chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: awakened me from sleep.; arm pain; swelling; Vaccination site induration; Vaccination site pain; Restless night with pain on any movement, mostly joint-lines; headache; myalgias; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (awakened me from sleep.), PAIN (arm pain), SWELLING (swelling), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee surgery NOS (Four distant past surgeries on left knee).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INSOMNIA (awakened me from sleep.), PAIN (arm pain), SWELLING (swelling), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Restless night with pain on any movement, mostly joint-lines), HEADACHE (headache), MYALGIA (myalgias) and FATIGUE (fatigue). At the time of the report, INSOMNIA (awakened me from sleep.), VACCINATION SITE INDURATION (Vaccination site induration), ARTHRALGIA (Restless night with pain on any movement, mostly joint-lines), HEADACHE (headache) and MYALGIA (myalgias) outcome was unknown and PAIN (arm pain), SWELLING (swelling), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that her symptoms began 15-16 hours post vaccination. No concomitant medication was reported. The treatment information included ice and topical pain relief.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Significant follow up appended On 07-Jul-2021: Followup received on 07-JUL-2021 contain information about events reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Vaccination site induration, Vaccination site pain
Clinical narrative: awakened me from sleep.; arm pain; swelling; Vaccination site induration; Vaccination site pain; Restless night with pain on any movement, mostly joint-lines; headache; myalgias; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (awakened me from sleep.), PAIN (arm pain), SWELLING (swelling), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee surgery NOS (Four distant past surgeries on left knee).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INSOMNIA (awakened me from sleep.), PAIN (arm pain), SWELLING (swelling), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Restless night with pain on any movement, mostly joint-lines), HEADACHE (headache), MYALGIA (myalgias) and FATIGUE (fatigue). At the time of the report, INSOMNIA (awakened me from sleep.), VACCINATION SITE INDURATION (Vaccination site induration), ARTHRALGIA (Restless night with pain on any movement, mostly joint-lines), HEADACHE (headache) and MYALGIA (myalgias) outcome was unknown and PAIN (arm pain), SWELLING (swelling), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that her symptoms began 15-16 hours post vaccination. No concomitant medication was reported. The treatment information included ice and topical pain relief.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Significant follow up appended On 07-Jul-2021: Followup received on 07-JUL-2021 contain information about events reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Urticaria, Vaccination site urticaria
Clinical narrative: Hives all over her body; She couldn't swallow; Hives in her arm at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body), DYSPHAGIA (She couldn't swallow) and VACCINATION SITE URTICARIA (Hives in her arm at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 URTICARIA (Hives all over her body), DYSPHAGIA (She couldn't swallow) and VACCINATION SITE URTICARIA (Hives in her arm at the injection site). At the time of the report, URTICARIA (Hives all over her body) and VACCINATION SITE URTICARIA (Hives in her arm at the injection site) had not resolved and DYSPHAGIA (She couldn't swallow) was resolving.            No relevant concomitant medications were reported.   Treatment information included steroids, medicine to drink for dysphagia.  Patient went to the family doctor and the physician prescribed steroids for six days. At that time, patient couldn't swallow, so patient was sent to the emergency room on 17 Mar 2021, they gave her something to drink which allowed her to swallow again. Then the patient went to a gastrologist, and who put something down her throat and took a biopsy. The biopsy result was unknown at the tome of this report.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and LOSARTAN POTASSIUM for Blood pressure, HYDROXYCARBAMIDE (HYDROXYUREA) for Cancer, SIMVASTATIN for Cholesterol, GABAPENTIN for Nerve pain, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) had resolved.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on. Patient second dose was reported.Concomitant product was reported. On 06-Aug-2021: Follow up information was received on 06-Aug-2021. Outcome of event rash updated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: negative [antibody test]; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Antibody test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD21-060893 (E2B Linked Report).; Sender's Comments:  MOD21-060893:wife
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Headache, Nausea, Polymerase chain reaction
Clinical narrative: They were fever; chills; nausea; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (They were fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (severe headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma, Blood pressure high, Hyperparathyroidism, Hypothyroidism, Penicillin allergy, Drug allergy (Allergy to compazine) and Latex allergy. Concomitant products included METOPROLOL for Blood pressure high, TIMOLOL MALEATE (TIMOPTIC) and TAFLUPROST (ZIOPTAN) for Glaucoma, ROSUVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (They were fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (severe headache). On 11-Mar-2021, PYREXIA (They were fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Antibody test: positive positive. On 12-Aug-2021, Polymerase chain reaction: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication was reported. no treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-064728 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-JUN-2021. contain significant information updated second dose lot number, additional events after 2nd dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064728:Sister case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: They were fever; chills; nausea; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (They were fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (severe headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma, Blood pressure high, Hyperparathyroidism, Hypothyroidism, Penicillin allergy, Drug allergy (Allergy to compazine) and Latex allergy. Concomitant products included METOPROLOL for Blood pressure high, TIMOLOL MALEATE (TIMOPTIC) and TAFLUPROST (ZIOPTAN) for Glaucoma, ROSUVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (They were fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (severe headache). On 11-Mar-2021, PYREXIA (They were fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Antibody test: positive positive. On 12-Aug-2021, Polymerase chain reaction: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication was reported. no treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-064728 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-JUN-2021. contain significant information updated second dose lot number, additional events after 2nd dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064728:Sister case
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: orange patch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (orange patch) 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 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (orange patch). At the time of the report, SKIN DISCOLOURATION (orange patch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test normal, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 06-Jan-2021 to an unknown date and VITAMIN D NOS from 06-Jan-2021 to an unknown date for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 04-Jun-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The vaginal delivery occurred on 01-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 3500 grams (7lbs 11oz). The outcome was reported as Delivered NOS. length of the baby (male) was 50 cm. On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2020, Pregnancy test: positive (Positive) Positive. On 15-Feb-2021, Ultrasound scan: normal (normal) Normal. On 17-Mar-2021, Glucose tolerance test normal: normal (normal) normal.     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.   Previous pregnancy end date was 30 Jan 2018 and outcome was live birth. On 03 Mar 2021, Chorionic villus sampling (CVS) was performed and results were normal.   This case was linked to MOD-2021-266107 (Parent-Child Link).   See case MOD-2021-266107 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains- Pregnancy outcome update
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: vaccination liquid in eyes; A spontaneous report was received from a other healthcare professional concerning a 36 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination liquid in eye (Occupational exposure to product).   The patient's past medical history was not provided. Concomitant product use was not provided.    On 25-Mar-2021, prior to the onset of the events, the patient received dose of mRNA-1273 (batch no 016B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25-Mar-2021, the patient states their nurse was drawing up vaccination liquid to fill syringes. During this time the nurse got the vaccination liquid in her eyes.  Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, vaccination liquid in her eyes, was unknown.; Reporter's Comments: This report refers to a case of Occupational exposure to product, for mRNA-1273, lot #: 016B21A , with no associated AEs.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: intermittent radiating pain initially; Cant sleep because of arm pain; radiating pain from injection site to elbow; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (intermittent radiating pain initially), SLEEP DISORDER (Cant sleep because of arm pain) and INJECTION SITE PAIN (radiating pain from injection site to elbow) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (intermittent radiating pain initially), SLEEP DISORDER (Cant sleep because of arm pain) and INJECTION SITE PAIN (radiating pain from injection site to elbow). At the time of the report, PAIN (intermittent radiating pain initially), SLEEP DISORDER (Cant sleep because of arm pain) and INJECTION SITE PAIN (radiating pain from injection site to elbow) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No relevant concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-057900 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: cannot lift left arm; injection site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of MOBILITY DECREASED (cannot lift left arm) and INJECTION SITE PAIN (injection site pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MOBILITY DECREASED (cannot lift left arm) and INJECTION SITE PAIN (injection site pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dose per day. At the time of the report, MOBILITY DECREASED (cannot lift left arm) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-044390 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Nasal congestion, Pyrexia
Clinical narrative: Vaccination site arm is hot; Stuffy nose; Malaise; Vaccination site arm is hard; A small fever 100F; Chills; Pain on her vaccination arm; Swelling on her vaccination arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site arm is hot), NASAL CONGESTION (Stuffy nose), MALAISE (Malaise), VACCINATION SITE PAIN (Pain on her vaccination arm) and VACCINATION SITE SWELLING (Swelling on her vaccination arm) in a 64-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.     Concurrent medical conditions included Blood pressure high.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on her vaccination arm) and VACCINATION SITE SWELLING (Swelling on her vaccination arm). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site arm is hot), NASAL CONGESTION (Stuffy nose), MALAISE (Malaise), VACCINATION SITE INDURATION (Vaccination site arm is hard), PYREXIA (A small fever 100F) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (Vaccination site arm is hot), NASAL CONGESTION (Stuffy nose), MALAISE (Malaise), VACCINATION SITE PAIN (Pain on her vaccination arm), VACCINATION SITE SWELLING (Swelling on her vaccination arm), VACCINATION SITE INDURATION (Vaccination site arm is hard), PYREXIA (A small fever 100F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 100f (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided by the reporter included allergy medication. Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site arm is hot; Stuffy nose; Malaise; Vaccination site arm is hard; A small fever 100F; Chills; Pain on her vaccination arm; Swelling on her vaccination arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site arm is hot), NASAL CONGESTION (Stuffy nose), MALAISE (Malaise), VACCINATION SITE PAIN (Pain on her vaccination arm) and VACCINATION SITE SWELLING (Swelling on her vaccination arm) in a 64-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.     Concurrent medical conditions included Blood pressure high.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on her vaccination arm) and VACCINATION SITE SWELLING (Swelling on her vaccination arm). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site arm is hot), NASAL CONGESTION (Stuffy nose), MALAISE (Malaise), VACCINATION SITE INDURATION (Vaccination site arm is hard), PYREXIA (A small fever 100F) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (Vaccination site arm is hot), NASAL CONGESTION (Stuffy nose), MALAISE (Malaise), VACCINATION SITE PAIN (Pain on her vaccination arm), VACCINATION SITE SWELLING (Swelling on her vaccination arm), VACCINATION SITE INDURATION (Vaccination site arm is hard), PYREXIA (A small fever 100F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 100f (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided by the reporter included allergy medication. Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breasfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breasfeeding) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breasfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breasfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on arm). At the time of the report, VACCINATION SITE RASH (Rash on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Tenderness
Clinical narrative: Soreness in the arm; tenderness; rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), TENDERNESS (tenderness) and RASH (rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm), TENDERNESS (tenderness) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm), TENDERNESS (tenderness) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Reporter information updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (outcome: Live, full-term birth none complications) from August 2015 to 13-May-2016, Pregnancy (outcome: Live, full-term birth none complications) from October 2017 to 31-Jul-2018 and Alcohol use in 2020. Concurrent medical conditions included Gestational diabetes. Concomitant products included DOCOSAHEXAENOIC ACID (PRENATAL DHA) for Pregnancy, PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 11-May-2021. On 22-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 22-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Glucose tolerance test: failed (Inconclusive) failed. On 10-Feb-2021, Glucose tolerance test: failed (Inconclusive) failed. On 01-Sep-2021, Pregnancy test: positive (Inconclusive) positive. On 28-Oct-2021, Ultrasound foetal: normal (Inconclusive) normal. On 16-Dec-2021, Ultrasound foetal: normal (Inconclusive) normal.     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.   Patient reported that her Father is a diabetic.   This case was linked to US-MODERNATX, INC.-MOD-2021-082277 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received contains NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082277:Case for dose 2
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site erythema
Clinical narrative: Left side of face went numb/Left side of my body numb; Very large hot red spot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left side of face went numb/Left side of my body numb) and VACCINATION SITE ERYTHEMA (Very large hot red spot at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Left side of face went numb/Left side of my body numb) and VACCINATION SITE ERYTHEMA (Very large hot red spot at injection site). At the time of the report, HYPOAESTHESIA (Left side of face went numb/Left side of my body numb) and VACCINATION SITE ERYTHEMA (Very large hot red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication includes Diuretic. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up document was received on 17-JUN-2021. Added Reporter contact details and additional Event-left side of my body numb.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nasal congestion, Nasopharyngitis, Pyrexia
Clinical narrative: cold symptoms; sneezing; sinus headache; congestion face.; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), NASOPHARYNGITIS (cold symptoms) and SNEEZING (sneezing) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19. Concomitant products included VITAMINS NOS for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), SNEEZING (sneezing), SINUS HEADACHE (sinus headache) and NASAL CONGESTION (congestion face.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]) for Symptomatic treatment, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), NASOPHARYNGITIS (cold symptoms), SNEEZING (sneezing), SINUS HEADACHE (sinus headache) and NASAL CONGESTION (congestion face.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         Action taken with mRNA-1273 in response to the event was not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus headache, Sneezing
Clinical narrative: cold symptoms; sneezing; sinus headache; congestion face.; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), NASOPHARYNGITIS (cold symptoms) and SNEEZING (sneezing) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19. Concomitant products included VITAMINS NOS for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), SNEEZING (sneezing), SINUS HEADACHE (sinus headache) and NASAL CONGESTION (congestion face.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]) for Symptomatic treatment, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), NASOPHARYNGITIS (cold symptoms), SNEEZING (sneezing), SINUS HEADACHE (sinus headache) and NASAL CONGESTION (congestion face.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         Action taken with mRNA-1273 in response to the event was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) 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 provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urine abnormality
Clinical narrative: pain in the right side of body including hip; Urine was cloudy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in the right side of body including hip) and URINE ABNORMALITY (Urine was cloudy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stone. Concomitant products included OMEPRAZOLE, OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (pain in the right side of body including hip) and URINE ABNORMALITY (Urine was cloudy). The patient was treated with ACETAMINOPHEN on 25-Mar-2021 at a dose of 1 dosage form and NITROFURANTOIN for Kidney stones, at a dose of 100 milligram. At the time of the report, PAIN (pain in the right side of body including hip) and URINE ABNORMALITY (Urine was cloudy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy feeling 2 hours after receiving the 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy feeling 2 hours after receiving the 2nd dose of vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, GLIPIZIDE, EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, ROSUVASTATIN, CALCIUM, FISH OIL, PANTOPRAZOLE, HYDROCHLOROTHIAZIDE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and PREGABALIN (LYRICA) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (dizzy feeling 2 hours after receiving the 2nd dose of vaccine). At the time of the report, DIZZINESS (dizzy feeling 2 hours after receiving the 2nd dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided by the reporter aloglipitin, Citalopram- Hydrobromide, Flexural. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-058325 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058325:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: sky high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (sky high blood pressure) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver resection in 2018. Concurrent medical conditions included Cancer (Liver cancer). Concomitant products included LENVATINIB MESILATE (LENVIMA) for Cancer of liver, primary.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERTENSION (sky high blood pressure). The patient was treated with LOSARTAN (oral) in February 2021 for Hypertension, at an unspecified dose and frequency and AMLODIPINE (oral) in February 2021 for Hypertension, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (sky high blood pressure) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Symptom of dizziness after receiving the 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Symptom of dizziness after receiving the 1st dose of vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ALOGLIPTIN, GLIPIZIDE, EMPAGLIFLOZIN (JARDIANCE), CITALOPRAM HYDROBROMIDE, LISINOPRIL, ROSUVASTATIN, CALCIUM, FISH OIL, PANTOPRAZOLE, HYDROCHLOROTHIAZIDE, METAXALONE (FLEXURA), LORATADINE (CLARITIN [LORATADINE]) and PREGABALIN (LYRICA) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Symptom of dizziness after receiving the 1st dose of vaccine). At the time of the report, DIZZINESS (Symptom of dizziness after receiving the 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-058297 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Rash, Vaccination site mass
Clinical narrative: Raised bumps; Rash; Diarrhea; Stomach hurt; Felt lousy; Injection site has itched; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (Raised bumps), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), FEELING ABNORMAL (Felt lousy) and VACCINATION SITE PRURITUS (Injection site has itched) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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 LOSARTAN, PRAVASTATIN, MONTELUKAST and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), FEELING ABNORMAL (Felt lousy) and VACCINATION SITE PRURITUS (Injection site has itched). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Raised bumps) and RASH (Rash). On 14-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt) and FEELING ABNORMAL (Felt lousy) had resolved. At the time of the report, VACCINATION SITE MASS (Raised bumps), VACCINATION SITE PRURITUS (Injection site has itched) and RASH (Rash) 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.   No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Raised bumps; Rash; Diarrhea; Stomach hurt; Felt lousy; Injection site has itched; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (Raised bumps), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), FEELING ABNORMAL (Felt lousy) and VACCINATION SITE PRURITUS (Injection site has itched) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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 LOSARTAN, PRAVASTATIN, MONTELUKAST and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), FEELING ABNORMAL (Felt lousy) and VACCINATION SITE PRURITUS (Injection site has itched). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Raised bumps) and RASH (Rash). On 14-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt) and FEELING ABNORMAL (Felt lousy) had resolved. At the time of the report, VACCINATION SITE MASS (Raised bumps), VACCINATION SITE PRURITUS (Injection site has itched) and RASH (Rash) 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.   No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Lumpectomy (Left breast).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at injection site). On 25-Feb-2021, VACCINATION SITE PRURITUS (Itch at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-058335 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash erythematous
Clinical narrative: red rash on arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on arm) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031M204) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on arm) and CHILLS (chills). At the time of the report, RASH ERYTHEMATOUS (red rash on arm) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-044787, MOD-2021-044787 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizzy; vertigo; on a tilt a whirl; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VERTIGO (vertigo) and VERTIGO (on a tilt a whirl) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (dizzy), VERTIGO (vertigo) and VERTIGO (on a tilt a whirl). At the time of the report, DIZZINESS (dizzy), VERTIGO (vertigo) and VERTIGO (on a tilt a whirl) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.