chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Product dose omission issue
Clinical narrative: Hearing loss; more than 36 days from1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-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 DEAFNESS (Hearing loss) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (more than 36 days from1st vaccination). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DEAFNESS (Hearing loss) and PRODUCT DOSE OMISSION ISSUE (more than 36 days from1st vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided  Company Comment: This is a product dose omission issue for mRNA 1273, with associated event of deafness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness was automatically upgraded by list and will be kept that way until further follow-up information is received.; Sender's Comments: This is a product dose omission issue for mRNA 1273, with associated event of deafness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness was automatically upgraded by list and will be kept that way until further followup information is received.
Sex: U
Vaccine: COVID19
Symptoms: Cleft lip
Clinical narrative: During my 20 week ultrasound I was informed my baby has cleft lip; This spontaneous case was reported by a consumer and describes the occurrence of CLEFT LIP (During my 20 week ultrasound I was informed my baby has cleft lip) in a  foetus of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during pregnancy.    No Medical History information was reported.   On 05-Mar-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the foetus was diagnosed with CLEFT LIP (During my 20 week ultrasound I was informed my baby has cleft lip) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, CLEFT LIP (During my 20 week ultrasound I was informed my baby has cleft lip) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company Comment: This is a case of product exposure during pregnancy with an associated adverse event of Cleft lip in the foetus. Based on temporal association a causal relationship cannot be excluded. . Patient´s mother  will continue to be contacted for further monitoring.   This case was linked to MOD-2021-290269 (Parent-Child Link).   See case MOD-2021-290269 for details regarding the Parent case.; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of Cleft lip in the foetus. Based on temporal association a causal relationship cannot be excluded. . Patient´s mother  will continue to be contacted for further monitoring.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: had not been feeling well since; could not eat; not being able to lift arm at all, not being able to move arm at all; random cramps in her left arm; could not sleep; chest pain stating that it felt like "heart burn"; shortness of breath; pain was excruciating; woke up with fever; headache with a pulsing feeling on her temples (both sides); aches in her left arm (can't lift her arm to put hair up), body aches; felt nauseous; given an expired second dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired second dose), MALAISE (had not been feeling well since), FEEDING DISORDER (could not eat), MOBILITY DECREASED (not being able to lift arm at all, not being able to move arm at all) and MUSCLE SPASMS (random cramps in her left arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired second dose). On an unknown date, the patient experienced MALAISE (had not been feeling well since), FEEDING DISORDER (could not eat), MOBILITY DECREASED (not being able to lift arm at all, not being able to move arm at all), MUSCLE SPASMS (random cramps in her left arm), INSOMNIA (could not sleep), DYSPEPSIA (chest pain stating that it felt like "heart burn"), DYSPNOEA (shortness of breath), PAIN (pain was excruciating), PYREXIA (woke up with fever), HEADACHE (headache with a pulsing feeling on her temples (both sides)), MYALGIA (aches in her left arm (can't lift her arm to put hair up), body aches) and NAUSEA (felt nauseous). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given an expired second dose), MALAISE (had not been feeling well since), FEEDING DISORDER (could not eat), MOBILITY DECREASED (not being able to lift arm at all, not being able to move arm at all), MUSCLE SPASMS (random cramps in her left arm), INSOMNIA (could not sleep), DYSPEPSIA (chest pain stating that it felt like "heart burn"), DYSPNOEA (shortness of breath), PAIN (pain was excruciating), PYREXIA (woke up with fever), HEADACHE (headache with a pulsing feeling on her temples (both sides)), MYALGIA (aches in her left arm (can't lift her arm to put hair up), body aches) and NAUSEA (felt nauseous) outcome was unknown.            No treatment information was reported.   This case was linked to MOD-2021-278676 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: follow up recived on 04-AUG-2021 It contain no new information
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: arm shot area was itching; arm shot area swelled up like a golf ball; Flu like symptoms; achy; Extremely tired; nauseated; 101 degree fever; Throbbing headaches on forehead; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (achy), VACCINATION SITE PRURITUS (arm shot area was itching), VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball) and PYREXIA (101 degree fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hives. Concurrent medical conditions included Drug allergy (Allergic to Q Var), Drug allergy (Oral Voltaren), Asthma and Lymphatic disorder (Lymphedema).   On 20-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021 at 3:30 AM, the patient experienced HEADACHE (Throbbing headaches on forehead). On 21-Mar-2021 at 8:00 AM, the patient experienced PAIN (achy), PYREXIA (101 degree fever), FATIGUE (Extremely tired) and NAUSEA (nauseated). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (arm shot area was itching) and VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (arm shot area was itching) and VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball) outcome was unknown, PAIN (achy), PYREXIA (101 degree fever), FATIGUE (Extremely tired) and NAUSEA (nauseated) had resolved and HEADACHE (Throbbing headaches on forehead) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever. Concomitant medication was not provided by the reporter. This case was linked to MOD-2021-075110 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm shot area was itching; arm shot area swelled up like a golf ball; Flu like symptoms; achy; Extremely tired; nauseated; 101 degree fever; Throbbing headaches on forehead; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (achy), VACCINATION SITE PRURITUS (arm shot area was itching), VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball) and PYREXIA (101 degree fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hives. Concurrent medical conditions included Drug allergy (Allergic to Q Var), Drug allergy (Oral Voltaren), Asthma and Lymphatic disorder (Lymphedema).   On 20-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021 at 3:30 AM, the patient experienced HEADACHE (Throbbing headaches on forehead). On 21-Mar-2021 at 8:00 AM, the patient experienced PAIN (achy), PYREXIA (101 degree fever), FATIGUE (Extremely tired) and NAUSEA (nauseated). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (arm shot area was itching) and VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (arm shot area was itching) and VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball) outcome was unknown, PAIN (achy), PYREXIA (101 degree fever), FATIGUE (Extremely tired) and NAUSEA (nauseated) had resolved and HEADACHE (Throbbing headaches on forehead) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever. Concomitant medication was not provided by the reporter. This case was linked to MOD-2021-075110 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Myalgia, Vision blurred
Clinical narrative: blurred vision that felt like her eyes were crossed.; my eye felt weird like something was moving in it; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision that felt like her eyes were crossed.), EYE DISORDER (my eye felt weird like something was moving in it) and MYALGIA (body aches) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No specified medical history has been reported.     On 29-Jun-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 VISION BLURRED (blurred vision that felt like her eyes were crossed.), EYE DISORDER (my eye felt weird like something was moving in it) and MYALGIA (body aches). At the time of the report, VISION BLURRED (blurred vision that felt like her eyes were crossed.), EYE DISORDER (my eye felt weird like something was moving in it) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication include birth control pills Treatment information was not provided.   This case was linked to MOD-2021-278653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: FU received on 24-AUG-2021 contains no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Sore Arm after first vaccine; Felt like a torn rotator cuff after first vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm after first vaccine) and MYALGIA (Felt like a torn rotator cuff after first vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm after first vaccine) and MYALGIA (Felt like a torn rotator cuff after first vaccine). On 24-Jan-2021, VACCINATION SITE PAIN (Sore Arm after first vaccine) and MYALGIA (Felt like a torn rotator cuff after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided. Patient stated to agent that  she had a Robust response to the first vaccine, when she got home her arm was very Sore, Felt like a torn rotator cuff and lasted for 3 days.   This case was linked to MOD-2021-278793 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Great amount of confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Great amount of confusion) 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 CONFUSIONAL STATE (Great amount of confusion) (seriousness criterion hospitalization). At the time of the report, CONFUSIONAL STATE (Great amount of confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  Company comment: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A and 039K20A) for COVID-19 vaccination.     no patient identifier no patient medical history was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 6 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 5 dosage form. On 02-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 5 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 6 dosage form. On 09-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 18 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 12 dosage form. On 16-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 11 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 7 dosage form. On 30-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 7 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was updated.  They used the same day as per Moderna guidelines.   No treatment medication was updated.   This case was linked to MOD21-126826, MOD21-126827 (E2B Linked Report). This case was linked to MOD-2021-278071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Significant follow up; Sender's Comments:  MOD21-126826: MOD21-126827:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chest pain, Chills, Cough, Fatigue
Clinical narrative: sleeping 12 to 13 hours a day; Coughing; bed ridden for 3 days; flu-like symptoms; chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing; chills; been having continued ongoing fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (Coughing), BEDRIDDEN (bed ridden for 3 days), SOMNOLENCE (sleeping 12 to 13 hours a day) and CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BEDRIDDEN (bed ridden for 3 days), CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing), CHILLS (chills), FATIGUE (been having continued ongoing fatigue) and PYREXIA (fever). On an unknown date, the patient experienced COUGH (Coughing) and SOMNOLENCE (sleeping 12 to 13 hours a day). The patient was treated with MORPHINE for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (Coughing), BEDRIDDEN (bed ridden for 3 days), SOMNOLENCE (sleeping 12 to 13 hours a day), CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing), CHILLS (chills), FATIGUE (been having continued ongoing fatigue) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not provided.  Patient lab data includes-EKG and blood work and indicated that patient had not experienced a heart attack. Patient went to the emergency room on Monday 02-AUG-2021.   This case was linked to MOD-2021-278786 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Somnolence
Clinical narrative: sleeping 12 to 13 hours a day; Coughing; bed ridden for 3 days; flu-like symptoms; chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing; chills; been having continued ongoing fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (Coughing), BEDRIDDEN (bed ridden for 3 days), SOMNOLENCE (sleeping 12 to 13 hours a day) and CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BEDRIDDEN (bed ridden for 3 days), CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing), CHILLS (chills), FATIGUE (been having continued ongoing fatigue) and PYREXIA (fever). On an unknown date, the patient experienced COUGH (Coughing) and SOMNOLENCE (sleeping 12 to 13 hours a day). The patient was treated with MORPHINE for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (Coughing), BEDRIDDEN (bed ridden for 3 days), SOMNOLENCE (sleeping 12 to 13 hours a day), CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing), CHILLS (chills), FATIGUE (been having continued ongoing fatigue) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not provided.  Patient lab data includes-EKG and blood work and indicated that patient had not experienced a heart attack. Patient went to the emergency room on Monday 02-AUG-2021.   This case was linked to MOD-2021-278786 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I think i am having a side effect from my shot.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I think i am having a side effect from my shot.) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION COMPLICATION (I think i am having a side effect from my shot.). At the time of the report, VACCINATION COMPLICATION (I think i am having a side effect from my shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant products were not provided.  Treatment medication were not reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Swelling, Vaccination site pain
Clinical narrative: She states she is swollen; she states she had sore arm for a while / she is sore.; she is still having some pain in the exact spot where the shot is; She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (She states she is swollen), MYALGIA (she states she had sore arm for a while / she is sore.), VACCINATION SITE PAIN (she is still having some pain in the exact spot where the shot is) and LYMPHADENOPATHY (She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     treatment medications was not provided.  Concomitant products included METFORMIN, LISINOPRIL, NAPROXEN and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced SWELLING (She states she is swollen), MYALGIA (she states she had sore arm for a while / she is sore.), VACCINATION SITE PAIN (she is still having some pain in the exact spot where the shot is) and LYMPHADENOPATHY (She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen). At the time of the report, SWELLING (She states she is swollen), MYALGIA (she states she had sore arm for a while / she is sore.), VACCINATION SITE PAIN (she is still having some pain in the exact spot where the shot is) and LYMPHADENOPATHY (She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-278968 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Paresis
Clinical narrative: semi paralized; This spontaneous case was reported by a consumer and describes the occurrence of PARESIS (semi paralized) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARESIS (semi paralized) (seriousness criterion hospitalization prolonged). At the time of the report, PARESIS (semi paralized) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Somnolence
Clinical narrative: Felt very sleepy, wanted to sleep all day; Flu like symptoms; Headache for 24 hours; felt chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt very sleepy, wanted to sleep all day), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache for 24 hours) and CHILLS (felt chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PIOGLITAZONE, INSULIN LISPRO (HUMALOG), FENOFIBRATE, ATORVASTATIN and LISINOPRIL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 SOMNOLENCE (Felt very sleepy, wanted to sleep all day), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache for 24 hours) and CHILLS (felt chills). At the time of the report, SOMNOLENCE (Felt very sleepy, wanted to sleep all day) and HEADACHE (Headache for 24 hours) had resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (felt chills) outcome was unknown.            No concomitant medication information was provided.  No treatment medication were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pericardial effusion, Product dose omission issue
Clinical narrative: fluid around my heart/fluid on my heart/water on my heart; didn't get the second shot; medical history of asthma,/more frequents asthma attacks/my asthma bothered me; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around my heart/fluid on my heart/water on my heart) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emphysema. Concurrent medical conditions included Asthma and COPD. Concomitant products included OXYGEN, GABAPENTIN, DILTIAZEM, CLONIDINE, PREDNISONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CLONAZEPAM and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 22-Jan-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 PERICARDIAL EFFUSION (fluid around my heart/fluid on my heart/water on my heart) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (didn't get the second shot) and ASTHMA (medical history of asthma,/more frequents asthma attacks/my asthma bothered me). At the time of the report, PERICARDIAL EFFUSION (fluid around my heart/fluid on my heart/water on my heart), PRODUCT DOSE OMISSION ISSUE (didn't get the second shot) and ASTHMA (medical history of asthma,/more frequents asthma attacks/my asthma bothered me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient concomitant information was water pill, nebulizer, steroid, night pill for asthma, Advair diskus, Advair emergency inhaler. Patient laboratory information was given an oxygen test that is normally 6 minutes. Patient said she had a pneumonia shot a month before her COVID-19 shot 'July they told about the fluid'. No treatment medication information was provided.  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. However, patient's history of emphysema remains a contributory factor.; 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. However, patient's history of emphysema remains a contributory factor.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Fluid in lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (Fluid in lungs) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY OEDEMA (Fluid in lungs) outcome was unknown.            Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information can't be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information can't be requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dysphagia, Lung abscess, Malaise, Night sweats
Clinical narrative: infection in his lungs/pneumonia; abscess on his lungs; started feeling sick the second week after the vaccine/couldn't do anything; night sweats; Swallowing difficult; back pain; lost weight; fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (infection in his lungs/pneumonia) and LUNG ABSCESS (abscess on his lungs) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy in 1991. Concomitant products included ATORVASTATIN for Cholesterol, GABAPENTIN for Nerve pain, WARFARIN and TRAMADOL for an unknown indication.    On 12-Jul-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 PNEUMONIA (infection in his lungs/pneumonia) (seriousness criteria hospitalization prolonged and medically significant), LUNG ABSCESS (abscess on his lungs) (seriousness criteria hospitalization prolonged and medically significant), MALAISE (started feeling sick the second week after the vaccine/couldn't do anything), NIGHT SWEATS (night sweats), DYSPHAGIA (Swallowing difficult), BACK PAIN (back pain), WEIGHT DECREASED (lost weight) and PYREXIA (fever). The patient was hospitalized from 31-Jul-2021 to 05-Aug-2021 due to LUNG ABSCESS and PNEUMONIA. At the time of the report, PNEUMONIA (infection in his lungs/pneumonia), LUNG ABSCESS (abscess on his lungs), MALAISE (started feeling sick the second week after the vaccine/couldn't do anything), NIGHT SWEATS (night sweats), DYSPHAGIA (Swallowing difficult), BACK PAIN (back pain), WEIGHT DECREASED (lost weight) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient should have never gotten the vaccine because he doesn't have a spleen it was removed in 1991 was reported.  Patient went to the doctor on 30-Jul-2021 and the emergency room on 31-Jul-2021 was reported.  Treatment medication was not reported. Concomitant includes cholesterol meds, atorvastatin and blood pressure med was reported.  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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, Weight decreased
Clinical narrative: infection in his lungs/pneumonia; abscess on his lungs; started feeling sick the second week after the vaccine/couldn't do anything; night sweats; Swallowing difficult; back pain; lost weight; fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (infection in his lungs/pneumonia) and LUNG ABSCESS (abscess on his lungs) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy in 1991. Concomitant products included ATORVASTATIN for Cholesterol, GABAPENTIN for Nerve pain, WARFARIN and TRAMADOL for an unknown indication.    On 12-Jul-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 PNEUMONIA (infection in his lungs/pneumonia) (seriousness criteria hospitalization prolonged and medically significant), LUNG ABSCESS (abscess on his lungs) (seriousness criteria hospitalization prolonged and medically significant), MALAISE (started feeling sick the second week after the vaccine/couldn't do anything), NIGHT SWEATS (night sweats), DYSPHAGIA (Swallowing difficult), BACK PAIN (back pain), WEIGHT DECREASED (lost weight) and PYREXIA (fever). The patient was hospitalized from 31-Jul-2021 to 05-Aug-2021 due to LUNG ABSCESS and PNEUMONIA. At the time of the report, PNEUMONIA (infection in his lungs/pneumonia), LUNG ABSCESS (abscess on his lungs), MALAISE (started feeling sick the second week after the vaccine/couldn't do anything), NIGHT SWEATS (night sweats), DYSPHAGIA (Swallowing difficult), BACK PAIN (back pain), WEIGHT DECREASED (lost weight) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient should have never gotten the vaccine because he doesn't have a spleen it was removed in 1991 was reported.  Patient went to the doctor on 30-Jul-2021 and the emergency room on 31-Jul-2021 was reported.  Treatment medication was not reported. Concomitant includes cholesterol meds, atorvastatin and blood pressure med was reported.  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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Insomnia, Tinnitus
Clinical narrative: Hard time falling asleep last night; Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste; increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste   ), TINNITUS (increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again) and INSOMNIA (Hard time falling asleep last night) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced DYSGEUSIA (Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste   ) and TINNITUS (increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again). On an unknown date, the patient experienced INSOMNIA (Hard time falling asleep last night). At the time of the report, DYSGEUSIA (Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste   ), TINNITUS (increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again) and INSOMNIA (Hard time falling asleep last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 06-Aug-2021: New event was updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: half of her face went numbed; face swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (half of her face went numbed) and SWELLING FACE (face swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Jun-2021, the patient experienced HYPOAESTHESIA (half of her face went numbed). 25-Jun-2021, the patient experienced SWELLING FACE (face swollen). At the time of the report, HYPOAESTHESIA (half of her face went numbed) and SWELLING FACE (face swollen) outcome was unknown.            No concomitant medication was reported No treatment drug was reported
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness/Got our second shot in May and still experiencing tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/Got our second shot in May and still experiencing tiredness) 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 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 FATIGUE (tiredness/Got our second shot in May and still experiencing tiredness). At the time of the report, FATIGUE (tiredness/Got our second shot in May and still experiencing tiredness) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (I had a sore arm). At the time of the report, VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-279435 (Patient Link).