chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Pain
Clinical narrative: Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt; Could not sleep at night; Felt more ache; Very very very tired, worst that when got COVID.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt), INSOMNIA (Could not sleep at night), PAIN (Felt more ache) and FATIGUE (Very very very tired, worst that when got COVID.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13F21A, 031B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Flu shots (had flu shots every year and did not have any of this symptoms and some sore arm but not near this reaction.). Past adverse reactions to the above products included Pain in arm with Flu shots.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt), INSOMNIA (Could not sleep at night), PAIN (Felt more ache) and FATIGUE (Very very very tired, worst that when got COVID.). At the time of the report, FEELING ABNORMAL (Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt), INSOMNIA (Could not sleep at night), PAIN (Felt more ache) and FATIGUE (Very very very tired, worst that when got COVID.) outcome was unknown.            No concomitant and treatment medication reported by the reporter.  After 8 to 10 hours of getting booster, patient experienced more side effects that when had COVID, stated like body felt like dying, could not sleep at night, almost have to go to the hospital. Patient felt more ache, very tired, worst that when got COVID. Patient mentioned knowing lots of nurses that have high risk exposure to COVID, that preferred not to take the booster.   This case was linked to MOD-2021-386173 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to the touch right arm; swollen right arm; red right arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE ERYTHEMA (red right arm) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE ERYTHEMA (red right arm) and CHILLS (chills). At the time of the report, VACCINATION SITE WARMTH (hot to the touch right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE ERYTHEMA (red right arm) outcome was unknown and CHILLS (chills) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient used cold compress on her right arm.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Severe Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe Fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-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 FATIGUE (Severe Fatigue). At the time of the report, FATIGUE (Severe Fatigue) outcome was unknown.            No adverse events were experienced on first dose. Patient took Lorazepam because she was really scared and anxious about the symptoms she had. No Concomitant medications were reported   This case was linked to MOD-2021-385969 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: 14 patients administered expired vaccine; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to intravenous contrast media.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant information was received on 05-Nov-2021 and contains expiry date of vaccine and occupation of reporter; Sender's Comments: This is a spontaneous case concerning a  30-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of maternal exposure during pregnancy and expired product administration. The events occurred approximately on the same day after the first dose of mRna 1273-Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRna 1273-Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.; 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 (Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recieved Moderna booster dose of 0.25 mL less than 12 hours after expiration.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia
Clinical narrative: I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.; I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) and MYALGIA (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 0205L20A and 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM, PROBIOTICS NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), HYOSCYAMINE, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), TRIAMTERENE, ATENOLOL, CALCIUM, LISINOPRIL and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) and MYALGIA (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.). At the time of the report, GAIT DISTURBANCE (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) and MYALGIA (I am experiencing muscle soreness in legs to waist down, pain is getting worse and its hard to walk.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Your vaccine almost killed me/sent me to the hospital; 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 VACCINATION COMPLICATION (Your vaccine almost killed me/sent me to the hospital) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Your vaccine almost killed me/sent me to the hospital). At the time of the report, VACCINATION COMPLICATION (Your vaccine almost killed me/sent me to the hospital) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (103 Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (underwent monoclonal antibodies treatment 30 days prior to the vaccination). Concurrent medical conditions included Asthma.    On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PYREXIA (103 Fever). At the time of the report, PYREXIA (103 Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 F.     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 relevant concomitant medications were reported. No treatment information was provided.  Patient told the pharmacist that she was feeling feverish before, but reporter stated that there is not any way of knowing if the fever was caused by the vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Inappropriate schedule of vaccine administered; Lymph nodes swelling/ Lymph node of the size of a grape fruit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelling/ Lymph node of the size of a grape fruit) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (The patient received the 1st and 2nd dose of Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In November 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swelling/ Lymph node of the size of a grape fruit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 12-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph nodes swelling/ Lymph node of the size of a grape fruit) outcome was unknown.            Other concomitant medications included Birth control pill.  The patient received the 1st and 2nd dose of Pfizer and the booster shot of Moderna.  The patient got lymph nodes swelling and lymph node of the size of a grape fruit. To treat the symptoms, the patient took Advil last night and this morning.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 13 patients received a 0,5 ml booster dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (13 patients received a 0,5 ml booster dose.) 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 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 10-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (13 patients received a 0,5 ml booster dose.). On 10-Nov-2021, ACCIDENTAL OVERDOSE (13 patients received a 0,5 ml booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the dose administered past the expiry date was their first dose, administered on 20Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the dose administered past the expiry date was their first dose, administered on 20Oct2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and GERD.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the dose administered past the expiry date was their first dose, administered on 20Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (the dose administered past the expiry date was their first dose, administered on 20Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow up (Other medical information updated)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-386277 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: kind of memory loss; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (kind of memory loss) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (kind of memory loss). At the time of the report, AMNESIA (kind of memory loss) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.  Patient mentioned that had experienced kind of memory loss and it lasted for about 2 or 3 weeks to a month.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Migraine
Clinical narrative: Migraine; Severe bloody nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), EPISTAXIS (Severe bloody nose) and HEADACHE (Headache) 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 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MIGRAINE (Migraine), EPISTAXIS (Severe bloody nose) and HEADACHE (Headache). At the time of the report, MIGRAINE (Migraine), EPISTAXIS (Severe bloody nose) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication and concomitant medications were not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia
Clinical narrative: she is unable to get up; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (she is unable to get up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Immunocompromised and Migraine (low-grade migraine pre-vaccination). Concomitant products included METHOTREXATE and FOLIC ACID for Psoriatic arthritis.   On 25-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 DYSSTASIA (she is unable to get up). At the time of the report, DYSSTASIA (she is unable to get up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-385954 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site swelling
Clinical narrative: Arm was all red; Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was all red) and VACCINATION SITE SWELLING (Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge) in a 68-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ERYTHEMA (Arm was all red) and VACCINATION SITE SWELLING (Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge). At the time of the report, ERYTHEMA (Arm was all red) and VACCINATION SITE SWELLING (Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge) was resolving.            The reporter reported that, his wife had received the first two doses of Moderna COVID-19 vaccine, and this events were after she received her booster dose of the Moderna COVID-19 vaccine. No medical history was provided by the reporter. Relevant concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15 Nov 2021 contain Additional information received and event details were added. On 15-Nov-2021: Follow-up received on 15 Nov 2021 and does not contain any new information
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Weight decreased
Clinical narrative: Hair falling out; Lost 40 lbs; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out) and WEIGHT DECREASED (Lost 40 lbs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 ALOPECIA (Hair falling out) and WEIGHT DECREASED (Lost 40 lbs). At the time of the report, ALOPECIA (Hair falling out) and WEIGHT DECREASED (Lost 40 lbs) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  patient gender was not specified.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Have been feeling sick ever since getting the Moderna vaccine; 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 MALAISE (Have been feeling sick ever since getting the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Have been feeling sick ever since getting the Moderna vaccine). At the time of the report, MALAISE (Have been feeling sick ever since getting the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Off label use, Pyrexia, Vaccination complication, Vaccination site erythema
Clinical narrative: Had quite a reaction to that dose; Felt rotten for a week; A big, round, bad place on her injection arm that was red and sore; Had a temperature; A big, round, bad place on her injection arm that was red & sore; Possibly received the 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 004M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Possibly received the 3rd dose despite not being immunocompromised). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore). On 21-Aug-2021, OFF LABEL USE (Possibly received the 3rd dose despite not being immunocompromised) had resolved. At the time of the report, VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore) outcome was unknown.     No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received on 17-Nov-2021 and contain no new information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had quite a reaction to that dose; Felt rotten for a week; A big, round, bad place on her injection arm that was red and sore; Had a temperature; A big, round, bad place on her injection arm that was red & sore; Possibly received the 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 004M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Possibly received the 3rd dose despite not being immunocompromised). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore). On 21-Aug-2021, OFF LABEL USE (Possibly received the 3rd dose despite not being immunocompromised) had resolved. At the time of the report, VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore) outcome was unknown.     No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received on 17-Nov-2021 and contain no new information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-386478, MOD-2021-386479 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Pain in extremity, SARS-CoV-2 test
Clinical narrative: feels heavy; chest pain; pain on left hand; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PAIN IN EXTREMITY (pain on left hand) and DISCOMFORT (feels heavy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced CHEST PAIN (chest pain) and PAIN IN EXTREMITY (pain on left hand). On an unknown date, the patient experienced DISCOMFORT (feels heavy). At the time of the report, CHEST PAIN (chest pain) and PAIN IN EXTREMITY (pain on left hand) had not resolved and DISCOMFORT (feels heavy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         no concomitant medication were reported no treatment medication were reported
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dry throat and cough in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011O21A) for COVID-19 immunization. No medical history reported. Concomitant products included valsartan for blood pressure high, Eliquis (apixaban) for an unknown indication. On Nov 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dry throat and cough. At the time of the report, dry throat and cough outcome: unknown. No treatment information provided. This case linked to MOD-2021-386469 (patient link). Reporter did not allow further contact. Most recent follow-up information incorporated: On Nov 13, 2021: Non-significant follow-up received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  This case concerns a 67 year-old, female patient with a history of Multiple sclerosis and concomitant use of ocrelizumab, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 7 months after the first dose of mRNA-1273 vaccine. The re-challenge was not applicable. The medical history, of Multiple sclerosis and concomitant use of ocrelizumab remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 67 year-old, female patient with a history of Multiple sclerosis and concomitant use of ocrelizumab, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 7 months after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The medical history, of Multiple sclerosis and concomitant use of ocrelizumab remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by another health care professional and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations off & on over period over about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations off & on over period over about 5 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, 051F21A and 02Apr2021) for COVID-19 vaccination.     The patient's past medical history included Cardiac catheterization (6-7 yrs ago. Dx: Stress-related).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PALPITATIONS (Palpitations off & on over period over about 5 days). At the time of the report, PALPITATIONS (Palpitations off & on over period over about 5 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-385842, MOD-2021-386519 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Myalgia, Palpitations, Tachycardia
Clinical narrative: heart palpitations; a rapid heartbeat; I had an acute case of diarrhea/diarrhea; I was achy/full body aching; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I had an acute case of diarrhea/diarrhea), PALPITATIONS (heart palpitations), TACHYCARDIA (a rapid heartbeat), MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 040A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac catheterization (6-7 yrs ago). Concurrent medical conditions included Stress.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site). On 09-Nov-2021, the patient experienced DIARRHOEA (I had an acute case of diarrhea/diarrhea). On 10-Nov-2021, the patient experienced PALPITATIONS (heart palpitations) and TACHYCARDIA (a rapid heartbeat). At the time of the report, DIARRHOEA (I had an acute case of diarrhea/diarrhea), PALPITATIONS (heart palpitations), TACHYCARDIA (a rapid heartbeat), MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Heart rate: rapid (abnormal) a rapid heartbeat. On 11-Nov-2021, Heart rate: rapid (abnormal) a rapid heartbeat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had no history of myo/pericarditis and COVID-19. On 09 Nov 2021. patient had an acute case of diarrhea and full body aching. On 10 Nov and 11 Nov 2021 patient had one episode of heart palpitations & rapid heartbeat,  On 11Nov 2021, patient had diarrhea until 2:30pm On 12 Nov 2021, patient felt fine.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-386518 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: heart palpitations; a rapid heartbeat; I had an acute case of diarrhea/diarrhea; I was achy/full body aching; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I had an acute case of diarrhea/diarrhea), PALPITATIONS (heart palpitations), TACHYCARDIA (a rapid heartbeat), MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 040A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac catheterization (6-7 yrs ago). Concurrent medical conditions included Stress.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site). On 09-Nov-2021, the patient experienced DIARRHOEA (I had an acute case of diarrhea/diarrhea). On 10-Nov-2021, the patient experienced PALPITATIONS (heart palpitations) and TACHYCARDIA (a rapid heartbeat). At the time of the report, DIARRHOEA (I had an acute case of diarrhea/diarrhea), PALPITATIONS (heart palpitations), TACHYCARDIA (a rapid heartbeat), MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Heart rate: rapid (abnormal) a rapid heartbeat. On 11-Nov-2021, Heart rate: rapid (abnormal) a rapid heartbeat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had no history of myo/pericarditis and COVID-19. On 09 Nov 2021. patient had an acute case of diarrhea and full body aching. On 10 Nov and 11 Nov 2021 patient had one episode of heart palpitations & rapid heartbeat,  On 11Nov 2021, patient had diarrhea until 2:30pm On 12 Nov 2021, patient felt fine.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-386518 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID after the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (Tested positive for COVID after the Moderna vaccine). At the time of the report, COVID-19 (Tested positive for COVID after the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  This is a Spontaneous case concerning a male patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVD 19. The event occurred after a dose of mRNA 1273 vaccine. Unknown time to onset or dosage number.  The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-386605 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVD 19. The event occurred after a dose of mRNA 1273 vaccine. Unknown time to onset or dosage number.  The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she has tinnitus/felt like someone was blowing a leaf blower/There were sounds; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she has tinnitus/felt like someone was blowing a leaf blower/There were sounds) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 016B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced TINNITUS (she has tinnitus/felt like someone was blowing a leaf blower/There were sounds). At the time of the report, TINNITUS (she has tinnitus/felt like someone was blowing a leaf blower/There were sounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.