chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: totally stiff and totally sore; terrible body ache; hardly walk; freezing to the bones; chills; feeling exhausted; pain at right arm; with nightmares; flu like symptoms; sweats; shaking; coldness; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (totally stiff and totally sore), PAIN (terrible body ache), GAIT DISTURBANCE (hardly walk), FREEZING PHENOMENON (freezing to the bones) and NIGHTMARE (with nightmares) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (similar symptoms.). Concurrent medical conditions included Spinal stenosis (undergone operation.), Arthritis, Blood pressure management and Cholesterol. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, AMLODIPINE BESILATE (NORVASC) and IRBESARTAN (AVAPRO) for Blood pressure management, PRAVASTATIN for Cholesterol, METAXALONE for Muscle relaxant, DIAZEPAM (VALIUM) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced NIGHTMARE (with nightmares) and VACCINATION SITE PAIN (pain at right arm). On 10-Apr-2021, the patient experienced FATIGUE (feeling exhausted). On 11-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (totally stiff and totally sore), PAIN (terrible body ache), GAIT DISTURBANCE (hardly walk), FREEZING PHENOMENON (freezing to the bones) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweats), TREMOR (shaking) and FEELING COLD (coldness). On 09-Apr-2021, VACCINATION SITE PAIN (pain at right arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (totally stiff and totally sore), PAIN (terrible body ache), GAIT DISTURBANCE (hardly walk), FREEZING PHENOMENON (freezing to the bones), NIGHTMARE (with nightmares), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweats), TREMOR (shaking), FEELING COLD (coldness), CHILLS (chills) and FATIGUE (feeling exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includedm1 Skalexin, tylenol and Vallium before bed and one Tylenol in morning.   This case was linked to MOD21-073300 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Events (Hyperhidrosis, tremor, feeling cold) were added and event pain in extremity updated to vaccination site pain. Patient received second dose on 07 May 2021.; Sender's Comments:  MOD21-073300:Link to Dose 2 MOD-2021-123837
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Insomnia, Rash pruritic
Clinical narrative: Rash in Arm of the injection and lower leg; the rash is so itchy that she can not sleep; Lack of sleep; PAIN AT THE SITE OF INJECTION; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash in Arm of the injection and lower leg), RASH PRURITIC (the rash is so itchy that she can not sleep), INSOMNIA (Lack of sleep) and INJECTION SITE PAIN (PAIN AT THE SITE OF INJECTION) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Latex allergy).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5. On 08-Mar-2021, the patient experienced INJECTION SITE PAIN (PAIN AT THE SITE OF INJECTION). On 05-Apr-2021, the patient experienced INJECTION SITE RASH (Rash in Arm of the injection and lower leg), RASH PRURITIC (the rash is so itchy that she can not sleep) and INSOMNIA (Lack of sleep). At the time of the report, INJECTION SITE RASH (Rash in Arm of the injection and lower leg), RASH PRURITIC (the rash is so itchy that she can not sleep), INSOMNIA (Lack of sleep) and INJECTION SITE PAIN (PAIN AT THE SITE OF INJECTION) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported self administration of Benadryl and hydro-cortisol balm to try to alleviate the symptoms.; Reporter's Comments: Patient reported that preferred way of contact is telephone by a different language speaking agent.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Paraesthesia
Clinical narrative: tingling in her right arm; a hard time making a grip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her right arm) and GRIP STRENGTH DECREASED (a hard time making a grip) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 27-Dec-2020.    On 28-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 PARAESTHESIA (tingling in her right arm) and GRIP STRENGTH DECREASED (a hard time making a grip). At the time of the report, PARAESTHESIA (tingling in her right arm) and GRIP STRENGTH DECREASED (a hard time making a grip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Very red, bloodshot eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Very red, bloodshot eye) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Very red, bloodshot eye). At the time of the report, OCULAR HYPERAEMIA (Very red, bloodshot eye) had not resolved.            Additional information the patient noticed that her right eye was "Very red, bloodshot". This symptom is still ongoing.  Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided    This case was linked to MOD-2021-073107 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage, Vaccination site mass
Clinical narrative: capillary bleed on top of the patient's left hand; bumps over both arms; bruises in patients' left wrist about half an inch size; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (capillary bleed on top of the patient's left hand), VACCINATION SITE MASS (bumps over both arms) and CONTUSION (bruises in patients' left wrist about half an inch size) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included DICLOFENAC SODIUM (PROFENAC) for Back pain, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SINUS MEDICATION) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HAEMORRHAGE (capillary bleed on top of the patient's left hand), VACCINATION SITE MASS (bumps over both arms) and CONTUSION (bruises in patients' left wrist about half an inch size). At the time of the report, HAEMORRHAGE (capillary bleed on top of the patient's left hand) and VACCINATION SITE MASS (bumps over both arms) outcome was unknown and CONTUSION (bruises in patients' left wrist about half an inch size) had resolved.            Concomitant medication include supplements.  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.   This case was linked to MOD-2021-073125 (Patient Link).; 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: the side effects were similar to what I experienced; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (the side effects were similar to what I experienced) in a  patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (the side effects were similar to what I experienced). At the time of the report, ADVERSE EVENT (the side effects were similar to what I experienced) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or treatment information provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: strong body pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (strong body pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Epileptic seizure. Concomitant products included TIAGABINE HYDROCHLORIDE (GABITRIL) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (strong body pain). The patient was treated with LORAZEPAM (ATIVAN) at a dose of 1 dosage form. On 01-Mar-2021, PAIN (strong body pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included cardatril   This case was linked to MOD-2021-073145.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102 degrees) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal muscular atrophy. Concomitant products included RISDIPLAM (EVRYSDI) for an unknown indication.   On 31-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 31-Mar-2021, the patient experienced PYREXIA (fever of 102 degrees). On 03-Apr-2021, PYREXIA (fever of 102 degrees) had resolved.            Treatment information were not provided.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Vaccination site pain
Clinical narrative: Tingling in feet after 1st dose; Sharp pains in hands and feet after 1st dose; Tingling in hands after 1st dose; Rash on feet /hands after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in feet after 1st dose), VACCINATION SITE PAIN (Sharp pains in hands and feet after 1st dose), PARAESTHESIA (Tingling in hands after 1st dose) and RASH (Rash on feet /hands after 1st dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a217) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in feet after 1st dose), VACCINATION SITE PAIN (Sharp pains in hands and feet after 1st dose), PARAESTHESIA (Tingling in hands after 1st dose) and RASH (Rash on feet /hands after 1st dose). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Pain in hand, Rash and Tingling feet/hands, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in feet after 1st dose), VACCINATION SITE PAIN (Sharp pains in hands and feet after 1st dose), PARAESTHESIA (Tingling in hands after 1st dose) and RASH (Rash on feet /hands after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contain significant information and outcome of event updated from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: having a hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having a hard time breathing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having a hard time breathing). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (having a hard time breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Depression
Clinical narrative: More and more depressed; Other side effects; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSION (More and more depressed) and ADVERSE DRUG REACTION (Other side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEPRESSION (More and more depressed) and ADVERSE DRUG REACTION (Other side effects). At the time of the report, DEPRESSION (More and more depressed) and ADVERSE DRUG REACTION (Other side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications were reported.  Reportedly, ever since The patient had first and second dose of the vaccine, the patient was becoming more and more depressed besides other side effects. Patient believed the vaccine was a reason for this. I The patient was going to look into this further since the patient never had mental illness or depression. If it is the Moderna vaccine patient would make them accountable. This was a rushed vaccine that should have bee studied further before releasing to the public. reported the patient.  Treatment information was not provided.   This case was linked to MOD-2021-073169 (Patient Link). o...
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Exfoliative rash, Gait disturbance, Malaise
Clinical narrative: Had a Reaction; Not doing well; Rash area Peels, New Skin is Thick and Leathery; Can Hardly Move; Tender Joints; Joint Pain (Left Knee, Left Leg, all Hands Joints); Red Rash on Abdomen, Back , Arm, Chest and Groin Area; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had a Reaction), MALAISE (Not doing well), EXFOLIATIVE RASH (Rash area Peels, New Skin is Thick and Leathery), GAIT DISTURBANCE (Can Hardly Move) and TENDERNESS (Tender Joints) in a 62-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.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ADVERSE REACTION (Had a Reaction), MALAISE (Not doing well), EXFOLIATIVE RASH (Rash area Peels, New Skin is Thick and Leathery), GAIT DISTURBANCE (Can Hardly Move), TENDERNESS (Tender Joints), ARTHRALGIA (Joint Pain (Left Knee, Left Leg, all Hands Joints)) and RASH (Red Rash on Abdomen, Back , Arm, Chest and Groin Area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at a dose of 2 UNK, bid and CEFIXIME (FLEXERIL [CEFIXIME]) at a dose of 1 dosage form. At the time of the report, ADVERSE REACTION (Had a Reaction), MALAISE (Not doing well), EXFOLIATIVE RASH (Rash area Peels, New Skin is Thick and Leathery), GAIT DISTURBANCE (Can Hardly Move), TENDERNESS (Tender Joints), ARTHRALGIA (Joint Pain (Left Knee, Left Leg, all Hands Joints)) and RASH (Red Rash on Abdomen, Back , Arm, Chest and Groin Area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), the reporter did not provide any causality assessment. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), was unknown  no concomitant medications were reported
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Tenderness
Clinical narrative: Had a Reaction; Not doing well; Rash area Peels, New Skin is Thick and Leathery; Can Hardly Move; Tender Joints; Joint Pain (Left Knee, Left Leg, all Hands Joints); Red Rash on Abdomen, Back , Arm, Chest and Groin Area; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had a Reaction), MALAISE (Not doing well), EXFOLIATIVE RASH (Rash area Peels, New Skin is Thick and Leathery), GAIT DISTURBANCE (Can Hardly Move) and TENDERNESS (Tender Joints) in a 62-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.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ADVERSE REACTION (Had a Reaction), MALAISE (Not doing well), EXFOLIATIVE RASH (Rash area Peels, New Skin is Thick and Leathery), GAIT DISTURBANCE (Can Hardly Move), TENDERNESS (Tender Joints), ARTHRALGIA (Joint Pain (Left Knee, Left Leg, all Hands Joints)) and RASH (Red Rash on Abdomen, Back , Arm, Chest and Groin Area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at a dose of 2 UNK, bid and CEFIXIME (FLEXERIL [CEFIXIME]) at a dose of 1 dosage form. At the time of the report, ADVERSE REACTION (Had a Reaction), MALAISE (Not doing well), EXFOLIATIVE RASH (Rash area Peels, New Skin is Thick and Leathery), GAIT DISTURBANCE (Can Hardly Move), TENDERNESS (Tender Joints), ARTHRALGIA (Joint Pain (Left Knee, Left Leg, all Hands Joints)) and RASH (Red Rash on Abdomen, Back , Arm, Chest and Groin Area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), the reporter did not provide any causality assessment. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), was unknown  no concomitant medications were reported
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness; itchy; Skin warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itchy) and SKIN WARM (Skin warm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (itchy) and SKIN WARM (Skin warm). At the time of the report, ERYTHEMA (Redness), PRURITUS (itchy) and SKIN WARM (Skin warm) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional information received on 12-May-2021 as Adverse Events outcome was updated.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Pyrexia
Clinical narrative: severe back pain; diarrhea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe back pain), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (severe back pain), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). At the time of the report, BACK PAIN (severe back pain), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) had resolved.            The reporter stated that the patient developed fever, chills, diarrhea, severe back pain and nausea.No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10 May 2021.Updated outcome of events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Fear, Feeling abnormal, Feeling hot
Clinical narrative: felt weird for 2 days; bright; Vision and audio was not normal; never felt like this before in her life; felt like some one drugged me LSD; nausea,; throwing up; fatigue; very scary; could not read her vision was not clear; very strange; fussy feel; very odd; ringing in her ear; so sick,; sweating; very hot; shaking; dripping sweat; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel) and FEELING ABNORMAL (very odd) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue). On an unknown date, the patient experienced FEELING ABNORMAL (felt weird for 2 days). At the time of the report, FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), FEELING ABNORMAL (felt weird for 2 days), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The pharmacist gave her a pill for her adverse events but she doesn't know the name.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Nausea, Sensory disturbance, Tinnitus
Clinical narrative: felt weird for 2 days; bright; Vision and audio was not normal; never felt like this before in her life; felt like some one drugged me LSD; nausea,; throwing up; fatigue; very scary; could not read her vision was not clear; very strange; fussy feel; very odd; ringing in her ear; so sick,; sweating; very hot; shaking; dripping sweat; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel) and FEELING ABNORMAL (very odd) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue). On an unknown date, the patient experienced FEELING ABNORMAL (felt weird for 2 days). At the time of the report, FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), FEELING ABNORMAL (felt weird for 2 days), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The pharmacist gave her a pill for her adverse events but she doesn't know the name.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred, Visual brightness, Vomiting
Clinical narrative: felt weird for 2 days; bright; Vision and audio was not normal; never felt like this before in her life; felt like some one drugged me LSD; nausea,; throwing up; fatigue; very scary; could not read her vision was not clear; very strange; fussy feel; very odd; ringing in her ear; so sick,; sweating; very hot; shaking; dripping sweat; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel) and FEELING ABNORMAL (very odd) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue). On an unknown date, the patient experienced FEELING ABNORMAL (felt weird for 2 days). At the time of the report, FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), FEELING ABNORMAL (felt weird for 2 days), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The pharmacist gave her a pill for her adverse events but she doesn't know the name.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Influenza like illness, Lethargy, Somnolence
Clinical narrative: sick for 30 days; flu like symptoms; slept for 15 hours on that day; tremendous joint pain; very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 30 days), INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (very lethargic), SOMNOLENCE (slept for 15 hours on that day) and ARTHRALGIA (tremendous joint pain) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and SOMNOLENCE (slept for 15 hours on that day). In February 2021, the patient experienced LETHARGY (very lethargic) and ARTHRALGIA (tremendous joint pain). On an unknown date, the patient experienced ILLNESS (sick for 30 days). At the time of the report, ILLNESS (sick for 30 days) was resolving and INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (very lethargic), SOMNOLENCE (slept for 15 hours on that day) and ARTHRALGIA (tremendous joint pain) outcome was unknown.            Concomitant medication and treatment information were not reported.     Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13 may 2021 contain information  include: reporter details updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Felt tired; Injection arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and VACCINATION SITE PAIN (Injection arm became sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 0492119) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy in 1983. Concurrent medical conditions included Acromegaly since 1970. Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Pituitary disorder, HYDROCORTISONE for Pituitary gland operation, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 25-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) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PAIN (Injection arm became sore). At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PAIN (Injection arm became sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.    This case was linked to MOD-2021-073158 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information was received on 12-May-2021, HCP details updated, patient details, past medical history, Vaccine facility details and concomitant medication details were updated.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. On 09-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 09-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dysphonia, Dyspnoea, Migraine, Myalgia
Clinical narrative: hoarse voice goes in and out; pains in chest; shortness of breath; Migraines more often; High fever; Muscle aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath), MIGRAINE (Migraines more often) and PYREXIA (High fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 06-Apr-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) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (High fever) and MYALGIA (Muscle aching). On an unknown date, the patient experienced DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath) and MIGRAINE (Migraines more often). On 07-Apr-2021, PYREXIA (High fever) and MYALGIA (Muscle aching) had resolved. At the time of the report, DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath) and MIGRAINE (Migraines more often) outcome was unknown.            Concomitant medications were not provided. Treatment for the events was not provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow Up received- Email Address of reporter updated. On 03-Jul-2021: Follow Up received- 4 new events added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: hoarse voice goes in and out; pains in chest; shortness of breath; Migraines more often; High fever; Muscle aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath), MIGRAINE (Migraines more often) and PYREXIA (High fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 06-Apr-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) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (High fever) and MYALGIA (Muscle aching). On an unknown date, the patient experienced DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath) and MIGRAINE (Migraines more often). On 07-Apr-2021, PYREXIA (High fever) and MYALGIA (Muscle aching) had resolved. At the time of the report, DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath) and MIGRAINE (Migraines more often) outcome was unknown.            Concomitant medications were not provided. Treatment for the events was not provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow Up received- Email Address of reporter updated. On 03-Jul-2021: Follow Up received- 4 new events added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Fall, Fatigue, Feeling abnormal
Clinical narrative: "Globs" of stuff came out of nose; Unable to sleep; Fell down; Felt disoriented; Became foggy and groggy; Lost continence of urine; Head congestion; Fatigue; extreme chills; Injection arm became sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), RHINORRHOEA ("Globs" of stuff came out of nose) and DISORIENTATION (Felt disoriented) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0492119 and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy in 1983. Concurrent medical conditions included Acromegaly since 1970. Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Hypothalamo-pituitary disorder, HYDROCORTISONE for Pituitary tumor removal, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 25-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) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (extreme chills), VACCINATION SITE PAIN (Injection arm became sore) and FATIGUE (tired). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), DISORIENTATION (Felt disoriented) and FALL (Fell down). On 27-Mar-2021, the patient experienced RHINORRHOEA ("Globs" of stuff came out of nose) and INSOMNIA (Unable to sleep). On 26-Mar-2021, CHILLS (extreme chills) had resolved. At the time of the report, FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), RHINORRHOEA ("Globs" of stuff came out of nose), DISORIENTATION (Felt disoriented), INSOMNIA (Unable to sleep), FALL (Fell down), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection arm became sore) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-073152, MOD-2021-073152 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: HCP details, patient demographics, patient medical history, concomitant products, AE progress/outcome added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nasal congestion, Rhinorrhoea, Urinary incontinence, Vaccination site pain
Clinical narrative: "Globs" of stuff came out of nose; Unable to sleep; Fell down; Felt disoriented; Became foggy and groggy; Lost continence of urine; Head congestion; Fatigue; extreme chills; Injection arm became sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), RHINORRHOEA ("Globs" of stuff came out of nose) and DISORIENTATION (Felt disoriented) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0492119 and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy in 1983. Concurrent medical conditions included Acromegaly since 1970. Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Hypothalamo-pituitary disorder, HYDROCORTISONE for Pituitary tumor removal, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 25-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) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (extreme chills), VACCINATION SITE PAIN (Injection arm became sore) and FATIGUE (tired). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), DISORIENTATION (Felt disoriented) and FALL (Fell down). On 27-Mar-2021, the patient experienced RHINORRHOEA ("Globs" of stuff came out of nose) and INSOMNIA (Unable to sleep). On 26-Mar-2021, CHILLS (extreme chills) had resolved. At the time of the report, FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), RHINORRHOEA ("Globs" of stuff came out of nose), DISORIENTATION (Felt disoriented), INSOMNIA (Unable to sleep), FALL (Fell down), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection arm became sore) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-073152, MOD-2021-073152 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: HCP details, patient demographics, patient medical history, concomitant products, AE progress/outcome added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site swelling
Clinical narrative: swelling on her left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on her left arm) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Hypertension (high blood pressure). Concomitant products included CANDESARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ACETYLSALICYLIC ACID (ASPIRIN LOW) 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 SWELLING (swelling on her left arm) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 12-Mar-2021 at an unspecified dose and frequency. On 13-Mar-2021, VACCINATION SITE SWELLING (swelling on her left arm) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-073171 (Patient Link).