chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Runny nose; Upset stomach; Extreme Headache; Fatigue; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ACETAMINOPHEN for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.            Concomitant product used included Acetaminophen.  No treatment information was reported. After the second dose of my Moderna Covid-19 vaccination on 26FEB2021 I had an extreme Headache, chills, fatigue, body aches, runny nose, nausea, upset stomach.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea
Clinical narrative: Runny nose; Upset stomach; Extreme Headache; Fatigue; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ACETAMINOPHEN for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.            Concomitant product used included Acetaminophen.  No treatment information was reported. After the second dose of my Moderna Covid-19 vaccination on 26FEB2021 I had an extreme Headache, chills, fatigue, body aches, runny nose, nausea, upset stomach.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Nervousness, Tremor
Clinical narrative: Shaking; Nervousness; Patient took the first dose was on Feb 16th 2 weeks prior to second dose; Chills; A spontaneous report was received from a healthcare professional concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 16 Feb 2021, 2 weeks prior to second dose/Inappropriate schedule of vaccine administered and experienced events wobbly, shaking, nervousness, chills.  The patient's medical history was not provided. Concomitant medications reported were duloxetine, fenofibrate, metformin,verapamil,meclizine,losartan, allopurinol, for drug use for unknown indication.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 2 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013A21A) via unknown route in the left  arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient experienced the events wobbly, shaking, nervousness, chills.Treatment details included None.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event, Inappropriate schedule of vaccine administered, was considered resolved on 02 mar 2021. The outcome of events, wobbly, shaking, nervousness, chills, were unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity, Peripheral swelling, Wrist deformity
Clinical narrative: arm swollen; arthritis; wrist carpel tunnel flares up; Arm is hurting especially under her armpit; 2 fingers same arm are hurting; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (arm swollen), ARTHRITIS (arthritis), WRIST DEFORMITY (wrist carpel tunnel flares up) and PAIN IN EXTREMITY (Arm is hurting especially under her armpit) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included SIMVASTATIN, LISINOPRIL, LEVOTHYROXINE SODIUM (LEVOTHROID), AMLODIPINE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.  Treatment medication includes Tylenol for arthritis.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm swollen), ARTHRITIS (arthritis), WRIST DEFORMITY (wrist carpel tunnel flares up), PAIN IN EXTREMITY (Arm is hurting especially under her armpit) and PAIN IN EXTREMITY (2 fingers same arm are hurting). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. On 29-Jan-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen), ARTHRITIS (arthritis), WRIST DEFORMITY (wrist carpel tunnel flares up), PAIN IN EXTREMITY (Arm is hurting especially under her armpit) and PAIN IN EXTREMITY (2 fingers same arm are hurting) outcome was unknown.          This case was linked to MOD-2021-044410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: declined further follow-up
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Achy muscles; Injection site rash; Fatigue; Injection site which was hot; Injection site which was itching; Knot at the injection site; A blue spot that resembles a bruise between her neck and her hairline/ large bruise; Stiff neck on the right side; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side), CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise), VACCINATION SITE WARMTH (Injection site which was hot), VACCINATION SITE PRURITUS (Injection site which was itching) and VACCINATION SITE INDURATION (Knot at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Slight headache). On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side). On 15-Mar-2021, the patient experienced CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site which was hot), VACCINATION SITE PRURITUS (Injection site which was itching) and VACCINATION SITE INDURATION (Knot at the injection site). On an unknown date, the patient experienced MYALGIA (Achy muscles), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Fatigue). On 06-Mar-2021, HEADACHE (Slight headache) had resolved. On 18-Mar-2021, VACCINATION SITE WARMTH (Injection site which was hot) and VACCINATION SITE PRURITUS (Injection site which was itching) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side), CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise), VACCINATION SITE INDURATION (Knot at the injection site), MYALGIA (Achy muscles), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included biofreeze, some stuff in a tube for achy muscles and heatable neck pillow with a scent for neck.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Achy muscles; Injection site rash; Fatigue; Injection site which was hot; Injection site which was itching; Knot at the injection site; A blue spot that resembles a bruise between her neck and her hairline/ large bruise; Stiff neck on the right side; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side), CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise), VACCINATION SITE WARMTH (Injection site which was hot), VACCINATION SITE PRURITUS (Injection site which was itching) and VACCINATION SITE INDURATION (Knot at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Slight headache). On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side). On 15-Mar-2021, the patient experienced CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site which was hot), VACCINATION SITE PRURITUS (Injection site which was itching) and VACCINATION SITE INDURATION (Knot at the injection site). On an unknown date, the patient experienced MYALGIA (Achy muscles), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Fatigue). On 06-Mar-2021, HEADACHE (Slight headache) had resolved. On 18-Mar-2021, VACCINATION SITE WARMTH (Injection site which was hot) and VACCINATION SITE PRURITUS (Injection site which was itching) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck on the right side), CONTUSION (A blue spot that resembles a bruise between her neck and her hairline/ large bruise), VACCINATION SITE INDURATION (Knot at the injection site), MYALGIA (Achy muscles), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included biofreeze, some stuff in a tube for achy muscles and heatable neck pillow with a scent for neck.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm discomfort) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) and CIPROFLOXACIN for an unknown indication.    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 LIMB DISCOMFORT (arm discomfort). At the time of the report, LIMB DISCOMFORT (arm discomfort) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No treatment medication information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Pain in extremity
Clinical narrative: sore arm which went away after 2 days; Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a; headache which went away after 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm which went away after 2 days), HYPERTENSION (Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a) and HEADACHE (headache which went away after 3 days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 which went away after 2 days), HYPERTENSION (Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a) and HEADACHE (headache which went away after 3 days). At the time of the report, PAIN IN EXTREMITY (sore arm which went away after 2 days) and HEADACHE (headache which went away after 3 days) had resolved and HYPERTENSION (Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were Pill for blood pressure.  No treatment information was provided.   This case was linked to MOD-2021-051810 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: having lots of back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (having lots of back 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 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 BACK PAIN (having lots of back pain). At the time of the report, BACK PAIN (having lots of back pain) 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 was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Birth mark, Fatigue, Oral mucosal roughening
Clinical narrative: Scratchy throat; Tired; Huge purple birth mark with a lump; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ROUGHENING (Scratchy throat), FATIGUE (Tired) and BIRTH MARK (Huge purple birth mark with a lump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Feb-2021, the patient experienced ORAL MUCOSAL ROUGHENING (Scratchy throat), FATIGUE (Tired) and BIRTH MARK (Huge purple birth mark with a lump). At the time of the report, ORAL MUCOSAL ROUGHENING (Scratchy throat), FATIGUE (Tired) and BIRTH MARK (Huge purple birth mark with a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Sore Arm; Achiness; chills; sore arm; Achiness; "Felt like flu"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), the first episode of PAIN (Achiness), INFLUENZA LIKE ILLNESS ("Felt like flu"), PAIN IN EXTREMITY (Sore Arm) and the second episode of PAIN (Achiness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (sore arm), the first episode of PAIN (Achiness) and INFLUENZA LIKE ILLNESS ("Felt like flu"). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), the second episode of PAIN (Achiness) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS ("Felt like flu"), PAIN IN EXTREMITY (Sore Arm), the last episode of PAIN (Achiness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ice.  Concomitant medication included Acid Reflux Medication.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Vision blurred
Clinical narrative: 5-10 minutes his vision was blurred; dizziness; For a week he had some shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (For a week he had some shortness of breath), VISION BLURRED (5-10 minutes his vision was blurred) and DIZZINESS (dizziness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included no adverse drug effect. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VALSARTAN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (For a week he had some shortness of breath). On an unknown date, the patient experienced VISION BLURRED (5-10 minutes his vision was blurred) and DIZZINESS (dizziness). Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Chills, Fatigue, Head discomfort
Clinical narrative: chest pain; upset stomach; fever , temperature of 102; sore throat; achy all over; stuffy head; chills; tired; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat) and PAIN (achy all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and DO1A21A) 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 historical condition reported.). Concomitant products included zenlafaxine, cholecaltif, METOPROLOL, DIPHENHYDRAMINE, FUROSEMIDE, NORTRIPTYLINE, MAGNESIUM OXIDE, POTASSIUM CHLORIDE, ALPHA LIPOIC ACID, BIFIDOBACTERIUM INFANTIS (ALIGN), SALBUTAMOL (ALBUTEROL HFA), FLECAINIDE ACETATE, ROSUVASTATIN, EZETIMIBE, Calcium / Vitamin D, BUPROPION, BENZTROPINE MESYLATE, ometrazole, RIBOFLAVIN, LEVOTHYROXINE, LORATADINE, VALPROATE SEMISODIUM (DIVALPROEX), L-LYSINE ACETATE and PIROXICAM 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Mar-2021, the patient experienced CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat), PAIN (achy all over), HEAD DISCOMFORT (stuffy head), CHILLS (chills), FATIGUE (tired) and HEADACHE (Headache). At the time of the report, CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat), PAIN (achy all over), HEAD DISCOMFORT (stuffy head), CHILLS (chills), FATIGUE (tired), PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) 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 events was not Applicable.  Treatment medications included, Benadryl Dayquil Nyquil Tylenol
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: chest pain; upset stomach; fever , temperature of 102; sore throat; achy all over; stuffy head; chills; tired; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat) and PAIN (achy all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and DO1A21A) 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 historical condition reported.). Concomitant products included zenlafaxine, cholecaltif, METOPROLOL, DIPHENHYDRAMINE, FUROSEMIDE, NORTRIPTYLINE, MAGNESIUM OXIDE, POTASSIUM CHLORIDE, ALPHA LIPOIC ACID, BIFIDOBACTERIUM INFANTIS (ALIGN), SALBUTAMOL (ALBUTEROL HFA), FLECAINIDE ACETATE, ROSUVASTATIN, EZETIMIBE, Calcium / Vitamin D, BUPROPION, BENZTROPINE MESYLATE, ometrazole, RIBOFLAVIN, LEVOTHYROXINE, LORATADINE, VALPROATE SEMISODIUM (DIVALPROEX), L-LYSINE ACETATE and PIROXICAM 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Mar-2021, the patient experienced CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat), PAIN (achy all over), HEAD DISCOMFORT (stuffy head), CHILLS (chills), FATIGUE (tired) and HEADACHE (Headache). At the time of the report, CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat), PAIN (achy all over), HEAD DISCOMFORT (stuffy head), CHILLS (chills), FATIGUE (tired), PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) 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 events was not Applicable.  Treatment medications included, Benadryl Dayquil Nyquil Tylenol
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hyperhidrosis, Paraesthesia, Somnolence
Clinical narrative: Sweating profusely; Woke him up from sleeping; Jolt or a tingle in his chest which lasted for 2-3 min; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Jolt or a tingle in his chest which lasted for 2-3 min), HYPERHIDROSIS (Sweating profusely) and SOMNOLENCE (Woke him up from sleeping) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A2) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (Jolt or a tingle in his chest which lasted for 2-3 min). On 27-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating profusely) and SOMNOLENCE (Woke him up from sleeping). On 25-Mar-2021, PARAESTHESIA (Jolt or a tingle in his chest which lasted for 2-3 min) had resolved. On 27-Mar-2021, HYPERHIDROSIS (Sweating profusely) and SOMNOLENCE (Woke him up from sleeping) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Heart rate: 77 (Inconclusive) 77 beats per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: lower back pain; Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and ARTHRALGIA (Hip pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BACK PAIN (lower back pain) and ARTHRALGIA (Hip pain). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain) had not resolved and ARTHRALGIA (Hip pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-062528 (E2B Linked Report). This case was linked to MOD-2021-062528 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Tylenol added as treatment drug. Anatomical Location added. Outcome updated to not resolved for back pain. Action taken updated to no change. Company causality updated to possible for back pain.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062528:dose 1
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash, Rash erythematous
Clinical narrative: "very red" body rash; circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash; headache; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS ("very red" body rash), HEADACHE (headache) and RASH (circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013N20A. and 048A21A.) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (headache). Concomitant products included PARACETAMOL (TYLENOL) and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & SINUS HEADACHE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 29-Mar-2021, the patient experienced HEADACHE (headache). On 30-Mar-2021, the patient experienced RASH ERYTHEMATOUS ("very red" body rash) and RASH (circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash). At the time of the report, RASH ERYTHEMATOUS ("very red" body rash), HEADACHE (headache) and RASH (circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-064525 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064525:case for first dose
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to 16-year-old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16-year-old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023N20A) 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) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16-year-old). On 03-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16-year-old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Hypertension
Clinical narrative: Chills; Heartbeat at 90 beats a minute an hour; blood pressure went up a bit; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEART RATE INCREASED (Heartbeat at 90 beats a minute an hour) and HYPERTENSION (blood pressure went up a bit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication.     The patient's past medical history included No adverse event. Concurrent medical conditions included Blood pressure (Patient reported that she is currently on blood pressure medication blood pressure went down as of 5Feb2021.) since 04-Feb-2021. Concomitant products included AMLODIPINE.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Chills), HEART RATE INCREASED (Heartbeat at 90 beats a minute an hour) and HYPERTENSION (blood pressure went up a bit). On 05-Feb-2021, HYPERTENSION (blood pressure went up a bit) had resolved. At the time of the report, CHILLS (Chills) and HEART RATE INCREASED (Heartbeat at 90 beats a minute an hour) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate abnormal: 90 bpm a fast heartbeat, and higher than normal blood pressure.Patient reported that she began experiencing  a heart rate of 90bpm..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: severe pain in her right arm\got worse; Pain radiates down to the butt cheek\got worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in her right arm\got worse) and PAIN (Pain radiates down to the butt cheek\got worse) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Pain.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her right arm\got worse) and PAIN (Pain radiates down to the butt cheek\got worse). At the time of the report, PAIN IN EXTREMITY (severe pain in her right arm\got worse) and PAIN (Pain radiates down to the butt cheek\got worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided. No treatment is provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: red; itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), PRURITUS (itchy) and RASH (rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Mar-2021, the patient experienced ERYTHEMA (red), PRURITUS (itchy) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. On 26-Mar-2021, ERYTHEMA (red), PRURITUS (itchy) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 twice in PCR test; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for Covid-19 twice in PCR test) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 COVID-19 (tested positive for Covid-19 twice in PCR test). At the time of the report, COVID-19 (tested positive for Covid-19 twice in PCR test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19 twice in a PCR test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter confirmed patient had exposure to someone with COVID-19. No concomitant medications were reported. No treatment details were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: feeling warm; lot of redness; where she got the shot, my mother is experiencing pain; almost feverish; little soreness in arm of the injection; hand of the arm where she got the shot feels cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in arm of the injection), FEELING HOT (feeling warm), ERYTHEMA (lot of redness), PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold) and VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (little soreness in arm of the injection). On 01-Apr-2021, the patient experienced FEELING HOT (feeling warm), ERYTHEMA (lot of redness), VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) and PYREXIA (almost feverish). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (little soreness in arm of the injection), FEELING HOT (feeling warm), ERYTHEMA (lot of redness), PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold), VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) and PYREXIA (almost feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter, she had ice on the injection site.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feeling warm; lot of redness; where she got the shot, my mother is experiencing pain; almost feverish; little soreness in arm of the injection; hand of the arm where she got the shot feels cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in arm of the injection), FEELING HOT (feeling warm), ERYTHEMA (lot of redness), PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold) and VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (little soreness in arm of the injection). On 01-Apr-2021, the patient experienced FEELING HOT (feeling warm), ERYTHEMA (lot of redness), VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) and PYREXIA (almost feverish). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (little soreness in arm of the injection), FEELING HOT (feeling warm), ERYTHEMA (lot of redness), PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold), VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) and PYREXIA (almost feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter, she had ice on the injection site.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: some achyness; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (some achyness), FATIGUE (fatigue) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020 and Hair loss in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, LISINOPRIL for Blood pressure high, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ESCITALOPRAM OXALATE (LEXAPRO), COLECALCIFEROL (VITAMIN D 3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (some achyness), FATIGUE (fatigue) and HEADACHE (Headache). On 07-Mar-2021, MYALGIA (some achyness), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that back in September 2020, was very ill and dehydrated and went to the hospital a couple of times,  but every once in a while starts feeling funny, strange, very fatigued, feels kind of like a shortness of breath and a heaviness on her chest, it comes out of nowhere. Treatment medication included Tylenol.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia
Clinical narrative: Muscle ache; Headache; Chills; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills) and ASTHENIA (Weakness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills) and ASTHENIA (Weakness). At the time of the report, MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills) and ASTHENIA (Weakness) outcome was unknown.            no concomitant medications are provided. treatment to the events not provided.  patient want to know whether it is advisable to go for the second dose, given these symptoms. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at the injection site; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (pain at the injection site) 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 31-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 VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: body aches; Headache; joint pain; muscle pain; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL) 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 PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; Headache; joint pain; muscle pain; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL) 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 PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.