chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram ambulatory, Hypersomnia, Hypokinesia, Memory impairment
Clinical narrative: having memory problems (he did not know where he was); could not sit up or move/did not have the strength to sit up; he slept for minimum 12-13 hours each day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (he slept for minimum 12-13 hours each day), HYPOKINESIA (could not sit up or move/did not have the strength to sit up) and MEMORY IMPAIRMENT (having memory problems (he did not know where he was)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced HYPERSOMNIA (he slept for minimum 12-13 hours each day). On 16-Mar-2021, the patient experienced HYPOKINESIA (could not sit up or move/did not have the strength to sit up). On an unknown date, the patient experienced MEMORY IMPAIRMENT (having memory problems (he did not know where he was)). On 17-Mar-2021, HYPERSOMNIA (he slept for minimum 12-13 hours each day) had resolved. At the time of the report, HYPOKINESIA (could not sit up or move/did not have the strength to sit up) and MEMORY IMPAIRMENT (having memory problems (he did not know where he was)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal. On an unknown date, Electrocardiogram ambulatory: abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment Tylenol fluids.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone swelling, Headache, Lymphadenopathy, Neck pain
Clinical narrative: pain in neck; swelling of clavicle; swollen lymph nodes in neck; she had headache at base of skull; pain in shoulder and back side of shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in neck), BONE SWELLING (swelling of clavicle), LYMPHADENOPATHY (swollen lymph nodes in neck), HEADACHE (she had headache at base of skull) and ARTHRALGIA (pain in shoulder and back side of shoulder) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, THYROID (ARMOUR THYROID) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced NECK PAIN (pain in neck), BONE SWELLING (swelling of clavicle), LYMPHADENOPATHY (swollen lymph nodes in neck), HEADACHE (she had headache at base of skull) and ARTHRALGIA (pain in shoulder and back side of shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain in neck), BONE SWELLING (swelling of clavicle), LYMPHADENOPATHY (swollen lymph nodes in neck), HEADACHE (she had headache at base of skull) and ARTHRALGIA (pain in shoulder and back side of shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-060245 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR form is received on (24-MAY-2021) and does not contain any new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060245:Second dose
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Neuralgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever 99.6; Pain in the injection site (left); Activated nerve in left arm to fingers; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Activated nerve in left arm to fingers), PYREXIA (Fever 99.6) and VACCINATION SITE PAIN (Pain in the injection site (left)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NEURALGIA (Activated nerve in left arm to fingers) and VACCINATION SITE PAIN (Pain in the injection site (left)). On 24-Mar-2021, the patient experienced PYREXIA (Fever 99.6). On 25-Mar-2021, PYREXIA (Fever 99.6) had resolved. At the time of the report, NEURALGIA (Activated nerve in left arm to fingers) and VACCINATION SITE PAIN (Pain in the injection site (left)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.6 (Inconclusive) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. Patient took Excedrin (1) dose on 24-Mar-2021 and (1) dose on 25-Mar-2021 as treatment medication.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: A week later the injection site became itchy; A week later the injection site became itchy and red; Injection site arm hurt real bad, pain lasted for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A week later the injection site became itchy), VACCINATION SITE PAIN (Injection site arm hurt real bad, pain lasted for two days) and VACCINATION SITE ERYTHEMA (A week later the injection site became itchy and red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm hurt real bad, pain lasted for two days). On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (A week later the injection site became itchy) and VACCINATION SITE ERYTHEMA (A week later the injection site became itchy and red). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 13-Mar-2021, VACCINATION SITE PAIN (Injection site arm hurt real bad, pain lasted for two days) had resolved. On 26-Mar-2021, VACCINATION SITE PRURITUS (A week later the injection site became itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (A week later the injection site became itchy and red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Benadryl pills and applied Benadryl cream for 2-3 days for itchiness.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Husband received the vaccine as well and only his arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Husband received the vaccine as well and only his arm hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Husband received the vaccine as well and only his arm hurt). At the time of the report, VACCINATION SITE PAIN (Husband received the vaccine as well and only his arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-060269 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant Follow-up received on 09-AUG-2021.  events updated from initial version, events experienced by female patient were deleted and event experienced by male patient was retained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Experienced fever of 104 Degrees of Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Experienced fever of 104 Degrees of Fahrenheit) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), METOPROLOL, WARFARIN, QUINAPRIL, LATANOPROST and PANTOPRAZOLE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (Experienced fever of 104 Degrees of Fahrenheit). The patient was treated with IBUPROFEN on 17-Mar-2021 at an unspecified dose and frequency. At the time of the report, PYREXIA (Experienced fever of 104 Degrees of Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 104 (High) fever of 104 Degrees of Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cough; Sore throat; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 081A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Bone swelling, Headache, Lymphadenopathy
Clinical narrative: Clavicle bone is still sore; Swelling of clavicle bone; Swollen lymph nodes; Shoulder hurt / shoulder pain; Pain at base of skull and headache; Pain in neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in neck), BONE PAIN (Clavicle bone is still sore), BONE SWELLING (Swelling of clavicle bone), LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (Shoulder hurt / shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart block (30% blockage in heart), Emphysema and Bursitis (shoulder pain was diagnosed as bursitis.). Concomitant products included LOSARTAN, THYROID (ARMOUR THYROID) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced NECK PAIN (Pain in neck), BONE SWELLING (Swelling of clavicle bone), LYMPHADENOPATHY (Swollen lymph nodes), ARTHRALGIA (Shoulder hurt / shoulder pain) and HEADACHE (Pain at base of skull and headache). On an unknown date, the patient experienced BONE PAIN (Clavicle bone is still sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NECK PAIN (Pain in neck), BONE PAIN (Clavicle bone is still sore), BONE SWELLING (Swelling of clavicle bone), LYMPHADENOPATHY (Swollen lymph nodes), ARTHRALGIA (Shoulder hurt / shoulder pain) and HEADACHE (Pain at base of skull and headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-060224 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021: Medical history was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060224:First dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Clavicle bone is still sore; Swelling of clavicle bone; Swollen lymph nodes; Shoulder hurt / shoulder pain; Pain at base of skull and headache; Pain in neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in neck), BONE PAIN (Clavicle bone is still sore), BONE SWELLING (Swelling of clavicle bone), LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (Shoulder hurt / shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart block (30% blockage in heart), Emphysema and Bursitis (shoulder pain was diagnosed as bursitis.). Concomitant products included LOSARTAN, THYROID (ARMOUR THYROID) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced NECK PAIN (Pain in neck), BONE SWELLING (Swelling of clavicle bone), LYMPHADENOPATHY (Swollen lymph nodes), ARTHRALGIA (Shoulder hurt / shoulder pain) and HEADACHE (Pain at base of skull and headache). On an unknown date, the patient experienced BONE PAIN (Clavicle bone is still sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NECK PAIN (Pain in neck), BONE PAIN (Clavicle bone is still sore), BONE SWELLING (Swelling of clavicle bone), LYMPHADENOPATHY (Swollen lymph nodes), ARTHRALGIA (Shoulder hurt / shoulder pain) and HEADACHE (Pain at base of skull and headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-060224 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021: Medical history was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060224:First dose
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness
Clinical narrative: Bone Aches; Little bit Dizzy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Aches), DIZZINESS (Little bit Dizzy) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021 at 4:00 PM, the patient experienced BONE PAIN (Bone Aches), DIZZINESS (Little bit Dizzy) and CHILLS (Chills). At the time of the report, BONE PAIN (Bone Aches), DIZZINESS (Little bit Dizzy) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD21-063332 (E2B Linked Report). This case was linked to MOD-2021-059986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non significant information provided (Reporter's address).; Sender's Comments:  MOD21-063332:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Off label use, Pruritus, Rash papular
Clinical narrative: torso was itchy; red dots under the injection site; Off label dosing frequency; swollen lump at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (torso was itchy), RASH PAPULAR (red dots under the injection site), OFF LABEL USE (Off label dosing frequency), INJECTION SITE SWELLING (swollen lump at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a 78-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 reported medical history). Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, AMIODARONE, BIOTIN, METOPROLOL TARTRATE, SODIUM BICARBONATE, VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN D3 for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (torso was itchy), RASH PAPULAR (red dots under the injection site), OFF LABEL USE (Off label dosing frequency), INJECTION SITE SWELLING (swollen lump at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, PRURITUS (torso was itchy), RASH PAPULAR (red dots under the injection site), OFF LABEL USE (Off label dosing frequency), INJECTION SITE SWELLING (swollen lump at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided Caller also stated that they received the second dose 2 weeks after the first dose (approximately 12March2021).Patient ok for safety follow-up.   This case was linked to MOD-2021-076698, US-MODERNATX, INC.-MOD-2021-076698 (E2B Linked Report).; Sender's Comments:  MOD-2021-076698:2nd dose US-MODERNATX, INC.-MOD-2021-076698:first dose
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Induration, Irritability, Peripheral swelling, Swelling
Clinical narrative: Swollen arm; Hardness; Swelling; Hotness; Feeling crabby; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), INDURATION (Hardness), SWELLING (Swelling), FEELING HOT (Hotness) and IRRITABILITY (Feeling crabby) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included IBUPROFEN, PARACETAMOL (TYLENOL) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), INDURATION (Hardness), SWELLING (Swelling), FEELING HOT (Hotness) and IRRITABILITY (Feeling crabby). At the time of the report, PERIPHERAL SWELLING (Swollen arm), INDURATION (Hardness), SWELLING (Swelling), FEELING HOT (Hotness) and IRRITABILITY (Feeling crabby) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information reported
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pruritus, Rash, Rash macular
Clinical narrative: Rash looks worse in morning; Symptoms spread to stomach; Blotchy; Told by Medical Doctor "its a reaction to the vaccine; Itched like "crazy"; Red; Rash from shoulder to hands on injected arm; Symptoms spread to right arm; This case was initially received via regulatory authority (Reference number: 128231) on 26-Mar-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), PRURITUS (Itched like "crazy"), ERYTHEMA (Red) and INJECTION SITE RASH (Rash from shoulder to hands on injected arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), PRURITUS (Itched like "crazy"), ERYTHEMA (Red), INJECTION SITE RASH (Rash from shoulder to hands on injected arm) and RASH (Symptoms spread to right arm). On 25-Mar-2021, the patient experienced RASH (Symptoms spread to stomach). On 26-Mar-2021, the patient experienced RASH (Rash looks worse in morning). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), ERYTHEMA (Red), INJECTION SITE RASH (Rash from shoulder to hands on injected arm), RASH (Symptoms spread to right arm) and RASH (Symptoms spread to stomach) outcome was unknown, PRURITUS (Itched like "crazy") had resolved and RASH (Rash looks worse in morning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said she had some breaking out in February, 2021 from the first shot of the  vaccine. She had to go to the hospital to receive an antibody shot. Treatment medication include Steroid cream(unknown name), Steroid injection, Steroid taper and Zyrtec. Patient had allergies to food and environmental. Rash was exacerbated by heat/sunlight     Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant information picked from initial source document such as Vaccine information. Treatment medication added from  initial. Product indication for Synthroid updated. Event outcome for iching was added from  initial. Event Rash deleted.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Rash looks worse in morning; Symptoms spread to stomach; Blotchy; Told by Medical Doctor "its a reaction to the vaccine; Itched like "crazy"; Red; Rash from shoulder to hands on injected arm; Symptoms spread to right arm; This case was initially received via regulatory authority (Reference number: 128231) on 26-Mar-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), PRURITUS (Itched like "crazy"), ERYTHEMA (Red) and INJECTION SITE RASH (Rash from shoulder to hands on injected arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), PRURITUS (Itched like "crazy"), ERYTHEMA (Red), INJECTION SITE RASH (Rash from shoulder to hands on injected arm) and RASH (Symptoms spread to right arm). On 25-Mar-2021, the patient experienced RASH (Symptoms spread to stomach). On 26-Mar-2021, the patient experienced RASH (Rash looks worse in morning). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy), VACCINATION COMPLICATION (Told by Medical Doctor "its a reaction to the vaccine), ERYTHEMA (Red), INJECTION SITE RASH (Rash from shoulder to hands on injected arm), RASH (Symptoms spread to right arm) and RASH (Symptoms spread to stomach) outcome was unknown, PRURITUS (Itched like "crazy") had resolved and RASH (Rash looks worse in morning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said she had some breaking out in February, 2021 from the first shot of the  vaccine. She had to go to the hospital to receive an antibody shot. Treatment medication include Steroid cream(unknown name), Steroid injection, Steroid taper and Zyrtec. Patient had allergies to food and environmental. Rash was exacerbated by heat/sunlight     Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant information picked from initial source document such as Vaccine information. Treatment medication added from  initial. Product indication for Synthroid updated. Event outcome for iching was added from  initial. Event Rash deleted.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; 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 PAIN IN EXTREMITY (Arm soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Myalgia, Somnolence, Vertigo
Clinical narrative: She wakes up like she's drunk and feels like she's going to fall; severe muscle aches, very bad; vertigo; very dizzy; sleepy all the time; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (very dizzy), SOMNOLENCE (sleepy all the time), BALANCE DISORDER (She wakes up like she's drunk and feels like she's going to fall) and MYALGIA (severe muscle aches, very bad) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (very dizzy), SOMNOLENCE (sleepy all the time) and MYALGIA (severe muscle aches, very bad). On an unknown date, the patient experienced BALANCE DISORDER (She wakes up like she's drunk and feels like she's going to fall). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) outcome was unknown and DIZZINESS (very dizzy), SOMNOLENCE (sleepy all the time), BALANCE DISORDER (She wakes up like she's drunk and feels like she's going to fall) and MYALGIA (severe muscle aches, very bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU- AE Outcome was updated
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Dizziness, Nausea
Clinical narrative: Dizzy; Diarrhea; Dehydrated; Nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and NAUSEA (Nausea) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product METHOTREXATE (OTREXUP) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 08-Feb-2017, the patient started METHOTREXATE (OTREXUP) (Subcutaneous) 12.5 mg once a week. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Mass, Skin discolouration
Clinical narrative: above his wrist had a black and blue mark, with some redish and a lump; above his wrist had a black and blue mark, with some redish and a lump; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (above his wrist had a black and blue mark, with some redish and a lump), MASS (above his wrist had a black and blue mark, with some redish and a lump) and CHILLS (Had chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 26-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 26-Mar-2021, the patient experienced CHILLS (Had chills). On 27-Mar-2021, the patient experienced SKIN DISCOLOURATION (above his wrist had a black and blue mark, with some redish and a lump) and MASS (above his wrist had a black and blue mark, with some redish and a lump). At the time of the report, SKIN DISCOLOURATION (above his wrist had a black and blue mark, with some redish and a lump), MASS (above his wrist had a black and blue mark, with some redish and a lump) and CHILLS (Had chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills, headache, nausea and myalgia (muscle pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), chills, headache, nausea and myalgia (muscle pain). At the time of the report, pyrexia (fever), chills, headache, nausea and myalgia (muscle pain) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body Aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), CHILLS (Chills) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Body Aches), CHILLS (Chills) and HEADACHE (Headache). On 20-Mar-2021, PAIN (Body Aches), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No concomitants were reported. No treatment was reported. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Red face; Rash on face; Rash on neck; Rash  on arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), RASH (Rash on face), RASH (Rash on neck), RASH (Rash  on arm) and RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included CORTISONE ACETATE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ERYTHEMA (Red face), RASH (Rash on face), RASH (Rash on neck), RASH (Rash  on arm) and RASH (Rash). At the time of the report, ERYTHEMA (Red face), RASH (Rash on face), RASH (Rash on neck), RASH (Rash  on arm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance
Clinical narrative: DizzinesS; stumbling; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DizzinesS), GAIT DISTURBANCE (stumbling) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included TRAZODONE, Olosetram and DULOXETINE for an unknown indication, LEVOTHYROXINE.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (DizzinesS), GAIT DISTURBANCE (stumbling) and CHILLS (chills). At the time of the report, DIZZINESS (DizzinesS), GAIT DISTURBANCE (stumbling) and CHILLS (chills) outcome was unknown. Not Provided          Treatment details not included.The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chest discomfort (chest tightness), dyspnea (could not breath) and swelling in the chest in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. No medical history reported. On Mar 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, patient experienced chest discomfort (chest tightness), dyspnea (could not breath) and swelling in the chest. At the time of the report, chest discomfort (chest tightness), dyspnea (could not breath) and swelling in the chest outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication use provided by the reporter. No treatment of events reported. Most recent follow-up information incorporated above included: On Apr 7, 2021: Voicemail left for patient to call back. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: ended up testing positive for covid 19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (ended up testing positive for covid 19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (ended up testing positive for covid 19). At the time of the report, COVID-19 (ended up testing positive for covid 19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Diarrhoea, Fatigue, Haemorrhoids, Lymphadenopathy
Clinical narrative: sore arm; Haemorrhoids; fatigue; daily diarrhea; axillary lymph nodes swollen in the same arm as injection; increased nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NEURALGIA (increased nerve pain), HAEMORRHOIDS (Haemorrhoids), DIARRHOEA (daily diarrhea) and LYMPHADENOPATHY (axillary lymph nodes swollen in the same arm as injection) in a 40-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.     The patient's past medical history included COVID-19 on 14-Oct-2020 and Esophagitis. Previously administered products included for Product used for unknown indication: influenza. Concurrent medical conditions included Back pain (chronic back pain), Hypothyroidism since 2020 and Tachycardia since 2020. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and HYDROCODONE for Pain, BISOPROLOL for Tachycardia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced NEURALGIA (increased nerve pain) and LYMPHADENOPATHY (axillary lymph nodes swollen in the same arm as injection). On 11-Mar-2021, the patient experienced DIARRHOEA (daily diarrhea). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HAEMORRHOIDS (Haemorrhoids) and FATIGUE (fatigue). The patient was treated with LOPERAMIDE for Diarrhea, at an unspecified dose and frequency. On 19-Mar-2021, NEURALGIA (increased nerve pain) and LYMPHADENOPATHY (axillary lymph nodes swollen in the same arm as injection) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), HAEMORRHOIDS (Haemorrhoids) and FATIGUE (fatigue) outcome was unknown and DIARRHOEA (daily diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Colonoscopy: normal (normal) no causative factor was identified..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a history of esophagitis which was treated with PPI's.  Pcp advised not to take 2nd Moderna dose.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Vaccination facility information was added. Vaccination information was added. Medical history was added. Event outcome was added. Laboratory data was added. Concomitant medications was added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: sore arm; Haemorrhoids; fatigue; daily diarrhea; axillary lymph nodes swollen in the same arm as injection; increased nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NEURALGIA (increased nerve pain), HAEMORRHOIDS (Haemorrhoids), DIARRHOEA (daily diarrhea) and LYMPHADENOPATHY (axillary lymph nodes swollen in the same arm as injection) in a 40-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.     The patient's past medical history included COVID-19 on 14-Oct-2020 and Esophagitis. Previously administered products included for Product used for unknown indication: influenza. Concurrent medical conditions included Back pain (chronic back pain), Hypothyroidism since 2020 and Tachycardia since 2020. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and HYDROCODONE for Pain, BISOPROLOL for Tachycardia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced NEURALGIA (increased nerve pain) and LYMPHADENOPATHY (axillary lymph nodes swollen in the same arm as injection). On 11-Mar-2021, the patient experienced DIARRHOEA (daily diarrhea). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HAEMORRHOIDS (Haemorrhoids) and FATIGUE (fatigue). The patient was treated with LOPERAMIDE for Diarrhea, at an unspecified dose and frequency. On 19-Mar-2021, NEURALGIA (increased nerve pain) and LYMPHADENOPATHY (axillary lymph nodes swollen in the same arm as injection) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), HAEMORRHOIDS (Haemorrhoids) and FATIGUE (fatigue) outcome was unknown and DIARRHOEA (daily diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Colonoscopy: normal (normal) no causative factor was identified..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a history of esophagitis which was treated with PPI's.  Pcp advised not to take 2nd Moderna dose.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Vaccination facility information was added. Vaccination information was added. Medical history was added. Event outcome was added. Laboratory data was added. Concomitant medications was added.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Rash erythematous, Vaccination site erythema
Clinical narrative: looks like shingles; red rash; itching; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (looks like shingles), RASH ERYTHEMATOUS (red rash), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (looks like shingles), RASH ERYTHEMATOUS (red rash), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, HERPES ZOSTER (looks like shingles), RASH ERYTHEMATOUS (red rash), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: NNI
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had taken Regeneron through IV  Patient had received monoclonal antibody shot  No concomitant information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Pyrexia
Clinical narrative: has lost a bit of his taste; has a temperature of 99.0 deg F; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (has lost a bit of his taste) and PYREXIA (has a temperature of 99.0 deg F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced AGEUSIA (has lost a bit of his taste) and PYREXIA (has a temperature of 99.0 deg F). At the time of the report, AGEUSIA (has lost a bit of his taste) and PYREXIA (has a temperature of 99.0 deg F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.0 (High) temperature of 99.0 deg F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR attached- outcome updated