chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Swollen tongue
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chills-Mild, Additional Details: Patients mother called to report her daughter had to go to ED on the night of the 24th to receive care for anaphylactic shock after having difficulty breathing and swollen tongue at home. She reports common side effects earlier on (chills,sweats,etc). cost of care on ed were ~$1000+ and she wants the company to be responsible for administering the vaccine. reports RPH didnt scan the doctor's orders, which were specific to what had to be administered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chills-Mild, Additional Details: Patients mother called to report her daughter had to go to ED on the night of the 24th to receive care for anaphylactic shock after having difficulty breathing and swollen tongue at home. She reports common side effects earlier on (chills,sweats,etc). cost of care on ed were ~$1000+ and she wants the company to be responsible for administering the vaccine. reports RPH didnt scan the doctor's orders, which were specific to what had to be administered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing, intense for the first 7 days and occasional ringing afterwards
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Exposure during pregnancy, Injection site pain, Limb injury, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient is pregnant. Has "frozen shoulder" Unalbe to lift arm. Feels like immunization site was high and close to color bone as per husband who reported. Wife is a dentist too.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Periarthritis, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient is pregnant. Has "frozen shoulder" Unalbe to lift arm. Feels like immunization site was high and close to color bone as per husband who reported. Wife is a dentist too.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Vomiting, nausea, headache, sore throat, temp around 100. Began 18 or so hours after vaccination.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pruritus, Rash
Clinical narrative: Rash around waistline below the belly button. Very itchy.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills, fever, and body acks
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: Severe chest pains. Started at 9:00a, lasting until 7:30-8:00p. Pain came in waves, high pain waves followed by aches.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in jaw, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Fever; sinus pressure and pain so bad it caused upper jaw pain; visibly swollen and painful underarm lymph node on side of injection
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Fever; sinus pressure and pain so bad it caused upper jaw pain; visibly swollen and painful underarm lymph node on side of injection
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Taste disorder
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: "silty taste in mouth"-Mild
Age: 3.0
Sex: F
Vaccine: DTAPIPV, FLUC4, HEPA, HIBV, PNC13
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Resident physician ordered incorrect vaccine preparation and dose was given to the patient. The patient needed both DTaP and IPV, so Kinrix was ordered. Kinrix is only approved for use in patients ages 4-6 years. The patient was 3.5 years old.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, fatigue, aches all over, headache
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in hands and feet
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Neck pain, Oropharyngeal pain, Swelling
Clinical narrative: Swelling and pain in neck, metallic taste, sore throat
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Nausea, Pain
Clinical narrative: Fever (100.9-101.4) for 36 hours straight, body aches, headache, nausea, generalized fatigue.  Side effects were almost bad as to keeping me from doing basic daily tasks like feeding dogs
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (100.9-101.4) for 36 hours straight, body aches, headache, nausea, generalized fatigue.  Side effects were almost bad as to keeping me from doing basic daily tasks like feeding dogs
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrested labour, Blood loss anaemia, Caesarean section, Exposure during pregnancy, Packed red blood cell transfusion
Clinical narrative: Patient presented with PPROM at 32w5d (EDC 11/5/2021) on 9/15/2021 and experienced spontaneous labor.  Pregnancy previously complicated by IVF conception, hypothyroidism with normal TFTs, anxiety.   Underwent primary cesarean delivery due to arrest of descent.  Acute blood loss anemia with transfusion of PRBC, FFP.  Newborn with Apgars of 0/0/0 and severe HIE and died 9/27/2021
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Transfusion
Clinical narrative: Patient presented with PPROM at 32w5d (EDC 11/5/2021) on 9/15/2021 and experienced spontaneous labor.  Pregnancy previously complicated by IVF conception, hypothyroidism with normal TFTs, anxiety.   Underwent primary cesarean delivery due to arrest of descent.  Acute blood loss anemia with transfusion of PRBC, FFP.  Newborn with Apgars of 0/0/0 and severe HIE and died 9/27/2021
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: One day  after shot,   hives broke out on left arm, left shoulder, left torso, left thigh. Raised, red, very itchy.  Also had delayed hypersensitivity rash/ hives  Day 9 after first Moderna dose previously reported.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Pallor, diaphoresis, syncope
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Blood clots in her  lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her  lungs) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her  lungs) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Blood clots in her  lungs) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Company Comment : This case concerns a 50 year old female patient with no relevant medical history, who experienced the unexpected event of pulmonary embolism.. The event occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-325359 (Patient Link).; Sender's Comments: This case concerns a 50 year old female patient with no relevant medical history, who experienced the unexpected event of pulmonary embolism.. The event occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Heart rate increased, Malaise, Myalgia
Clinical narrative: Sinus problems; Stomach pain; Sick feeling; Fast heart beat; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat) and MYALGIA (Muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat), MYALGIA (Muscle pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat), MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-325764 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: Sinus problems; Stomach pain; Sick feeling; Fast heart beat; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat) and MYALGIA (Muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat), MYALGIA (Muscle pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat), MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-325764 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia
Clinical narrative: a little ill; headache; feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (a little ill), HEADACHE (headache) and PYREXIA (feeling feverish) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Borderline personality disorder. Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced ILLNESS (a little ill), HEADACHE (headache) and PYREXIA (feeling feverish). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Sep-2021, ILLNESS (a little ill) and PYREXIA (feeling feverish) had resolved. At the time of the report, HEADACHE (headache) had not resolved.            Patient stated that headache comes back every time.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-325495 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pelvic pain, Urinary tract infection
Clinical narrative: urinary infection; pelvic pain; soreness in the abdominal area; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary infection), PELVIC PAIN (pelvic pain) and ABDOMINAL PAIN (soreness in the abdominal area) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary infection), PELVIC PAIN (pelvic pain) and ABDOMINAL PAIN (soreness in the abdominal area). At the time of the report, URINARY TRACT INFECTION (urinary infection), PELVIC PAIN (pelvic pain) and ABDOMINAL PAIN (soreness in the abdominal area) 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.   Concomitant medication included asthma medication (inhalers).  No treatment medication was reported.  Scheduled for second dose on 17 Sep 2021 (but patient still had not gone).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: 1 vial (2 doses were administered past 24 hours); vial stayed in refrigerator for about 24 hours after 1st puncture to administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vial stayed in refrigerator for about 24 hours after 1st puncture to administration) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial (2 doses were administered past 24 hours)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vial stayed in refrigerator for about 24 hours after 1st puncture to administration). On 18-Sep-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial (2 doses were administered past 24 hours)). On 17-Sep-2021, PRODUCT STORAGE ERROR (vial stayed in refrigerator for about 24 hours after 1st puncture to administration) outcome was unknown. On 18-Sep-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial (2 doses were administered past 24 hours)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.  Date the vial was initially stored in the refrigerator: 13Sep2021
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the vaccine past expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date). On 18-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Influenza like illness, Pain in extremity
Clinical narrative: Felt awful, Feel crappy, Annoyed; Sweating; Flu-like symptoms; Left arm pain; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt awful, Feel crappy, Annoyed), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Left arm pain) and HEADACHE (Bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced FEELING ABNORMAL (Felt awful, Feel crappy, Annoyed), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Left arm pain) and HEADACHE (Bad headache). At the time of the report, FEELING ABNORMAL (Felt awful, Feel crappy, Annoyed), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Left arm pain) and HEADACHE (Bad headache) outcome was unknown.            Patient reported that he had a scheduled eye injection on 21-Sep-2021 and no additional information was provided about eye injection.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter   This case was linked to MOD-2021-325410 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: ongoing fatigue after 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (ongoing fatigue after 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (ongoing fatigue after 3rd dose). At the time of the report, FATIGUE (ongoing fatigue after 3rd dose) had not resolved.        Concomitant medication was not reported. Treatment medication was not reported. Patient was received the 1st and 2nd dose of Moderna vaccine "about 7-8 months ago"
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Illness, Muscle spasms
Clinical narrative: we're still sick from that shot; she has terrible muscle pain; nausea; headache; joint pain; we had a real adverse reaction to it; spasms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we're still sick from that shot), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A and 002F21A) 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 PAROXETINE for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION COMPLICATION (we had a real adverse reaction to it), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (joint pain). On 20-Sep-2021, the patient experienced ILLNESS (we're still sick from that shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we're still sick from that shot), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 102 (High) Patient  had highest temperature she recorded was 102 degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination complication
Clinical narrative: we're still sick from that shot; she has terrible muscle pain; nausea; headache; joint pain; we had a real adverse reaction to it; spasms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we're still sick from that shot), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A and 002F21A) 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 PAROXETINE for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION COMPLICATION (we had a real adverse reaction to it), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (joint pain). On 20-Sep-2021, the patient experienced ILLNESS (we're still sick from that shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we're still sick from that shot), MYALGIA (she has terrible muscle pain), MUSCLE SPASMS (spasms), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 102 (High) Patient  had highest temperature she recorded was 102 degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: site reaction with about 2 inches in size/grew larger about 4 inches wide; pain; redness; accidentally received Moderna vaccine age 6; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (site reaction with about 2 inches in size/grew larger about 4 inches wide), VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received Moderna vaccine age 6) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included Multivitamins for an unknown indication.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced VACCINATION SITE REACTION (site reaction with about 2 inches in size/grew larger about 4 inches wide), VACCINATION SITE PAIN (pain), VACCINATION SITE ERYTHEMA (redness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received Moderna vaccine age 6). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received Moderna vaccine age 6) had resolved. At the time of the report, VACCINATION SITE REACTION (site reaction with about 2 inches in size/grew larger about 4 inches wide), VACCINATION SITE PAIN (pain) and VACCINATION SITE ERYTHEMA (redness) 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: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Product administered to patient of inappropriate age, Vaccination site reaction
Clinical narrative: Reaction site about 2 inches in size; Can't barely lift his arm; Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction site about 2 inches in size), LIMB DISCOMFORT (Can't barely lift his arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical history were provided.  Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for ADHD, MULTIVITAMINS [VITAMINS NOS] for Immune imbalance.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced VACCINATION SITE REACTION (Reaction site about 2 inches in size), LIMB DISCOMFORT (Can't barely lift his arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old). On 15-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist mistakenly administered Moderna COVID vaccine to 10 years old) had resolved. On 16-Sep-2021, VACCINATION SITE REACTION (Reaction site about 2 inches in size) and LIMB DISCOMFORT (Can't barely lift his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information were provided by the reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Factor V Leiden mutation, Inappropriate schedule of product administration
Clinical narrative: 1st dose 5Apr2021, 2nd dose 31Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 5Apr2021, 2nd dose 31Jul2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 044A21A) for COVID-19 vaccination.   Concurrent medical conditions included Vasculitis (Autoimmune disorder (Vasculitis)) and Factor V Leiden mutation.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 5Apr2021, 2nd dose 31Jul2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 5Apr2021, 2nd dose 31Jul2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Factor V Leiden mutation: positive (Positive) Positive.   No concomitant medications were reported.  No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: a big lump under the arm; fever in the arm for 5 days; rash spreading down her arm; swelling in the arm; swelling; really bad itchiness; numbness in the arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm) and SWELLING (swelling) in a 31-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.     Concomitant products included TRAMADOL, PROGESTERONE, LORAZEPAM, IBUPROFEN, GABAPENTIN, FENOFIBRATE (ADIPEX [FENOFIBRATE]) and ESTRADIOL for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm), SWELLING (swelling), PRURITUS (really bad itchiness), HYPOAESTHESIA (numbness in the arm) and MYALGIA (soreness). In September 2021, SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm), SWELLING (swelling), PRURITUS (really bad itchiness), HYPOAESTHESIA (numbness in the arm) and MYALGIA (soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin mass, Swelling
Clinical narrative: a big lump under the arm; fever in the arm for 5 days; rash spreading down her arm; swelling in the arm; swelling; really bad itchiness; numbness in the arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm) and SWELLING (swelling) in a 31-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.     Concomitant products included TRAMADOL, PROGESTERONE, LORAZEPAM, IBUPROFEN, GABAPENTIN, FENOFIBRATE (ADIPEX [FENOFIBRATE]) and ESTRADIOL for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm), SWELLING (swelling), PRURITUS (really bad itchiness), HYPOAESTHESIA (numbness in the arm) and MYALGIA (soreness). In September 2021, SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm), SWELLING (swelling), PRURITUS (really bad itchiness), HYPOAESTHESIA (numbness in the arm) and MYALGIA (soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Illness, Pain, Pyrexia
Clinical narrative: Pain over the left eyebrow; Fever; A bad headache they could hardly see out of their eyes, it was like an optical headache/forehead hurt; Got really sick; A bad headache they could hardly see out of their eyes, it was like an optical headache; Eyes hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick), VISUAL IMPAIRMENT (A bad headache they could hardly see out of their eyes, it was like an optical headache), EYE PAIN (Eyes hurt), PAIN (Pain over the left eyebrow) and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20 and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic, Blood pressure high and Cholesterol.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Got really sick), VISUAL IMPAIRMENT (A bad headache they could hardly see out of their eyes, it was like an optical headache), EYE PAIN (Eyes hurt), PYREXIA (Fever) and HEADACHE (A bad headache they could hardly see out of their eyes, it was like an optical headache/forehead hurt). On 20-Sep-2021, the patient experienced PAIN (Pain over the left eyebrow). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Got really sick), VISUAL IMPAIRMENT (A bad headache they could hardly see out of their eyes, it was like an optical headache), EYE PAIN (Eyes hurt), PAIN (Pain over the left eyebrow), PYREXIA (Fever) and HEADACHE (A bad headache they could hardly see out of their eyes, it was like an optical headache/forehead hurt) outcome was unknown.            Concomitant medication includes: Oral medication for diabetes, high cholesterol medication and high blood pressure medication since 2 months ago. Patient states they usually had low blood pressure but since a couple of month ago their HCP indicated they start taking high blood pressure medication.   This case was linked to MOD-2021-326448 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Pain over the left eyebrow; Fever; A bad headache they could hardly see out of their eyes, it was like an optical headache/forehead hurt; Got really sick; A bad headache they could hardly see out of their eyes, it was like an optical headache; Eyes hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick), VISUAL IMPAIRMENT (A bad headache they could hardly see out of their eyes, it was like an optical headache), EYE PAIN (Eyes hurt), PAIN (Pain over the left eyebrow) and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20 and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic, Blood pressure high and Cholesterol.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Got really sick), VISUAL IMPAIRMENT (A bad headache they could hardly see out of their eyes, it was like an optical headache), EYE PAIN (Eyes hurt), PYREXIA (Fever) and HEADACHE (A bad headache they could hardly see out of their eyes, it was like an optical headache/forehead hurt). On 20-Sep-2021, the patient experienced PAIN (Pain over the left eyebrow). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Got really sick), VISUAL IMPAIRMENT (A bad headache they could hardly see out of their eyes, it was like an optical headache), EYE PAIN (Eyes hurt), PAIN (Pain over the left eyebrow), PYREXIA (Fever) and HEADACHE (A bad headache they could hardly see out of their eyes, it was like an optical headache/forehead hurt) outcome was unknown.            Concomitant medication includes: Oral medication for diabetes, high cholesterol medication and high blood pressure medication since 2 months ago. Patient states they usually had low blood pressure but since a couple of month ago their HCP indicated they start taking high blood pressure medication.   This case was linked to MOD-2021-326448 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Deltoid region indurated/deltoid region has been tender; Delayed injection site pain / quite painful to shoulder range of motion at the injection site / deltoid region has been tender; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE INDURATION (Deltoid region indurated/deltoid region has been tender) and VACCINATION SITE PAIN (Delayed injection site pain / quite painful to shoulder range of motion at the injection site / deltoid region has been tender) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Deltoid region indurated/deltoid region has been tender) and VACCINATION SITE PAIN (Delayed injection site pain / quite painful to shoulder range of motion at the injection site / deltoid region has been tender). At the time of the report, VACCINATION SITE INDURATION (Deltoid region indurated/deltoid region has been tender) and VACCINATION SITE PAIN (Delayed injection site pain / quite painful to shoulder range of motion at the injection site / deltoid region has been tender) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle tightness, Myalgia
Clinical narrative: The muscles in my legs are tight, it feels like when I had the flew last month; It's an achy pain; pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE TIGHTNESS (The muscles in my legs are tight, it feels like when I had the flew last month), MYALGIA (It's an achy pain) and INJECTION SITE PAIN (pain at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced MUSCLE TIGHTNESS (The muscles in my legs are tight, it feels like when I had the flew last month), MYALGIA (It's an achy pain) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, MUSCLE TIGHTNESS (The muscles in my legs are tight, it feels like when I had the flew last month), MYALGIA (It's an achy pain) and INJECTION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received Johnson and Johnson vaccine initially,went ahead and received a dose of Moderna vaccine as the patient did not feel that Johnson & Johnson was adequate vaccine. No concomitant medications were reported.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Injection site pain, Pyrexia
Clinical narrative: Feeling warm; Sore injection site arm; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), INJECTION SITE PAIN (Sore injection site arm), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling warm), INJECTION SITE PAIN (Sore injection site arm), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FEELING HOT (Feeling warm), INJECTION SITE PAIN (Sore injection site arm), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-325855 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: 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 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Scleroderma, Autoimmune disorder and UTI. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), FAMOTIDINE and PILOCARPINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with NITROFURANTOIN (NITROFURANTOIN MONO/MACRO) for UTI, at a dose of 100 mg. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.            It was reported that the patient had autoimmune disorder . It was reported that the UTI was not associated with the vaccine, there was another cause as per reporter, UTI was started a week ago.