chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Feeling cold, Gait inability
Clinical narrative: Felt like she was going to pass out; Had tightness in her chest; Sweating profusely; Could not walk; Felt very weak; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing) and FEELING ABNORMAL (Felt like she was going to pass out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-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. In March 2021, the patient experienced HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak) and FEELING COLD (Freezing). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract disorder prophylaxis, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing), FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest) outcome was unknown.            No Concomitant medications were provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Felt like she was going to pass out; Had tightness in her chest; Sweating profusely; Could not walk; Felt very weak; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing) and FEELING ABNORMAL (Felt like she was going to pass out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-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. In March 2021, the patient experienced HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak) and FEELING COLD (Freezing). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract disorder prophylaxis, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing), FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest) outcome was unknown.            No Concomitant medications were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: thigh stiffness; pain at the injected arm; mild fever; body aches; body aches; mild fever; This spontaneous case was reported by a physician and describes the occurrence of the first episode of PYREXIA (mild fever), the first episode of PAIN (body aches), MUSCULOSKELETAL STIFFNESS (thigh stiffness), INJECTION SITE PAIN (pain at the injected arm) and the second episode of PYREXIA (mild fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced the first episode of PYREXIA (mild fever). On 12-Feb-2021, the patient experienced the first episode of PAIN (body aches), INJECTION SITE PAIN (pain at the injected arm), the second episode of PYREXIA (mild fever) and the second episode of PAIN (body aches). On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (thigh stiffness). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (thigh stiffness), INJECTION SITE PAIN (pain at the injected arm), the last episode of PYREXIA (mild fever) and the last episode of PAIN (body aches) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Rapid heart beat; trouble breathing at the time; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time). At the time of the report, HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter details and vaccine details updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Limb discomfort, Muscle spasticity, Pain in extremity
Clinical narrative: Her arm is hanging, can move fingers but could not hold anything; Can hardly move her arm; Arm been sore and has a lot of pain; injection less than an inch under collar bone, does not agree on where she receive the vaccine, shot she received was too high; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain,sore arm,  hardly move her arm, arm was hanging like it doesn't belong to her, could move her fingers but could not hold anything and received injection less than an inch under collar bone,   The patient's medical history, as provided by the reporter, included multiple sclerosis. Products known to have been used by patient, within two weeks prior to the event, included gabapentin.  On 04-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013M20A). On 04 Mar 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 030A21A) for prophylaxis of COVID-19 infection.   On 04-Mar-2021, the patient experienced sore arm and had a lot of pain, could hardly move her arm, her arm was hanging like it doesn't belong to her, could move her fingers but could not hold anything. Treatment included ibuprofen and acetaminophen.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of events, experienced sore arm and had a lot of pain,  could hardly move her arm,  her arm was hanging like it doesn't belong to her, could move her fingers but could not hold anything and injection less than an inch under collar bone,  were considered resolved on 08-Mar-2021.; Reporter'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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulum, Oropharyngeal pain
Clinical narrative: diverticulosis; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and DIVERTICULUM (diverticulosis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced DIVERTICULUM (diverticulosis). At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved and DIVERTICULUM (diverticulosis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included salt water gargle.  Sore throat is reported to be caused by pollution and other environmental factors.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received - Outcome of the event sore throat updated, causality was updated and new event diverticulosis added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Sore arm; Arm was hurting, felt pain down to the arm going to the wrist and fingers; Can't move because of the pain; Solid deep pain with moments of shooting pain; Headache; had bad chills with no fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (Pre-existing type 2 diabetes for 40 years.) and Neuropathy peripheral.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain), HEADACHE (Headache) and CHILLS (had bad chills with no fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Prophylaxis, at a dose of 2 Tab and TRAMADOL (oral) for Prophylaxis, at a dose of 1 Tab. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain), HEADACHE (Headache) and CHILLS (had bad chills with no fever) outcome was unknown.            Treatment for the event included Tylenol extra strength two tablets and Tramadol 1 tablet. No Concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysuria, Headache, Movement disorder
Clinical narrative: Felt worse than she did when she had COVID-19; Extremely light headed; Wasn't able to move; Vertigo; Trouble peeing; Headache; Had a 102 F fever; Chills; Unable to keep anything in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), VERTIGO (Vertigo) and DYSURIA (Trouble peeing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In December). Concomitant products included FENOFIBRATE, UBIDECARENONE (COQ10 EXCEL), CALCIUM and MULTIVITAMIN [VITAMINS NOS] 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 04-Mar-2021, the patient experienced VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), VERTIGO (Vertigo), DYSURIA (Trouble peeing), HEADACHE (Headache), PYREXIA (Had a 102 F fever), CHILLS (Chills) and VOMITING (Unable to keep anything in). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 07-Mar-2021, VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), PYREXIA (Had a 102 F fever) and VOMITING (Unable to keep anything in) had resolved. At the time of the report, VERTIGO (Vertigo), DYSURIA (Trouble peeing), HEADACHE (Headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vertigo, Vomiting
Clinical narrative: Felt worse than she did when she had COVID-19; Extremely light headed; Wasn't able to move; Vertigo; Trouble peeing; Headache; Had a 102 F fever; Chills; Unable to keep anything in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), VERTIGO (Vertigo) and DYSURIA (Trouble peeing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In December). Concomitant products included FENOFIBRATE, UBIDECARENONE (COQ10 EXCEL), CALCIUM and MULTIVITAMIN [VITAMINS NOS] 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 04-Mar-2021, the patient experienced VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), VERTIGO (Vertigo), DYSURIA (Trouble peeing), HEADACHE (Headache), PYREXIA (Had a 102 F fever), CHILLS (Chills) and VOMITING (Unable to keep anything in). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 07-Mar-2021, VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), PYREXIA (Had a 102 F fever) and VOMITING (Unable to keep anything in) had resolved. At the time of the report, VERTIGO (Vertigo), DYSURIA (Trouble peeing), HEADACHE (Headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Irritable bowel syndrome, Vertigo
Clinical narrative: vertigo; IBSD; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea ), VERTIGO (vertigo) and IRRITABLE BOWEL SYNDROME (IBSD) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (diarrhea ) and IRRITABLE BOWEL SYNDROME (IBSD). On 08-Feb-2021, the patient experienced VERTIGO (vertigo). At the time of the report, DIARRHOEA (diarrhea ), VERTIGO (vertigo) and IRRITABLE BOWEL SYNDROME (IBSD) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site pain, Vaccination site pruritus
Clinical narrative: the red has faded out now and there are little puffy spots/dots and indentation in a couple of; left arm injection area is still sensitive; getting itchy; left arm was swollen; sore at injection site; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE ERYTHEMA (Red at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Solitary kidney. Concomitant products included Thyroid pills, CALCIUM, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and ASCORBIC ACID, COPPER GLUCONATE, FISH OIL, TOCOPHEROL, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE]) for an unknown indication.   On 03-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 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE PRURITUS (getting itchy), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown, VACCINATION SITE SWELLING (left arm was swollen) had resolved and VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-033117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Live significant follow-up appended for case ID MOD21-085628for AE"s - Arm Swelling, Vaccination site hypersensitivity.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: the red has faded out now and there are little puffy spots/dots and indentation in a couple of; left arm injection area is still sensitive; getting itchy; left arm was swollen; sore at injection site; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE ERYTHEMA (Red at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Solitary kidney. Concomitant products included Thyroid pills, CALCIUM, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and ASCORBIC ACID, COPPER GLUCONATE, FISH OIL, TOCOPHEROL, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE]) for an unknown indication.   On 03-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 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE PRURITUS (getting itchy), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown, VACCINATION SITE SWELLING (left arm was swollen) had resolved and VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-033117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Live significant follow-up appended for case ID MOD21-085628for AE"s - Arm Swelling, Vaccination site hypersensitivity.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm is itchy; left arm got swollen; left arm got a large red circle on injection site; arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE SWELLING (left arm got swollen), INJECTION SITE ERYTHEMA (left arm got a large red circle on injection site) and VACCINATION SITE PAIN (arm is painful) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE SWELLING (left arm got swollen), INJECTION SITE ERYTHEMA (left arm got a large red circle on injection site) and VACCINATION SITE PAIN (arm is painful). The patient was treated with ARNICA MONTANA (ARNICARE) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE SWELLING (left arm got swollen), INJECTION SITE ERYTHEMA (left arm got a large red circle on injection site) and VACCINATION SITE PAIN (arm is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced delayed reaction. concomitant med- allergy medication.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.8 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M204) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.8 degrees). On 09-Feb-2021, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 101.8 (Inconclusive) body temperature 101.8 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Tinnitus
Clinical narrative: Woke up ringing in the ear: pretty loud; Swollen arm; Lots of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Woke up ringing in the ear: pretty loud), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Lots of fatigue) in a 72-year-old male patient 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 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 06-Mar-2021, the patient experienced TINNITUS (Woke up ringing in the ear: pretty loud), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Lots of fatigue). At the time of the report, TINNITUS (Woke up ringing in the ear: pretty loud), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Lots of fatigue) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Dermatitis psoriasiform, Fatigue, Feeling abnormal, Rash macular
Clinical narrative: Psoriasis Reaction; hives; rash/ Rash that is bright red and bump from elbow to wrist, and lower back; itch; red blotches; tired; felt foggy; agitated; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt foggy), AGITATION (agitated), DERMATITIS PSORIASIFORM (Psoriasis Reaction), RASH MACULAR (red blotches) and FATIGUE (tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included BPH. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Blood pressure, TADALAFIL, BETAMETHASONE from 05-Mar-2021 to an unknown date, METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) from 16-Apr-2021 to 22-Apr-2021 and TRIAMCINOLONE from 27-Apr-2021 to an unknown date for an unknown indication, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 03-Mar-2021 to an unknown date and BETAMETHASONE.   On 03-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 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt foggy), AGITATION (agitated), RASH MACULAR (red blotches) and FATIGUE (tired). On an unknown date, the patient experienced DERMATITIS PSORIASIFORM (Psoriasis Reaction), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (rash/ Rash that is bright red and bump from elbow to wrist, and lower back) and VACCINATION SITE PRURITUS (itch). On 03-Mar-2021, FEELING ABNORMAL (felt foggy), AGITATION (agitated), RASH MACULAR (red blotches) and FATIGUE (tired) had resolved. At the time of the report, DERMATITIS PSORIASIFORM (Psoriasis Reaction), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (rash/ Rash that is bright red and bump from elbow to wrist, and lower back) and VACCINATION SITE PRURITUS (itch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drug not reported.   This case was linked to MOD-2021-033582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Lower level term updated from Injection site itching to Vaccination site pruritus, Injection site hives to Vaccination site urticaria.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site urticaria
Clinical narrative: Psoriasis Reaction; hives; rash/ Rash that is bright red and bump from elbow to wrist, and lower back; itch; red blotches; tired; felt foggy; agitated; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt foggy), AGITATION (agitated), DERMATITIS PSORIASIFORM (Psoriasis Reaction), RASH MACULAR (red blotches) and FATIGUE (tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included BPH. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Blood pressure, TADALAFIL, BETAMETHASONE from 05-Mar-2021 to an unknown date, METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) from 16-Apr-2021 to 22-Apr-2021 and TRIAMCINOLONE from 27-Apr-2021 to an unknown date for an unknown indication, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 03-Mar-2021 to an unknown date and BETAMETHASONE.   On 03-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 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt foggy), AGITATION (agitated), RASH MACULAR (red blotches) and FATIGUE (tired). On an unknown date, the patient experienced DERMATITIS PSORIASIFORM (Psoriasis Reaction), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (rash/ Rash that is bright red and bump from elbow to wrist, and lower back) and VACCINATION SITE PRURITUS (itch). On 03-Mar-2021, FEELING ABNORMAL (felt foggy), AGITATION (agitated), RASH MACULAR (red blotches) and FATIGUE (tired) had resolved. At the time of the report, DERMATITIS PSORIASIFORM (Psoriasis Reaction), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (rash/ Rash that is bright red and bump from elbow to wrist, and lower back) and VACCINATION SITE PRURITUS (itch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drug not reported.   This case was linked to MOD-2021-033582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Lower level term updated from Injection site itching to Vaccination site pruritus, Injection site hives to Vaccination site urticaria.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Erythema, Flushing, Headache, Hot flush
Clinical narrative: Flushed face; Clogged ears; hot flash that got worse" and "her face felt weird."; Face felt flushed and red; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed face), EAR CONGESTION (Clogged ears), HOT FLUSH (hot flash that got worse" and "her face felt weird."), ERYTHEMA (Face felt flushed and red) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 FLUSHING (Flushed face), EAR CONGESTION (Clogged ears), HOT FLUSH (hot flash that got worse" and "her face felt weird."), ERYTHEMA (Face felt flushed and red) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 02-Mar-2021, FLUSHING (Flushed face), EAR CONGESTION (Clogged ears), HOT FLUSH (hot flash that got worse" and "her face felt weird."), ERYTHEMA (Face felt flushed and red) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Herpes zoster
Clinical narrative: Pain in right chest area; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in right chest area) and HERPES ZOSTER (Shingles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHEST PAIN (Pain in right chest area) and HERPES ZOSTER (Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency and IBUPROFEN for Chest pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Pain in right chest area) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI - FU failed
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Broke out in sweats and sweating through his shirt, jacket and hat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Broke out in sweats and sweating through his shirt, jacket and hat) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONIDINE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERHIDROSIS (Broke out in sweats and sweating through his shirt, jacket and hat). At the time of the report, HYPERHIDROSIS (Broke out in sweats and sweating through his shirt, jacket and hat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by the patient for the event.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm is swollen and burning; Arm is swollen and burning; Red across her arm; Injected her subcutaneously instead of intramuscularly; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm is swollen and burning), INJECTION SITE SWELLING (Arm is swollen and burning), INJECTION SITE ERYTHEMA (Red across her arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected her subcutaneously instead of intramuscularly) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected her subcutaneously instead of intramuscularly). On an unknown date, the patient experienced INJECTION SITE PAIN (Arm is swollen and burning), INJECTION SITE SWELLING (Arm is swollen and burning) and INJECTION SITE ERYTHEMA (Red across her arm). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected her subcutaneously instead of intramuscularly) had resolved. At the time of the report, INJECTION SITE PAIN (Arm is swollen and burning), INJECTION SITE SWELLING (Arm is swollen and burning) and INJECTION SITE ERYTHEMA (Red across her arm) outcome was unknown.            Concomitant medication were not provided. Patient has been icing it for the treatment. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-043127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional Information received on 22-JUN-2021. Reporter's email id was added. It contains non significant information.; Reporter'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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Headache; Itching; Feels like a bee sting, soreness; Whole arm is swollen; Red; Tired; Had fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red) and FATIGUE (Tired) in a 52-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 was reported.  Concomitant products included IRBESARTAN and ATORVASTATIN 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 PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red), FATIGUE (Tired), PYREXIA (Had fever) and CHILLS (Chills). On 06-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red), FATIGUE (Tired), PYREXIA (Had fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Headache; Itching; Feels like a bee sting, soreness; Whole arm is swollen; Red; Tired; Had fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red) and FATIGUE (Tired) in a 52-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 was reported.  Concomitant products included IRBESARTAN and ATORVASTATIN 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 PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red), FATIGUE (Tired), PYREXIA (Had fever) and CHILLS (Chills). On 06-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, PRURITUS (Itching), PAIN (Feels like a bee sting, soreness), SWELLING (Whole arm is swollen), ERYTHEMA (Red), FATIGUE (Tired), PYREXIA (Had fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling jittery, Hyperhidrosis, Insomnia, Psychomotor hyperactivity, Restlessness
Clinical narrative: jittery; sweating; could not sleep; hyperactive; restlessness; Lost 2.5 pounds weight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive) and RESTLESSNESS (restlessness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder and Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive), RESTLESSNESS (restlessness) and WEIGHT DECREASED (Lost 2.5 pounds weight). At the time of the report, FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive), RESTLESSNESS (restlessness) and WEIGHT DECREASED (Lost 2.5 pounds weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified heart medications.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: jittery; sweating; could not sleep; hyperactive; restlessness; Lost 2.5 pounds weight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive) and RESTLESSNESS (restlessness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder and Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive), RESTLESSNESS (restlessness) and WEIGHT DECREASED (Lost 2.5 pounds weight). At the time of the report, FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive), RESTLESSNESS (restlessness) and WEIGHT DECREASED (Lost 2.5 pounds weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified heart medications.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Dyspnoea, Post viral fatigue syndrome, SARS-CoV-2 test, X-ray
Clinical narrative: "regular side effects"; difficulty breathing; "long haulers syndrome"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT ("regular side effects"), DYSPNOEA (difficulty breathing) and POST VIRAL FATIGUE SYNDROME ("long haulers syndrome") in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MDA) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced ADVERSE EVENT ("regular side effects"), DYSPNOEA (difficulty breathing) and POST VIRAL FATIGUE SYNDROME ("long haulers syndrome"). The patient was treated with PREDNISONE ongoing since an unknown date for Dyspnea, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT ("regular side effects"), DYSPNOEA (difficulty breathing) and POST VIRAL FATIGUE SYNDROME ("long haulers syndrome") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) negative. In January 2021, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, X-ray: showed long haulers (abnormal) showed "long haulers syndrome".     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included prednisone and inhalers.