chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle was not  tighten on hub of vaccine; Small amount of vaccine went in; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Needle was not  tighten on hub of vaccine) and UNDERDOSE (Small amount of vaccine went in) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  The patient's past medical history included No adverse event.    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 DEVICE CONNECTION ISSUE (Needle was not  tighten on hub of vaccine) and UNDERDOSE (Small amount of vaccine went in). At the time of the report, DEVICE CONNECTION ISSUE (Needle was not  tighten on hub of vaccine) and UNDERDOSE (Small amount of vaccine went in) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Productive cough
Clinical narrative: my arm was swollen; arm was swollen and it hurt; cough, it gets really deep, I could spit something out; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was swollen), PAIN (arm was swollen and it hurt) and PRODUCTIVE COUGH (cough, it gets really deep, I could spit something out) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation.     No medical history was reported.  The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (my arm was swollen) and PAIN (arm was swollen and it hurt). In March 2021, the patient experienced PRODUCTIVE COUGH (cough, it gets really deep, I could spit something out). On 07-Mar-2021, PERIPHERAL SWELLING (my arm was swollen) and PAIN (arm was swollen and it hurt) had resolved. At the time of the report, PRODUCTIVE COUGH (cough, it gets really deep, I could spit something out) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified water pill, gout pill and potassium pill.   Patient used ice packs for swollen arm.   This case was linked to MOD21-051121 (E2B Linked Report).; Sender's Comments:  MOD21-051121:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Mild dizziness; Nausea; Slight Headache; Weakness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild dizziness), NAUSEA (Nausea), HEADACHE (Slight Headache), ASTHENIA (Weakness) and FATIGUE (Tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.   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 10-Mar-2021, the patient experienced DIZZINESS (Mild dizziness), NAUSEA (Nausea), HEADACHE (Slight Headache), ASTHENIA (Weakness) and FATIGUE (Tired). At the time of the report, DIZZINESS (Mild dizziness), NAUSEA (Nausea), HEADACHE (Slight Headache), ASTHENIA (Weakness) and FATIGUE (Tired) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Somnolence
Clinical narrative: felt tired; felt "achy" or achiness; slept a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (felt tired), MYALGIA (felt "achy" or achiness) and SOMNOLENCE (slept a lot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphedema and Anxiety. Concurrent medical conditions included Muscle atrophy (Muscle atrophy in her arms), Degenerative disc disease and Fibromyalgia.   On 02-Feb-2021 at 9:31 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (felt tired), MYALGIA (felt "achy" or achiness) and SOMNOLENCE (slept a lot). On 06-Feb-2021, FATIGUE (felt tired), MYALGIA (felt "achy" or achiness) and SOMNOLENCE (slept a lot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-041185 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain in extremity
Clinical narrative: big chills; sweating; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (big chills), HYPERHIDROSIS (sweating) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event. Concomitant products included LOSARTAN for an unknown indication.    On 09-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 PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced CHILLS (big chills) and HYPERHIDROSIS (sweating). On 10-Mar-2021, CHILLS (big chills), HYPERHIDROSIS (sweating) and PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: Having trouble sleeping; Both arms severe aches and pains; Extreme fatigue; A spontaneous report was received from a female consumer of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme fatigue/Fatigue, both arms severe aches and pains/Pain in extremity, having trouble sleeping/ Insomnia,  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) Intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events extreme fatigue, both arms severe aches and pains, having trouble sleeping. Treatment details included None given.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, extreme fatigue, both arms severe aches and pains and having trouble sleeping was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiffness of arm; Soreness of arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness of arm) and PAIN IN EXTREMITY (Soreness of arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included WARFARIN for an unknown indication.    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 MUSCULOSKELETAL STIFFNESS (Stiffness of arm) and PAIN IN EXTREMITY (Soreness of arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness of arm) and PAIN IN EXTREMITY (Soreness of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FLUOXETINE, AMLODIPINE and ATENOLOL 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 05-MAY-2021 and updated patient demographics, concomitant medications, treatment information and outcome of the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Rash, Urticaria, Vaccination site reaction
Clinical narrative: Johnson and Johnson vaccine as my second dose; Hives/ hives came back a little bit / Developed welts in the mouth; Spider bite like reaction; Developed rashes on the body and stomach; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine as my second dose), URTICARIA (Hives/ hives came back a little bit / Developed welts in the mouth), VACCINATION SITE REACTION (Spider bite like reaction) and RASH (Developed rashes on the body and stomach) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, WARFARIN, IRBESARTAN and SIMVASTATIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Hives/ hives came back a little bit / Developed welts in the mouth), VACCINATION SITE REACTION (Spider bite like reaction) and RASH (Developed rashes on the body and stomach). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine as my second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form once a day. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine as my second dose) had resolved and URTICARIA (Hives/ hives came back a little bit / Developed welts in the mouth), VACCINATION SITE REACTION (Spider bite like reaction) and RASH (Developed rashes on the body and stomach) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient took Johnson and Johnson as the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05-May-2021 contains significant information about second dose of vaccine and treatment drug information updated. On 21-Jun-2021: Follow-up information received on 21-Jun-2021 contains non-significant information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red patch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red patch). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red patch) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. Treatment included Neosporin ointment
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever 99.1 degrees Fahrenheit/temperature was 100.3 degrees Fahrenheit; aching all over; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 99.1 degrees Fahrenheit/temperature was 100.3 degrees Fahrenheit) and MYALGIA (aching all over) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 10-Mar-2021, the patient experienced PYREXIA (fever 99.1 degrees Fahrenheit/temperature was 100.3 degrees Fahrenheit) and MYALGIA (aching all over). At the time of the report, PYREXIA (fever 99.1 degrees Fahrenheit/temperature was 100.3 degrees Fahrenheit) and MYALGIA (aching all over) outcome was unknown.            No concomitants were reported. No treatment medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 23-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        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.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pyrexia: 101f (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-041249 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history information provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Aug-2021. On 11-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On 11-Mar-2021, EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided by the reporter. Concomitant medication also include medication for nausea.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Anxiety, Asthenopia, Asthma
Clinical narrative: Swelling Left arm, upper Calves and legs swelling; Bruise/ Lump on the injection Site; Sore Arm; Itching all over the body and injection site; upper Calves and legs swelling; Asthma attack; Anxiety; Stomach Cramps; stomach Bloating; Runny Nose; Weak / Tired eyes; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site) and PERIPHERAL SWELLING (upper Calves and legs swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety, Neuropathy, Celiac disease, White blood cell count low and Immunoglobulin therapy (IVIG treatment was recommended two years ago). Concurrent medical conditions included Asthma and Heart disease, unspecified.    On 09-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 PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Xanax and Breathing Treatment
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Swelling Left arm, upper Calves and legs swelling; Bruise/ Lump on the injection Site; Sore Arm; Itching all over the body and injection site; upper Calves and legs swelling; Asthma attack; Anxiety; Stomach Cramps; stomach Bloating; Runny Nose; Weak / Tired eyes; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site) and PERIPHERAL SWELLING (upper Calves and legs swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety, Neuropathy, Celiac disease, White blood cell count low and Immunoglobulin therapy (IVIG treatment was recommended two years ago). Concurrent medical conditions included Asthma and Heart disease, unspecified.    On 09-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 PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Xanax and Breathing Treatment
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site bruising
Clinical narrative: Swelling Left arm, upper Calves and legs swelling; Bruise/ Lump on the injection Site; Sore Arm; Itching all over the body and injection site; upper Calves and legs swelling; Asthma attack; Anxiety; Stomach Cramps; stomach Bloating; Runny Nose; Weak / Tired eyes; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site) and PERIPHERAL SWELLING (upper Calves and legs swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety, Neuropathy, Celiac disease, White blood cell count low and Immunoglobulin therapy (IVIG treatment was recommended two years ago). Concurrent medical conditions included Asthma and Heart disease, unspecified.    On 09-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 PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling Left arm, upper Calves and legs swelling), VACCINATION SITE BRUISING (Bruise/ Lump on the injection Site), PAIN IN EXTREMITY (Sore Arm), PRURITUS (Itching all over the body and injection site), PERIPHERAL SWELLING (upper Calves and legs swelling), ASTHMA (Asthma attack), ANXIETY (Anxiety), ABDOMINAL PAIN UPPER (Stomach Cramps), ABDOMINAL DISTENSION (stomach Bloating), RHINORRHOEA (Runny Nose), ASTHENOPIA (Weak / Tired eyes), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Xanax and Breathing Treatment
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: Sore; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-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 PAIN IN EXTREMITY (Sore) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue
Clinical narrative: itching all over; her tongue swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over) and SWOLLEN TONGUE (her tongue swelled up) in a 76-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 No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (itching all over) and SWOLLEN TONGUE (her tongue swelled up). At the time of the report, PRURITUS (itching all over) and SWOLLEN TONGUE (her tongue swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment included Benadryl
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Insomnia, Pain, Skin burning sensation
Clinical narrative: Sore & Hurting; Loss of taste; Difficulty sleeping on the side; Felt injection of the vaccine down in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore & Hurting), AGEUSIA (Loss of taste), INSOMNIA (Difficulty sleeping on the side) and SKIN BURNING SENSATION (Felt injection of the vaccine down in her leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore & Hurting), AGEUSIA (Loss of taste), INSOMNIA (Difficulty sleeping on the side) and SKIN BURNING SENSATION (Felt injection of the vaccine down in her leg). At the time of the report, PAIN (Sore & Hurting), AGEUSIA (Loss of taste), INSOMNIA (Difficulty sleeping on the side) and SKIN BURNING SENSATION (Felt injection of the vaccine down in her leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Feeling feverish; Chill; Fatigue; Arm became sore at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Arm became sore at the site of injection), CHILLS (Chill) and PYREXIA (Feeling feverish) 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 05-Feb-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 2:00 PM, the patient experienced VACCINATION SITE PAIN (Arm became sore at the site of injection). On 05-Feb-2021 at 7:00 PM, the patient experienced FATIGUE (Fatigue). On 05-Feb-2021 at 9:30 PM, the patient experienced CHILLS (Chill). On 06-Feb-2021, the patient experienced PYREXIA (Feeling feverish). On 06-Feb-2021 at 6:00 AM, VACCINATION SITE PAIN (Arm became sore at the site of injection), CHILLS (Chill) and PYREXIA (Feeling feverish) had resolved. On 06-Feb-2021 at 8:00 PM, FATIGUE (Fatigue) had resolved. Not Provided          Concomitant medications were not provided by the reporter. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive. In March 2021, Pyrexia: 100.7 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not given.
Age: 0.33
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Diarrhoea, Exposure via breast milk, Gastrooesophageal reflux disease, Malaise
Clinical narrative: vaccine exposure via breast milk; Diarrhea; Not feeling well; fussiness (abnormal for patient); spitting up a lot; not eating regular amount; threw up; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk), DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)) and GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot) in a 16-week-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 05-Mar-2021.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.    On 05-Mar-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 05-Mar-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk), DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)), GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot), POOR FEEDING INFANT (not eating regular amount) and VOMITING (threw up). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 05-Mar-2021, EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved. On 11-Mar-2021, DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)), GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot), POOR FEEDING INFANT (not eating regular amount) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 0.33
Sex: M
Vaccine: COVID19
Symptoms: Poor feeding infant, Vomiting
Clinical narrative: vaccine exposure via breast milk; Diarrhea; Not feeling well; fussiness (abnormal for patient); spitting up a lot; not eating regular amount; threw up; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk), DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)) and GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot) in a 16-week-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 05-Mar-2021.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.    On 05-Mar-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 05-Mar-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk), DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)), GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot), POOR FEEDING INFANT (not eating regular amount) and VOMITING (threw up). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 05-Mar-2021, EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved. On 11-Mar-2021, DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)), GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot), POOR FEEDING INFANT (not eating regular amount) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inflammation
Clinical narrative: Inflammation syndrome; back ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation syndrome) and BACK PAIN (back ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation syndrome) and BACK PAIN (back ache). At the time of the report, INFLAMMATION (Inflammation syndrome) and BACK PAIN (back ache) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD21-051697, MOD21-051726 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-051697: MOD21-051726:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb deformity, Pain in extremity
Clinical narrative: unable to use his left arm fully; sore arm; arm numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPOAESTHESIA (arm numbness) and LIMB DEFORMITY (unable to use his left arm fully) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history information provided by the reporter.  The patient's past medical history included No adverse event.    On 03-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 PAIN IN EXTREMITY (sore arm) and HYPOAESTHESIA (arm numbness). On an unknown date, the patient experienced LIMB DEFORMITY (unable to use his left arm fully). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) and HYPOAESTHESIA (arm numbness) had not resolved and LIMB DEFORMITY (unable to use his left arm fully) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not given. Treatment included Ibuprofen
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance
Clinical narrative: Shivering; patient can not walk; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering) and GAIT DISTURBANCE (patient can not walk) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis (Patient has 20 years history of Multiple Sclerosis.).    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 CHILLS (Shivering) and GAIT DISTURBANCE (patient can not walk). At the time of the report, CHILLS (Shivering) and GAIT DISTURBANCE (patient can not walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatments were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Night sweats, Pain, Pyrexia
Clinical narrative: he got hit by a bus, very painful; night sweats; had joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (he got hit by a bus, very painful), NIGHT SWEATS (night sweats) and ARTHRALGIA (had joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN (he got hit by a bus, very painful), NIGHT SWEATS (night sweats) and ARTHRALGIA (had joint pain). At the time of the report, PAIN (he got hit by a bus, very painful), NIGHT SWEATS (night sweats) and ARTHRALGIA (had joint pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Patient lost sense of taste stating ketchup tasted like chemicals.. On 10-Mar-2021, Pyrexia: 100°f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment included Ibuprofen and Allergy pill
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Fatigue, Nausea
Clinical narrative: fever; chill; tiredness; mild nausea; stomach pain; loss of appetite; feel like hit by train; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea) and ABDOMINAL PAIN UPPER (stomach pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (loss of appetite) and PAIN (feel like hit by train). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (loss of appetite) and PAIN (feel like hit by train) 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; chill; tiredness; mild nausea; stomach pain; loss of appetite; feel like hit by train; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea) and ABDOMINAL PAIN UPPER (stomach pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (loss of appetite) and PAIN (feel like hit by train). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (loss of appetite) and PAIN (feel like hit by train) 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.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Vaccination site pain
Clinical narrative: blood pressure higher than usual; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure higher than usual) and VACCINATION SITE PAIN (pain at the injection site) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure (Patient's blood pressure is higher than usual).    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 (pain at the injection site). On 10-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure higher than usual). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure higher than usual) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include blood pressure medication.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up document was attached which contains NNI.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Rash
Clinical narrative: Rash on the back side of Left arm that started 4 weeks after vaccination; Cluster migraines headaches which effected the left eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Cluster migraines headaches which effected the left eye) and RASH (Rash on the back side of Left arm that started 4 weeks after vaccination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concurrent medical conditions included Arthritis. Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE NO. 3) for Arthritis, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN DS [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;MANGANESE ASCORBATE]), VITAMIN D3, SIMETICONE (GAS-X), AZELASTINE HCL, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), PIMECROLIMUS, HYDROCORTISONE, BETAMETHASONE, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), MULTIVITAMIN FOR WOMEN and VITAMIN B12 NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MIGRAINE (Cluster migraines headaches which effected the left eye). On 11-Mar-2021, the patient experienced RASH (Rash on the back side of Left arm that started 4 weeks after vaccination). At the time of the report, MIGRAINE (Cluster migraines headaches which effected the left eye) outcome was unknown and RASH (Rash on the back side of Left arm that started 4 weeks after vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up information was received on 4 May 2021 and  included no new information.