chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Pain
Clinical narrative: Sore arm; chills; headache; fatigue; hot flushes; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue) and HOT FLUSH (hot flushes) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), HOT FLUSH (hot flushes) and PAIN (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), HOT FLUSH (hot flushes) and PAIN (body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non significant follow up received on 26-APR-2021, no new information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, chills and fatigue are consistent with the product safety profile.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; chills; headache; fatigue; hot flushes; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue) and HOT FLUSH (hot flushes) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), HOT FLUSH (hot flushes) and PAIN (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), HOT FLUSH (hot flushes) and PAIN (body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non significant follow up received on 26-APR-2021, no new information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, chills and fatigue are consistent with the product safety profile.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Pins and Needles in the Joints; Muscle Pain; spine pain; hand pain; Chills; Fatigue; Shaking; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain), PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), SPINAL PAIN (spine pain) and PAIN IN EXTREMITY (hand pain) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain). On 17-Feb-2021, the patient experienced PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), PAIN IN EXTREMITY (hand pain), CHILLS (Chills) and FATIGUE (Fatigue). 17-Feb-2021, the patient experienced SPINAL PAIN (spine pain) and TREMOR (Shaking). At the time of the report, ARTHRALGIA (Joint Pain), PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), SPINAL PAIN (spine pain), PAIN IN EXTREMITY (hand pain), CHILLS (Chills), FATIGUE (Fatigue) and TREMOR (Shaking) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Arthralgia, myalgia, chills and fatigue are consistent with the product safety profile
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Spinal pain, Tremor
Clinical narrative: Pins and Needles in the Joints; Muscle Pain; spine pain; hand pain; Chills; Fatigue; Shaking; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain), PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), SPINAL PAIN (spine pain) and PAIN IN EXTREMITY (hand pain) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain). On 17-Feb-2021, the patient experienced PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), PAIN IN EXTREMITY (hand pain), CHILLS (Chills) and FATIGUE (Fatigue). 17-Feb-2021, the patient experienced SPINAL PAIN (spine pain) and TREMOR (Shaking). At the time of the report, ARTHRALGIA (Joint Pain), PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), SPINAL PAIN (spine pain), PAIN IN EXTREMITY (hand pain), CHILLS (Chills), FATIGUE (Fatigue) and TREMOR (Shaking) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Arthralgia, myalgia, chills and fatigue are consistent with the product safety profile
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: abdominal cramps again; diarrhea; vomiting; headaches; chills; nauseated; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nauseated, abdominal cramps, diarrhea, vomiting, headaches and chills.  The patient's medical history, consumer included osteoarthritis. No relevant concomitant medications were reported.   On 16 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced nauseated and abdominal cramps that subsided. On 18 Feb 2021, the patient experienced abdominal cramps again, diarrhea, vomiting, headaches and chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events nauseated, abdominal cramps, diarrhea, vomiting, headaches and chills was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: abdominal cramps again; diarrhea; vomiting; headaches; chills; nauseated; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nauseated, abdominal cramps, diarrhea, vomiting, headaches and chills.  The patient's medical history, consumer included osteoarthritis. No relevant concomitant medications were reported.   On 16 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced nauseated and abdominal cramps that subsided. On 18 Feb 2021, the patient experienced abdominal cramps again, diarrhea, vomiting, headaches and chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events nauseated, abdominal cramps, diarrhea, vomiting, headaches and chills was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04IL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 4 - 5 hours. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product safety profile
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red warm spot around the injection site; Red warm spot around the injection site; Injection site a little itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Red warm spot around the injection site), VACCINATION SITE PRURITUS (Injection site a little itchy) and VACCINATION SITE ERYTHEMA (Red warm spot around the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site a little itchy). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red warm spot around the injection site) and VACCINATION SITE ERYTHEMA (Red warm spot around the injection site). At the time of the report, VACCINATION SITE WARMTH (Red warm spot around the injection site), VACCINATION SITE PRURITUS (Injection site a little itchy) and VACCINATION SITE ERYTHEMA (Red warm spot around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications included- Vitamins. No treatment reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm is red around injection site; Puffy around injection site; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm is red around injection site), VACCINATION SITE SWELLING (Puffy around injection site) and VACCINATION SITE PAIN (Pain at injection) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm is red around injection site), VACCINATION SITE SWELLING (Puffy around injection site) and VACCINATION SITE PAIN (Pain at injection). At the time of the report, VACCINATION SITE ERYTHEMA (Arm is red around injection site), VACCINATION SITE SWELLING (Puffy around injection site) and VACCINATION SITE PAIN (Pain at injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: very weak; loss of taste; almost fainted if I didn't lay down; out of breath from just walking around; bowel movement  are loose; started having nausea again; Experince a fever of 103.4F; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around) and DIARRHOEA (bowel movement  are loose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDRODIURIL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (Experince a fever of 103.4F) and NAUSEA (nausea). On 16-Feb-2021, the patient experienced ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around), DIARRHOEA (bowel movement  are loose) and NAUSEA (started having nausea again). On 08-Feb-2021, PYREXIA (Experince a fever of 103.4F) and NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around), DIARRHOEA (bowel movement  are loose) and NAUSEA (started having nausea again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Pyrexia (97-99): increased (High) 103.4F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: very weak; loss of taste; almost fainted if I didn't lay down; out of breath from just walking around; bowel movement  are loose; started having nausea again; Experince a fever of 103.4F; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around) and DIARRHOEA (bowel movement  are loose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDRODIURIL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (Experince a fever of 103.4F) and NAUSEA (nausea). On 16-Feb-2021, the patient experienced ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around), DIARRHOEA (bowel movement  are loose) and NAUSEA (started having nausea again). On 08-Feb-2021, PYREXIA (Experince a fever of 103.4F) and NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (very weak), AGEUSIA (loss of taste), PRESYNCOPE (almost fainted if I didn't lay down), DYSPNOEA (out of breath from just walking around), DIARRHOEA (bowel movement  are loose) and NAUSEA (started having nausea again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Pyrexia (97-99): increased (High) 103.4F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: chills; fever; body aches; really bad nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), NAUSEA (really bad nausea), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid activity decreased.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (body aches), NAUSEA (really bad nausea) and HEADACHE (headache). On 16-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PAIN (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, NAUSEA (really bad nausea) had not resolved.            No concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea, headaches, chills and fever are consistent with the product safety profile
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash macular, Vaccination site reaction
Clinical narrative: Red blotchiness; COVID arm; A mild temperature; Mild chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotchiness), VACCINATION SITE REACTION (COVID arm), PYREXIA (A mild temperature) and CHILLS (Mild chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (A mild temperature) and CHILLS (Mild chills). On 16-Feb-2021, the patient experienced RASH MACULAR (Red blotchiness) and VACCINATION SITE REACTION (COVID arm). At the time of the report, RASH MACULAR (Red blotchiness), VACCINATION SITE REACTION (COVID arm), PYREXIA (A mild temperature) and CHILLS (Mild chills) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Itch/severe pruritus; Hardness in arm; Redness/arm redness; Rash; arm  swelling; Nausea; Sick and tired/Fatigue; Pain in left arm/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/arm soreness), ILLNESS (Sick and tired/Fatigue), INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm) and INJECTION SITE ERYTHEMA (Redness/arm redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypertension since 2007, Cholesterosis since 2007 and Acid reflux (oesophageal) since 2008. Concomitant products included LISINOPRIL from 2007 to an unknown date for Blood pressure high, ATORVASTATIN from 2011 to an unknown date for High cholesterol, AMLODIPINE from 2011 to an unknown date for Hypertension, OMEPRAZOLE from 2018 to an unknown date for Reflux esophagitis.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm/arm soreness). On 19-Jan-2021, the patient experienced ILLNESS (Sick and tired/Fatigue) and HEADACHE (Nausea). On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm), INJECTION SITE ERYTHEMA (Redness/arm redness), INJECTION SITE RASH (Rash) and INJECTION SITE SWELLING (arm  swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 19-Jan-2021, PAIN IN EXTREMITY (Pain in left arm/arm soreness) had resolved. On 20-Jan-2021, ILLNESS (Sick and tired/Fatigue) had resolved. On 08-Feb-2021, INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm) and INJECTION SITE RASH (Rash) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness/arm redness) and INJECTION SITE SWELLING (arm  swelling) had not resolved and HEADACHE (Nausea) had resolved.            This case was linked to MOD-2021-052523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Updated patient demographics, Medical history, added concomitant and treatment medicines, added new events Injection site swelling, Headache, updated outcome of the event injection site erythema, pain in extremity from Recovered to Not Recovered; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Itch/severe pruritus; Hardness in arm; Redness/arm redness; Rash; arm  swelling; Nausea; Sick and tired/Fatigue; Pain in left arm/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/arm soreness), ILLNESS (Sick and tired/Fatigue), INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm) and INJECTION SITE ERYTHEMA (Redness/arm redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypertension since 2007, Cholesterosis since 2007 and Acid reflux (oesophageal) since 2008. Concomitant products included LISINOPRIL from 2007 to an unknown date for Blood pressure high, ATORVASTATIN from 2011 to an unknown date for High cholesterol, AMLODIPINE from 2011 to an unknown date for Hypertension, OMEPRAZOLE from 2018 to an unknown date for Reflux esophagitis.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm/arm soreness). On 19-Jan-2021, the patient experienced ILLNESS (Sick and tired/Fatigue) and HEADACHE (Nausea). On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm), INJECTION SITE ERYTHEMA (Redness/arm redness), INJECTION SITE RASH (Rash) and INJECTION SITE SWELLING (arm  swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 19-Jan-2021, PAIN IN EXTREMITY (Pain in left arm/arm soreness) had resolved. On 20-Jan-2021, ILLNESS (Sick and tired/Fatigue) had resolved. On 08-Feb-2021, INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm) and INJECTION SITE RASH (Rash) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness/arm redness) and INJECTION SITE SWELLING (arm  swelling) had not resolved and HEADACHE (Nausea) had resolved.            This case was linked to MOD-2021-052523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Updated patient demographics, Medical history, added concomitant and treatment medicines, added new events Injection site swelling, Headache, updated outcome of the event injection site erythema, pain in extremity from Recovered to Not Recovered; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 12-Feb-2021, VACCINATION SITE PAIN (Sore arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Vaccination site pain is consistent with the product safety profile.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: pain on both their legs and their back; pain on both their legs and their back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain on both their legs and their back) and PAIN IN EXTREMITY (pain on both their legs and their back) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced BACK PAIN (pain on both their legs and their back) and PAIN IN EXTREMITY (pain on both their legs and their back). At the time of the report, BACK PAIN (pain on both their legs and their back) and PAIN IN EXTREMITY (pain on both their legs and their back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge, Vaccination site haemorrhage
Clinical narrative: Bubble of blood at injection site; Yellow crystalline precipitate (potentially be vaccine, did not receive full dose); A regulatory authority report was received from a consumer concerning a 69-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced bubble of blood at injection site and yellow crystalline precipitate.  There were no medical history and concomitant medications reported.  On an unreported date, the patient experienced COVID-19 with a positive COVID-19 test. No symptoms were reported. On 18 Feb 2021, approximately 1 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced bubble of blood at injection site, yellow crystalline precipitate. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, bubble of blood at injection site, yellow crystalline precipitate (Vaccination site discharge) was considered as resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: Weakness; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and MYALGIA (Body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood sugar abnormal (Blood sugar disorder).    On 06-Feb-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 ASTHENIA (Weakness) and MYALGIA (Body aches). At the time of the report, ASTHENIA (Weakness) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was reported..   This case was linked to MOD-2021-096674, MOD-2021-096674 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains significant information. The event outcome was updated from Unknown to recovered/resolved.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmness; Severe itchiness; Soreness of the injection arm; Swelling; Redness of one to one and half inches in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PRURITUS (Severe itchiness), VACCINATION SITE PAIN (Soreness of the injection arm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness of one to one and half inches in size) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PRURITUS (Severe itchiness), VACCINATION SITE PAIN (Soreness of the injection arm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness of one to one and half inches in size). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 18-Feb-2021, VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PRURITUS (Severe itchiness), VACCINATION SITE PAIN (Soreness of the injection arm) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness of one to one and half inches in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-036518 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Vaccination site pain, vaccination site erythema, vaccination site pruritus and vaccination site swelling are consistent with the product safety profile.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: injection site itchy; injection site red; injection site rash; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE RASH (injection site rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, FUROSEMIDE, ALLOPURINOL, LEVOTHYROXINE, POTASSIUM, FAMOTIDINE, CLOPIDOGREL, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and LABETALOL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE RASH (injection site rash). At the time of the report, INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site pain, injection site erythema and injection site pruritus are consistent with the product safety profile.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches early this morning; Patient stated he is experiencing fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches early this morning) and PYREXIA (Patient stated he is experiencing fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (Aches early this morning) and PYREXIA (Patient stated he is experiencing fever). At the time of the report, PAIN (Aches early this morning) and PYREXIA (Patient stated he is experiencing fever) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dyspnoea, Hot flush, Malaise
Clinical narrative: Feels unsteady on her feet; Feels nauseas; Body got really hot; Very weak; Felt sick; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick), DYSPNOEA (Short of breath) and BALANCE DISORDER (Feels unsteady on her feet) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Blood pressure high, Asthma and High cholesterol. Concomitant products included LISINOPRIL, MONTELUKAST, PANTOPRAZOLE and RIVAROXABAN (XARELTO) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick) and DYSPNOEA (Short of breath). On 18-Feb-2021, the patient experienced BALANCE DISORDER (Feels unsteady on her feet) and NAUSEA (Feels nauseas). At the time of the report, HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick), DYSPNOEA (Short of breath), BALANCE DISORDER (Feels unsteady on her feet) and NAUSEA (Feels nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the product safety profile.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Feels unsteady on her feet; Feels nauseas; Body got really hot; Very weak; Felt sick; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick), DYSPNOEA (Short of breath) and BALANCE DISORDER (Feels unsteady on her feet) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Blood pressure high, Asthma and High cholesterol. Concomitant products included LISINOPRIL, MONTELUKAST, PANTOPRAZOLE and RIVAROXABAN (XARELTO) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick) and DYSPNOEA (Short of breath). On 18-Feb-2021, the patient experienced BALANCE DISORDER (Feels unsteady on her feet) and NAUSEA (Feels nauseas). At the time of the report, HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick), DYSPNOEA (Short of breath), BALANCE DISORDER (Feels unsteady on her feet) and NAUSEA (Feels nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the product safety profile.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy all over her body; a little bit of hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy all over her body) and URTICARIA (a little bit of hives) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013MZ0A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) 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 06-Feb-2021, the patient experienced PRURITUS (itchy all over her body) and URTICARIA (a little bit of hives). At the time of the report, PRURITUS (itchy all over her body) and URTICARIA (a little bit of hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment was provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: slight sore arm; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (slight sore arm) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Full term birth) on 11-Oct-2018. Concurrent medical conditions included Pregnancy (Due date-04jun-2021) on 20-Jul-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Jun-2021. On 16-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (slight sore arm). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (slight sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10-Nov-2018, the patient had a previous pregnancy ended in live, full-term birth.  No treatment was provided for the adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Upon internal review on 22-july-2021 resulted in pregnancy updates.; Sender's Comments: This case concerns a 34-Year-old female with missing obstetric history who received mRNA-1273 while pregnant (vaccine exposure during pregnancy)  and experienced sore arm. The patient's estimated due date was 04-Jun-2021. the event of sore arm is temporarily associated between with the product use and causal relationship cannot be excluded. Vaccine exposure during pregnancy is assessed as not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: sore arm, extremely painful arm; chest felt tight; belching; light headed; finding hard to stand up; hard to breath; feeling weak; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, extremely painful arm), CHEST DISCOMFORT (chest felt tight), ERUCTATION (belching), DIZZINESS (light headed) and DYSSTASIA (finding hard to stand up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included BENZTROPINE [BENZATROPINE], ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D NOS for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm, extremely painful arm), ERUCTATION (belching), DIZZINESS (light headed), DYSSTASIA (finding hard to stand up) and HEADACHE (headache). 18-Feb-2021, the patient experienced CHEST DISCOMFORT (chest felt tight), DYSPNOEA (hard to breath) and ASTHENIA (feeling weak). On 18-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm, extremely painful arm), CHEST DISCOMFORT (chest felt tight), ERUCTATION (belching), DIZZINESS (light headed), DYSSTASIA (finding hard to stand up), DYSPNOEA (hard to breath) and ASTHENIA (feeling weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking concomitant medication for her mental condition and blood thinner.  Treatment medication was not reported.  Patient got their first dose of the Moderna vaccine on 16 Feb 2021, on their right arm and had a sore arm at first. Woke up around 5am with an extremely painful arm, their chest felt tight, they were belching and had a headache. the went back to bed and then woke up at 7:30am, feeling light headed, hard to breath, and still with a headache that has now subsided. Now patient is still belching and feeling weak, finding hard to stand up. Patient did not have lot number at hand.