chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Headache, Nausea
Clinical narrative: vomiting; lost her sense of taste; pain; swelling in arm; chills; fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), CHILLS (chills) and PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Down's syndrome. Concomitant products included TOPIRAMATE, LEVOTHYROXINE and BIOTIN 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 13-Mar-2021, the patient experienced AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), CHILLS (chills), PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit), HEADACHE (headache) and NAUSEA (nausea ). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (chills) and NAUSEA (nausea ) had resolved. On 24-Mar-2021, VOMITING (vomiting) had resolved. At the time of the report, AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. On 13-Mar-2021, Body temperature: 103.8 (High) 103.8 degree Fahrenheit. On 15-Mar-2021, Body temperature: 101.1 (High) 101.1 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, Swelling, Vomiting
Clinical narrative: vomiting; lost her sense of taste; pain; swelling in arm; chills; fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), CHILLS (chills) and PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Down's syndrome. Concomitant products included TOPIRAMATE, LEVOTHYROXINE and BIOTIN 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 13-Mar-2021, the patient experienced AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), CHILLS (chills), PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit), HEADACHE (headache) and NAUSEA (nausea ). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (chills) and NAUSEA (nausea ) had resolved. On 24-Mar-2021, VOMITING (vomiting) had resolved. At the time of the report, AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. On 13-Mar-2021, Body temperature: 103.8 (High) 103.8 degree Fahrenheit. On 15-Mar-2021, Body temperature: 101.1 (High) 101.1 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dyspnoea, Heart rate
Clinical narrative: anxiety; short of breath; weak; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), DYSPNOEA (short of breath) and ASTHENIA (weak) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (24 years ago.) in 1996 and Dialysis (dialysis for a long time in left arm).   On 04-Mar-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (weak). On 15-Mar-2021, the patient experienced ANXIETY (anxiety) and DYSPNOEA (short of breath). At the time of the report, ANXIETY (anxiety), DYSPNOEA (short of breath) and ASTHENIA (weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: increased (High) heart beat fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Followup information was received and outcome of events, second dose  were updated. On 22-Jul-2021: Updated Patient denies for further follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Limb discomfort, Nausea, Ocular discomfort
Clinical narrative: eye feels hot; Dizziness; Arm feel not ok; Terrible nausea; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eye feels hot), DIZZINESS (Dizziness), LIMB DISCOMFORT (Arm feel not ok), NAUSEA (Terrible nausea) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced OCULAR DISCOMFORT (eye feels hot), DIZZINESS (Dizziness), LIMB DISCOMFORT (Arm feel not ok), NAUSEA (Terrible nausea) and HEADACHE (Headache). At the time of the report, OCULAR DISCOMFORT (eye feels hot), DIZZINESS (Dizziness), LIMB DISCOMFORT (Arm feel not ok), NAUSEA (Terrible nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient on concomitant medication for high blood pressure medication cholesterol medication
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Vomiting
Clinical narrative: stomachache; hotness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), FEELING HOT (hotness) and VOMITING (vomiting) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomachache), FEELING HOT (hotness) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN UPPER (stomachache), FEELING HOT (hotness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: arm soreness; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm soreness) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm soreness) and CHILLS (chills). At the time of the report, MYALGIA (arm soreness) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Aches; Chills; Tired for two and a half days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills) and FATIGUE (Tired for two and a half days) in a 78-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 medical history was reported.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN),High blood pressure medications for an unknown indication.    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 PAIN (Aches), CHILLS (Chills) and FATIGUE (Tired for two and a half days). At the time of the report, PAIN (Aches), CHILLS (Chills) and FATIGUE (Tired for two and a half days) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: changed outcome of event from unknown to recovering/resolving
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-046523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received and had non-significant information.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information was received and the outcome of event was updated.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Rash, Swelling
Clinical narrative: terrible itching; swelling to a kind of hard knot; swelling to a kind of hard knot; kind of a rash; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (terrible itching), SWELLING (swelling to a kind of hard knot), INDURATION (swelling to a kind of hard knot), ERYTHEMA (redness) and RASH (kind of a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (redness). On 27-Feb-2021, the patient experienced PRURITUS (terrible itching), SWELLING (swelling to a kind of hard knot), INDURATION (swelling to a kind of hard knot) and RASH (kind of a rash). On 03-Mar-2021, PRURITUS (terrible itching), SWELLING (swelling to a kind of hard knot), INDURATION (swelling to a kind of hard knot), ERYTHEMA (redness) and RASH (kind of a rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Followup received on 16-MAR-2021 and contain no new information. On 23-Jul-2021: Patient withdrew consent for follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Abdominal cramping; Severe diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Severe diarrhea) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Severe diarrhea) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Severe diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Initial additional
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: 3 clear blisters; This spontaneous case was reported by a nurse and describes the occurrence of BLISTER (3 clear blisters) 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) (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 16-Mar-2021, the patient experienced BLISTER (3 clear blisters). At the time of the report, BLISTER (3 clear blisters) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021 and included details about the second dose information and outcome of the event was updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Skin mass, Tenderness
Clinical narrative: Itchiness; Bumpiness; Hot; Tenderness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness), SKIN MASS (Bumpiness), FEELING HOT (Hot) and TENDERNESS (Tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced ERYTHEMA (Redness) and TENDERNESS (Tenderness). On 10-Mar-2021, the patient experienced PRURITUS (Itchiness), SKIN MASS (Bumpiness) and FEELING HOT (Hot). On 16-Mar-2021, SKIN MASS (Bumpiness) had resolved. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itchiness), FEELING HOT (Hot) and TENDERNESS (Tenderness) 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 included Antihistamine. Concomitant medications were not provided.   This case was linked to MOD-2021-046099 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Not feeling well after first vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Not feeling well after first vaccine dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Not feeling well after first vaccine dose). At the time of the report, ILLNESS (Not feeling well after first vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Broke out in hives after second shot; terribly itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives after second shot) and RASH PRURITIC (terribly itchy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, LISINOPRIL, GLUCOSAMINE, OXYCODONE, COLECALCIFEROL (D3), ZINC, ISOSORBIDE MONONITRATE, LOVASTATIN, BUDESONIDE (NASOCORT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), UBIDECARENONE (COQ10 [UBIDECARENONE]), FISH OIL (OMEGA 3 [FISH OIL]), NABUMETONE, CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM), ASPIRIN [ACETYLSALICYLIC ACID], OXYMETAZOLINE (AFRIN [OXYMETAZOLINE]) and ZEAXANTHIN for an unknown indication.   On 16-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 16-Mar-2021, the patient experienced URTICARIA (Broke out in hives after second shot) and RASH PRURITIC (terribly itchy). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, URTICARIA (Broke out in hives after second shot) had not resolved and RASH PRURITIC (terribly itchy) outcome was unknown.            Concomitant medications also included stool softener,phenyl fibrate,leutin. Treatment included Antihistamines were taken for itching.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up document contains information about new event was added Treatment information was added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Oral herpes
Clinical narrative: Dizziness; Fever Blister; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and ORAL HERPES (Fever Blister) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0368218) for COVID-19 vaccination.     Concomitant products included MECLIZINE HCL and DOCOSANOL (ABREVA) 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 12-Mar-2021, the patient experienced DIZZINESS (Dizziness) and ORAL HERPES (Fever Blister). At the time of the report, DIZZINESS (Dizziness) and ORAL HERPES (Fever Blister) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Pain in extremity
Clinical narrative: arm pain; light headedness; cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DIZZINESS (light headedness) and NASOPHARYNGITIS (cold symptoms) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (light headedness) and NASOPHARYNGITIS (cold symptoms). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved and DIZZINESS (light headedness) and NASOPHARYNGITIS (cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Herpes zoster, Hypoaesthesia, Lacrimation increased
Clinical narrative: sleepy and tired; itching on the upper middle back, legs, foot, and in arms too; foot getting numb when she is trying to sleep or when she wake ups; eye and nose teary; shingles seems to be activated; sleepy and tired; right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary) and HERPES ZOSTER (shingles seems to be activated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (had shingles 20 years ago, it seems to have been activated (after mRNA-1273 administration)), Arthritis, Pinched nerve, Environmental allergy and Allergy to animals. Concomitant products included RIVAROXABAN.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary), HERPES ZOSTER (shingles seems to be activated), FATIGUE (sleepy and tired) and ARTHRALGIA (right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed). The patient was treated with Physical therapy (She went to physical therapy and had acupuncture.) for Arthralgia. At the time of the report, SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary), HERPES ZOSTER (shingles seems to be activated), FATIGUE (sleepy and tired) and ARTHRALGIA (right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included physical therapy and acupuncture, Benadryl for her nose, Tylenol, and pain medication for the knee.  On 08-Mar-2021 the patient talked to a neurologist who gave her a prescription for Valtrex. She took 1 tablet the next day and 2 tablets the day after. It looked like her symptoms went away but then they returned.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Somnolence
Clinical narrative: sleepy and tired; itching on the upper middle back, legs, foot, and in arms too; foot getting numb when she is trying to sleep or when she wake ups; eye and nose teary; shingles seems to be activated; sleepy and tired; right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary) and HERPES ZOSTER (shingles seems to be activated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (had shingles 20 years ago, it seems to have been activated (after mRNA-1273 administration)), Arthritis, Pinched nerve, Environmental allergy and Allergy to animals. Concomitant products included RIVAROXABAN.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary), HERPES ZOSTER (shingles seems to be activated), FATIGUE (sleepy and tired) and ARTHRALGIA (right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed). The patient was treated with Physical therapy (She went to physical therapy and had acupuncture.) for Arthralgia. At the time of the report, SOMNOLENCE (sleepy and tired), PRURITUS (itching on the upper middle back, legs, foot, and in arms too), HYPOAESTHESIA (foot getting numb when she is trying to sleep or when she wake ups), LACRIMATION INCREASED (eye and nose teary), HERPES ZOSTER (shingles seems to be activated), FATIGUE (sleepy and tired) and ARTHRALGIA (right knee started getting sharp pain, middle and behind the knee, couldn'nt weight on it, hard time getting off the bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included physical therapy and acupuncture, Benadryl for her nose, Tylenol, and pain medication for the knee.  On 08-Mar-2021 the patient talked to a neurologist who gave her a prescription for Valtrex. She took 1 tablet the next day and 2 tablets the day after. It looked like her symptoms went away but then they returned.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Injected Arm Felt a little Heavy; 16-year-old son received the first dose of Moderna COVID-19; Sore Arm a little; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Injected Arm Felt a little Heavy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old son received the first dose of Moderna COVID-19) and VACCINATION SITE PAIN (Sore Arm a little) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced LIMB DISCOMFORT (Injected Arm Felt a little Heavy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old son received the first dose of Moderna COVID-19) and VACCINATION SITE PAIN (Sore Arm a little). On 18-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old son received the first dose of Moderna COVID-19) had resolved. On 20-Feb-2021, LIMB DISCOMFORT (Injected Arm Felt a little Heavy) had resolved and VACCINATION SITE PAIN (Sore Arm a little) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low-grade temperature around 100 degrees Fahrenheit for around 10 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade temperature around 100 degrees Fahrenheit for around 10 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included PREGABALIN (LYRICA) and TRAMADOL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (low-grade temperature around 100 degrees Fahrenheit for around 10 days). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (low-grade temperature around 100 degrees Fahrenheit for around 10 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100 (Inconclusive) 100 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling face
Clinical narrative: swelling on my face; rash all over my body; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on my face), RASH (rash all over my body) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021 at 5:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 7:30 PM, the patient experienced SWELLING FACE (swelling on my face), RASH (rash all over my body) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swelling on my face), RASH (rash all over my body) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Lymphadenopathy, Pyrexia
Clinical narrative: swelling under arm, axillary area / swelling in her arm pit area; redness at injection site; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a little fever), INJECTION SITE ERYTHEMA (redness at injection site) and LYMPHADENOPATHY (swelling under arm, axillary area / swelling in her arm pit area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (a little fever). On 14-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling under arm, axillary area / swelling in her arm pit area). On 13-Mar-2021, PYREXIA (a little fever) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site) and LYMPHADENOPATHY (swelling under arm, axillary area / swelling in her arm pit area) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Myalgia
Clinical narrative: Legs are like rubber; Soreness; Headache; Muscle Pain; Chills; Nausea; Vomiting; Pain at injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs are like rubber), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle Pain) and CHILLS (Chills) in a 78-year-old female 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.     Concomitant products included HYDROCHLOROTHIAZIDE, ROSUVASTATIN CALCIUM (CRESTOR), CEFALEXIN (CEPHALEXINE) and CHYMOTRYPSIN, TRYPSIN (CHYMORAL [CHYMOTRYPSIN;TRYPSIN]) 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 13-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs are like rubber), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Legs are like rubber) outcome was unknown and PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain, Vomiting
Clinical narrative: Legs are like rubber; Soreness; Headache; Muscle Pain; Chills; Nausea; Vomiting; Pain at injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs are like rubber), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle Pain) and CHILLS (Chills) in a 78-year-old female 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.     Concomitant products included HYDROCHLOROTHIAZIDE, ROSUVASTATIN CALCIUM (CRESTOR), CEFALEXIN (CEPHALEXINE) and CHYMOTRYPSIN, TRYPSIN (CHYMORAL [CHYMOTRYPSIN;TRYPSIN]) 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 13-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs are like rubber), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Legs are like rubber) outcome was unknown and PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Somnolence
Clinical narrative: goofy; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (goofy) and SOMNOLENCE (sleepy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 ABNORMAL BEHAVIOUR (goofy) and SOMNOLENCE (sleepy). At the time of the report, ABNORMAL BEHAVIOUR (goofy) and SOMNOLENCE (sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Palpitations
Clinical narrative: she had a pumping, like an adrenaline rush, just her racing heart beat for 15 Sec; felt giddy like a histamine reaction; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (she had a pumping, like an adrenaline rush, just her racing heart beat for 15 Sec), DIZZINESS (felt giddy like a histamine reaction) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0311.20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure, Hypothyroidism and Heart rate high (she had had this in the past, probably a year ago). Concurrent medical conditions included Penicillin allergy, Overweight and Arthritis.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PALPITATIONS (she had a pumping, like an adrenaline rush, just her racing heart beat for 15 Sec), DIZZINESS (felt giddy like a histamine reaction) and HEADACHE (slight headache). On 19-Feb-2021, PALPITATIONS (she had a pumping, like an adrenaline rush, just her racing heart beat for 15 Sec), DIZZINESS (felt giddy like a histamine reaction) and HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: high blood pressure; Rapid heart rate; light headed; chills; fever; light headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever) and HEADACHE (light headache) in a 52-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.     Concomitant products included VITAMIN D NOS and CIMICIFUGA RACEMOSA EXTRACT (REMIFEMIN) 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 24-Feb-2021, the patient experienced HYPERTENSION (high blood pressure), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever) and HEADACHE (light headache). 24-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; METOPROLOL at a dose of 25 milligram once a day and LISINOPRIL at a dose of 10 milligram once a day. At the time of the report, HYPERTENSION (high blood pressure), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever), HEADACHE (light headache) and HEART RATE INCREASED (Rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 118 (abnormal) Evening after her nap her heart rate went up high to 118.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was reported as Eye drops, Treatment details included Acetaminophen, Metoprolol 25mg/day, Lisinopril 10mg/day and for high blood pressure she was given medicine through IV.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: high blood pressure; Rapid heart rate; light headed; chills; fever; light headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever) and HEADACHE (light headache) in a 52-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.     Concomitant products included VITAMIN D NOS and CIMICIFUGA RACEMOSA EXTRACT (REMIFEMIN) 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 24-Feb-2021, the patient experienced HYPERTENSION (high blood pressure), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever) and HEADACHE (light headache). 24-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; METOPROLOL at a dose of 25 milligram once a day and LISINOPRIL at a dose of 10 milligram once a day. At the time of the report, HYPERTENSION (high blood pressure), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever), HEADACHE (light headache) and HEART RATE INCREASED (Rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 118 (abnormal) Evening after her nap her heart rate went up high to 118.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was reported as Eye drops, Treatment details included Acetaminophen, Metoprolol 25mg/day, Lisinopril 10mg/day and for high blood pressure she was given medicine through IV.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Facial paresis, Malaise, Nausea, Tinnitus
Clinical narrative: ringing in ears; shortness of breath; "face doesn't look right"; "started to not feel well"; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), DYSPNOEA (shortness of breath), FACIAL PARESIS ("face doesn't look right"), MALAISE ("started to not feel well") and NAUSEA (nauseas) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure, COPD and Lichen planus. Concurrent medical conditions included Ragweed allergy, Penicillin allergy and Allergic reaction to antibiotics.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TINNITUS (ringing in ears), DYSPNOEA (shortness of breath), FACIAL PARESIS ("face doesn't look right"), MALAISE ("started to not feel well") and NAUSEA (nauseas). At the time of the report, TINNITUS (ringing in ears), DYSPNOEA (shortness of breath), FACIAL PARESIS ("face doesn't look right"), MALAISE ("started to not feel well") and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic sclerosis pulmonary (Scleroderma with interstitial lung disease (systemic sclerosis)) and Autoimmune disorder. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Scleroderma.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with CELECOXIB for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event, sore arm was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided\