chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) 1 total, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient had no problems at all. The patient had the test last week and got antibody blood test and it showed no antibodies left. The test came back with word Equivocal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20211103729-Covid-19 vaccine ad26.cov2.-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid, atorvastatin calcium, ergocalciferol, ocrelizumab, regeneron (unknown ingredients) and zinc.  On 15-AUG-2021, the patient experienced suspected covid-19 infection(symptomatic) (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000200117; Sender's Comments: V0: 20211103997- COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, Hyperhidrosis, Malaise
Clinical narrative: Feeling sick/"About to get sick/body not feel very well; Feeling badly/ Not ok; Hot very hot; Sweaty; I'm about to throw up/Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty) and NAUSEA (I'm about to throw up/Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F218, 022D20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-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 MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty), NAUSEA (I'm about to throw up/Nausea) and HEADACHE (Headache). At the time of the report, MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty), NAUSEA (I'm about to throw up/Nausea) and HEADACHE (Headache) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient wanted to know that how long will take the symptoms to go away and if she could take Tylenol or not.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Feeling sick/"About to get sick/body not feel very well; Feeling badly/ Not ok; Hot very hot; Sweaty; I'm about to throw up/Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty) and NAUSEA (I'm about to throw up/Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F218, 022D20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-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 MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty), NAUSEA (I'm about to throw up/Nausea) and HEADACHE (Headache). At the time of the report, MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty), NAUSEA (I'm about to throw up/Nausea) and HEADACHE (Headache) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient wanted to know that how long will take the symptoms to go away and if she could take Tylenol or not.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DIZAZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore). At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided.    This case was linked to MOD-2021-363679, MOD-2021-363695 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received dose from vial beyond 30-day use by date) in a 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 16, 2021, patient administered expired product (patient received dose from vial beyond 30-day use by date). On Jun 16, 2021, administered expired product (patient received dose from vial beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vial: May 7, 2021.  This case linked to MOD-2021-363753 (patient link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heart which she thinks was Atrial fibrillation; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Rapid heart which she thinks was Atrial fibrillation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Rapid heart which she thinks was Atrial fibrillation). At the time of the report, HEART RATE INCREASED (Rapid heart which she thinks was Atrial fibrillation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Heart rate: increased (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains Non-Significant followup:Email Address Verified
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Slight fever; Sore injection spot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and VACCINATION SITE PAIN (Sore injection spot) 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 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PYREXIA (Slight fever) and VACCINATION SITE PAIN (Sore injection spot). At the time of the report, PYREXIA (Slight fever) and VACCINATION SITE PAIN (Sore injection spot) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Illness, Myalgia
Clinical narrative: Sick all night; Stomach cramps; Just all over don't feel good; The shot location is real hot; Shot location is hard; Chills; Headache; Nausea; All over body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all night), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot) and VACCINATION SITE INDURATION (Shot location is hard) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 028L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ILLNESS (Sick all night), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (All over body aches). 25-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and VACCINATION SITE INDURATION (Shot location is hard). At the time of the report, ILLNESS (Sick all night), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot), VACCINATION SITE INDURATION (Shot location is hard), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (All over body aches) outcome was unknown.     No concomitant medication was reported. The treatment information was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication, Vaccination site induration, Vaccination site warmth
Clinical narrative: Sick all night; Stomach cramps; Just all over don't feel good; The shot location is real hot; Shot location is hard; Chills; Headache; Nausea; All over body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all night), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot) and VACCINATION SITE INDURATION (Shot location is hard) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 028L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ILLNESS (Sick all night), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (All over body aches). 25-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and VACCINATION SITE INDURATION (Shot location is hard). At the time of the report, ILLNESS (Sick all night), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot), VACCINATION SITE INDURATION (Shot location is hard), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (All over body aches) outcome was unknown.     No concomitant medication was reported. The treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 VACCINATION SITE PAIN (Sore arm after the second dose). At the time of the report, VACCINATION SITE PAIN (Sore arm after the second dose) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient had a sore arm after the second dose.   This case was linked to MOD-2021-363822, MOD-2021-363885 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 MYALGIA (sore arm after the first dose). At the time of the report, MYALGIA (sore arm after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-363881, MOD-2021-363822 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Incorrect dose administered
Clinical narrative: Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down; Recieved a booster dose at 0.5 mL; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down) and INCORRECT DOSE ADMINISTERED (Recieved a booster dose at 0.5 mL) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MIRTAZAPINE for Post-traumatic stress disorder.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 23-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Recieved a booster dose at 0.5 mL). On 26-Oct-2021, the patient experienced HEART RATE INCREASED (Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down). On 23-Oct-2021, INCORRECT DOSE ADMINISTERED (Recieved a booster dose at 0.5 mL) had resolved. At the time of the report, HEART RATE INCREASED (Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Heart rate increased: increased (High) Increased.         No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of vaccination complication (minor viral symptoms) and vaccination complication (mild symptoms) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included allergy to chemicals (PEG2000). On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (minor viral symptoms) and vaccination complication (mild symptoms). At the time of the report, vaccination complication (minor viral symptoms) and vaccination complication (mild symptoms) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses for boosters instead of half doses.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Pharmacist states they gave full doses for boosters instead of half doses. This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). On 25-Oct-2021, OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired afterwards; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired afterwards) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    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 FATIGUE (felt tired afterwards). At the time of the report, FATIGUE (felt tired afterwards) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided. The patient received flu shot 14 days prior to booster dose.   This case was linked to MOD-2021-364285 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. 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 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml)). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) had resolved.        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.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Illness, Influenza like illness, Muscular weakness
Clinical narrative: My legs are weak; My head is funding; I'm sick like I've never been. It's like I have the flu; I'm sick like a dog; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (My legs are weak), HEAD DISCOMFORT (My head is funding), INFLUENZA LIKE ILLNESS (I'm sick like I've never been. It's like I have the flu) and ILLNESS (I'm sick like a dog) 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 MUSCULAR WEAKNESS (My legs are weak), HEAD DISCOMFORT (My head is funding), INFLUENZA LIKE ILLNESS (I'm sick like I've never been. It's like I have the flu) and ILLNESS (I'm sick like a dog). At the time of the report, MUSCULAR WEAKNESS (My legs are weak), HEAD DISCOMFORT (My head is funding), INFLUENZA LIKE ILLNESS (I'm sick like I've never been. It's like I have the flu) and ILLNESS (I'm sick like a dog) outcome was unknown.            Concomitant medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included ATENOLOL for Blood pressure management, METFORMIN for Diabetes, OMEPRAZOLE for an unknown indication.   On 24-Oct-2021, the patient 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 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 HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitants included  Blood thinner, cholesterol pill. No Treatment medication was reported.   This case was linked to MOD-2021-364075, MOD-2021-364085 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Lymph node pain, Pain
Clinical narrative: flu like; achiness; lymph nodes feel sore all over; feels feverish/slightly elevated temperature; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A71A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-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 INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature), ARTHRALGIA (joint pain) and HEADACHE (headache) was resolving.            No Treatment informations were reported.   This case was linked to MOD-2021-365061, MOD-2021-365066 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like; achiness; lymph nodes feel sore all over; feels feverish/slightly elevated temperature; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A71A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-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 INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature), ARTHRALGIA (joint pain) and HEADACHE (headache) was resolving.            No Treatment informations were reported.   This case was linked to MOD-2021-365061, MOD-2021-365066 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after excursion). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered after excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medication was reported.  The temperature excursion occurred on 20-OCT-2021.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Constant sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Constant sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Constant sweating). At the time of the report, HYPERHIDROSIS (Constant sweating) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Dyspepsia, Product dose omission issue
Clinical narrative: Never got the 2nd shot; Chest pain/Felt that after the first 2 hours; Chest pressure; Thought it was heart burn; Back pain/Pain in the back too; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain/Felt that after the first 2 hours), CHEST DISCOMFORT (Chest pressure), DYSPEPSIA (Thought it was heart burn), BACK PAIN (Back pain/Pain in the back too) and PRODUCT DOSE OMISSION ISSUE (Never got the 2nd shot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included AFib (For 5 years).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHEST PAIN (Chest pain/Felt that after the first 2 hours) and CHEST DISCOMFORT (Chest pressure). 17-Feb-2021, the patient experienced DYSPEPSIA (Thought it was heart burn) and BACK PAIN (Back pain/Pain in the back too). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never got the 2nd shot). On 17-Feb-2021, CHEST PAIN (Chest pain/Felt that after the first 2 hours), CHEST DISCOMFORT (Chest pressure), DYSPEPSIA (Thought it was heart burn) and BACK PAIN (Back pain/Pain in the back too) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never got the 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated he is taking lot of concomitant medications but not reported. No treatment medications were reported.  It was reported that the patient laid down and took a nap after experiencing events and the events went away and it did not last longer.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: Didn't have much energy; Upset stomach; Sick in bed all day; Nausea; Vomiting; Left arm pain/sore arm-left; Very Cold; Fatigue; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain/sore arm-left), ASTHENIA (Didn't have much energy), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Sick in bed all day) and FEELING COLD (Very Cold) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain/sore arm-left), FEELING COLD (Very Cold), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). On 23-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Sick in bed all day), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Oct-2021, the patient experienced ASTHENIA (Didn't have much energy). The patient was treated with MELOXICAM at an unspecified dose and frequency. On 23-Oct-2021, MALAISE (Sick in bed all day), FEELING COLD (Very Cold), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) had resolved. On 26-Oct-2021, ABDOMINAL DISCOMFORT (Upset stomach) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm pain/sore arm-left), ASTHENIA (Didn't have much energy) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Didn't have much energy; Upset stomach; Sick in bed all day; Nausea; Vomiting; Left arm pain/sore arm-left; Very Cold; Fatigue; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain/sore arm-left), ASTHENIA (Didn't have much energy), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Sick in bed all day) and FEELING COLD (Very Cold) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain/sore arm-left), FEELING COLD (Very Cold), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). On 23-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Sick in bed all day), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Oct-2021, the patient experienced ASTHENIA (Didn't have much energy). The patient was treated with MELOXICAM at an unspecified dose and frequency. On 23-Oct-2021, MALAISE (Sick in bed all day), FEELING COLD (Very Cold), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) had resolved. On 26-Oct-2021, ABDOMINAL DISCOMFORT (Upset stomach) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm pain/sore arm-left), ASTHENIA (Didn't have much energy) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patent had swelling in her injection site arm after her first or the second vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Patent had swelling in her injection site arm after her first or the second vaccine.) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032Z0A, 041620A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-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 VACCINATION SITE SWELLING (Patent had swelling in her injection site arm after her first or the second vaccine.). At the time of the report, VACCINATION SITE SWELLING (Patent had swelling in her injection site arm after her first or the second vaccine.) outcome was unknown.            Patient received her Moderna Booster dose on 26OCT2021 no Adverse reactions reported. Concomitant medications were not provided. Treatment information was not provided.  The patient's weight was reported to be 14 lbs.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus/scalp itching (started sometime after the patient received both Moderna COVID-19 vaccinations) and vaccination site pain (sore left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 012M20A) for COVID-19 immunization. Concurrent medical conditions included allergy (NOS) and rheumatoid arthritis. Concomitant medications included loratadine for allergy, prednisone for rheumatoid arthritis, vitamins, oxycodone, venlafaxine, Zetia (ezetimibe), Vitamin D, Fiber (polycarbophil calcium), D-Mannose and zoledronic acid for an unknown indication. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had pruritus/scalp itching (started sometime after the patient received both Moderna COVID-19 vaccinations) and vaccination site pain (sore left arm). At the time of the report, pruritus/scalp itching (started sometime after the patient received both Moderna COVID-19 vaccinations) and vaccination site pain (sore left arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-364408 (patient link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: extremely sore arm down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extremely sore arm down to the elbow) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced MYALGIA (extremely sore arm down to the elbow). At the time of the report, MYALGIA (extremely sore arm down to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-364223 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-364223:patient 1
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired 3 dose of vaccine is given in a clinic for immunocompromised patients No concomitant and treatment information were reported by the reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: fever; very achy; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (very achy) and FATIGUE (fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 039K20A and 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Osteoporosis (broken bones in her foot for osteoporosis).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (fever), MYALGIA (very achy) and FATIGUE (fatigued). On 05-Feb-2021, PYREXIA (fever), MYALGIA (very achy) and FATIGUE (fatigued) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-364321 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml)). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Lymphadenopathy, Nasopharyngitis
Clinical narrative: Little cold; Armpit hurt so bad; Swollen lymph node on left arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Little cold), AXILLARY PAIN (Armpit hurt so bad), LYMPHADENOPATHY (Swollen lymph node on left arm) and FATIGUE (Tired) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 003B21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (Patient is obese, so she qualifies as "high risk".) and Lactose intolerant (takes lactase pills). Concomitant products included LACTASE for Lactose intolerance, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Sleepy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced NASOPHARYNGITIS (Little cold), AXILLARY PAIN (Armpit hurt so bad), LYMPHADENOPATHY (Swollen lymph node on left arm) and FATIGUE (Tired). On 24-Oct-2021, NASOPHARYNGITIS (Little cold), AXILLARY PAIN (Armpit hurt so bad), LYMPHADENOPATHY (Swollen lymph node on left arm) and FATIGUE (Tired) had resolved.      Patient took some gas pills because of some beans she ate. Treatment includes Warm compresses to relieve armpit pain  Patient stated since thursday night she hasn't been taking Zyrtec, as she was unsure if it might interact somehow with the vaccine and she has not discontinued of taking lactase pills, because of the vaccine and kept taking them   This case was linked to MOD-2021-364024 (Patient Link).