chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: tchy Arm; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (tchy Arm) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (tchy Arm) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, VACCINATION SITE PRURITUS (tchy Arm) and VACCINATION SITE ERYTHEMA (Red at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in her Bicep and deltoid; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her Bicep and deltoid) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling in her Bicep and deltoid). At the time of the report, PERIPHERAL SWELLING (swelling in her Bicep and deltoid) outcome was unknown.            Patient has been using ice to treat the ailments.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hypersomnia, Pyrexia
Clinical narrative: experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).; experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).; slept for 14 hours (normal is 7-8 hours); Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSOMNIA (slept for 14 hours (normal is 7-8 hours)), PYREXIA (Fever), HEADACHE (experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).) and CHILLS (experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HYPERSOMNIA (slept for 14 hours (normal is 7-8 hours)) and PYREXIA (Fever). On an unknown date, the patient experienced HEADACHE (experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).) and CHILLS (experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).). At the time of the report, HYPERSOMNIA (slept for 14 hours (normal is 7-8 hours)), PYREXIA (Fever), HEADACHE (experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).) and CHILLS (experiencing headache, chills/shakes, and fever of 100.2 F (normal is 97.5 F).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 100.2 f (High) high. On 07-Feb-2021, Body temperature: 97.1 (abnormal) His temperature has bounced up and down between 97.1- 98.6 F..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitants were added. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-121138.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded. On 21-Apr-2021: NNI On 23-Jun-2021: Follow up was received on 23-Jun-2021. Its regarding second dose outcome. No new information regarding first dose events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pain
Clinical narrative: loss of appetite; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and DECREASED APPETITE (loss of appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Lily infusion for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (body aches). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, PAIN (body aches) and DECREASED APPETITE (loss of appetite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI Urinary Track infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI Urinary Track infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Low back pain (low back pain from herniated disc). Concurrent medical conditions included Emphysema (lung disease emphysema).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI Urinary Track infection). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Low back pain, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (UTI Urinary Track infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patients second dose was scheduled on 25-Feb-2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 UNK. 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-025114 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Vaccination site erythema
Clinical narrative: headache; intense itching at the injection site; redness approximately 2cm; bruising developed; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), INJECTION SITE PRURITUS (intense itching at the injection site), INJECTION SITE ERYTHEMA (redness approximately 2cm) and VACCINATION SITE ERYTHEMA (bruising developed) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), INJECTION SITE PRURITUS (intense itching at the injection site), INJECTION SITE ERYTHEMA (redness approximately 2cm) and VACCINATION SITE ERYTHEMA (bruising developed). At the time of the report, HEADACHE (headache), INJECTION SITE PRURITUS (intense itching at the injection site), INJECTION SITE ERYTHEMA (redness approximately 2cm) and VACCINATION SITE ERYTHEMA (bruising developed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications included by reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Insomnia, Vomiting
Clinical narrative: lightheaded; Diarrhoea; can't sleep; threw up once; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), DIARRHOEA (Diarrhoea), INSOMNIA (can't sleep) and VOMITING (threw up once) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, METFORMIN, PIOGLITAZONE, LISINOPRIL, TAMSULOSIN, INSULIN and PREDNISONE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Diarrhoea), INSOMNIA (can't sleep) and VOMITING (threw up once). On 17-Feb-2021, the patient experienced DIZZINESS (lightheaded). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheaded) had not resolved and DIARRHOEA (Diarrhoea), INSOMNIA (can't sleep) and VOMITING (threw up once) outcome was unknown.        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.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Accidentally administered 1.0 mL of the Moderna Covid-19 vaccine; A spontaneous report was received from a nurse concerning a patient who was accidentally administered 1.0 mLof the Moderna Covid-19 vaccine.    The patient's medical history was not provided by reporter. Concomitant product use was not provided by the reporter.    On 24-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 24-FEB-2021, vaccine was  accidentally administered 1.0 mLof the Moderna Covid-19 vaccine. Treatment information was not provided.    The outcome of the event, accidentally administered 1.0 mLof the Moderna Covid-19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Congestion; Covid virus; upper respiratory tightness; Flu like symptoms; Cough; fever; Headache; 36 days have passed since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchitis and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, FAMOTIDINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and COVID-19 (Covid virus). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose) had resolved and NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, COVID-19: positive (Positive) positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, an Inhaler, Steroid-Prednisone and Monoclonal Antibody treatment.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: FU source document attached on 16th April and it contains Adverse event information On 14-Jun-2021: received; Sender's Comments: Although a temporal association exist between the product use and reported events.  Patient was most-likely infected with COVID-19 prior to mRNA-1273 administration.  Other events are likely symptoms of the infection.  However, based on temporal association and known safety profile of the vaccine, the event of headache cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, Respiratory disorder
Clinical narrative: Congestion; Covid virus; upper respiratory tightness; Flu like symptoms; Cough; fever; Headache; 36 days have passed since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchitis and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, FAMOTIDINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and COVID-19 (Covid virus). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose) had resolved and NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, COVID-19: positive (Positive) positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, an Inhaler, Steroid-Prednisone and Monoclonal Antibody treatment.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: FU source document attached on 16th April and it contains Adverse event information On 14-Jun-2021: received; Sender's Comments: Although a temporal association exist between the product use and reported events.  Patient was most-likely infected with COVID-19 prior to mRNA-1273 administration.  Other events are likely symptoms of the infection.  However, based on temporal association and known safety profile of the vaccine, the event of headache cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: dizzy; Fever of 102.6; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: high (High) 102.6  High..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  No treatment information was reported. Patient wants to know why she cant take Tylenol for her symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: Antibody test yesterday and was non-reactive; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive). At the time of the report, ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Antibody test: non reactive (Negative) Non reactive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Tremor
Clinical narrative: Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose; Muscle cramps and shaking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) 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) (unknown route) 1 dosage form. On 18-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 MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking). At the time of the report, MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms, Tremor
Clinical narrative: Muscle cramps and shaking worse; Muscle cramps and shaking worse; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) 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) (unknown route) 1 dosage form. On 18-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 MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ROSACEA (Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rosacea (took antibiotics).    On 13-Feb-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 ROSACEA (Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline). The patient was treated with DOXYCYCLINE for Rosacea, at an unspecified dose and frequency. At the time of the report, ROSACEA (Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medications were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Feb-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-027049, MOD-2021-026665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up document received  included no new information. NNI for daughter case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Paraesthesia
Clinical narrative: Arm pain; Had a pulsating tingling feeling by side of head next to left eye; Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (FOSAMAX) and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Cold sores, at a dose of 800 mg three times a day and PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pain, Swelling
Clinical narrative: Headaches and body aches; Redness on the arm; "A ball" on the arm; Headaches and body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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 an unknown date, the patient experienced PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills). At the time of the report, PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (Chills), the first episode of HEADACHE (Headache), the second episode of CHILLS (Chills) and the second episode of HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced the first episode of CHILLS (Chills) and the first episode of HEADACHE (Headache). On 24-Feb-2021, the patient experienced the second episode of CHILLS (Chills) and the second episode of HEADACHE (Headache). At the time of the report, last episode of CHILLS (Chills) and the last episode of HEADACHE (Headache) outcome was unknown. Not Provided          No Concomitant medication were reported. Treatment medication includes Coricidin.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Bump under injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Bump under injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) 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 INJECTION SITE MASS (Bump under injection site). At the time of the report, INJECTION SITE MASS (Bump under injection site) outcome was unknown.            Treatment was unknown Action taken with mRNA-1273 in response to the event was not applicable
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included HYDROCORTISONE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash). At the time of the report, RASH (rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: Shortness of breath; Fever 103.0; Chills; Nausea; Body aches; Severe pain in left side of head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 103 High. On 03-Feb-2021, COVID-19: Negative.     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 medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Shortness of breath; Fever 103.0; Chills; Nausea; Body aches; Severe pain in left side of head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 103 High. On 03-Feb-2021, COVID-19: Negative.     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 medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: hoarseness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarseness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPHONIA (hoarseness). At the time of the report, DYSPHONIA (hoarseness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: received on 14 JULY 2021 and 2nd dose details added without any AE . event outcome updated.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: painful to use arm; left leg is not working; severe fatigue; attacked the muscle in upper arm and now locked; attacked left hip joint and pain is so intense; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (painful to use arm), LIMB DISCOMFORT (left leg is not working), FATIGUE (severe fatigue), MYALGIA (attacked the muscle in upper arm and now locked) and ARTHRALGIA (attacked left hip joint and pain is so intense) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (painful to use arm), LIMB DISCOMFORT (left leg is not working), FATIGUE (severe fatigue), MYALGIA (attacked the muscle in upper arm and now locked) and ARTHRALGIA (attacked left hip joint and pain is so intense). On 29-Jan-2021, FATIGUE (severe fatigue) had resolved. On 30-Jan-2021, PAIN IN EXTREMITY (painful to use arm) and MYALGIA (attacked the muscle in upper arm and now locked) had resolved. On 31-Jan-2021, LIMB DISCOMFORT (left leg is not working) and ARTHRALGIA (attacked left hip joint and pain is so intense) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included topical Product, hot/cold compress and injection (steroid or pain killer) administered by orthopedic doctor.  No concomitant medication was provided.    This case was linked to MOD-2021-090574 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: Wasnt feeling good; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wasnt feeling good), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (Wasnt feeling good), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING ABNORMAL (Wasnt feeling good), HEADACHE (Headache) and NAUSEA (Nausea) 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia oral
Clinical narrative: Numb mouth and tongue; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb mouth and tongue) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numb mouth and tongue) and FATIGUE (Tiredness). At the time of the report, HYPOAESTHESIA ORAL (Numb mouth and tongue) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR form received on 15-JUL-2021. Patient does not consent to further contact.; Sender's Comments: 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. However, details including the medical history, concomitant medications, diagnostics/ treatment administered is required for further analysis.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Feeling unwell; Slept for 13 hours; Felt like she was beaten with a stick, Aching, whole body aching , body ache; Cant get her breathe; Dizzy; Havent gotten better; So weak; Feeling tired, Fatigued, Cant be up more than 10 minutes; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe) and DIZZINESS (Dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCODONE for Pain, INSULIN LISPRO (HUMALOG), LOSARTAN, DULOXETINE, LEVOTHYROXINE, GABAPENTIN, VITAMIN D3, VITAMIN B12 NOS, SIMVASTATIN, HYDROCHLOROTHIAZIDE and FLUOCINONIDE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches). At the time of the report, MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow up received: Reporter's address was updated, Con-meds and treatment medication updated. On 12-Jul-2021: Non significant FU_Received
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Malaise, Pain
Clinical narrative: Feeling unwell; Slept for 13 hours; Felt like she was beaten with a stick, Aching, whole body aching , body ache; Cant get her breathe; Dizzy; Havent gotten better; So weak; Feeling tired, Fatigued, Cant be up more than 10 minutes; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe) and DIZZINESS (Dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCODONE for Pain, INSULIN LISPRO (HUMALOG), LOSARTAN, DULOXETINE, LEVOTHYROXINE, GABAPENTIN, VITAMIN D3, VITAMIN B12 NOS, SIMVASTATIN, HYDROCHLOROTHIAZIDE and FLUOCINONIDE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches). At the time of the report, MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow up received: Reporter's address was updated, Con-meds and treatment medication updated. On 12-Jul-2021: Non significant FU_Received
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: administration error (vaccine brands interchanged for 1st and 2nd doses); A spontaneous report was received from a physician concerning, a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administration error as the vaccine brands interchanged for 1st and 2nd doses.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection at a different site.   On 25 Feb 2021, the patient was given the Pfizer vaccine for their second dose at the pharmacy in the reporter's facility.  Treatment information for the event was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was unknown.   On 25 Feb 2021, the outcome of the event administration error as the vaccine brands interchanged for 1st and 2nd doses was considered resolved.; Reporter's Comments: This report refers to a case of wrong vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: Frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Cystitis interstitial.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, POLLAKIURIA (Frequent urination) outcome was unknown.            No concomitant medication was provided. Action taken with mRNA-1273 in response to the event was not applicable.