chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Limb discomfort, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache) and CHILLS (chills so bad she was shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-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 LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache), CHILLS (chills so bad she was shaking), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache), CHILLS (chills so bad she was shaking), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 103 (High) 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included respiratory inhaler for asthma.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache) and CHILLS (chills so bad she was shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-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 LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache), CHILLS (chills so bad she was shaking), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache), CHILLS (chills so bad she was shaking), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 103 (High) 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included respiratory inhaler for asthma.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Lip dry, Myalgia
Clinical narrative: Dry lips; Body aches; Chills; Muscle pain; Joint pain; Fatigue; Fever; Pain in the arm, legs, other arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm, legs, other arm), LIP DRY (Dry lips), PAIN (Body aches), CHILLS (Chills) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm, legs, other arm), PAIN (Body aches), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced LIP DRY (Dry lips). At the time of the report, PAIN IN EXTREMITY (Pain in the arm, legs, other arm), LIP DRY (Dry lips), PAIN (Body aches), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No relevant concomitant medications reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Dry lips; Body aches; Chills; Muscle pain; Joint pain; Fatigue; Fever; Pain in the arm, legs, other arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm, legs, other arm), LIP DRY (Dry lips), PAIN (Body aches), CHILLS (Chills) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm, legs, other arm), PAIN (Body aches), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced LIP DRY (Dry lips). At the time of the report, PAIN IN EXTREMITY (Pain in the arm, legs, other arm), LIP DRY (Dry lips), PAIN (Body aches), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No relevant concomitant medications reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: has a strong feeling of nausea but has not vomited yet; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (has a strong feeling of nausea but has not vomited yet) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Paralysis in 2019 and Infection (infection of 2 legs) in 2019. Concurrent medical conditions included Blood pressure high. Concomitant products included METFORMIN for Diabetes mellitus management.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced NAUSEA (has a strong feeling of nausea but has not vomited yet). At the time of the report, NAUSEA (has a strong feeling of nausea but has not vomited yet) 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.   Patient does physical therapy. Other relevant medication history included insulin and metformin for blood sugar level control for 10 years. No treatment information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Urticaria
Clinical narrative: bone pain; hives on neck; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), URTICARIA (hives on neck) and MYALGIA (muscle pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, OMEPRAZOLE, RIVAROXABAN (XARELTO) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BONE PAIN (bone pain), URTICARIA (hives on neck) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, BONE PAIN (bone pain), URTICARIA (hives on neck) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included Vitamins.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; vomiting; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (vomiting) and ARTHRALGIA (Joint 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) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (vomiting) and ARTHRALGIA (Joint pain). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (vomiting) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: feeling bad all week; felt dizzy; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad all week), DIZZINESS (felt dizzy), HEADACHE (headache) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A211A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING ABNORMAL (feeling bad all week), DIZZINESS (felt dizzy), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (feeling bad all week), DIZZINESS (felt dizzy), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant medication history included Blood pressure medication,Thyroid medication,heart medication. Patient took Tylenol and medication for the nauseas since 01Mar2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: arm was itching; body pain; change in taste sensation; arm was hot; lump at the injection site; very tired; nausea; fever; chills; muscle ache; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE MASS (lump at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Allergy to chemicals (allergic to unknown dye used during CAT scans) and Pre-diabetic. Concomitant products included METFORMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt) and PYREXIA (fever). On 03-Mar-2021, the patient experienced PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), FATIGUE (very tired) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt), FATIGUE (very tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.5 (High) 99.5 F. On 03-Mar-2021, Body temperature: 101.5 (High) 101.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she takes occasionally a sinus pill.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pruritus, Pyrexia, Taste disorder
Clinical narrative: arm was itching; body pain; change in taste sensation; arm was hot; lump at the injection site; very tired; nausea; fever; chills; muscle ache; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE MASS (lump at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Allergy to chemicals (allergic to unknown dye used during CAT scans) and Pre-diabetic. Concomitant products included METFORMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt) and PYREXIA (fever). On 03-Mar-2021, the patient experienced PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), FATIGUE (very tired) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt), FATIGUE (very tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.5 (High) 99.5 F. On 03-Mar-2021, Body temperature: 101.5 (High) 101.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she takes occasionally a sinus pill.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: arm was itching; body pain; change in taste sensation; arm was hot; lump at the injection site; very tired; nausea; fever; chills; muscle ache; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE MASS (lump at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Allergy to chemicals (allergic to unknown dye used during CAT scans) and Pre-diabetic. Concomitant products included METFORMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt) and PYREXIA (fever). On 03-Mar-2021, the patient experienced PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), FATIGUE (very tired) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, PRURITUS (arm was itching), PAIN (body pain), TASTE DISORDER (change in taste sensation), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE MASS (lump at the injection site), CHILLS (chills), MYALGIA (muscle ache), HEADACHE (head hurt), FATIGUE (very tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.5 (High) 99.5 F. On 03-Mar-2021, Body temperature: 101.5 (High) 101.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she takes occasionally a sinus pill.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Dry skin, Erythema, Skin warm
Clinical narrative: I had a reaction in both of my legs at the front going from 5 inches below knee and above the ankles; RED; DRY; HOT; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (I had a reaction in both of my legs at the front going from 5 inches below knee and above the ankles), ERYTHEMA (RED), DRY SKIN (DRY) and FEELING HOT (HOT) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM for Blood pressure management, LISINOPRIL, METOPROLOL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 25-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 ADVERSE DRUG REACTION (I had a reaction in both of my legs at the front going from 5 inches below knee and above the ankles), ERYTHEMA (RED), DRY SKIN (DRY) and FEELING HOT (HOT). At the time of the report, ADVERSE DRUG REACTION (I had a reaction in both of my legs at the front going from 5 inches below knee and above the ankles), ERYTHEMA (RED), DRY SKIN (DRY) and FEELING HOT (HOT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Lymphadenopathy, Night sweats
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)), PAIN (body aches) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (light headache) and VACCINATION SITE PAIN (soreness at injection site). On 07-Feb-2021, the patient experienced NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)) and CHILLS (Chills). On 08-Feb-2021, the patient experienced PAIN (body aches). On 05-Feb-2021, HEADACHE (light headache) and VACCINATION SITE PAIN (soreness at injection site) had resolved. On 11-Feb-2021, NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)), PAIN (body aches) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)), PAIN (body aches) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (light headache) and VACCINATION SITE PAIN (soreness at injection site). On 07-Feb-2021, the patient experienced NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)) and CHILLS (Chills). On 08-Feb-2021, the patient experienced PAIN (body aches). On 05-Feb-2021, HEADACHE (light headache) and VACCINATION SITE PAIN (soreness at injection site) had resolved. On 11-Feb-2021, NIGHT SWEATS (night sweats), FEELING COLD (Felt like they couldn't get warm.), LYMPHADENOPATHY (breasts were tender (swollen lymph nodes)), PAIN (body aches) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: rash in the injection site; it's slightly painful; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash in the injection site) and INJECTION SITE PAIN (it's slightly painful) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE RASH (rash in the injection site) and INJECTION SITE PAIN (it's slightly painful). At the time of the report, INJECTION SITE RASH (rash in the injection site) and INJECTION SITE PAIN (it's slightly painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pain
Clinical narrative: Not feeling well; Tired; Ache all over; Low energy level; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Low energy level), MALAISE (Not feeling well), FATIGUE (Tired) and PAIN (Ache all over) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ASTHENIA (Low energy level). On an unknown date, the patient experienced MALAISE (Not feeling well), FATIGUE (Tired) and PAIN (Ache all over). At the time of the report, ASTHENIA (Low energy level), MALAISE (Not feeling well), FATIGUE (Tired) and PAIN (Ache all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: NNI
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Muscular weakness, Pain in extremity
Clinical narrative: Sore arm; diarrhea; Hamstring muscles weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (diarrhea) and MUSCULAR WEAKNESS (Hamstring muscles weakness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (diarrhea) and MUSCULAR WEAKNESS (Hamstring muscles weakness). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (diarrhea) and MUSCULAR WEAKNESS (Hamstring muscles weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting projectile
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VOMITING PROJECTILE (projectile vomiting) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VOMITING PROJECTILE (projectile vomiting) and NAUSEA (nausea). At the time of the report, VOMITING PROJECTILE (projectile vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sinusitis
Clinical narrative: periodic sinus infections; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SINUSITIS (periodic sinus infections) in a 77-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 XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced SINUSITIS (periodic sinus infections). At the time of the report, PAIN IN EXTREMITY (sore arm) and SINUSITIS (periodic sinus infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Headache, Pain
Clinical narrative: appetite; achy; Low grade fever; severe bad headaches; chills for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite), PAIN (achy), PYREXIA (Low grade fever), HEADACHE (severe bad headaches) and CHILLS (chills for 2-3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Low grade fever), HEADACHE (severe bad headaches) and CHILLS (chills for 2-3 days). On 07-Mar-2021, the patient experienced DECREASED APPETITE (appetite) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL RAPID RELEASE GELS) at a dose of 1 dosage form. On 07-Mar-2021, PYREXIA (Low grade fever), HEADACHE (severe bad headaches) and CHILLS (chills for 2-3 days) had resolved. At the time of the report, DECREASED APPETITE (appetite) and PAIN (achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101.5 (High) 101.5.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No medical history was provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: appetite; achy; Low grade fever; severe bad headaches; chills for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite), PAIN (achy), PYREXIA (Low grade fever), HEADACHE (severe bad headaches) and CHILLS (chills for 2-3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Low grade fever), HEADACHE (severe bad headaches) and CHILLS (chills for 2-3 days). On 07-Mar-2021, the patient experienced DECREASED APPETITE (appetite) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL RAPID RELEASE GELS) at a dose of 1 dosage form. On 07-Mar-2021, PYREXIA (Low grade fever), HEADACHE (severe bad headaches) and CHILLS (chills for 2-3 days) had resolved. At the time of the report, DECREASED APPETITE (appetite) and PAIN (achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101.5 (High) 101.5.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No medical history was provided by the reporter.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Injection site erythema, Injection site warmth
Clinical narrative: 2 inch diameter that is warm; angry; 2 inch diameter that is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (2 inch diameter that is warm), ANGER (angry) and INJECTION SITE ERYTHEMA (2 inch diameter that is red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L70A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 INJECTION SITE WARMTH (2 inch diameter that is warm), ANGER (angry) and INJECTION SITE ERYTHEMA (2 inch diameter that is red). At the time of the report, INJECTION SITE WARMTH (2 inch diameter that is warm), ANGER (angry) and INJECTION SITE ERYTHEMA (2 inch diameter that is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medication was reported.  Patient said she doesn't want to provide any details.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20 JUL 2021: No new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling hot, Headache
Clinical narrative: Diarrhea; body felt warm; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FEELING HOT (body felt warm), CHILLS (Chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING HOT (body felt warm), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 03-Mar-2021, DIARRHOEA (Diarrhea) had resolved. On 04-Mar-2021, FEELING HOT (body felt warm), CHILLS (Chills) and HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and MYALGIA (body ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 09-Feb-2021, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and MYALGIA (body ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Followup received and reporter contact details were updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Oedema peripheral, Pyrexia
Clinical narrative: Flu-like symptoms; Ball in the mid part of her foot; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), OEDEMA PERIPHERAL (Ball in the mid part of her foot), PYREXIA (Fever) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), OEDEMA PERIPHERAL (Ball in the mid part of her foot), PYREXIA (Fever) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), OEDEMA PERIPHERAL (Ball in the mid part of her foot), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-035546 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; 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 PYREXIA (High fever) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Catarrh, Computerised tomogram thorax, Dyspnoea, Feeling abnormal, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty in breathing), CATARRH (Mucus through throat), PHARYNGEAL SWELLING (Swollen throat), FEELING ABNORMAL (Didn't feel good) and LYMPHADENOPATHY (Swollen throat and Lymph Node) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072M204) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DYSPNOEA (Difficulty in breathing). On 07-Feb-2021, the patient experienced CATARRH (Mucus through throat). On 08-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat) and LYMPHADENOPATHY (Swollen throat and Lymph Node). On 21-Feb-2021, the patient experienced FEELING ABNORMAL (Didn't feel good). The patient was treated with ALBUTEROL [SALBUTAMOL] at a dose of 1 dosage form and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty in breathing), CATARRH (Mucus through throat), PHARYNGEAL SWELLING (Swollen throat), FEELING ABNORMAL (Didn't feel good) and LYMPHADENOPATHY (Swollen throat and Lymph Node) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Computerised tomogram thorax: normal (normal) normal. On 21-Feb-2021, Pulmonary function test: normal (normal) normal. On an unknown date, Nasoendoscopy: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Nasoendoscopy, Pharyngeal swelling, Pulmonary function test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty in breathing), CATARRH (Mucus through throat), PHARYNGEAL SWELLING (Swollen throat), FEELING ABNORMAL (Didn't feel good) and LYMPHADENOPATHY (Swollen throat and Lymph Node) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072M204) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DYSPNOEA (Difficulty in breathing). On 07-Feb-2021, the patient experienced CATARRH (Mucus through throat). On 08-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat) and LYMPHADENOPATHY (Swollen throat and Lymph Node). On 21-Feb-2021, the patient experienced FEELING ABNORMAL (Didn't feel good). The patient was treated with ALBUTEROL [SALBUTAMOL] at a dose of 1 dosage form and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty in breathing), CATARRH (Mucus through throat), PHARYNGEAL SWELLING (Swollen throat), FEELING ABNORMAL (Didn't feel good) and LYMPHADENOPATHY (Swollen throat and Lymph Node) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Computerised tomogram thorax: normal (normal) normal. On 21-Feb-2021, Pulmonary function test: normal (normal) normal. On an unknown date, Nasoendoscopy: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20B) 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 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No medical history was provided by the reporter. No relevant concomitant medications reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: got terribly sick; was feeling horrible; because of her compromised immune system she may have had a delayed reaction; Diarrhea; Loss of appetite; Headache; Nausea; Fatigue; Body aches; 103 fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS ("has a bunch of autoimmune disease since before the vaccination").   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills). On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible), HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that the patient's doctor advised her to get tested in case she picked up Covid or the flu. She was subsequently tested and both were negative.  The patient reported that her reactions ("terribly sick", 103 fever, chills, body aches, "feeling horrible" and "may have had a delayed reaction") lasted for 4-5 days and then stopped and she no longer has symptoms.   This case was linked to MOD-2021-035549, MOD-2021-035549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received: Additional events were added ("got terribly sick", "feeling horrible" and "may have had a delayed reaction"); outcome for fever, chills and body aches updated; reporter details updated; narrative updated.