chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Vaccine exposure during pregnancy; arm hurt; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (arm hurt) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1st dose. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Aug-2021. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient was treated with ACETAMINOPHEN for Chills and Pain, at a dose of 1 dosage form. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and PAIN IN EXTREMITY (arm hurt) outcome was unknown.     No treatment medication details was reported.  This case was linked to MOD-2021-056023 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Internal review on 27-JUL-2021 resulted in update of Gravida,Birth type and fetal outcome
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection positive) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 an unknown date, the patient experienced COVID-19 (COVID-19 infection positive). At the time of the report, COVID-19 (COVID-19 infection positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details were not provided. Husband got dose first dose on 15Mar2021. Tested positive for COVID recently.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (June 2020 miscarriage first few weeks "standard miscarriage") in June 2020 and Raynaud's syndrome on 01-Dec-2014. Concurrent medical conditions included Pregnancy (Pregnancy is current condition). Concomitant products included CARBASALATE CALCIUM (CARBASALAATCALCIUM CARDIO) from 12-Oct-2020 to 20-May-2021 for Anticoagulant therapy, DOCUSATE SODIUM from 12-Jan-2020 to an unknown date for Constipation, DOCOSAHEXAENOIC ACID (PRENATAL DHA) for Multi-vitamins deficiency, CALCIUM from 20-Nov-2020 to an unknown date for Supplementation therapy.    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 14-Sep-2020 and the estimated date of delivery was 23-Jun-2021. On 24-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 24-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided. Lab tests: Ultrasounds - 9 ultrasounds total-  28Oct2020 confirmed pregnancy/03Feb2021Anatomy Scan, Blood work - 22Mar2021: Checked Gall Bladder. Estimated date of conception is Sep 27 2020.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non significant follow up
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: sore arm; red blotch on the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch on the arm of injection) and PAIN IN EXTREMITY (sore arm) in a 72-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). In March 2021, the patient experienced RASH MACULAR (red blotch on the arm of injection). At the time of the report, RASH MACULAR (red blotch on the arm of injection) had not resolved and PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Feeling like flu; Feeling like bad cold; Feeling like chills; Head ache; Body ache was horrible; Pain; Hand and arm hurting; Hand and arm hurting; Low grade fever having temperature of 100 degree; side effects took her to bad, "did not leave the bed except for bathroom; A spontaneous report (United States) was received from a healthcare professional concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling like flu, feeling like bad cold, feeling like chills, head ache, body ache was horrible, pain, hand and arm hurting, low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom.  The patient's medical history was not provided. Concomitant medications reported were Statin for drug use for unknown indication.  On 23 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNK) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Feeling like flu, Feeling like bad cold, Feeling like chills, Head ache, Body ache was horrible, Pain, Hand and arm hurting, Low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), feeling like flu, feeling like bad cold, feeling like chills, head ache, body ache was horrible, pain, hand and arm hurting, low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pain in extremity, Pyrexia
Clinical narrative: Feeling like flu; Feeling like bad cold; Feeling like chills; Head ache; Body ache was horrible; Pain; Hand and arm hurting; Hand and arm hurting; Low grade fever having temperature of 100 degree; side effects took her to bad, "did not leave the bed except for bathroom; A spontaneous report (United States) was received from a healthcare professional concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling like flu, feeling like bad cold, feeling like chills, head ache, body ache was horrible, pain, hand and arm hurting, low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom.  The patient's medical history was not provided. Concomitant medications reported were Statin for drug use for unknown indication.  On 23 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNK) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Feeling like flu, Feeling like bad cold, Feeling like chills, Head ache, Body ache was horrible, Pain, Hand and arm hurting, Low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), feeling like flu, feeling like bad cold, feeling like chills, head ache, body ache was horrible, pain, hand and arm hurting, low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Strong pain in hip area; Pain in right hip that worsened at night; Pain of left hip that made it hard to walk and this pain worsened at night; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in right hip that worsened at night), ARTHRALGIA (Pain of left hip that made it hard to walk and this pain worsened at night) and ARTHRALGIA (Strong pain in hip area) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Chronic kidney disease stage 3. Concomitant products included METFORMIN, BENAZEPRIL, TAMSULOSIN, ATORVASTATIN, PANTOPRAZOLE and REPAGLINIDE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA (Pain in right hip that worsened at night) and ARTHRALGIA (Pain of left hip that made it hard to walk and this pain worsened at night). On 06-Mar-2021, the patient experienced ARTHRALGIA (Strong pain in hip area). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Mar-2021, ARTHRALGIA (Pain in right hip that worsened at night) had resolved. On 13-Mar-2021, ARTHRALGIA (Pain of left hip that made it hard to walk and this pain worsened at night) had resolved. On 14-Mar-2021, ARTHRALGIA (Strong pain in hip area) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 5-06-2021 include patient medical history and an event was added
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Nausea, Pyrexia, Sleep disorder
Clinical narrative: in the morning I vomited; I had diarrhea; One hour ago when I saw my temperature it was 100.1 F; Yesterday I did not sleep well; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Yesterday I did not sleep well), NAUSEA (nausea), VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01AB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SLEEP DISORDER (Yesterday I did not sleep well) and NAUSEA (nausea). On 27-Mar-2021, the patient experienced VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg 2 TABS. At the time of the report, SLEEP DISORDER (Yesterday I did not sleep well), NAUSEA (nausea), VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) I saw my temperature it was 100.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes MegaRed Omega 3s & Krill Oil, URINOZINC 320mg QD taken for 10 days.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: in the morning I vomited; I had diarrhea; One hour ago when I saw my temperature it was 100.1 F; Yesterday I did not sleep well; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Yesterday I did not sleep well), NAUSEA (nausea), VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01AB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SLEEP DISORDER (Yesterday I did not sleep well) and NAUSEA (nausea). On 27-Mar-2021, the patient experienced VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg 2 TABS. At the time of the report, SLEEP DISORDER (Yesterday I did not sleep well), NAUSEA (nausea), VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) I saw my temperature it was 100.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes MegaRed Omega 3s & Krill Oil, URINOZINC 320mg QD taken for 10 days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Lymphadenopathy, Paraesthesia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: loss of taste; swollen glands underneath jaw; prickling feeling; tingling feeling; itchiness; soreness in am of injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling feeling), PARAESTHESIA (prickling feeling), AGEUSIA (loss of taste), VACCINATION SITE PRURITUS (itchiness) and LYMPHADENOPATHY (swollen glands underneath jaw) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE PAIN (soreness in am of injection). On 20-Mar-2021, the patient experienced PARAESTHESIA (tingling feeling). On 21-Mar-2021, the patient experienced PARAESTHESIA (prickling feeling). On 22-Mar-2021, the patient experienced AGEUSIA (loss of taste) and LYMPHADENOPATHY (swollen glands underneath jaw). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling feeling), PARAESTHESIA (prickling feeling), AGEUSIA (loss of taste), VACCINATION SITE PRURITUS (itchiness), LYMPHADENOPATHY (swollen glands underneath jaw) and VACCINATION SITE PAIN (soreness in am of injection) outcome was unknown.            Concomitant medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Age at Vaccination added. No adverse event removed as relevant history. Second dose regimen information was added. Lower level term changed from Pruritus to vaccination site pruritus. Action taken, dechallenge and rechallenge was updated to not applicable. On 18-Aug-2021: Follow up received contains no new information added.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Body aches; Minor Fever; Feels really tired; Headache; Throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PYREXIA (Minor Fever), FATIGUE (Feels really tired), HEADACHE (Headache) and VOMITING (Throwing up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 in July 2020).    On 25-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Minor Fever), FATIGUE (Feels really tired), HEADACHE (Headache) and VOMITING (Throwing up). At the time of the report, PAIN (Body aches), PYREXIA (Minor Fever), FATIGUE (Feels really tired), HEADACHE (Headache) and VOMITING (Throwing up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taken to the ER twice: firsts for the body aches and they gave her morphine and second time liquid tylenol to control the fever the second time and was throwing up.  Concomitant medication was for thyroid was provided by the reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: difficulty walking; small fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficulty walking) and PYREXIA (small fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Neurological disorder NOS.   On 25-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 an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking) and PYREXIA (small fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (difficulty walking) and PYREXIA (small fever) outcome was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Illness
Clinical narrative: Headache (After Second Dose); Fatigue (After Second Dose); Diarrhea; Diarrhea (After Second Dose); Sore Left Arm (After Second Dose); Dizziness (After Second Dose); Heart palpitation (After Second Dose); A little Sick for one day (After First Shot); This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (A little Sick for one day (After First Shot)), PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)) and HEADACHE (Headache (After Second Dose)) in a 61-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.     The patient's past medical history included BP.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (A little Sick for one day (After First Shot)). On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)), FATIGUE (Fatigue (After Second Dose)), DIARRHOEA (Diarrhea) and DIARRHOEA (Diarrhea (After Second Dose)). On an unknown date, the patient experienced HEADACHE (Headache (After Second Dose)). On 31-Mar-2021, PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIARRHOEA (Diarrhea) and DIARRHOEA (Diarrhea (After Second Dose)) outcome was unknown. At the time of the report, ILLNESS (A little Sick for one day (After First Shot)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)), HEADACHE (Headache (After Second Dose)) and FATIGUE (Fatigue (After Second Dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations
Clinical narrative: Headache (After Second Dose); Fatigue (After Second Dose); Diarrhea; Diarrhea (After Second Dose); Sore Left Arm (After Second Dose); Dizziness (After Second Dose); Heart palpitation (After Second Dose); A little Sick for one day (After First Shot); This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (A little Sick for one day (After First Shot)), PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)) and HEADACHE (Headache (After Second Dose)) in a 61-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.     The patient's past medical history included BP.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (A little Sick for one day (After First Shot)). On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)), FATIGUE (Fatigue (After Second Dose)), DIARRHOEA (Diarrhea) and DIARRHOEA (Diarrhea (After Second Dose)). On an unknown date, the patient experienced HEADACHE (Headache (After Second Dose)). On 31-Mar-2021, PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIARRHOEA (Diarrhea) and DIARRHOEA (Diarrhea (After Second Dose)) outcome was unknown. At the time of the report, ILLNESS (A little Sick for one day (After First Shot)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)), HEADACHE (Headache (After Second Dose)) and FATIGUE (Fatigue (After Second Dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Pruritus, Rash
Clinical narrative: Redness/erythema; itching/pruritus; swelling of left lymph node; still some swelling on the arm; welt around the injection site; rash spread to the front and back of her whole upper arm/bullseye type of rash.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt around the injection site), PERIPHERAL SWELLING (still some swelling on the arm), ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced URTICARIA (welt around the injection site) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.). On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (still some swelling on the arm). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and LYMPHADENOPATHY (swelling of left lymph node). On 19-Mar-2021, URTICARIA (welt around the injection site) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.) had resolved. At the time of the report, PERIPHERAL SWELLING (still some swelling on the arm) had not resolved and ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and LYMPHADENOPATHY (swelling of left lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment medication included a steroid cream for rash.  Follow-up received on 04-AUG-2021 included no new information   This case was linked to MOD-2021-276028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non Significant information. The patient was assuming that she will need a booster as she had underlying conditions. On 04-Aug-2021: Follow-up received contains non- significant information
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Redness/erythema; itching/pruritus; swelling of left lymph node; still some swelling on the arm; welt around the injection site; rash spread to the front and back of her whole upper arm/bullseye type of rash.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt around the injection site), PERIPHERAL SWELLING (still some swelling on the arm), ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced URTICARIA (welt around the injection site) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.). On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (still some swelling on the arm). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and LYMPHADENOPATHY (swelling of left lymph node). On 19-Mar-2021, URTICARIA (welt around the injection site) and RASH (rash spread to the front and back of her whole upper arm/bullseye type of rash.) had resolved. At the time of the report, PERIPHERAL SWELLING (still some swelling on the arm) had not resolved and ERYTHEMA (Redness/erythema), PRURITUS (itching/pruritus) and LYMPHADENOPATHY (swelling of left lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment medication included a steroid cream for rash.  Follow-up received on 04-AUG-2021 included no new information   This case was linked to MOD-2021-276028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non Significant information. The patient was assuming that she will need a booster as she had underlying conditions. On 04-Aug-2021: Follow-up received contains non- significant information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Constipation, Diarrhoea, Disorientation
Clinical narrative: dizzy, woozy; second dose really messed her over; face was slightly swollen; diarrhea; constipation; headache; chills; knees hurt; aches/muscle aches/pains; nausea; arm hurt/right arm felt as if she had gotten the shot in that side; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DISORIENTATION (disorientation) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side). On 02-Apr-2021, the patient experienced DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BEN GAY) at an unspecified dose and frequency and CAFFEINE, ETHENZAMIDE, PHENAZONE (HEADACHE POWDER) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains), NAUSEA (nausea) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: dizzy, woozy; second dose really messed her over; face was slightly swollen; diarrhea; constipation; headache; chills; knees hurt; aches/muscle aches/pains; nausea; arm hurt/right arm felt as if she had gotten the shot in that side; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DISORIENTATION (disorientation) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side). On 02-Apr-2021, the patient experienced DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BEN GAY) at an unspecified dose and frequency and CAFFEINE, ETHENZAMIDE, PHENAZONE (HEADACHE POWDER) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains), NAUSEA (nausea) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site pain
Clinical narrative: dizzy, woozy; second dose really messed her over; face was slightly swollen; diarrhea; constipation; headache; chills; knees hurt; aches/muscle aches/pains; nausea; arm hurt/right arm felt as if she had gotten the shot in that side; disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DISORIENTATION (disorientation) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side). On 02-Apr-2021, the patient experienced DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BEN GAY) at an unspecified dose and frequency and CAFFEINE, ETHENZAMIDE, PHENAZONE (HEADACHE POWDER) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (disorientation), DIZZINESS (dizzy, woozy), FEELING ABNORMAL (second dose really messed her over), SWELLING FACE (face was slightly swollen), DIARRHOEA (diarrhea), CONSTIPATION (constipation), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (knees hurt), MYALGIA (aches/muscle aches/pains), NAUSEA (nausea) and VACCINATION SITE PAIN (arm hurt/right arm felt as if she had gotten the shot in that side) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Peripheral swelling
Clinical narrative: Legs were swollen like water retention; Legs became increasingly sore throughout day; Get up and go to the bathroom like a racehorse; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs were swollen like water retention), PAIN IN EXTREMITY (Legs became increasingly sore throughout day), DIARRHOEA (Get up and go to the bathroom like a racehorse) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included Trigeminal neuralgia in May 2021. Previously administered products included for an unreported indication: Moderna COVID-19 Vaccine (nasal swab.) in October 2020. Concurrent medical conditions included Penicillin allergy. Concomitant products included LOSARTAN for Elevated blood pressure reading without diagnosis of hypertension.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (Legs were swollen like water retention), PAIN IN EXTREMITY (Legs became increasingly sore throughout day) and DIARRHOEA (Get up and go to the bathroom like a racehorse). The patient was treated with OXCARBAZEPINE (TRILEPTAL) ongoing from February 2013 for Pain, at a dose of UNK, qd. On 31-Mar-2021, PERIPHERAL SWELLING (Legs were swollen like water retention), PAIN IN EXTREMITY (Legs became increasingly sore throughout day) and DIARRHOEA (Get up and go to the bathroom like a racehorse) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Follow up received  patient demographic details , historical disease , concomitant medications, treatment medications, dose batch no  , dosage regimens are updated.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Vaccination site pain
Clinical narrative: Menstrual cramps; Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the left arm) and DYSMENORRHOEA (Menstrual cramps) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for an unknown indication.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the left arm) and DYSMENORRHOEA (Menstrual cramps). At the time of the report, PAIN IN EXTREMITY (Soreness of the left arm) and DYSMENORRHOEA (Menstrual cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Headache, Heart rate
Clinical narrative: dizziness; headache; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 02-Apr-2021 at a dose of 25 milligram. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 130/82 mmHg (High) Blood pressure Increased. On 02-Apr-2021, Heart rate: 72 (Inconclusive) 72 per minute. On 02-Apr-2021, Oxygen saturation: 97 (normal) 97 Percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: dizziness; headache; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 02-Apr-2021 at a dose of 25 milligram. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 130/82 mmHg (High) Blood pressure Increased. On 02-Apr-2021, Heart rate: 72 (Inconclusive) 72 per minute. On 02-Apr-2021, Oxygen saturation: 97 (normal) 97 Percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: mild localized reaction this many days later  in upper left arm close to injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (mild localized reaction this many days later  in upper left arm close to injection site) in a 55-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (mild localized reaction this many days later  in upper left arm close to injection site). At the time of the report, VACCINATION SITE REACTION (mild localized reaction this many days later  in upper left arm close to injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Pain, Pain in extremity, Teething
Clinical narrative: metallic taste; teeth were hurting; Felt like I had a been sting; sore arm; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste), TEETHING (teeth were hurting), PAIN (Felt like I had a been sting), PAIN IN EXTREMITY (sore arm) and HEADACHE (severe headache) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D/O31MZ0A and 0/Q25A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Lost taste and smell as ongoing side effects) in December 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (metallic taste), TEETHING (teeth were hurting), PAIN (Felt like I had a been sting), PAIN IN EXTREMITY (sore arm) and HEADACHE (severe headache). The patient was treated with DOXYCYCLINE HYCLATE at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Pain relief, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (metallic taste), TEETHING (teeth were hurting), PAIN (Felt like I had a been sting), PAIN IN EXTREMITY (sore arm) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Chest pain, Chills, Headache, Hypertension
Clinical narrative: flu like symptoms; Hypertension; sore arm; chest pain; Fever; Chills; Nausea; Worst headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERTENSION (Hypertension), PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product FOLIC ACID for an unknown indication.    Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), QUETIAPINE FUMARATE (SEROQUEL), RISPERIDONE (RESIDON), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), METOPROLOL TARTRATE (LOPRESSOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SENNA ACUTIFOLIA, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LEVOTHYROXINE SODIUM (SYNTHROID), TESTOSTERONE PROPIONATE (TESTOSTERONE [TESTOSTERONE PROPIONATE]), CLOPIDOGREL BISULFATE (PLAVIX), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and VITAMIN B2 [RIBOFLAVIN] for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started FOLIC ACID (unknown route) 1 mg. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERTENSION (Hypertension), PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Worst headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERTENSION (Hypertension), PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Worst headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 165/105 mmHg High.         Treatment details not provided Action taken with mRNA-1273 in response to the events was not applicable