chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Illness, Nausea
Clinical narrative: she became sick; headache; chills; sweating; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she became sick), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ILLNESS (she became sick), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and NAUSEA (nausea). At the time of the report, ILLNESS (she became sick), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fall, Fatigue, Feeling abnormal, Sinus pain
Clinical narrative: Pain in her head that went down to her ear; sinus pain; Almost fell out of chair when she tried to stand up; Legs felt like they were going to give out; Same thing happened the next day when she got out of bed in the morning; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Pain in her head that went down to her ear), SINUS PAIN (sinus pain), FALL (Almost fell out of chair when she tried to stand up), FATIGUE (Legs felt like they were going to give out) and FEELING ABNORMAL (Same thing happened the next day when she got out of bed in the morning) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EAR PAIN (Pain in her head that went down to her ear), SINUS PAIN (sinus pain), FALL (Almost fell out of chair when she tried to stand up), FATIGUE (Legs felt like they were going to give out) and FEELING ABNORMAL (Same thing happened the next day when she got out of bed in the morning). At the time of the report, EAR PAIN (Pain in her head that went down to her ear), FALL (Almost fell out of chair when she tried to stand up), FATIGUE (Legs felt like they were going to give out) and FEELING ABNORMAL (Same thing happened the next day when she got out of bed in the morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: very red at the injection site; warm at the injection site; bumpy at the injection site; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), VACCINATION SITE ERYTHEMA (very red at the injection site), VACCINATION SITE WARMTH (warm at the injection site) and VACCINATION SITE MASS (bumpy at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-Mar-2021, the patient experienced FATIGUE (felt tired). On 20-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm at the injection site) and VACCINATION SITE MASS (bumpy at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (very red at the injection site). At the time of the report, FATIGUE (felt tired), VACCINATION SITE ERYTHEMA (very red at the injection site), VACCINATION SITE WARMTH (warm at the injection site) and VACCINATION SITE MASS (bumpy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant  medication included vitamins  Treatment included ice pack   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on arm of injection, right neck and right thumb; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm of injection, right neck and right thumb) in a 65-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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash on arm of injection, right neck and right thumb). At the time of the report, RASH (rash on arm of injection, right neck and right thumb) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 09-Mar-2021 rash was recovered but on  21-Mar-2021 mild rash came back.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lip swelling, Nasal oedema
Clinical narrative: flu like pains; chills; swelling on my lips; slight swelling right under my nose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling on my lips), INFLUENZA LIKE ILLNESS (flu like pains), NASAL OEDEMA (slight swelling right under my nose) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced LIP SWELLING (swelling on my lips) and NASAL OEDEMA (slight swelling right under my nose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like pains) and CHILLS (chills). At the time of the report, LIP SWELLING (swelling on my lips) and NASAL OEDEMA (slight swelling right under my nose) had not resolved and INFLUENZA LIKE ILLNESS (flu like pains) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02-JUN-2021 contains non-significant information. Email address was added
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Herpes zoster, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles), pain (painful) and diarrhea in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025L20A and 011M20A) for COVID-19 immunization. No medical history reported. On Jan 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. March 2021, patient experienced herpes zoster (shingles), pain (painful) and diarrhea. The patient treated with prednisone at an unspecified dose and frequency; and acyclovir at an unspecified dose and frequency; Covarex (miconazole nitrate) at an unspecified dose and frequency and sulfamethoxazole at an unspecified dose and frequency. At the time of the report, herpes zoster (shingles), pain (painful) and diarrhea outcome: unknown. Concomitant product use not provided. Action taken with mRNA-1273 in response to the event: not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: occasional slight dizziness; fever with 99.7 body temperature; chill; She had a sore arm; she felt foggy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), DIZZINESS (occasional slight dizziness), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill). On 20-Mar-2021, the patient experienced DIZZINESS (occasional slight dizziness). At the time of the report, PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), DIZZINESS (occasional slight dizziness), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.7 (High) 99.7.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: non-significant follow up appended. AE Update: Email address provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: occasional slight dizziness; fever with 99.7 body temperature; chill; She had a sore arm; she felt foggy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), DIZZINESS (occasional slight dizziness), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill). On 20-Mar-2021, the patient experienced DIZZINESS (occasional slight dizziness). At the time of the report, PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), DIZZINESS (occasional slight dizziness), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.7 (High) 99.7.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: non-significant follow up appended. AE Update: Email address provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: my second dose given 39 days later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my second dose given 39 days later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my second dose given 39 days later). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my second dose given 39 days later) had resolved. Not Provided          Concomitant medication were not provided/unknown. Treatment medication were not provided/unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Sluggishness, Vaccination site pain
Clinical narrative: Sluggishness; Feel bad, off and crappy; Fatigue/Tiredness; Chills; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness), FEELING ABNORMAL (Feel bad, off and crappy), FATIGUE (Fatigue/Tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-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 SLUGGISHNESS (Sluggishness), FEELING ABNORMAL (Feel bad, off and crappy), FATIGUE (Fatigue/Tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, SLUGGISHNESS (Sluggishness), FEELING ABNORMAL (Feel bad, off and crappy), FATIGUE (Fatigue/Tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site due to a rash/ vaccination had a rash or break out around the injection site; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site due to a rash/ vaccination had a rash or break out around the injection site) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (injection site due to a rash/ vaccination had a rash or break out around the injection site) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE RASH (injection site due to a rash/ vaccination had a rash or break out around the injection site) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's past medical history was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow 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 events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go; past the dosing window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go) and PRODUCT DOSE OMISSION ISSUE (past the dosing window) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go) and PRODUCT DOSE OMISSION ISSUE (past the dosing window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go) and PRODUCT DOSE OMISSION ISSUE (past the dosing window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Feeding disorder, Headache, Pyrexia, Vomiting
Clinical narrative: does not eat anything; dehydrated; Fever; headache; vomits; This spontaneous case was reported by a physician and describes the occurrence of FEEDING DISORDER (does not eat anything), DEHYDRATION (dehydrated), PYREXIA (Fever), HEADACHE (headache) and VOMITING (vomits) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced FEEDING DISORDER (does not eat anything), DEHYDRATION (dehydrated), PYREXIA (Fever), HEADACHE (headache) and VOMITING (vomits). At the time of the report, FEEDING DISORDER (does not eat anything), DEHYDRATION (dehydrated), PYREXIA (Fever), HEADACHE (headache) and VOMITING (vomits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included medication for diabetes.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles Outbreak; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles Outbreak) in a 54-year-old female patient 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 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles Outbreak). The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles Outbreak) 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.   Concomitant product use was not provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: 3" Injection Site Rash; Injection site itchiness; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (3" Injection Site Rash), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE PAIN (Injection site pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 VACCINATION SITE RASH (3" Injection Site Rash), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE RASH (3" Injection Site Rash), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Vomiting
Clinical narrative: She was dizzy; She was disoriented; She vomited; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She was dizzy), DISORIENTATION (She was disoriented) and VOMITING (She vomited) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]), LISINOPRIL, ATORVASTATIN and FUROSEMIDE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced DIZZINESS (She was dizzy), DISORIENTATION (She was disoriented) and VOMITING (She vomited). At the time of the report, DIZZINESS (She was dizzy), DISORIENTATION (She was disoriented) and VOMITING (She vomited) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Achy; chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (chills) and PYREXIA (Slight fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and PRAVASTATIN for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (Achy), CHILLS (chills) and PYREXIA (Slight fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), CHILLS (chills) and PYREXIA (Slight fever) 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin irritation, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Face is irritated; Face is red; Hardness at the injection site; Swollen at the injection site; Redness at the injection site; Soreness in the arm, at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Soreness in the arm, at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis rheumatoid.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm, at the injection site). On 22-Mar-2021, the patient experienced SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE PAIN (Soreness in the arm, at the injection site) had resolved. At the time of the report, SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was seen in the ER on 22-MAR-2021.  Patient was treated with a (STEROID) (NOS). No hospitalization was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Face is irritated; Face is red; Hardness at the injection site; Swollen at the injection site; Redness at the injection site; Soreness in the arm, at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Soreness in the arm, at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis rheumatoid.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm, at the injection site). On 22-Mar-2021, the patient experienced SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE PAIN (Soreness in the arm, at the injection site) had resolved. At the time of the report, SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was seen in the ER on 22-MAR-2021.  Patient was treated with a (STEROID) (NOS). No hospitalization was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: arm is red; itching on arm; some swelling on arm; warm arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PRURITUS (itching on arm), PERIPHERAL SWELLING (some swelling on arm) and FEELING HOT (warm arm) in a 72-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (arm is red), PRURITUS (itching on arm), PERIPHERAL SWELLING (some swelling on arm) and FEELING HOT (warm arm).            Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Hypertension, Neck pain
Clinical narrative: high blood pressure.; chills; his left ear started hurting; headache; sore arm; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), EAR PAIN (his left ear started hurting) and HYPERTENSION (high blood pressure.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 11-Mar-2021 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NECK PAIN (Neck pain). On 13-Mar-2021, the patient experienced HEADACHE (headache). On 20-Mar-2021, the patient experienced EAR PAIN (his left ear started hurting). On 22-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced HYPERTENSION (high blood pressure.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), EAR PAIN (his left ear started hurting), HYPERTENSION (high blood pressure.) and NECK PAIN (Neck pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: F/U received on 26-MAR-2021, new event added , treatment details added.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: high blood pressure.; chills; his left ear started hurting; headache; sore arm; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), EAR PAIN (his left ear started hurting) and HYPERTENSION (high blood pressure.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 11-Mar-2021 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NECK PAIN (Neck pain). On 13-Mar-2021, the patient experienced HEADACHE (headache). On 20-Mar-2021, the patient experienced EAR PAIN (his left ear started hurting). On 22-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced HYPERTENSION (high blood pressure.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), EAR PAIN (his left ear started hurting), HYPERTENSION (high blood pressure.) and NECK PAIN (Neck pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: F/U received on 26-MAR-2021, new event added , treatment details added.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: arm was still sore; arm was still red; 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 PAIN IN EXTREMITY (arm was still sore) and ERYTHEMA (arm was still red) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was still sore) and ERYTHEMA (arm was still red). At the time of the report, PAIN IN EXTREMITY (arm was still sore) and ERYTHEMA (arm was still red) had not resolved.        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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Mild body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-053200 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmness around the injection site; Itchiness around the injection site; Hardness around the injection site; Swelling aroun the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE INDURATION (Hardness around the injection site), VACCINATION SITE SWELLING (Swelling aroun the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE INDURATION (Hardness around the injection site), VACCINATION SITE SWELLING (Swelling aroun the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE INDURATION (Hardness around the injection site), VACCINATION SITE SWELLING (Swelling aroun the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unspecified medication for high blood pressure.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 10 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 10 days after receiving 1st dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 10 days after receiving 1st dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 10 days after receiving 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment products information  provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 022M20A) with no associated AEs.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; aching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and PAIN (aching all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Arthritis, OMEPRAZOLE, FAMOTIDINE and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Pain) and PAIN (aching all over the body). On 18-Mar-2021, PAIN (Pain) and PAIN (aching all over the body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Tremor
Clinical narrative: Shaking; lack of energy; feel freezing "to death"; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (lack of energy), CHILLS (feel freezing "to death"), MYALGIA (body aches) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TREMOR (Shaking), ASTHENIA (lack of energy), CHILLS (feel freezing "to death"), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, TREMOR (Shaking), ASTHENIA (lack of energy), CHILLS (feel freezing "to death"), MYALGIA (body aches) and HEADACHE (headache) 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.  No treatment information was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Vaccination site lymphadenopathy
Clinical narrative: muscle cramps; swollen lymph nodes under left armpit; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left armpit), HEADACHE (headache) and CHILLS (chills) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCLE SPASMS (muscle cramps), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left armpit), HEADACHE (headache) and CHILLS (chills). On 21-Mar-2021, MUSCLE SPASMS (muscle cramps), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.  All symptoms resolved after about a week they have started.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Start date of all the events are updated. Outcome of the event [VACCINATION SITE LYMPHADENOPATHY] has been updated to recovered from unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area feels warm to the touch; Noticed rash that has developed around injection sight; Area looks a little inflamed.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE RASH (Noticed rash that has developed around injection sight) and VACCINATION SITE SWELLING (Area looks a little inflamed.) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE RASH (Noticed rash that has developed around injection sight) and VACCINATION SITE SWELLING (Area looks a little inflamed.). At the time of the report, VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE RASH (Noticed rash that has developed around injection sight) and VACCINATION SITE SWELLING (Area looks a little inflamed.) 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.   Concomitant product use was not provided by the reporter.  No treatment information was provided by the reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN, CLONAZEPAM and ESTRADIOL for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and CHILLS (Chills) and MYALGIA (Body aches) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-053194 (Patient Link).