided.   This case was linked to MOD-2021-297626 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever,101.9 was highest; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever,101.9 was highest) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced PYREXIA (Fever,101.9 was highest). At the time of the report, PYREXIA (Fever,101.9 was highest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 (High) 101.9 was highest.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site warmth
Clinical narrative: bumps on both areas that are itchy and raised; bumps on both areas that are itchy and raised.; Warm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bumps on both areas that are itchy and raised), SWELLING (bumps on both areas that are itchy and raised.) and VACCINATION SITE WARMTH (Warm injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02A21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, 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 experienced PRURITUS (bumps on both areas that are itchy and raised), SWELLING (bumps on both areas that are itchy and raised.) and VACCINATION SITE WARMTH (Warm injection site). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (bumps on both areas that are itchy and raised), SWELLING (bumps on both areas that are itchy and raised.) and VACCINATION SITE WARMTH (Warm injection site) outcome was unknown.            Concomitant medications included blood thinner, injection for macular degeneration, vitamins for eye.   This case was linked to MOD-2021-297429 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in April 2021 and the estimated date of delivery was 10-Feb-2022. In May 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Patient was found pregnant on May 2021. Patient did not have an Obstetrics and gynaecology yet. Patient had no adverse effects yet.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Causality for maternal exposure during pregnancy is assessed as not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache
Clinical narrative: Left knee pain; Headache; Much pain in the lower part of her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Much pain in the lower part of her back), ARTHRALGIA (Left knee pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     The patient's past medical history included Varicose veins, Clot blood and Surgery (Surgery for blood clots 12 years ago) in 2009. Concurrent medical conditions included Pain and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced BACK PAIN (Much pain in the lower part of her back) and HEADACHE (Headache). In August 2021, the patient experienced ARTHRALGIA (Left knee pain). On 29-Jul-2021, HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (Much pain in the lower part of her back) and ARTHRALGIA (Left knee pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant product use included medications for pain.   Patient also treated with steroids to treat knee pain.  Patient experienced headache that went away that same day and in the night had much pain in the lower part of back. Four days ago received an injection of steroids in left knee to treat pain.   The patient was scheduled for second dose on 26-Aug-2021 and wanted to know if should take it given that had this steroid injection before.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Fatigue, Hyperhidrosis, Mobility decreased
Clinical narrative: It hit her very fast and hard with a horrendous sore throat; Could hardly talk; Sweating profusely; Could hardly move; Collapsed on the floor from the effort; Chilled; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move) and FALL (Collapsed on the floor from the effort) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Oil allergy (Palm oil - (breaking out, having digestive issues, feeling depressed, irritable, experiencing hair loss, and memory loss)).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move), FALL (Collapsed on the floor from the effort), CHILLS (Chilled) and FATIGUE (Fatigued). On 24-Apr-2021, OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move), FALL (Collapsed on the floor from the effort), CHILLS (Chilled) and FATIGUE (Fatigued) had resolved.            It was  reported that patient has been  experiencing the allergies for many years and believed it was sulfite or histamine allergy. She was on recurring allergic injections.  Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-297984 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Speech disorder
Clinical narrative: It hit her very fast and hard with a horrendous sore throat; Could hardly talk; Sweating profusely; Could hardly move; Collapsed on the floor from the effort; Chilled; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move) and FALL (Collapsed on the floor from the effort) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Oil allergy (Palm oil - (breaking out, having digestive issues, feeling depressed, irritable, experiencing hair loss, and memory loss)).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move), FALL (Collapsed on the floor from the effort), CHILLS (Chilled) and FATIGUE (Fatigued). On 24-Apr-2021, OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move), FALL (Collapsed on the floor from the effort), CHILLS (Chilled) and FATIGUE (Fatigued) had resolved.            It was  reported that patient has been  experiencing the allergies for many years and believed it was sulfite or histamine allergy. She was on recurring allergic injections.  Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-297984 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue; Fever; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 014CZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) dosing remained unchanged.       The patient was a vaccine compromised person, has had vaccine injury.  No concomitant medications were provided by reporter.  Patient was treated with pain medication.   This case was linked to MOD-2021-298180 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: after 2nd dose, coughing was completely gone.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (after 2nd dose, coughing was completely gone.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Coughing (Excessive coughing since 2 years).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, 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 experienced THERAPEUTIC RESPONSE UNEXPECTED (after 2nd dose, coughing was completely gone.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (after 2nd dose, coughing was completely gone.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia, Biopsy bone marrow, Pancytopenia
Clinical narrative: Pancytopenia; Bone marrow biopsy consistent with aplastic anemia; This spontaneous case was reported by a physician and describes the occurrence of PANCYTOPENIA (Pancytopenia) and APLASTIC ANAEMIA (Bone marrow biopsy consistent with aplastic anemia) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concomitant products included ACETAZOLAMIDE SODIUM (DIAMOX [ACETAZOLAMIDE SODIUM]), ALPRAZOLAM (XANAX), AMLODIPINE BESILATE (NORVASC), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), EMPAGLIFLOZIN (JARDIANCE), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LATANOPROST (XALATAN), METFORMIN, MULTIVITAMIN [VITAMINS NOS], METOPROLOL, OMEPRAZOLE, ROSUVASTATIN CALCIUM (CRESTOR) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criteria hospitalization and medically significant) and APLASTIC ANAEMIA (Bone marrow biopsy consistent with aplastic anemia) (seriousness criteria hospitalization and medically significant). At the time of the report, PANCYTOPENIA (Pancytopenia) and APLASTIC ANAEMIA (Bone marrow biopsy consistent with aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy bone marrow: consistent with aplastic anemia (abnormal) consistent with aplastic anemia.     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.   Concomitant medication also included OTC vB12.  No treatment drug information provided.  Patient presented to hospital on 24-Aug-2021.  Physician reported that the patient had normal counts several months ago. Patient was previously also under the care of a nephrologist and blood counts were normal then as well.  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.; 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dizziness, Fatigue, Illness, Malaise
Clinical narrative: arm was sore; felt really sick; dizziness; once he got the shot he just went downhill; nauseous; extremely fatigued; died on 28JUL2021, 4 days after receiving the vaccine, passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died on 28JUL2021, 4 days after receiving the vaccine, passed away) in a 31-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.     The patient's past medical history included Cirrhosis liver, Acute kidney failure, Hypertension, Immune system disorder (weak immune system) and Hospitalization from 03-May-2021 to 11-May-2021.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued). The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued) outcome was unknown.            He had medications for his chronic illnesses. The patient had recent hospitalization from 03-May-2021 to 11-May-2021. No treatment information was reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient´s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient´s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Reported Cause(s) of Death: Unknown cause of death
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: arm was sore; felt really sick; dizziness; once he got the shot he just went downhill; nauseous; extremely fatigued; died on 28JUL2021, 4 days after receiving the vaccine, passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died on 28JUL2021, 4 days after receiving the vaccine, passed away) in a 31-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.     The patient's past medical history included Cirrhosis liver, Acute kidney failure, Hypertension, Immune system disorder (weak immune system) and Hospitalization from 03-May-2021 to 11-May-2021.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued). The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (arm was sore), ILLNESS (felt really sick), DIZZINESS (dizziness), MALAISE (once he got the shot he just went downhill), NAUSEA (nauseous) and FATIGUE (extremely fatigued) outcome was unknown.            He had medications for his chronic illnesses. The patient had recent hospitalization from 03-May-2021 to 11-May-2021. No treatment information was reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient´s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient´s underlying Cirrhosis , Acute kidney failure, Hypertension and Immune system disorder could be confounding factors for the case.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Experienced the exact same thing (dementia episode) after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Experienced the exact same thing (dementia episode) after the second dose) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (Experienced the exact same thing (dementia episode) after the second dose) (seriousness criterion medically significant). At the time of the report, DEMENTIA (Experienced the exact same thing (dementia episode) after the last dose) outcome was unknown.            No concomitant and treatment medications reported.  Company comment: Based on the current available information, although the use of the product and the start date of the events were not stated, a causal relationship cannot be excluded..; Sender's Comments: Based on the current available information, although the use of the product and the start date of the events were not stated, a causal relationship cannot be excluded..
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Extended interval between doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended interval between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) had resolved. Not Provided      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.   No concomitant medications were provided. No treatment information was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neutrophil count, Neutrophil count decreased, White blood cell count, White blood cell count decreased
Clinical narrative: lymphadenopathy in the left cervical/neck area; My WBC and Neutrophils are low; My WBC and Neutrophils are low; This is a spontaneous report from a contactable Nurse.   A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EL0142) via an intramuscular administered in Arm Left on 13jan2021 08:00 as single for COVID-19 immunisation. Medical history included drug hypersensitivity known allergies: PCN from an unknown date and unknown if ongoing and other medical history was none. Concomitant medications included (IBUPROFEN [IBUPROFEN SODIUM]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN9899) via intramuscular administered in arm right on dec2020 9:00 am as single dose for COVID-19 immunisation. On 12Feb2021 A month after receiving  2nd COVID 19 vaccine she developed lymphadenopathy in the left cervical/neck area. This has persisted to present.  WBC and Neutrophils were low and shr was seeing a Hem/Oncconcerns (as reported) about Lymphoma or Leukemia or autoimmune disease onset. Workup is pending. I wanted you to be aware of this data point being a possibility of adverse reaction. The patient underwent lab tests and procedures which included neutrophil count: low on 12Feb2021 her WBC and Neutrophils are low, white blood cell count: low on 12Feb2021 her WBC and Neutrophils are low. She had not tested for covid prior and post vaccination. The outcome of all events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Severe tinnitus/Terrible tinnitus; horrible brain fog; dizziness; vertigo; short term memory loss; shortness of breathe even when laying down; shortness of breathe even when laying down; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Jul2021 at 15:30 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to Penicillin. There were no concomitant medications. Patient received no other vaccine in four weeks and did not receive any other medications in two weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe tinnitus, horrible brain fog, dizziness, vertigo, short term memory loss, shortness of breath even when laying down, exhaustion on 10Jul2021. 8 days later patient was still experiencing symptoms and terrible tinnitus. The patient underwent lab tests and procedures which included Blood test IgM (sars-cov-2 antibody test): negative on 15Jul2021, Blood test IgG (sars-cov-2 antibody test): negative on 15Jul2021. Patient did not have covid prior vaccination and was covid tested post vaccination. Therapeutic measures were taken as result of events as Xanax, cat scan, x ray, bloodworm. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome for all events severe tinnitus, horrible brain fog, dizziness, vertigo, short term memory loss, shortness of breath even when laying down, exhaustion was not recovered.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Orthopnoea, SARS-CoV-2 antibody test, Tinnitus, Vertigo
Clinical narrative: Severe tinnitus/Terrible tinnitus; horrible brain fog; dizziness; vertigo; short term memory loss; shortness of breathe even when laying down; shortness of breathe even when laying down; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Jul2021 at 15:30 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to Penicillin. There were no concomitant medications. Patient received no other vaccine in four weeks and did not receive any other medications in two weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe tinnitus, horrible brain fog, dizziness, vertigo, short term memory loss, shortness of breath even when laying down, exhaustion on 10Jul2021. 8 days later patient was still experiencing symptoms and terrible tinnitus. The patient underwent lab tests and procedures which included Blood test IgM (sars-cov-2 antibody test): negative on 15Jul2021, Blood test IgG (sars-cov-2 antibody test): negative on 15Jul2021. Patient did not have covid prior vaccination and was covid tested post vaccination. Therapeutic measures were taken as result of events as Xanax, cat scan, x ray, bloodworm. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome for all events severe tinnitus, horrible brain fog, dizziness, vertigo, short term memory loss, shortness of breath even when laying down, exhaustion was not recovered.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Overdose
Clinical narrative: High Blood pressure; dose 1 and dose 2 on 07Jun2021; dose 1 and dose 2 on 07Jun2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 09:00 (Lot Number: EW0177) (at the age of 48 years old) as single, and dose 2 via an unspecified route of administration, administered in Arm Right on 07Jun2021 (Lot Number: EW0198) (at the age of 48 years old) as single, both for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications patient received with in two weeks of COVID vaccine. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient previously took tylenol with codeine and experienced drug allergy. The patient experienced high blood pressure on 10Jul2021, dose 1 and dose 2 on 07jun2021. Adverse event high blood pressure resulted in emergency room/department urgent care visit. No treatment given for the event high blood pressure. Patient did not tested for COVID post vaccination. Outcome of the event high blood pressure was recovering.