chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (Ear infection). At the time of the report, EAR INFECTION (Ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included amoxicillin.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Pruritus, Rash, Vaccination site rash, White blood cell count
Clinical narrative: Rash all over her body; rash at the injection site about a 2 inch circle; Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy), RASH (Rash all over her body) and VACCINATION SITE RASH (rash at the injection site about a 2 inch circle) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     N medical history was provided by the reporter.  Concomitant products included THYROID for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Itchy) and VACCINATION SITE RASH (rash at the injection site about a 2 inch circle). On an unknown date, the patient experienced RASH (Rash all over her body). At the time of the report, PRURITUS (Itchy), RASH (Rash all over her body) and VACCINATION SITE RASH (rash at the injection site about a 2 inch circle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood sodium: low. In 2021, White blood cell count: high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was also taking blood pressure medication. Treatment provided was Medrol dose pack .
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red welt around injection site; Rash around injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red welt around injection site) and VACCINATION SITE RASH (Rash around injection site) 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 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red welt around injection site) and VACCINATION SITE RASH (Rash around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red welt around injection site) and VACCINATION SITE RASH (Rash around injection site) 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 medications were not provided. Treatment information was not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red mark at the injection site; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark at the injection site) and VACCINATION SITE PRURITUS (itchiness at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ08) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ENALAPRIL and AMLODIPINE 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 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red mark at the injection site) and VACCINATION SITE PRURITUS (itchiness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red mark at the injection site) and VACCINATION SITE PRURITUS (itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: stomach upset; felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (felt nausea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NAUSEA (felt nausea). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (felt nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: pains; aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Neurological disorder NOS.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.            On 17-Feb-2021, the patient experienced aches, headache and pains. the Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: hives; rash around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (hives) and VACCINATION SITE RASH (rash around injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (hives) and VACCINATION SITE RASH (rash around injection site). At the time of the report, VACCINATION SITE URTICARIA (hives) and VACCINATION SITE RASH (rash around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness) and TENDERNESS (Achy and tender arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN C;VITAMIN D NOS;VITAMIN E, ZINC and POTASSIUM for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (Achy and tender arm). On 16-Feb-2021, the patient experienced SWELLING (Swelling) and ERYTHEMA (Redness). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness) and TENDERNESS (Achy and tender arm) outcome was unknown.            Treatment medication included acetaminophen and ice compress.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Cough, Dyspnoea, Fatigue
Clinical narrative: short of breath; positive for COVID-19; back pain; cough; fatigue; fever of 102F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for COVID-19), BACK PAIN (back pain), COUGH (cough), DYSPNOEA (short of breath) and FATIGUE (fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced BACK PAIN (back pain), COUGH (cough), FATIGUE (fatigue) and PYREXIA (fever of 102F). On 19-Feb-2021, the patient experienced COVID-19 (positive for COVID-19). On an unknown date, the patient experienced DYSPNOEA (short of breath). At the time of the report, COVID-19 (positive for COVID-19), BACK PAIN (back pain), FATIGUE (fatigue) and PYREXIA (fever of 102F) outcome was unknown and COUGH (cough) and DYSPNOEA (short of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient was treated with hycodan cough syrup, a Z-pack, aspirin, ascorbic acid, melatonin, and albuterol.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Additional initial document received.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: short of breath; positive for COVID-19; back pain; cough; fatigue; fever of 102F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for COVID-19), BACK PAIN (back pain), COUGH (cough), DYSPNOEA (short of breath) and FATIGUE (fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced BACK PAIN (back pain), COUGH (cough), FATIGUE (fatigue) and PYREXIA (fever of 102F). On 19-Feb-2021, the patient experienced COVID-19 (positive for COVID-19). On an unknown date, the patient experienced DYSPNOEA (short of breath). At the time of the report, COVID-19 (positive for COVID-19), BACK PAIN (back pain), FATIGUE (fatigue) and PYREXIA (fever of 102F) outcome was unknown and COUGH (cough) and DYSPNOEA (short of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient was treated with hycodan cough syrup, a Z-pack, aspirin, ascorbic acid, melatonin, and albuterol.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Additional initial document received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Duodenogastric reflux, Vertigo, Vomiting projectile
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness, vomiting projectile (projectile vomiting), vertigo (vertigo-like feeling) and duodenogastric reflux (bile released) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 029L20A) for COVID-19 immunization. No medical history reported. On Jan 23, 2021, at 9:00 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 24, 2021, patient experienced dizziness, vomiting projectile (projectile vomiting), vertigo (vertigo-like feeling) and duodenogastric reflux (bile released). On 24-Jan-2021, dizziness, vomiting projectile (projectile vomiting), vertigo (vertigo-like feeling) and duodenogastric reflux (bile released): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-172135 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Gingival pain, Headache, Hyperhidrosis, Limb mass
Clinical narrative: Has a lump in arm; Sore arm; Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat; Gums are sore; Headache; Threw up; Nausea; Shaking; Sweating; Really cold (thinks had fever); This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), LIMB MASS (Has a lump in arm) and PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), HEADACHE (Headache), VOMITING (Threw up) and NAUSEA (Nausea). On 15-Feb-2021, the patient experienced LIMB MASS (Has a lump in arm), PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat) and GINGIVAL PAIN (Gums are sore). On 14-Feb-2021, TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), VOMITING (Threw up) and NAUSEA (Nausea) had resolved. On 15-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, LIMB MASS (Has a lump in arm), PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat) and GINGIVAL PAIN (Gums are sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen for headache. The patient also received mouth sore relief-liquid- denzocaine 20%, denzalkonium corfain 13%, camahor 3% to relieve pain in her mouth and tongue.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral pain, Pain in extremity, Tremor, Vomiting
Clinical narrative: Has a lump in arm; Sore arm; Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat; Gums are sore; Headache; Threw up; Nausea; Shaking; Sweating; Really cold (thinks had fever); This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), LIMB MASS (Has a lump in arm) and PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), HEADACHE (Headache), VOMITING (Threw up) and NAUSEA (Nausea). On 15-Feb-2021, the patient experienced LIMB MASS (Has a lump in arm), PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat) and GINGIVAL PAIN (Gums are sore). On 14-Feb-2021, TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), VOMITING (Threw up) and NAUSEA (Nausea) had resolved. On 15-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, LIMB MASS (Has a lump in arm), PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat) and GINGIVAL PAIN (Gums are sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen for headache. The patient also received mouth sore relief-liquid- denzocaine 20%, denzalkonium corfain 13%, camahor 3% to relieve pain in her mouth and tongue.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: some soreness; injection site got inflammed; injection site got red and 6 inches round and 4 inches wide; injection site is "a little fever" and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness), VACCINATION SITE INFLAMMATION (injection site got inflammed), VACCINATION SITE ERYTHEMA (injection site got red and 6 inches round and 4 inches wide) and VACCINATION SITE WARMTH (injection site is "a little fever" and warm to touch) in a 75-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some soreness), VACCINATION SITE INFLAMMATION (injection site got inflammed), VACCINATION SITE ERYTHEMA (injection site got red and 6 inches round and 4 inches wide) and VACCINATION SITE WARMTH (injection site is "a little fever" and warm to touch). At the time of the report, PAIN IN EXTREMITY (some soreness), VACCINATION SITE INFLAMMATION (injection site got inflammed), VACCINATION SITE ERYTHEMA (injection site got red and 6 inches round and 4 inches wide) and VACCINATION SITE WARMTH (injection site is "a little fever" and warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Insomnia, Myalgia
Clinical narrative: had loss of appetite; Extreme chills; muscle pain; headache; insomnia; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (insomnia), DECREASED APPETITE (had loss of appetite), CHILLS (Extreme chills), MYALGIA (muscle pain) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and VITAMIN D NOS for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Injection. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced INSOMNIA (insomnia), CHILLS (Extreme chills), MYALGIA (muscle pain) and HEADACHE (headache). On 16-Feb-2021, the patient experienced DECREASED APPETITE (had loss of appetite). At the time of the report, INSOMNIA (insomnia), DECREASED APPETITE (had loss of appetite), CHILLS (Extreme chills), MYALGIA (muscle pain) and HEADACHE (headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment mediation included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Paraesthesia, Peripheral swelling, Tenderness
Clinical narrative: feet are jittery/hard to walk up stairs/difficulty in putting her feet still; swollen lower legs; Painful lower legs/ pain in her calves thatsometimes shift to her ankles; Red lower legs; Tender lower legs; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (feet are jittery/hard to walk up stairs/difficulty in putting her feet still), PERIPHERAL SWELLING (swollen lower legs), PAIN IN EXTREMITY (Painful lower legs/ pain in her calves thatsometimes shift to her ankles), ERYTHEMA (Red lower legs) and TENDERNESS (Tender lower legs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen lower legs), PAIN IN EXTREMITY (Painful lower legs/ pain in her calves thatsometimes shift to her ankles), ERYTHEMA (Red lower legs) and TENDERNESS (Tender lower legs). On an unknown date, the patient experienced PARAESTHESIA (feet are jittery/hard to walk up stairs/difficulty in putting her feet still). At the time of the report, PARAESTHESIA (feet are jittery/hard to walk up stairs/difficulty in putting her feet still), PERIPHERAL SWELLING (swollen lower legs), PAIN IN EXTREMITY (Painful lower legs/ pain in her calves thatsometimes shift to her ankles), ERYTHEMA (Red lower legs) and TENDERNESS (Tender lower legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    On 02 Feb 2021, the patient experienced red, tender, swollen painful lower legs. The patient reported that she had very sore, red legs that are swollen, difficulty in putting up her feet still, feet are jittery and has some pain in her calves that sometimes shifts to her ankles. The patient also reported that it is still kind of sore and hard to walk upstairs and her left leg is affected more than her right leg.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: joint pain; tingling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and PARAESTHESIA (tingling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pain) and PARAESTHESIA (tingling). At the time of the report, ARTHRALGIA (joint pain) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Tingling; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) and ARTHRALGIA (Joint pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PARAESTHESIA (Tingling) and ARTHRALGIA (Joint pain). At the time of the report, PARAESTHESIA (Tingling) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were not reported. The treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chattering chills that bothered her all the night; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chattering chills that bothered her all the night) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CHILLS (Chattering chills that bothered her all the night). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at a dose of UNK dosage form. At the time of the report, CHILLS (Chattering chills that bothered her all the night) outcome was unknown.            No concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Paraesthesia
Clinical narrative: sensation like "Needle injection on the face (mouth and nose); mild soreness arm; mild headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (sensation like "Needle injection on the face (mouth and nose)), PAIN IN EXTREMITY (mild soreness arm) and HEADACHE (mild headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PARAESTHESIA (sensation like "Needle injection on the face (mouth and nose)), PAIN IN EXTREMITY (mild soreness arm) and HEADACHE (mild headache). At the time of the report, PARAESTHESIA (sensation like "Needle injection on the face (mouth and nose)), PAIN IN EXTREMITY (mild soreness arm) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Throat irritation, Throat tightness
Clinical narrative: throat tight; throat whistling; throat itching on the outside; This spontaneous case was reported by a patient and describes the occurrence of THROAT TIGHTNESS (throat tight), OROPHARYNGEAL DISCOMFORT (throat whistling) and THROAT IRRITATION (throat itching on the outside) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ALLERGY MEDICATION (Allergy shots when the patient was younger). Concurrent medical conditions included Nature allergies (Nature allergies).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 29-Jan-2021, the patient experienced THROAT TIGHTNESS (throat tight), OROPHARYNGEAL DISCOMFORT (throat whistling) and THROAT IRRITATION (throat itching on the outside). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form and IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, THROAT TIGHTNESS (throat tight), OROPHARYNGEAL DISCOMFORT (throat whistling) and THROAT IRRITATION (throat itching on the outside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient also used an inhaler for treatment of the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: heat in injection arm; redness on the injection arm; swelling on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat in injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat in injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm). At the time of the report, VACCINATION SITE WARMTH (heat in injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified high blood pressure and diabetes medication.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Computerised tomogram, Dizziness, Fatigue
Clinical narrative: Dizziness; Nystagmus; chills; General body pain; low grade fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NYSTAGMUS (Nystagmus), CHILLS (chills), MYALGIA (General body pain) and PYREXIA (low grade fever) 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.     The patient's past medical history included Stroke (stroke 5 years ago.) and COVID-19 in October 2020.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (General body pain), PYREXIA (low grade fever) and FATIGUE (Tiredness). On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness) and NYSTAGMUS (Nystagmus). On 06-Feb-2021, CHILLS (chills), MYALGIA (General body pain), PYREXIA (low grade fever) and FATIGUE (Tiredness) had resolved. At the time of the report, DIZZINESS (Dizziness) and NYSTAGMUS (Nystagmus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: fever (High) Low grade fever. On an unknown date, Computerised tomogram: negative (Negative) negative for recurrent stroke. On an unknown date, Magnetic resonance imaging: negative (Negative) negative for recurrent stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Nystagmus, Pyrexia
Clinical narrative: Dizziness; Nystagmus; chills; General body pain; low grade fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NYSTAGMUS (Nystagmus), CHILLS (chills), MYALGIA (General body pain) and PYREXIA (low grade fever) 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.     The patient's past medical history included Stroke (stroke 5 years ago.) and COVID-19 in October 2020.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (General body pain), PYREXIA (low grade fever) and FATIGUE (Tiredness). On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness) and NYSTAGMUS (Nystagmus). On 06-Feb-2021, CHILLS (chills), MYALGIA (General body pain), PYREXIA (low grade fever) and FATIGUE (Tiredness) had resolved. At the time of the report, DIZZINESS (Dizziness) and NYSTAGMUS (Nystagmus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: fever (High) Low grade fever. On an unknown date, Computerised tomogram: negative (Negative) negative for recurrent stroke. On an unknown date, Magnetic resonance imaging: negative (Negative) negative for recurrent stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Ring shaped rash on his arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Ring shaped rash on his arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Ring shaped rash on his arm). At the time of the report, RASH (Ring shaped rash on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue; headache; body ache; slight fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), MYALGIA (body ache), PYREXIA (slight fever), CHILLS (Chills) and FATIGUE (Fatigue) 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache), PYREXIA (slight fever) and CHILLS (Chills). On 25-Jan-2021, the patient experienced FATIGUE (Fatigue). On 24-Jan-2021, HEADACHE (headache), MYALGIA (body ache), PYREXIA (slight fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fatigue; headache; little bit of fever; chills; body ache; pain in the injection arm/pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache), VACCINATION SITE PAIN (pain in the injection arm/pain in the arm) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection arm/pain in the arm). On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache), VACCINATION SITE PAIN (pain in the injection arm/pain in the arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified medications for her stomach.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fatigue; headache; little bit of fever; chills; body ache; pain in the injection arm/pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache), VACCINATION SITE PAIN (pain in the injection arm/pain in the arm) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection arm/pain in the arm). On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PYREXIA (little bit of fever), CHILLS (chills), MYALGIA (body ache), VACCINATION SITE PAIN (pain in the injection arm/pain in the arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified medications for her stomach.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: felt weak; hot sweats; could not get warm; lethargic; only wanted to sleep; tired; chills; low grade temperature; joint pain in their arms; headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (could not get warm), LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep), HOT FLUSH (hot sweats) and ASTHENIA (felt weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-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 15-Feb-2021, the patient experienced FEELING COLD (could not get warm), LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep), FATIGUE (tired), CHILLS (chills), PYREXIA (low grade temperature), ARTHRALGIA (joint pain in their arms) and HEADACHE (headache). On 17-Feb-2021, the patient experienced HOT FLUSH (hot sweats). On 18-Feb-2021, the patient experienced ASTHENIA (felt weak). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 16-Feb-2021 for Headache, at a dose of UNK dosage form. On 15-Feb-2021, ARTHRALGIA (joint pain in their arms) had resolved. On 16-Feb-2021, HEADACHE (headache) had resolved. On 17-Feb-2021, LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep) and FATIGUE (tired) had resolved. On 18-Feb-2021, HOT FLUSH (hot sweats) had resolved. At the time of the report, FEELING COLD (could not get warm), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade temperature) outcome was unknown.            No concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Lethargy, Pyrexia, Somnolence
Clinical narrative: felt weak; hot sweats; could not get warm; lethargic; only wanted to sleep; tired; chills; low grade temperature; joint pain in their arms; headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (could not get warm), LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep), HOT FLUSH (hot sweats) and ASTHENIA (felt weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-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 15-Feb-2021, the patient experienced FEELING COLD (could not get warm), LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep), FATIGUE (tired), CHILLS (chills), PYREXIA (low grade temperature), ARTHRALGIA (joint pain in their arms) and HEADACHE (headache). On 17-Feb-2021, the patient experienced HOT FLUSH (hot sweats). On 18-Feb-2021, the patient experienced ASTHENIA (felt weak). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 16-Feb-2021 for Headache, at a dose of UNK dosage form. On 15-Feb-2021, ARTHRALGIA (joint pain in their arms) had resolved. On 16-Feb-2021, HEADACHE (headache) had resolved. On 17-Feb-2021, LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep) and FATIGUE (tired) had resolved. On 18-Feb-2021, HOT FLUSH (hot sweats) had resolved. At the time of the report, FEELING COLD (could not get warm), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade temperature) outcome was unknown.            No concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Peripheral swelling, Vomiting
Clinical narrative: Diarrhea; Large arm swelling; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in arm the size of a baseball and is growing in size), DIARRHEA (Diarrhea) and VOMITING (Vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in arm the size of a baseball and  is growing in size), DIARRHEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, PERIPHERAL SWELLING (Swelling in arm the size of a baseball and  is growing in size), DIARRHEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.