chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning sensation in throat; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in 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 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 BURNING SENSATION (burning sensation in throat). At the time of the report, BURNING SENSATION (burning sensation in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Limb mass, Peripheral swelling, Skin warm
Clinical narrative: Woke up and had knot in it; Arm felt swollen and puffy; Had fever in it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB MASS (Woke up and had knot in it), PERIPHERAL SWELLING (Arm felt swollen and puffy) and SKIN WARM (Had fever in it) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, OMEPRAZOLE, SODIUM BICARBONATE, GABAPENTIN, ATORVASTATIN, LOSARTAN, METFORMIN, FOLIC ACID, AMLODIPINE, HYDROCHLOROTHIAZIDE, METOPROLOL, GLIPIZIDE, METHOTREXATE, CERTOLIZUMAB PEGOL (CIMZIA), ACETYLSALICYLIC ACID (BABY ASPIRIN) and GARLIC OIL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LIMB MASS (Woke up and had knot in it), PERIPHERAL SWELLING (Arm felt swollen and puffy) and SKIN WARM (Had fever in it). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, LIMB MASS (Woke up and had knot in it), PERIPHERAL SWELLING (Arm felt swollen and puffy) and SKIN WARM (Had fever in it) 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.   On an unknown date, the patient went to see a Dermatologist, who prescribed doxycycline twice daily for seven days.  Treatment included doxycycline.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Right arm around the wrist is puffy - during the day it went bigger and bigger; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right arm around the wrist is puffy - during the day it went bigger and bigger) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Right arm around the wrist is puffy - during the day it went bigger and bigger). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Right arm around the wrist is puffy - during the day it went bigger and bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: felt crappy; extreme achiness, it was hard for him to keep his eyes open; described the fever as if his "brain was not attached inside; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt crappy), MYALGIA (extreme achiness, it was hard for him to keep his eyes open) and PYREXIA (described the fever as if his "brain was not attached inside) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced MALAISE (felt crappy), MYALGIA (extreme achiness, it was hard for him to keep his eyes open) and PYREXIA (described the fever as if his "brain was not attached inside). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (felt crappy), MYALGIA (extreme achiness, it was hard for him to keep his eyes open) and PYREXIA (described the fever as if his "brain was not attached inside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Sleepiness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20A and 039k20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness) outcome was unknown.            Concomitant product used included cholesterol medication NOS.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Only half the dose was given; Moderna vaccine was running down her arm; A spontaneous report was received from a pharmacist concerning a 67-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) but only half the dose was given / under dose and the vaccine was running down her arm / product administration error was reported.  The patient's medical history and concomitant medications were not provided.   On 03 Mar 2021, the patient received their planned dose of mRNA-1273 (Lot number: 014M20A) in the arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, it was observed that only half the dose was given and Moderna vaccine was running down her arm. The pharmacist states that it was perhaps 0.25mL or less given to the patient. The event was considered to be a medication error.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event were considered resolved on 03 Mar 2021.; Reporter's Comments: This case concerns a 67-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot # 014M20A), reporting a medication error during product administration and underdose without any associated adverse events. Events considered resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Pain in extremity, Tremor
Clinical narrative: Shaking; Diarrhea; Exhausted; body sore; Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), TREMOR (Shaking), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and MYALGIA (body sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL and HCTZ for an unknown indication.    On 23-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 PAIN IN EXTREMITY (Sore arms). On 24-Feb-2021, the patient experienced TREMOR (Shaking), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and MYALGIA (body sore). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arms), TREMOR (Shaking), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and MYALGIA (body sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: Occupational exposure; A spontaneous report was received from a nurse, who is a patient of unspecified age and gender, who administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced occupational exposure (Occupational exposure to product).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 11 Mar 2021, prior to the onset of the events, the patient administered the first of two planned vaccine doses of mRNA-1273 (Batch Number: unknown) in the left arm of a 21-year-old female patient for prophylaxis of COVID-19 infection.  On 11 Mar 2021, when needle was put in, liquid leaked out probably due to needle not being tightened on hub of vaccine, and the nurse experienced occupational exposure.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the event, experienced occupational exposure, was recovered on 11 Mar 2021.; Reporter's Comments: This report refers to a case of Occupational exposure to product for mRNA-1273, lot # Unknown, with no associated AEs.; Sender's Comments:  MOD21-050022:Nurse case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site discolouration, Vaccination site erythema, Vaccination site reaction
Clinical narrative: a little sore; injection site was red; mild reaction; a dark pink blotch at the injection site; arm bacame more swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little sore), VACCINATION SITE REACTION (mild reaction), VACCINATION SITE DISCOLOURATION (a dark pink blotch at the injection site), PERIPHERAL SWELLING (arm bacame more swollen) and VACCINATION SITE ERYTHEMA (injection site was red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (a dark pink blotch at the injection site) and PERIPHERAL SWELLING (arm bacame more swollen). On 25-Feb-2021, the patient experienced VACCINATION SITE REACTION (mild reaction). On an unknown date, the patient experienced PAIN (a little sore) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, PAIN (a little sore), VACCINATION SITE REACTION (mild reaction), VACCINATION SITE DISCOLOURATION (a dark pink blotch at the injection site), PERIPHERAL SWELLING (arm bacame more swollen) and VACCINATION SITE ERYTHEMA (injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Limb discomfort, Pain
Clinical narrative: couldn't straighten his leg; flu-like symptoms; soreness; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't straighten his leg), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (soreness), HEADACHE (headache) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't straighten his leg), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (soreness), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't straighten his leg), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (soreness), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   .
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling cold, Hyperhidrosis, Illness
Clinical narrative: swollen eyelid; swollen upper lip; tired; she broke out in a sweat; couldn't get warm; started to throw up; ached all over; Felt terrible; No energy; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt terrible), ASTHENIA (No energy), HYPERHIDROSIS (she broke out in a sweat), FEELING COLD (couldn't get warm) and VOMITING (started to throw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-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 VACCINATION SITE PAIN (Arm was sore). On 09-Mar-2021, the patient experienced ILLNESS (Felt terrible), ASTHENIA (No energy) and MYALGIA (ached all over). On 10-Mar-2021, the patient experienced HYPERHIDROSIS (she broke out in a sweat), FEELING COLD (couldn't get warm) and VOMITING (started to throw up). On 11-Mar-2021, the patient experienced FATIGUE (tired). On 12-Mar-2021, the patient experienced SWELLING OF EYELID (swollen eyelid) and LIP SWELLING (swollen upper lip). At the time of the report, ILLNESS (Felt terrible), ASTHENIA (No energy), HYPERHIDROSIS (she broke out in a sweat), FEELING COLD (couldn't get warm), VOMITING (started to throw up), VACCINATION SITE PAIN (Arm was sore), FATIGUE (tired), MYALGIA (ached all over), SWELLING OF EYELID (swollen eyelid) and LIP SWELLING (swollen upper lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment information for the events was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: F/U received on 12 March 2021,new ADR added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Myalgia, Swelling of eyelid, Vaccination site pain, Vomiting
Clinical narrative: swollen eyelid; swollen upper lip; tired; she broke out in a sweat; couldn't get warm; started to throw up; ached all over; Felt terrible; No energy; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt terrible), ASTHENIA (No energy), HYPERHIDROSIS (she broke out in a sweat), FEELING COLD (couldn't get warm) and VOMITING (started to throw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-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 VACCINATION SITE PAIN (Arm was sore). On 09-Mar-2021, the patient experienced ILLNESS (Felt terrible), ASTHENIA (No energy) and MYALGIA (ached all over). On 10-Mar-2021, the patient experienced HYPERHIDROSIS (she broke out in a sweat), FEELING COLD (couldn't get warm) and VOMITING (started to throw up). On 11-Mar-2021, the patient experienced FATIGUE (tired). On 12-Mar-2021, the patient experienced SWELLING OF EYELID (swollen eyelid) and LIP SWELLING (swollen upper lip). At the time of the report, ILLNESS (Felt terrible), ASTHENIA (No energy), HYPERHIDROSIS (she broke out in a sweat), FEELING COLD (couldn't get warm), VOMITING (started to throw up), VACCINATION SITE PAIN (Arm was sore), FATIGUE (tired), MYALGIA (ached all over), SWELLING OF EYELID (swollen eyelid) and LIP SWELLING (swollen upper lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment information for the events was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: F/U received on 12 March 2021,new ADR added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg; Hard swelling about size of quarter at injection site; Hard swelling about size of quarter at injection site; Sore in the left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg), VACCINATION SITE INDURATION (Hard swelling about size of quarter at injection site), VACCINATION SITE PAIN (Sore in the left upper arm) and VACCINATION SITE SWELLING (Hard swelling about size of quarter at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore in the left upper arm). On 04-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hard swelling about size of quarter at injection site) and VACCINATION SITE SWELLING (Hard swelling about size of quarter at injection site). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg). At the time of the report, PAIN IN EXTREMITY (Right leg is sore to touch from leg to knee to thigh area/Periodic lightening pain through out the right leg), VACCINATION SITE INDURATION (Hard swelling about size of quarter at injection site), VACCINATION SITE PAIN (Sore in the left upper arm) and VACCINATION SITE SWELLING (Hard swelling about size of quarter at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information indicated none.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: COPD flare up; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flare up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included ATENOLOL for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flare up). The patient was treated with DOXYCYCLINE HYCLATE (oral) on 27-Feb-2021 for COPD exacerbation, at a dose of 100 mg. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flare up) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Headache, Nausea
Clinical narrative: Stomach is really sore; Back pain; On the right side by the kidney it hurts a lot like someone hit me there; Headache; Nauseaous; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain), RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there), HEADACHE (Headache) and NAUSEA (Nauseaous) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-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 HEADACHE (Headache), NAUSEA (Nauseaous) and CHILLS (Chills). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain) and RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there). The patient was treated with PARACETAMOL (TYLENOL) on 08-Mar-2021 for Headache and Chills, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) in March 2021 at an unspecified dose and frequency. On 10-Mar-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain), RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there) and NAUSEA (Nauseaous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-June-2021 and event outcome updated to resolved/recovered
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Stomach is really sore; Back pain; On the right side by the kidney it hurts a lot like someone hit me there; Headache; Nauseaous; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain), RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there), HEADACHE (Headache) and NAUSEA (Nauseaous) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-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 HEADACHE (Headache), NAUSEA (Nauseaous) and CHILLS (Chills). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain) and RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there). The patient was treated with PARACETAMOL (TYLENOL) on 08-Mar-2021 for Headache and Chills, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) in March 2021 at an unspecified dose and frequency. On 10-Mar-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain), RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there) and NAUSEA (Nauseaous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-June-2021 and event outcome updated to resolved/recovered
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Itchiness; Injection site sore; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red) in a 93-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itchiness), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Heart rate increased
Clinical narrative: Fast heartbeat; Weakness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, HEART RATE INCREASED (Fast heartbeat), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: My arm is swollen; Arm is red; Arm is hot to touch; Arm is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My arm is swollen), ERYTHEMA (Arm is red), FEELING HOT (Arm is hot to touch) and PRURITUS (Arm is very itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE (TOPROL), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (My arm is swollen), ERYTHEMA (Arm is red), FEELING HOT (Arm is hot to touch) and PRURITUS (Arm is very itchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) in March 2021 for Swollen arm, Feeling hot and Redness, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (My arm is swollen), ERYTHEMA (Arm is red), FEELING HOT (Arm is hot to touch) and PRURITUS (Arm is very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: soreness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ROSUVASTATIN, COLESEVELAM, MESALAZINE (LIALDA), TAMSULOSIN, METFORMIN, INSULIN DEGLUDEC (TRESIBA), POTASSIUM CHLORIDE and EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (soreness), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (soreness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-040792 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: fever of 104F; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 104F), MYALGIA (Muscle ache) and CHILLS (Chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever of 104F), MYALGIA (Muscle ache) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and ibuprofen at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 104F), MYALGIA (Muscle ache) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 104 f (High) 104 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in an 8-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 30-Jan-2021.    No Medical History information was reported.    On 30-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Jan-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Reporter email added.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 100-101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100-101 degrees Fahrenheit) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever of 100-101 degrees Fahrenheit). At the time of the report, PYREXIA (fever of 100-101 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included, paracetamol. No concomitant medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: headache; Bodyache; Nauseous; Fatigue; tired; chillness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), NAUSEA (Nauseous), FATIGUE (Fatigue; tired), CHILLS (chillness) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Bodyache), NAUSEA (Nauseous), FATIGUE (Fatigue; tired) and CHILLS (chillness). On 11-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, PAIN (Bodyache), NAUSEA (Nauseous), FATIGUE (Fatigue; tired), CHILLS (chillness) and HEADACHE (headache) outcome was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Just pain in the arm (muscle soreness); Just pain in the arm (muscle soreness); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Just pain in the arm (muscle soreness)) and MYALGIA (Just pain in the arm (muscle soreness)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Just pain in the arm (muscle soreness)) and MYALGIA (Just pain in the arm (muscle soreness)). On 21-Feb-2021, PAIN IN EXTREMITY (Just pain in the arm (muscle soreness)) and MYALGIA (Just pain in the arm (muscle soreness)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Foot fracture, Pollakiuria, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving) and POLLAKIURIA (Excess Urination) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 040A21A) 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 LEVOTHYROXINE, BENAZEPRIL, LOVASTATIN, VITAMINS NOS (DAILY VITAMINS) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FOOT FRACTURE (Fractured Toe). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving), POLLAKIURIA (Excess Urination) and ABDOMINAL PAIN UPPER (Stomach Ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving), POLLAKIURIA (Excess Urination), FOOT FRACTURE (Fractured Toe) and ABDOMINAL PAIN UPPER (Stomach Ache) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: ADR form received om 04-MAY-2021 Contains No New Information ( NNI )
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving) and POLLAKIURIA (Excess Urination) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 040A21A) 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 LEVOTHYROXINE, BENAZEPRIL, LOVASTATIN, VITAMINS NOS (DAILY VITAMINS) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FOOT FRACTURE (Fractured Toe). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving), POLLAKIURIA (Excess Urination) and ABDOMINAL PAIN UPPER (Stomach Ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving), POLLAKIURIA (Excess Urination), FOOT FRACTURE (Fractured Toe) and ABDOMINAL PAIN UPPER (Stomach Ache) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: ADR form received om 04-MAY-2021 Contains No New Information ( NNI )
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness at vaccine site; Redness at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at vaccine site) and VACCINATION SITE ERYTHEMA (Redness at vaccine site) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at vaccine site) and VACCINATION SITE ERYTHEMA (Redness at vaccine site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at vaccine site) and VACCINATION SITE ERYTHEMA (Redness at vaccine site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Pyrexia, Rash erythematous
Clinical narrative: Rash all over her neck, which was red; Low grade fever that night; Feeling low; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling low), RASH ERYTHEMATOUS (Rash all over her neck, which was red) and PYREXIA (Low grade fever that night) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 DEPRESSED MOOD (Feeling low) and PYREXIA (Low grade fever that night). On 10-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Rash all over her neck, which was red). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DEPRESSED MOOD (Feeling low), RASH ERYTHEMATOUS (Rash all over her neck, which was red) and PYREXIA (Low grade fever that night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Illness, Nausea
Clinical narrative: sick all night; stomach cramps; feeling nauseous but haven't thrown up; slight headache; having chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all night), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (feeling nauseous but haven't thrown up), HEADACHE (slight headache) and CHILLS (having chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (sick all night), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (feeling nauseous but haven't thrown up), HEADACHE (slight headache) and CHILLS (having chills). At the time of the report, ILLNESS (sick all night), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (feeling nauseous but haven't thrown up), HEADACHE (slight headache) and CHILLS (having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 4th MAY 2021 contains no new information
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: lost his sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost his sense of taste) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) 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 11-Mar-2021, the patient experienced AGEUSIA (lost his sense of taste). At the time of the report, AGEUSIA (lost his sense of taste) outcome was unknown. Not Provided      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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Feeling sick; Shoulder pain; Neck pain; Hives on back and legs; Woke up in the middle of the night itching really bad; Arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on back and legs), PRURITUS (Woke up in the middle of the night itching really bad), PAIN IN EXTREMITY (Arm started hurting), NECK PAIN (Neck pain) and MALAISE (Feeling sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025H21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives on back and legs), PRURITUS (Woke up in the middle of the night itching really bad) and PAIN IN EXTREMITY (Arm started hurting). On 03-Mar-2021, the patient experienced NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced MALAISE (Feeling sick). On 02-Mar-2021, URTICARIA (Hives on back and legs) and PRURITUS (Woke up in the middle of the night itching really bad) had resolved. On 03-Mar-2021, NECK PAIN (Neck pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting) had resolved and MALAISE (Feeling sick) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: The patient said that she is feeling sick and was going to see the doctor. The patient stated that thedoctor is prescribing antibiotics and wants to know if she can take them.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Feeling sick; Shoulder pain; Neck pain; Hives on back and legs; Woke up in the middle of the night itching really bad; Arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on back and legs), PRURITUS (Woke up in the middle of the night itching really bad), PAIN IN EXTREMITY (Arm started hurting), NECK PAIN (Neck pain) and MALAISE (Feeling sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025H21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives on back and legs), PRURITUS (Woke up in the middle of the night itching really bad) and PAIN IN EXTREMITY (Arm started hurting). On 03-Mar-2021, the patient experienced NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced MALAISE (Feeling sick). On 02-Mar-2021, URTICARIA (Hives on back and legs) and PRURITUS (Woke up in the middle of the night itching really bad) had resolved. On 03-Mar-2021, NECK PAIN (Neck pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting) had resolved and MALAISE (Feeling sick) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: The patient said that she is feeling sick and was going to see the doctor. The patient stated that thedoctor is prescribing antibiotics and wants to know if she can take them.